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CP, we're not running Bavi+Doc/Pac Her2- Ph2 again – the new Dec'15-initiated n=150 Ph.2 trial comes AFTER the Ph.1 n=13 ArizCC/Dr.Stopeck IST which completed enrollment 4-2013 – that Ph.1 IST yielded very promising ORR=85% & 2 CR's...
You said, “I do not understand why we are doing a Breast PII Docetaxel+Paclitaxel AGAIN, we did that and with great results.” <=Not AGAIN, just logically MOVING FORWARD this indication/regimen into Ph2/3 due to excellent Ph.1 results…
12-10-15 VP/Clin+Reg Joe Shan Conf-Call: http://tinyurl.com/jkp885g
Now, beyond lung cancer, we plan to initiate addl. clinical trials in breast cancer based on our clinical experience to-date. Data from a Phase I IST of bavituximab+paclitaxel published in Cancer Medicine earlier this year [3-31-15/A.Stopeck, N=13: PFS=7.3mos, ORR=85%, 2 CR's http://tinyurl.com/nm5oog4 ] demonstrated an impressive 85% response rate of patients with HER2- metastatic breast cancer. Data from this IST, together with 2 prior Peregrine-sponsored trials of bavituximab with taxane-based chemotherapy, which yielded between 61-74% response rates and a MOS of over 20mos. in patients with advanced or metastatic breast cancer, provides strong rationale to advance this indication. Importantly, taxanes continue to be a key std. treatment option for different stages of breast cancer. Accordingly, we plan to initiate a Phase II/III trial in patients with HER2- metastatic breast cancer, with all patients receiving physicians’ choice of paclitaxel or docetaxel, either alone or in combination with bavituximab. The Phase II part of the trial will enroll approx. 150 patients with a primary end point from ORR. The first sites in this Phase II/III breast cancer trial are scheduled to be initiated before the end of the year. Furthermore, we're planning a trial evaluating neoadjuvant paclitaxel with or without bavituximab, in the hopes of further elucidating bavituximab’s immune modulating mechanism and look for clinical signals in early stage breast cancer.”
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J. 2nd IST Trial (Bavi+Paclitaxel vs. Her2- Met. Breast Cancer, open-label Ph.1, n=14)
Protocol: http://clinicaltrials.gov/ct2/show/NCT01288261
...3-31-15/A.Stopeck article(Ph1 data) “Cancer-Medicine” N=13: PFS=7.3mos, ORR=85%, 2 CR's http://tinyurl.com/nm5oog4
…6-3-13: ASCO’13/interim data, n=14: ORR=85%, 2 CR’s (15%) http://tinyurl.com/kq3uv4e
...4-29-13: Enrollment complete. http://tinyurl.com/cqrup9e
...4-3-12 AACR'12: "5pts. to-date, 2 CR's, 1 PR" http://tinyurl.com/7yrwqm7 (see #4404)
...1-19-11: IST (Her2- MBC) initiated at Arizona CC (PI=A.Stopeck), ~14 patients - http://tinyurl.com/5t7zomn
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P. Phase II/III Bavi+Paclitaxel-or-Docetaxel(Dr’sChoice), Her2- Breast Cancer, Randomized, Ph2/n=150, U.S.+Eur)
Protocol: http://clinicaltrials.gov/ct2/show/NCT02651610 (USA & Eur.)
...12-2015: Ph.2 Her2- MBC Trial Initiated http://tinyurl.com/zhdy37a
1-11-16/PR: ”The Phase II portion of the study will enroll approximately 150 patients at sites in the U.S. & Europe.
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Website Pipeline Chart updated 1-23-16
http://www.peregrineinc.com/pipeline/overview.html
No error; the Her2-/MBC is in 2parts: Ph2-then-Ph3. We're in the Ph.2 part now, ~150pts, randomized, USA+EUR. Ph3 to follow Ph2...
P. Phase II/III Bavi+Paclitaxel-or-Docetaxel(Dr’sChoice), Her2- Breast Cancer, Randomized, Ph2/n=150, U.S.+Eur)
Protocol: http://clinicaltrials.gov/ct2/show/NCT02651610 (USA & Eur.)
...12-2015: Ph.2 Her2- MBC Trial Initiated http://tinyurl.com/zhdy37a
1-11-16/PR: "The Phase II portion of the study will enroll approximately 150 patients at sites in the U.S. & Europe.
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Website Pipeline Chart updated 1-23-16
http://www.peregrineinc.com/pipeline/overview.html
Website Pipeline Chart updated 1-24-16
http://www.peregrineinc.com/pipeline/overview.html
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1-16-16: Summary of Peregrine's New Collab's: Mem.Sloan-Kettering, AstraZeneca, NCCN – see: http://tinyurl.com/zkvebh6
I. Memorial Sloan Kettering (MSKCC) – 5-2015/Investigate Novel PS-Targeting Immunotherapy Combos
II. AstraZeneca (Bavi+Durvalumab) - 8-2015/multiple solid tumors, 10-2015/expanded to NSCLC
III. Natl-Comprehensive-Cancer-Network (NCCN) – 1-2016/$2mm grant to NCCN's Oncology Res. Pgm (ORP), “26 of the world's leading cancer centers”
...??Cancer Moonshot 2020 http://www.cancermoonshot2020.org – see S.King's 1-14-16 EP-Vantage comments: http://tinyurl.com/z59pc6a
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1-11-16/PR: Update on 4 New Bavi Clinical Trials (Lung/AZN, Breast/1Co./1MSKCC, Other Cancers/AZN). SUNRISE estimates: Interim1=Early'16, Interim2=Mid'16, FinalUnblinding=End'16… http://tinyurl.com/zhdy37a
1-6-16: Peregrine enters into Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN) http://tinyurl.com/zmxtpsb
...$2mm res. grant to NCCN's Oncology Res. Pgm (ORP), will “significantly expand our clinical evaluation of Bavi and augment Peregrine's IST pgm at 26 of the world's leading cancer centers”.
12-10-15 Qtly. Conf. Call (King/Shan/Worsley/Garnick/Lytle) Transcript http://tinyurl.com/jkp885g
...CEO SK: “Although our SUNRISE enrollment milestone has been reached, we have no intention of slowing down, quite the opposite. We are aggressively moving to initiate new clinical trials [Lung, Breast, Mult-Types] that will allow us to build the most robust oncology business possible… With each of these studies our goal is the same - we are committed to identifying key indications, patient populations, and therapeutics that can benefit from combination treatment with bavituximab. From what we have seen to-date, the opportunity appears vast and we are hard at work converting the most promising prospects into true value.”
10-15-15 Peregrine's ASM: ATTENDEE Reports & Link to SK's 18min/16slide webcast: http://tinyurl.com/o6z4bm4
10-15-15: Peregrine & AstraZeneca Expand Collab. w/Ph2/2ndLine-NSCLC Trial, Bavi+durvalumab(MEDI4736), squamous or non-squamous. http://tinyurl.com/q79bkam
9-9-15 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/ph22vdn
...CEO S.King: “The Memorial Sloan Kettering & AstraZeneca collaborations are an important part of our announced plans to expand our bavituximab clinical pgm.”
8-24-15: AstraZeneca & Peregrine Collaborate on Bavi+Durvalumab Ph1/1B Trial for “multiple solid tumors” http://tinyurl.com/owlxpsf
...Durvalumab=MEDI4736(anti-PD-L1 immune checkpoint inhibitor). AZN’s Head/I-O(Robert Iannone): “Our partnership with Peregrine provides the opportunity to explore an exciting, novel combination that could deliver important clinical benefit to patients across a range of cancers."
7-14-15 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/nw2v5u6
...CEO S.King: ”We recently entered into collaboration with investigators at Memorial Sloan Kettering Cancer Ctr to continue expanding on this important work, as well as to explore other potential applications of bavituximab and other agents that target PS-signaling pathway.”
5-29-15: Peregrine & Sloan Kettering Enter Collab. to “Investigate Novel PS-Targeting Immunotherapy Combos” http://tinyurl.com/qxu4w2x explore other potential applications of bavituximab and other agents that target PS-signaling pathway.”
Jan25/Dr.Hutchins, Jan26/Dr.Freimark “Immunotherapy World” & ”Combinatorial Immunotherapies”
1-20-16/PR: PEREGRINE PHARMACEUTICALS TO PRESENT AT TWO UPCOMING CANCER IMMUNOTHERAPY CONFERENCES http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=950909
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PPHM's Jeff Hutchins(VP/PreClinRes) speaking 1-25-16 at Immunotherapy World Conf. (WashDC). “750 deal-makers will gather to discuss the direction, future and value of cell, gene and immunotherapy portfolios.”
Jan25-27 2016: “Phacilitate's Immunotherapy World Conf.”, WashDC
http://www.immunotherapyforum.com/Content/Conference
“After years of posting impressive clinical results and pushing analyst projections to greater and greater heights, immuno-oncology has solidified its status as the most exciting development in cancer treatment for a long time. Now that checkpoint inhibitors have uncloaked cancer cells, drug developers are investigating dozens of immune drug cocktails (everything from CAR-T to antibodies, vaccines and other cellular therapies) to find well-tolerated treatments which could become the first-in-line to fight cancer in patients. We have all heard of the stunning breakthroughs at ASCO'15. BMS’ Opdivo + Yervoy study which lead to a 58% shrinkage of tumors and a PFS superiority of 8.6mos. against monotherapies in patients with melanoma. AstraZeneca’s own PD-L1 (MEDI4736/durvalumab) [see 10-15-15 AZN/PPHM Collab. Expansion: http://tinyurl.com/q79bkam ] and CTLA-4 (Tremelimumab) inhibitor combination, which demonstrated an ORR of 27% in the treatment of NSCLC… On Jan25-27 2016, 750 deal-makers will gather in the Grand Hyatt Hotel to discuss the direction, future and value of cell, gene and immunotherapy portfolios.”
1-24-16 Agenda Update due to storm – everything moved back ~30mins: http://www.immunotherapyforum.com/files/new_immunotherapy_agenda.pdf
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Jan25(Day1): Focus Session1, “Cellular Cancer Immunotherapy: Optimizing Combination Therapy Development Strategy”
3:15pm: Chair's intro, David Lebwohl, NOVARTIS
3:20: Michael Hanna, VACCINOGEN, “The Provocative Issues of Tumor Heterogeneity on Active Specific Immunotherapy...”
3:35: Laura Benjamin, ELI LILLY, “Challenges/Opportunities for Translational Science to Guide Angiogenesis/Combos w/Immunotherapy”
3:50: Taylor Schreiber, HEAT BIOLOGICS, “Dual-Acting Immunotherapy with ComPACT - Vaccination & Co-Stimulation...”
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1-25-16 4:05-4:20pm: Jeff T. Hutchins (PEREGRINE'S VP/PreClinRes), “Combination Immunotherapies - Opening the Gate: Increasing Tumor Infiltrating Activated T-cells to Optimize and Expand the Benefits of Immune Checkpoint Therapies”
* Analyzing complimentary mechanisms in therapeutics and building solid partnerships
* Utilizing scientifically-driven data to build a product value story
* Demonstrating how a product fits within a treatment in combination(s) and against competitive therapies
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4:20pm: Robert Preti, PCT(CALADRIUS), “What Does Commercialization Look Like?”
- - - - - - - - - - - - - - - -From PPHM's 1-20-16 PR: http://tinyurl.com/z65avfw
“In his talk, Dr. Hutchins will discuss strategies for expanding the therapeutic benefit seen with immuno-oncology monotherapies to a broader range of patients using combination treatment approaches. Specifically, he will highlight the strategy of leveraging treatments capable of increasing the number & activity of T-cells in the tumor microenvironment to optimize the therapeutic benefit of immune checkpoint inhibitors such as anti-PD-1/anti-PDL-1 agents. Dr. Hutchins will draw on the company's experience in working with preclinical equivalents of bavituximab, Peregrine's lead investigational phosphatidylserine (PS)-targeting immunotherapy candidate. PS-targeting antibodies have been shown to shift the immunosuppressive functions of immune cells in tumors, resulting in anti-tumor immune responses. Peregrine has generated results from multiple preclinical & clinical-translational studies demonstrating enhanced anti-tumor activity and immune activation when combining equivalent PS-targeting antibodies with conventional chemotherapy or checkpoint inhibitors such as anti-PD-1 agents.”
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Bruce Freimark (Dir/PreClin-Oncology) speaking 1-26-16 at GTCbio's Novel-Immunotherapeutics-Summit, SanDiego
Jan25-26 2016: “GTCbio's Novel Immunotherapeutics Summit”, San Diego
https://www.gtcbio.com/conferences/immunotherapeutics-summit-overview
GTC = Global Technology Community https://www.gtcbio.com/about-us
4 Sub-Conferences, including: 8TH IMMUNOTHERAPEUTICS & IMMUNOMONITORING
1-26-15: SESSION: ”Combinatorial Immunotherapies” - Moderator: Bruce Freimark, Peregrine Pharm.
4 Speakers:
*9:35am “DNA Vaccines with T-Cell Checkpoint Blockade”, Douglas McNeel, UNIV./WISCONSIN
*10:00am “Blockade of Phosphatidylserine Enhances the Anti-Tumor Activity of Targeted Therapy & Immune Checkpoint Inhibitors by Reducing Immunosuppressive Cells in the Tumor Microenvironment”, Bruce Freimark (Res.Dir./Preclin.Oncology), PEREGRINE PHARMACEUTICALS
Abstract: The underlying cause for the failure of immune checkpoint blockade is persistent, multifocal immune suppression in the tumor microenvironment. This is due to the absence of pre-existing antitumor Teff because of the action of immune checkpoints that induce immunosuppressive cytokines and recruit tumor infiltrating myeloid-derived suppressor cells (MDSCs), regulatory T cells (Treg), and M2 macrophages. Phosphatidylserine (PS) is segregated to the inner leaflet of the plasma membrane but becomes externalized to the outer leaflet in tumor cells where it contributes as an upstream checkpoint inhibitor to an immunosuppressive environment. Antibody blockade of PS reprograms the immune cells in the tumor microenvironment to support immune activation. Antibody-mediated PS blockade reduces the levels of MDSCs, TGF-beta, and IL-10 and increases the levels of TNF-alpha and IL-12. PS blockade also re-polarizes tumor-associated M2 macrophages to a M1 phenotype which promotes the maturation of dendritic cells and induces of adaptive T-cell responses. PS targeting antibodies enhance the anti-tumor activity of anti-CTLA-4 and anti-PD-1 antibodies in models of melanoma and breast cancer and correlates with an increase in the infiltration of activated T cells and the induction of adaptive immunity. In summary, PS blockade in combination with targeted therapy and other immune checkpoint inhibitors promotes a localized, anti-tumor response and represents a promising strategy to enhance cancer immunotherapy.
*10:25am “Cancer Vaccines in the Era of Checkpoint Blockade”, Willem Overwijk, MD.ANDERSON
*11:20am “Myeloid-Derived IL-10 & PD-1 Create a Vicious Immune...”, Keith Knutson, MAYO CLINIC
- - - - - - - - - - - - - - - -From PPHM's 1-20-16 PR: http://tinyurl.com/z65avfw
“Dr. Freimark will highlight data showing that blocking PS signaling in combination with immune checkpoint inhibitors promotes a localized, anti-tumor response. He will share research findings demonstrating that PS-targeting antibodies enhance the anti-tumor activity of anti-CTLA-4 & anti-PD-1 antibodies in models of melanoma & breast cancer and correlate with an increase in the infiltration of activated T-cells and the induction of adaptive immunity. Both [Dr.Hutchins/1-25-16 & Dr.Freimank/1-26-16] presentations will also highlight key recent research findings showing that PS-signaling pathway inhibitors demonstrate multiple signs of immune activation in low or negative PD-L1 tumors. This suggests that PS-targeting antibodies have the potential to show a clinical benefit in patients with low PD-L1 levels and who do not generally benefit from checkpoint treatment alone. The potential for bavituximab to improve the clinical outcome of checkpoint inhibitors will be evaluated as part of Peregrine's ongoing clinical research collaboration with AstraZeneca. To this end, a global Phase II study of bavituximab in combination with AstraZeneca's durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with previously treated squamous or non-squamous NSCLC is expected to begin during Q1/2016.”
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Jan26-28 2016: “20th Symposium on the Interface of Regulatory & Analytical Sciences for Biotechnology Health Products”, WashDC
http://www.casss.org/?WCBP1600
CASSS = Calif. Separation Science Society (“the detailed study & controlled separation of mixtures - also referred to as “chromatography”. Major advances in separation science have enabled biologists, chemists, pharmacists and environmentalists to make breakthroughs of their own. Genomics, drug discovery, DNA fingerprinting, and ultra-trace residue analysis, for instance, would not be possible without recourse to the findings generated by separation science.
Visit Avid at table #20.
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I. Memorial Sloan Kettering (MSKCC) – 5-2015/Investigate Novel PS-Targeting Immunotherapy Combos
II. AstraZeneca (Bavi+Durvalumab) - 8-2015/multiple solid tumors, 10-2015/expanded to NSCLC
III. Natl-Comprehensive-Cancer-Network (NCCN) – 1-2016/$2mm grant to NCCN's Oncology Res. Pgm (ORP), “26 of the world's leading cancer centers”
...??Cancer Moonshot 2020 http://www.cancermoonshot2020.org – see S.King's 1-14-16 EP-Vantage comments: http://tinyurl.com/z59pc6a
I do believe Dr. Raymond Birge is ALL-IN! Great find, Biopharm on Dr. Birge's Youtube statement (SEE BELOW) that perfect parallels Bavi's MOA… More later – gotta run...
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Rutgers' Dr. Raymond Birge, “PS: a Global Immunosuppressive Signal...”. Spoke at Peregrine's 11-2015 “Sci. Session” at SITC'15/Maryland; will be the chair in June'16 of the ICDS'16/Ireland session where Dr. Rolf Brekken (PPHM SAB) is speaking; and now also speaking in late June'16 at ICHC'16/Istanbul on, “Phosphatidylserine is a Global Immunosuppressive Signal in Cell Death & Cancer”… (Rutgers Univ. http://birgelab.org “The Birge laboratory conducts basic science focussed on the eradication of cancer.”)
June19-22 2016: “15th Intl. Congress of Histochemistry & Cytochemistry - from Molecules to Diseases”, Istanbul Turkey
“The main goal of ICHC 2016 is to bring the worldwide histochemists together and provide an environment for close cooperation, exchange of information, and collaborations.”
http://www.ichc2016.com
INVITED SPEAKER – Session: “Cellular Aging & Cell Death”
Dr. Raymond Birge (Rutgers Univ. http://birgelab.org ), “Phosphatidylserine is a Global Immunosuppressive Signal in Cell Death & Cancer”
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3-1-14/Youtube: “Cancer Research” - Raymond Birge Laboratory, Rutgers http://birgelab.org
Rutgers' Dr. Raymond Birge, “PS: a Global Immunosuppressive Signal...”. Spoke at Peregrine's 11-2015 “Sci. Session” at SITC'15/Maryland; will be the chair in June'16 of the ICDS'16 session where Dr. Rolf Brekken (PPHM SAB) is speaking; and now also speaking in late June'16 at ICHC'16/Istanbul on, “Phosphatidylserine is a Global Immunosuppressive Signal in Cell Death & Cancer”… (Rutgers Univ. http://birgelab.org “The Birge laboratory conducts basic science focussed on the eradication of cancer.”)
June19-22 2016: “15th Intl. Congress of Histochemistry & Cytochemistry - from Molecules to Diseases”, Istanbul Turkey
“The main goal of ICHC 2016 is to bring the worldwide histochemists together and provide an environment for close cooperation, exchange of information, and collaborations.”
http://www.ichc2016.com
INVITED SPEAKER – Session: “Cellular Aging & Cell Death”
Dr. Raymond Birge (Rutgers Univ. http://birgelab.org ), “Phosphatidylserine is a Global Immunosuppressive Signal in Cell Death & Cancer”
=======DR. RAY BIRGE (RUTGERS):
June2-4 2016: ICDS 2016: Translational Implications in Cell Death", Cork Ireland http://tinyurl.com/h2gvyld
...Dr. Rolf Brekken (USA, UTSE, PPHM SAB): “Blockade of PS & Immune Activation in Cancer” (Chair: Dr. Raymond Birge/Rutgers – see http://tinyurl.com/oks5uo6 )
Nov4-8 2015: “(SITC) Society for Immunotherapy of Cancer 30th Annual Meeting”, Natl-Harbor MD
”The premier destination for scientific exchange, education, and networking in the Cancer Immunotherapy Field”
SITC = The Society for Immunotherapy of Cancer http://www.sitcancer.org
SITC 2015 Meeting: http://www.sitcancer.org/2015
EXHIBITOR: Peregrine Pharm. - booth #121 (directly across from #120/ASCO & BMY/124; AstraZeneca/108 & DNA/113 are close by)
...Floorplan: http://www.eventscribe.com/2015/sitc/exhibitors/index.asp
...Join Peregrine for a Scientific Session - FRI Nov6 2015 7:30-9:00pm
“The PS Signaling Pathway: A Promising
Therapeutic Target Exploited by
Tumors for Immune Evasion”
PGM:
* Raymond Birge (PhD, Rutgers) http://birgelab.org
* Douglas Graham (MD, PhD, Emory) http://choa.org/Childrens-Hospital-Services/Cancer-and-Blood-Disorders/Meet-the-Team/Physicians-and-Researchers/Douglas-Graham
* Dmitry Gabrilovich (MD, PhD, Wistar Inst.) http://www.wistar.org/our-science/scientists/dmitry-gabrilovich-md-phd
* Rolf Brekken (PhD, UTSW/Dallas) http://www.utsouthwestern.edu/labs/brekken
* Maria Karasarides (PhD, AstraZeneca - Sr. Director, ImmunoOncology, Global Medicines Dev.) http://www.linkedin.com/pub/maria-karasarides-ph-d/6/769/136
...Brochure handout (not sure if exactly it): http://www.personalizedmedonc.com/article/phosphatidylserine-an-immune-modulating-checkpoint-ushers-in-the-next-wave-of-immuno-oncology-targets/
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SITC'15 Track: “Optimizing Combination Immunotherapy”
11-7-15/Sat./12:45-2:00pm
PPHM#1: Poster P357, “Targeting of Phosphatidylserine by Monoclonal Antibodies Augments the Activity of Paclitaxel & anti-pd1/pd-L1 Therapy in the Murine Breast Model E0771”
Presenting Author: Michael Gray, PhD (Sr.Scientist, Peregrine Pharmaceuticals)
Michael Gray 1, Jian Gong 1, Van Nguyen 1, Takuya Osada 2, Zachary Hartman 2, Jeff Hutchins 1, Bruce Freimark 1, Kim (Herbert K.) Lyerly, Duke Univ.** 2
...1=Peregrine Pharmaceuticals, Tustin CA
...2=Duke University, Durham, NC
**Dr. Herbert Kim Lyerly: http://surgery.duke.edu/faculty/details/0117267 (Professor of Surgery, Assistant Professor in Immunology, Associate Professor of Pathology, Duke Univ. MC)
The other 2 Duke co-author scientists:
* Dr. Takuya Osada (MD/PhD – Duke Cancer Inst. - Hematology, Oncology, Clinical Immunology http://www.researchgate.net/profile/Takuya_Osada2 )
* Dr. Zachary Hartman (PhD) – Duke MC, Section of Applied Therapeutics http://surgery.duke.edu/faculty/details/0281172 ”My group is also involved in strategies to modulate the immune response to tumors, which involves the use of novel immunotherapeutic strategies & dev. of vaccines to specific oncogenic targets.”
The upcoming Triple-/MBC Trial (MSKCC/Collab.) @ProvidenceCC = SUNRISE/Ph.3 Site too...
1-11-16 PR, “Peregrine Provides Update on Planned Expansion of Bavi Clinical Pgm in Lung, Breast and Other Cancers”… http://tinyurl.com/zhdy37a
PLANNED TRIALS...
#4. Phase II Trial in Early Stage TNBC in Combination with Chemotherapy
Peregrine is planning to initiate a Phase II trial of bavituximab in combination with neoadjuvant chemotherapy in early stage TNBC. The primary endpoint of this study is to determine the pathologic complete response rate (pCR), an accepted surrogate endpoint in early stage TNBC. The concept for this neoadjuvant setting trial, which will be conducted at a few select U.S. sites, originated from Peregrine's ongoing collaboration with Memorial Sloan Kettering Cancer Center (MSKCC). The company has filed a study protocol to its existing bavituximab IND application in the U.S. and is currently working to open clinical trial sites, including one that will be led by David B. Page, MD, at the Providence Cancer Center in Oregon [ http://oregon.providence.org/our-services/p/providence-cancer-center => http://oregon.providence.org/clinical-trials ].
...Note: ProvidenceCC is a Ph.3 SUNRISE site, PI=Rachel Sanborn MD, Dir./ThoracicONCO http://cancergrace.org/faculty/rachel-sanborn-md
Dr. Sanborn's Conflicts of interest: DNA, AZN
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Note DR. DAVID PAGE's prior work with Dr. Jedd Wolchok, chief of Mem.Sloan's Melanoma & Immunotherapeutics Service who “investigates novel approaches for cancer immunotherapy and mechanisms of tumor cell–immune cell interactions”… http://www.bcrfcure.org/researchers/david-page
5-29-15/PR re: MSKCC/Peregrine Collab… http://tinyurl.com/zkvebh6
"The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said Dr. Jedd Wolchok.
The studies at MSK will be performed under the direction of Taha Merghoub, PhD, [ http://www.mskcc.org/research-areas/labs/members/taha-merghoub-01 ] Associate Attending Biologist, Melanoma and Immunotherapeutics Service, Ludwig Collaborative and the Swim Across America Laboratory, a part of the laboratory of Jedd D. Wolchok, MD, PhD [ http://www.mskcc.org/research-areas/labs/jedd-wolchok ], a leader in the field of cancer immunotherapy. Dr. Wolchok serves as the Chief, Melanoma and Immunotherapeutics Service, Lloyd J. Old Chair for Clinical Investigation as well as an Associate Director of the Ludwig Center for Cancer Immunotherapy at MSK.
"The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said Dr. Jedd Wolchok.
"A key focus of the WOLCHOK LAB's research is studying novel immunotherapy combinations that work together to enable the immune system to recognize and destroy cancer. This collaboration will allow us to focus on the role and contribution of PS blockade therapy in determining which combination of the current and next generation of immune modulators is likely to increase the extent and amplitude of anti-tumor response. This important pre-clinical and translational work will potentially guide the design of the next generation of clinical studies with bavituximab," said Dr. Merghoub.
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1-16-16: Summary of Peregrine's New Collab's: Mem.Sloan-Kettering, AstraZeneca, NCCN http://tinyurl.com/zkvebh6
I. Memorial Sloan Kettering (MSKCC) – 5-2015/Investigate Novel PS-Targeting Immunotherapy Combos
II. AstraZeneca (Bavi+Durvalumab) - 8-2015/multiple solid tumors, 10-2015/expanded to NSCLC
III. Natl-Comprehensive-Cancer-Network (NCCN) – 1-2016/$2mm grant to NCCN's Oncology Res. Pgm (ORP), “26 of the world's leading cancer centers”
TRIPLE-NEGATIVE BREAST CANCER: ER- PR- HER2-
“Your pathology report may say that the breast cancer cells tested negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-). Testing negative for all 3 means the cancer is triple-negative [“TNBC”]. These negative results mean that the growth of the cancer is not supported by the hormones estrogen & progesterone, nor by the presence of too many HER2 receptors. Therefore, TNBC cancer does not respond to hormonal therapy (such as tamoxifen or aromatase inhibitors) nor therapies that target HER2 receptors, such as Herceptin (trastuzumab). However, other medicines can be used to treat TNBC. About 10-20% of breast cancers are found to be Triple-Negative.
For doctors & researchers, there is intense interest in finding new medications that can treat this kind of breast cancer. Early studies are trying to find out whether certain medications can interfere with the processes that cause TNBC to grow.” http://www.breastcancer.org/symptoms/diagnosis/trip_neg
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1-11-16 PR, “Peregrine Provides Update on Planned Expansion of Bavi Clinical Pgm in Lung, Breast and Other Cancers”… http://tinyurl.com/zhdy37a
PLANNED TRIALS...
#4. Phase II Trial in Early Stage TNBC in Combination with Chemotherapy
Peregrine is planning to initiate a Phase II trial of bavituximab in combination with neoadjuvant chemotherapy in early stage TNBC. The primary endpoint of this study is to determine the pathologic complete response rate (pCR), an accepted surrogate endpoint in early stage TNBC. The concept for this neoadjuvant setting trial, which will be conducted at a few select U.S. sites, originated from Peregrine's ongoing collaboration with Memorial Sloan Kettering Cancer Center (MSKCC). The company has filed a study protocol to its existing bavituximab IND application in the U.S. and is currently working to open clinical trial sites, including one that will be led by David B. Page, M.D., at the Providence Cancer Center in Oregon. http://tinyurl.com/zhdy37a
- - - - - - - -DR. DAVID PAGE: note his prior work with Dr. Jedd Wolchok, chief of Mem.Sloan's Melanoma & Immunotherapeutics Service who “investigates novel approaches for cancer immunotherapy and mechanisms of tumor cell–immune cell interactions”… http://www.bcrfcure.org/researchers/david-page
5-29-15: Peregrine/MSKCC Collab. Announced: http://tinyurl.com/zkvebh6
“The studies at MSK will be performed under the direction of Taha Merghoub, PhD, [ http://www.mskcc.org/research-areas/labs/members/taha-merghoub-01 ] Associate Attending Biologist, Melanoma and Immunotherapeutics Service, Ludwig Collaborative and the Swim Across America Laboratory, a part of the laboratory of Jedd D. Wolchok, MD, PhD [ http://www.mskcc.org/research-areas/labs/jedd-wolchok ], a leader in the field of cancer immunotherapy. Dr. Wolchok serves as the Chief, Melanoma and Immunotherapeutics Service, Lloyd J. Old Chair for Clinical Investigation as well as an Associate Director of the Ludwig Center for Cancer Immunotherapy at MSK.”
"The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said Dr. Jedd Wolchok (MSKCC).
"A key focus of the Wolchok Lab's research is studying novel immunotherapy combinations that work together to enable the immune system to recognize and destroy cancer. This collaboration will allow us to focus on the role and contribution of PS blockade therapy in determining which combination of the current and next generation of immune modulators is likely to increase the extent and amplitude of anti-tumor response. This important pre-clinical and translational work will potentially guide the design of the next generation of clinical studies with bavituximab," said Dr. Taha Merghoub (MSKCC).
Summary of Peregrine's New Collab's: Mem.Sloan-Kettering, AstraZeneca, NCCN
Post in 3 sections:
I. Memorial Sloan Kettering (MSKCC)_ – 5-2015/Investigate Novel PS-Targeting Immunotherapy Combos
II. AstraZeneca (Bavi+Durvalumab) - 8-2015/multiple solid tumors, 10-2015/expanded to NSCLC
III. Natl-Comprehensive-Cancer-Network (NCCN) – 1-2016/$2mm grant to NCCN's Oncology Res. Pgm (ORP), “26 of the world's leading cancer centers”
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I. MEMORIAL SLOAN KETTERING CANCER CENTER
5-29-15: Peregrine Pharmaceuticals Enters Into Research Collaboration to Investigate Novel PS-Targeting Immunotherapy Combinations
• Research Collaboration to Focus on Exploring Potential Combinations of PS-Targeting Agents Including Bavituximab With Other Immune Modulators
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915472
TUSTIN, May 29, 2015: Peregrine Pharmaceuticals, Inc., a biopharmaceutical company focused on advancing bavituximab, a novel immuno-oncology agent in Phase III development for the treatment of lung cancer, today announced that the company has entered into a sponsored research agreement with Memorial Sloan Kettering Cancer Center (MSK) to explore the potential of Peregrine's proprietary phosphatidylserine (PS)-targeting antibody platform. The goal of the research is to identify effective treatment combinations based on Peregrine's PS-targeting agents, including Peregrine's lead clinical agent bavituximab, with other checkpoint inhibitors or immune stimulating agents that will further guide the bavituximab clinical development program.
The studies at MSK will be performed under the direction of Taha Merghoub, PhD, [ http://www.mskcc.org/research-areas/labs/members/taha-merghoub-01 ] Associate Attending Biologist, Melanoma and Immunotherapeutics Service, Ludwig Collaborative and the Swim Across America Laboratory, a part of the laboratory of Jedd D. Wolchok, MD, PhD [ http://www.mskcc.org/research-areas/labs/jedd-wolchok ], a leader in the field of cancer immunotherapy. Dr. Wolchok serves as the Chief, Melanoma and Immunotherapeutics Service, Lloyd J. Old Chair for Clinical Investigation as well as an Associate Director of the Ludwig Center for Cancer Immunotherapy at MSK.
"The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said Dr. Wolchok.
As part of the collaboration, researchers at MSK will conduct research to further explore the combination of PS-targeting agents, including bavituximab, that block a primary immunosuppressive pathway thereby allowing anti-tumor immune responses with other immuno-stimulatory agents that enhance immune responses. Specifically, MSK researchers will examine the combination of bavituximab alongside models of checkpoint blockade that are unresponsive to inhibition or co-stimulation given the ability of bavituximab to reprogram myeloid derived suppressor cells (MDSC) and increase tumoricidal T-cells in tumors, a mechanism of action that is complementary to checkpoint blockade and T-cell activation.
"A key focus of the Wolchok Lab's research is studying novel immunotherapy combinations that work together to enable the immune system to recognize and destroy cancer. This collaboration will allow us to focus on the role and contribution of PS blockade therapy in determining which combination of the current and next generation of immune modulators is likely to increase the extent and amplitude of anti-tumor response. This important pre-clinical and translational work will potentially guide the design of the next generation of clinical studies with bavituximab," said Dr. Merghoub.
"We are delighted to be working with a world-renowned pioneer and leader in the immuno-oncology space, recognizing that there remains significant research in order for more cancer patients to realize the benefits of combination immune therapy," said Jeff T. Hutchins, PhD, VP of Preclinical Research at Peregrine. ”Our internal and collaborative research presented over the last year has established a robust foundation of PS-targeting activity on which to initiate this next chapter in PS research and development."
"This collaboration is an important extension of our established research efforts to further explore and understand the potential of our PS-targeting platform including bavituximab our lead clinical candidate. This research will focus on better understanding how treatment with PS-targeting agents can assist other anti-tumor immunotherapies in order to work better," said Steven King, CEO of Peregrine. ”Our goal is to change the way cancer patients are treated by allowing their immune system to recognize and fight their disease. This collaboration will undoubtedly assist us in identifying potential new opportunities to better treat patients with cancer."
Peregrine's antibodies target and bind to phosphatidylserine (PS), a highly immunosuppressive molecule normally located on the interior of cellular membranes, but, following stresses in the tumor environment, becomes exposed on tumor cells and cells that line tumor blood vessels, helping tumors to evade immune detection. PS-targeting antibodies block this immunosuppressive signal, thereby enabling the immune system to better recognize and fight the tumor. Preclinical data show that the combination of bavituximab and inhibitors of immune checkpoints reduce tumor-suppressive factors including myeloid-derived suppressor cells and confer increased tumor-specific immunity when compared to either treatment alone.
*snip*
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5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar - The Next Wave of Immune Modulating Checkpoint Inhibitors” - 7 panel members, incl. 3 Sloan Kettering researchers http://tinyurl.com/qxu4w2x
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1-11-16 PR, “Peregrine Provides Update on Planned Expansion of Bavi Clinical Pgm in Lung, Breast and Other Cancers”… http://tinyurl.com/zhdy37a
PLANNED TRIALS...
#4. Phase II Trial in Early Stage TNBC in Combination with Chemotherapy
Peregrine is planning to initiate a Phase II trial of bavituximab in combination with neoadjuvant chemotherapy in early stage TNBC. The primary endpoint of this study is to determine the pathologic complete response rate (pCR), an accepted surrogate endpoint in early stage TNBC. The concept for this neoadjuvant setting trial, which will be conducted at a few select U.S. sites, originated from Peregrine's ongoing collaboration with Memorial Sloan Kettering Cancer Center (MSKCC). The company has filed a study protocol to its existing bavituximab IND application in the U.S. and is currently working to open clinical trial sites, including one that will be led by David B. Page, M.D., at the Providence Cancer Center in Oregon. http://tinyurl.com/zhdy37a
- - - - - - - -DR. DAVID PAGE: note his prior work with Dr. Jedd Wolchok, chief of Mem.Sloan's Melanoma & Immunotherapeutics Service who “investigates novel approaches for cancer immunotherapy and mechanisms of tumor cell–immune cell interactions”… http://www.bcrfcure.org/researchers/david-page
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II. ASTRAZENECA
8-24-15: AstraZeneca and Peregrine Pharmaceuticals to Collaborate on Immuno-Oncology Combination Clinical Trial
• Collaboration to Focus on Cancer Immunotherapy Combination of Peregrine's PS-Targeting Bavituximab and AstraZeneca's PD-L1 Inhibitor MEDI4736
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=928488
TUSTIN, Aug. 24, 2015: AstraZeneca (NYSE:AZN) and Peregrine Pharmaceuticals, a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced that they have entered into a cancer immunotherapy clinical trial collaboration. The collaboration will evaluate Peregrine's investigational phosphatidylserine (PS)-signaling pathway inhibitor, bavituximab, in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The planned Phase I/Ib trial will evaluate the safety and efficacy of bavituximab in combination with durvalumab in multiple solid tumors.
Peregrine and AstraZeneca will collaborate on a non-exclusive basis, to evaluate the combination of bavituximab and durvalumab with chemotherapy as a potential treatment in various solid tumors. The Phase I part of the trial is expected to establish a recommended dose regimen for the combination and the Phase Ib part of the trial will assess the safety and efficacy of the investigational combination. Under the terms of the agreement, the initial trial will be conducted by Peregrine.
Robert Iannone, Head of Immuno-Oncology, Global Medicines Development, at AstraZeneca said, "We believe that combination therapy in immuno-oncology has the potential to be a novel and highly effective approach to treating cancer. Our partnership with Peregrine provides the opportunity to explore an exciting, novel combination that could deliver important clinical benefit to patients across a range of cancers."
Bavituximab and durvalumab are investigational immunotherapies with different mechanisms that assist the body's immune system in fighting cancer. Bavituximab targets and modulates the activity of phosphatidylserine, a highly immune-suppressive molecule expressed broadly on the surface of cells in the tumor microenvironment. The treatment increases activated T-cells in tumors and fights cancer by reversing the immunosuppressive environment that many tumors establish in order to proliferate. MEDI4736 is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. Preclinical data have demonstrated that combining the enhanced T-cell mediated anti-tumor activity of bavituximab with checkpoint inhibitors, like PD-L1 antibodies, prolong the ability of tumor-specific T-cells to continue attacking the tumor.
”Data generated to date have shown significant potential for combining bavituximab with agents targeting the PD-1/PDL-1 pathway and we're excited to further explore this approach in studies with AstraZeneca's durvalumab," said Steven W. King, President and CEO of Peregrine. "AstraZeneca is a recognized leader in the immuno-oncology field and this collaboration will play a key role as we continue to fully explore the potential of bavituximab in combination immunotherapies for a variety of clinical applications."
ABOUT BAVITUXIMAB: A Targeted Investigational Immunotherapy
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab, the lead compound in Peregrine's immuno-oncology development program, blocks PS to remove this immunosuppressive signal and sends an alternate immune activating signal. Targeting PS with bavituximab has been shown to shift the functions of immune cells in tumors, resulting in robust anti-tumor immune responses.
ABOUT DURVALUMAB (MEDI4736)
MEDI4736 is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumor's immune-evading tactics. MEDI4736 is being developed, alongside other immunotherapies, to empower the patient's immune system and attack the cancer.
*snip*
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10-15-15: AstraZeneca and Peregrine Pharmaceuticals Expand Ongoing Immuno-Oncology Collaboration to Include Phase II Lung Cancer Combination Clinical Trial
Global, Randomized Phase II Trial to Evaluate Immunotherapy Combination of Peregrine's PS-Targeting Bavituximab and AstraZeneca's PD-L1 Inhibitor Durvalumab (MEDI4736) in Previously Treated NSCLC
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=936766
TUSTIN, Oct. 15, 2015: Peregrine Pharmaceuticals, Inc., a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced that it has expanded its ongoing cancer immunotherapy clinical collaboration with AstraZeneca to include a second, later-stage trial. The companies will now also evaluate the immunotherapy combination of Peregrine's phosphatidylserine (PS)-targeted immune-activator, bavituximab, and AstraZeneca's anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in a global Phase II study in patients with previously treated squamous or non-squamous non-small cell lung cancer (NSCLC). The randomized Phase II trial will be conducted by Peregrine.
As part of the Phase II bavituximab and durvalumab combination trial, patients will be evaluated retrospectively for the correlation between their PD-L1 levels and clinical outcomes. This new study builds on the non-exclusive collaboration initiated between the companies in August 2015 [8-24-15: http://tinyurl.com/owlxpsf ] to conduct a Phase I/Ib basket clinical trial evaluating the combination of bavituximab and durvalumab with chemotherapy in multiple solid tumors.
Bavituximab and durvalumab are investigational immunotherapies with different mechanisms that assist the body's immune system in fighting cancer. Bavituximab targets and modulates the activity of phosphatidylserine, a highly immune-suppressive molecule expressed broadly on the surface of cells in the tumor microenvironment. In pre-clinical and translational clinical studies, the treatment increases activated T-cells in tumors and fights cancer by reversing the immunosuppressive environment that many tumors establish in order to proliferate. Durvalumab is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. Preclinical data have demonstrated that combining the enhanced T-cell mediated anti-tumor activity of bavituximab with checkpoint inhibitors, like PD-L1 antibodies, prolong the ability of tumor-specific T-cells to continue attacking the tumor.
"In the short period of time that we have been working with AstraZeneca, we have been very impressed with the company's commitment to innovative translational efforts that will help us better understand the dynamics of tumor immunity and clinical response to durvalumab and bavituximab combination in a range of cancers," said Joseph Shan, MPH, VP, Clinical and Regulatory Affairs of Peregrine. "We expect this extension of our collaboration with AstraZeneca will allow us to run a much more cost-effective and time-efficient trial than would have been possible under our previously planned study using Opdivo as the combination drug in the same lung cancer population. This Phase II study offers several key advantages including a supply of durvalumab that will enable us to conduct a global trial that can enroll patients more rapidly. In addition, the expanded collaboration provides for a more cohesive clinical program utilizing the same PD-L1 and other biomarker analysis across both the new Phase II trial and the already planned Phase I/Ib study combining durvalumab and bavituximab in multiple indications."
*snip*
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From the 1-11-2016 PR Update on New Bavi Trials ( http://tinyurl.com/zhdy37a ):
PLANNED TRIAL: Phase II NSCLC Trial in Combination with AstraZeneca's Durvalumab
Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca's durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with previously treated squamous or non-squamous NSCLC during the first quarter of 2016. The goal of this trial is to generate data on the combination of bavituximab & durvalumab to inform the potential advancement of this treatment regimen into later stage clinical trial. The study's primary endpoints are overall response rate (ORR) and safety. The trial is also designed to retrospectively evaluate patients for the correlation between their PD-L1 levels and clinical outcomes, providing further critical data to guide future development. The randomized, open-label trial will evaluate approx. 200 patients at sites in the U.S. & Europe. The company has filed a study protocol to its existing investigational new drug (IND) application for bavituximab in the U.S. and is currently working to open clinical trial sites.
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III. NATL-COMPREHENSIVE-CANCER-NETWORK (NCCN)
1-6-16: Peregrine Pharmaceuticals and National Comprehensive Cancer Network (NCCN) Form Clinical Collaboration to Evaluate Novel Cancer Treatment Combinations With Bavituximab
• NCCN Alliance Includes 26 Leading Cancer Centers and World-Class Thought Leaders on Innovative Cancer Combination Therapies
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=949024
TUSTIN, Jan. 6, 2016: Peregrine Pharmaceuticals, Inc., a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced a new research collaboration with the National Comprehensive Cancer Network (NCCN) [ http://www.nccn.org ] to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors. NCCN, a not-for-profit alliance of 26 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.
Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine's PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight cancer. According to Peregrine, a broad set of preclinical and translational data has been assembled that supports the ability of bavituximab to improve the therapeutic activity of a range of cancer treatments, from traditional approaches, such as chemotherapy and radiation, to novel immuno-oncology agents such as checkpoint inhibitors.
"This collaboration with NCCN will allow us to significantly expand our clinical evaluation of bavituximab and augment Peregrine's internal investigator sponsored trial (IST) program," said Steven W. King, President and CEO of Peregrine. "Importantly, NCCN shares our strong research interest in evaluating unique bavituximab combination therapies for the treatment of cancer, and the group's oversight of the program will allow for the conducting of many more studies than would have been otherwise possible."
"NCCN is very pleased to collaborate with Peregrine Pharmaceuticals on their first-in-class novel targeted monoclonal antibody, bavituximab," said Robert C. Young, MD, Interim Vice President, ORP, NCCN. "We look forward to a productive interaction in both clinical and pre-clinical studies undertaken at the NCCN Member Institutions."
Peregrine expects results from this collaboration to further support the ongoing development of bavituximab as a key component of various combination cancer treatments. Bavituximab is currently being evaluated in combination with docetaxel (chemotherapy) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in the ongoing Phase III SUNRISE trial. In addition, as part of its recently formed collaboration with AstraZeneca, Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in patients with previously treated squamous or non-squamous NSCLC. The company will also be evaluating bavituximab with chemotherapy combinations in HER2-negative breast cancer.
*snip*
ABOUT THE NATIONAL COMPREHENSIVE CANCER NETWORK [ http://www.nccn.org ]
The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 26 of the nation's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.
THE NCCN MEMBER INSTITUTIONS ARE: Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/Univ. Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the Univ. of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern Univ., Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State Univ. Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington Univ. School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The Univ. of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; Univ. of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; Univ. of Colorado Cancer Center, Aurora, CO; Univ. of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The Univ. of Texas MD Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.
Clinicians, visit http://NCCN.org . Patients and caregivers, visit http://NCCN.org/patients .
Safe Harbor *snip*
- - - - - - -NCCN's 1-6-16 PR: NCCN Awarded $2 Million in Research Funding from Peregrine Pharmaceuticals to Study Bavituximab in Various Cancers
• The NCCN Oncology Research Program (ORP) was awarded a $2-million grant from Peregrine Pharmaceuticals, Inc. to facilitate studies of bavituximab in various cancers.
http://www.nccn.org/about/news/newsinfo.aspx?NewsID=565
FORT WASHINGTON, PA —The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) has been awarded a $2-million grant from Peregrine Pharmaceuticals, Inc. to study bavituximab, a first-in-class treatment approach for various cancers.
“NCCN is very pleased to collaborate with Peregrine Pharmaceuticals on their first-in-class novel targeted monoclonal antibody, bavituximab,” said Robert C. Young, MD, Interim VP, ORP, NCCN. “We look forward to a productive interaction in both clinical and pre-clinical studies undertaken at the NCCN Member Institutions.”
“This collaboration with NCCN will allow us to significantly expand our clinical evaluation of bavituximab and augment Peregrine’s internal IST program,” said Steven W. King, Peregrine's CEO. “Importantly, NCCN shares our strong research interest in evaluating unique bavituximab combination therapies for the treatment of cancer, and the group’s oversight of the program will allow for the conducting of many more studies than would have been otherwise possible.”
Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine’s PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight canceri. According to Peregrine, a broad set of pre-clinical and translational data has been assembled that supports the ability of bavituximab to improve the therapeutic activity of a range of cancer treatments, from traditional approaches, such as chemotherapy and radiation, to novel immuno-oncology agents such as checkpoint inhibitors.
The first phase of the program will involve the establishment of an NCCN Bavituximab Request for Proposals Development Team to evaluate existing data and to discuss and define the data and type of studies necessary to further characterize the safety and clinical effectiveness of bavituximab.
The NCCN ORP draws on the expertise of the investigators of the NCCN Member Institutions and NCCN Affiliate Research Consortium (ARC) to facilitate all phases of clinical research. This research is made possible by collaborations with pharmaceutical and biotechnology companies in order to advance therapeutic options for patients with cancer.
The NCCN ORP will utilize the grant from Peregrine Pharmaceuticals to support investigator-initiated clinical and correlative studies at NCCN Member Institutions and their affiliate community hospitals for bavituximab. To date, this successful research model has received approximately $58 million in research grants and supported more than 132 studies that have produced a number of publications in peer-reviewed journals.
To learn more about the NCCN ORP and ongoing clinical trials, visit http://NCCN.org/ORP .
*end*
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From the 1-11-2016 PR Update on New Bavi Trials ( http://tinyurl.com/zhdy37a ):
PLANNED TRIAL: Multiple Clinical and Translational Studies in Collaboration with NCCN
Peregrine recently announced a new research collaboration with NCCN to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors. NCCN, a not-for-profit alliance of 26 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers will be initiated at NCCN Member Institutions and their affiliate community hospitals through a $2mm research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant. The company expects results from this collaboration to further support the ongoing development of bavituximab as a key component of various combination cancer treatments.
CEO Steve King quoted in 1-13-16 EP-Vantage article about advancing cancer immunotherapy combinations... “in an interview on the sidelines of the JP Morgan meeting.”…
1-13-16: “JP Morgan - Jumping In Front Of The Cancer Immunotherapy Parade”
EP Vantage Newsletter Provider (biotech, healthcare)
http://seekingalpha.com/article/3807976-jp-morgan-jumping-in-front-of-the-cancer-immunotherapy-parade
NantWorks’ Patrick Soon-Shiong has a very good idea about advancing cancer immunotherapy combinations - but this work is already being done. The billionaire’s Cancer Moonshot 2020 initiative is pushing for thousands of patients to be enrolled in trials combining such agents as checkpoint inhibitors with chemotherapies and other approaches in four years. Surely Dr Soon-Shiong must know that the sector looks like it might already be at least halfway there without his help. EP Vantage noted the first emergence of combination PD-1 trials two years ago, and the space has mushroomed since, counting no fewer than 170 combination studies of PD-1/PD-L1agents along as of last September (Merck & Co shows the way in immuno-oncology combinations, Nov. 23, 2015 http://epvantage.com/Universal/View.aspx?type=Story&id=609107 ).
PRIME OPPORTUNITY
Dr Soon-Shiong and his collaborators took the annual JP Morgan healthcare meeting in San Francisco as an opportunity to launch the National Immunotherapy Coalition, comprising big cap biotechs like Amgen and Celgene, smaller players like NantWorks, and insurers and employers. Fresh from a Dec. meeting with Joe Biden, whose son died of brain cancer last year, the coalition wants 20,000 patients to be enrolled in immunotherapy combination trials in 20 cancer types within 36mos. Absent from the scene were Bristol-Myers Squibb, Merck & Co and Roche, the undisputed leaders in the field of immunotherapies and combination trials. EP Vantage’s report, PD-1/PD-L1 Combination Therapies, found that these companies and others have already launched combination trials of their immunotherapies in at least 10 cancer types, and new indications seem to be added frequently.
Steven King, CEO of Peregrine Pharmaceuticals, sees the potential for this initiative to offer an opportunity for smaller companies to run more combination trials. While Peregrine is planning a trial in combination of its immuno-oncology agent bavituximab with AstraZeneca’s durvalumab and is collaborating with the National Comprehensive Cancer Network for other combination trials, this coalition might serve to stimulate an expansion of clinical work. “It’s often access to drugs. If you want to run a combination with Keytruda or Opdivo, you’re going to have to buy the drug,” he told EP Vantage in an interview on the sidelines of the JP Morgan meeting. “It becomes a cost issue. You’re not going to be able to run as many studies.”
WHERE THE RUBBER MEETS THE ROAD
Merck & Co’s (NYSE:MRK) Keytruda and Bristol’s Opdivo already accounted for around 96 separate combination trials, as of last September, covering such burdensome diseases as breast and lung cancer. AstraZeneca’s durvalumab and Roche’s atezolizumab added another 46. Where the Moonshot initiative is innovative is in what it calls the quantitative integrative lifelong trial (QUILT) approach, in which academic centers, oncologists, government agencies like the NIH and pharma groups will co-ordinate trials in patients who have undergone genome, transcriptome and quantitative proteomic analysis. While the strength in this approach will no doubt deliver some of the most robust analysis of immunotherapy combinations, the weakness is that these consortia studies often take more time to deliver their data than commercial counterparts. In the pursuit of a cure for cancers, having more allies, particularly in the payer community and at the highest levels in government, cannot be said to be a bad thing. However, while Dr Soon-Shiong has been busy talking and organising, Merck, Bristol and others have been doing the heavy lifting. As an elaborate public relations event for Dr Soon-Shiong’s companies this might have been a success. But the sector was already well on its way.
*end*
EP Vantage's report on the landscape for anti-PD-1/PD-L1 combination therapeutics is available for free by download. To contact the writer of this story email Jonathan Gardner in San Francisco at jonathang@epvantage.com or follow @ByJonGardner on Twitter
1-13-16: Heartware sees 35% stock-plunge on bad news@JPMorgan, to $26.50.
By: Don Seiffert, Editor Boston Business Journal
A Framingham heart pump-maker already under fire from one investor over a proposed acquisition, Heartware Intl., saw its shares collapse by a third Tuesday after disappointing revenue news and even more worrying trial news.
http://www.bizjournals.com/boston/blog/bioflash/2016/01/framingham-s-heartware-sees-35-stock-plunge-on.html
Heartware (Nasdaq: HTWR) shares fell 35% to $26.50 Tuesday, their lowest point since 2010. The stock low gives the company, which had 585 employees worldwide when it last reported headcount a year ago, a market valuation of $458mm.
The drop was driven by news from its presentation at the JP Morgan Healthcare Conference in San Fransisco. Particularly, the company said it completed a review of problems that caused a temporary delay of its European trial of a newer, smaller pump called the MVAD Pump and now believes it could take a few months to fix and may even require the company to start the trial over. Enrollment of patients into the trial, which began in July 2015, was paused a couple months later due to a manufacturing problem. The company now says it believes there is a software issue with the MVAD Pump that caused potential blood clotting.
It’s more bad news for a company that’s seen significant opposition lately since a proposed $929mmn acquisition of an Israeli company developing a device to prevent heart failure called Valtech Cardio. When the company first announced plans for the acquisition last September, its had a market value that was more than twice the point at which it closed yesterday. Heartware now faces a proxy fight with activist investor Engaged Capital, in which the Florida investment firm is looking to replace 3 of the 8 current board members. Among other problems with the Valtech acquisition, Engaged points to several provisions in the merger agreement that would accelerate certain milestone payments to Valtech’s current shareholders if Heartware itself is acquired in the next 10 years, effectively lowering the value of the company as a whole.
Also Tuesday, the company gave a preliminary revenue estimate of $68mm for the final 3mos of 2015, lower than the $73.2m reported for the same period in 2014. The company said the drop in sales of its HVAD Pump is largely due to an unfavorable foreign exchange rate. The revenue estimate led to a downgrade by analysts at the investment firm, JP Morgan.
N40K, this from iBox on Dr.Thorpe's 5-1-12 NYAS talk on PS-Targeting. The link below has captures of his 30 Slides, and some transcript excerpts I made back then of what stood out to me from listening to his most-interesting 46min. talk. There's a link to his talk REPLAY as well!!! (it doesn't work with Firefox, but does with MS Edge Browser, and I assume IE).
Ibox:
BAVI MOA: 5-1-12 Dr. Phil Thorpe's 46min talk at NYAS PS-Targeting Symposium http://tinyurl.com/9792gl5
. . .Symposium title: “Phosphatidylserine (PS) Asymmetry - Therapeutic Apps. in Cancer & Infectious Disease Symposium"
. . .Replays of 5 speakers: Alan Schroit, Chris Reutlingsperger, David Ucker, Ari Helenius, Philip Thorpe
The 4th New Bavi trial listed in today's PR, the Ph.2 Bavi+Chemo/Triple-BC, with Dr. David Page's (protege of Mem.Sloan's Dr. Jedd Wolchok) involvement at the Providence CC in Oregon, has EVOLVED since the 10-15-15 ASM Presentation (which said, “combination under review”) – obviously with further input from Mem.Sloan-Kettering...
Phase I => Phase II
Her2- => Triple-
- - - - - - - - - - - -
10-15-15/ASM: Phase1 Early Stage Her2- Breast Cancer http://tinyurl.com/o6z4bm4
=> 1-11-16 PR: Phase2, Bavi+Chemo, Early Stage TNBC(Triple-) Breast Cancer http://tinyurl.com/zhdy37a
= = = = = = = = =
From today's (1-11-16) PR - PLANNED TRIALS...
#4. Phase II Trial in Early Stage TNBC in Combination with Chemotherapy
Peregrine is planning to initiate a Phase II trial of bavituximab in combination with neoadjuvant chemotherapy in early stage TNBC. The primary endpoint of this study is to determine the pathologic complete response rate (pCR), an accepted surrogate endpoint in early stage TNBC. The concept for this neoadjuvant setting trial, which will be conducted at a few select U.S. sites, originated from Peregrine's ongoing collaboration with Memorial Sloan Kettering Cancer Center (MSKCC). The company has filed a study protocol to its existing bavituximab IND application in the U.S. and is currently working to open clinical trial sites, including one that will be led by David B. Page (worked prev. with Dr. Jedd Wolchok at Mem.Sloan), M.D., at the Providence Cancer Center in Oregon.
http://tinyurl.com/zhdy37a & http://tinyurl.com/h2g4nqd
I still like, "Wolchok Disciple to initiate Bavi trial in triple-BC" better!!
Stony, hats off to you for digging up Dr. Page's prior work with Dr. Wolchok so quickly. Took me about 4hrs to figure it all out! I also like the way you boiled my whole post down into 9 words!! => "Wolchok Disciple to initiate Bavi trial in triple- BC"
DELETE
Dr. David Page, mentioned in today's New Bavi-Trials PR re: the upcoming Ph.2 Triple- MBC trial that “originated from Peregrine's ongoing collaboration with Memorial Sloan Kettering” - note Dr. Page's prior work with Dr. Jedd Wolchok, chief of Mem.Sloan's Melanoma & Immunotherapeutics Service who “investigates novel approaches for cancer immunotherapy and mechanisms of tumor cell–immune cell interactions”….
From today's (1-11-16) PR, “Peregrine Provides Update on Planned Expansion of Bavi Clinical Pgm in Lung, Breast and Other Cancers”…
PLANNED TRIALS...
#4. Phase II Trial in Early Stage TNBC in Combination with Chemotherapy
Peregrine is planning to initiate a Phase II trial of bavituximab in combination with neoadjuvant chemotherapy in early stage TNBC. The primary endpoint of this study is to determine the pathologic complete response rate (pCR), an accepted surrogate endpoint in early stage TNBC. The concept for this neoadjuvant setting trial, which will be conducted at a few select U.S. sites, originated from Peregrine's ongoing collaboration with Memorial Sloan Kettering Cancer Center (MSKCC). The company has filed a study protocol to its existing bavituximab IND application in the U.S. and is currently working to open clinical trial sites, including one that will be led by David B. Page, M.D., at the Providence Cancer Center in Oregon. http://tinyurl.com/zhdy37a
FROM DR. PAGE's BREAST CANCER RES. FOUNDATION (BCRF) PROFILE:
David B. Page, MD, is a medical oncologist at Providence Portland Medical Center in Portland, Oregon. Dr. Page first became fascinated with cancer biology & immunology as an undergraduate at the Univ. of Chicago and later studied under the mentorship of medical oncologist Dr. Jedd Wolchok, a pioneer in immunotherapy, at Memorial Sloan Kettering Cancer Center. Alongside Dr. Wolchok, Dr. Page treated numerous patients with metastatic melanoma, a usually fatal skin cancer, some who have been cured of cancer and are still living today as a result of immunotherapy. As a fellow, Dr. Page developed several investigator-initiated clinical trials evaluating immunotherapy in breast cancer, including a pilot study...
http://www.bcrfcure.org/researchers/david-page
5-29-15: Peregrine & Sloan Kettering Enter Collab. to “Investigate Novel PS-Targeting Immunotherapy Combos” http://tinyurl.com/qxu4w2x
”The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said (Mem.Sloan’s) Dr. Jedd D. Wolchok.
= = = = = = = = = =
1-11-16/PR: Update on 4 New Bavi Clinical Trials (Lung/AZN, Breast/1Co./1MSKCC, Other Cancers/AZN). SUNRISE estimates: Interim1=Early'16, Interim2=Mid'16, FinalUnblinding=End'16… http://tinyurl.com/zhdy37a
9-9-15 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/ph22vdn
...CEO S.King: “The Memorial Sloan Kettering & AstraZeneca collaborations are an important part of our announced plans to expand our bavituximab clinical pgm.”
7-14-15 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/nw2v5u6
...CEO S.King: “We recently entered into collaboration with investigators at Memorial Sloan Kettering Cancer Ctr to continue expanding on this important work, as well as to explore other potential applications of bavituximab and other agents that target PS-signaling pathway.”
1-11-16/PR: Update on 4 New Bavi Clinical Trials (Lung/AZN, Breast/1Co./1MSKCC, Other Cancers/AZN). SUNRISE estimates: Interim1=Early'16, Interim2=Mid'16, FinalUnblinding=End'16…
1-11-16: Peregrine Pharmaceuticals Provides Update on Planned Expansion of Bavituximab Clinical Program in Lung, Breast and Other Cancers
– Phase II Study in NSCLC in Collaboration with AstraZeneca Evaluating Bavituximab Plus Durvalumab to Expand Lung Cancer Program in Q1 2016
– Phase II/III Study in HER2-Negative Metastatic Breast Cancer is Now Underway with a Second Phase II Study in Early Stage Triple Negative Breast Cancer to Begin in Q1 2016
– Additional Studies to Broaden Evaluation of Bavituximab Immunotherapy and Standard of Care Combinations in Multiple Solid Tumors Planned for 2016
TUSTIN, Jan. 11, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today provided a clinical development update for bavituximab, the company's investigational phosphatidylserine (PS)-targeting immunotherapy. In the first quarter of 2016, Peregrine plans to initiate two new Phase II clinical trials in breast and lung cancer in combination with current standard of care treatments including both chemotherapy and immuno-oncology agents. In addition, the company has entered into a collaboration with the National Comprehensive Cancer Network (NCCN) to evaluate bavituximab in other tumor types and combinations. Additionally, the company is nearing completion of enrollment of an ongoing Phase III trial in non-small cell lung cancer (NSCLC) named SUNRISE.
The planned trials include a Phase II NSCLC trial in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), and a Phase II trial in early stage triple negative breast cancer (TNBC). These are in addition to the recently initiated Phase II/III study in combination with chemotherapy in human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). The company expects that initial data from these trials may be available in late 2016 or early 2017. Additionally, the company looks forward to the initiation of additional trials of bavituximab combinations through its ongoing collaborations with AstraZeneca and NCCN.
"As we wrap up enrollment in the SUNRISE trial, we recognize that we are at an ideal juncture to continue expanding the potential of bavituximab with standard of care and immunotherapy combinations in multiple solid tumor types. Combined with the SUNRISE trial, the new studies we have planned can help solidify the potential of bavituximab in NSCLC while significantly expanding the market opportunity in breast cancer," said Steven W. King, President and CEO of Peregrine. "Driving our strategy is the goal of further demonstrating that bavituximab can provide therapeutic benefit to available cancer treatments, regardless of whether those are traditional therapies such as chemotherapy and radiation, or the emerging novel class of immuno-oncology agents. In today's update, it is evident that we are moving aggressively to compile a significant body of clinical evidence to support bavituximab's utility in multiple cancers and across a range of treatment regimens. By doing so, we hope to optimally position bavituximab for success."
Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine's PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight cancer.
Updated details on Peregrine's expanded bavituximab clinical development program include:
Bavituximab in NSCLC:
Phase III SUNRISE Trial
Peregrine's Phase III SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) trial is evaluating the use of bavituximab and docetaxel in patients with previously treated locally advanced or metastatic non-squamous NSCLC. Peregrine expects that the first interim analysis (33% of targeted number of deaths) will be conducted in early 2016 and the second interim analysis (50% of targeted number of deaths) in mid-2016. The final analysis, which will trigger the unblinding of the study data, is currently projected to occur at the end of 2016.
Phase II NSCLC Trial in Combination with AstraZeneca's Durvalumab
Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca's durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with previously treated squamous or non-squamous NSCLC during the first quarter of 2016. The goal of this trial is to generate data on the combination of bavituximab and durvalumab to inform the potential advancement of this treatment regimen into later stage clinical trial. The study's primary endpoints are overall response rate (ORR) and safety. The trial is also designed to retrospectively evaluate patients for the correlation between their PD-L1 levels and clinical outcomes, providing further critical data to guide future development.
The randomized, open-label trial will evaluate approximately 200 patients at sites in the U.S. and Europe. The company has filed a study protocol to its existing investigational new drug (IND) application for bavituximab in the U.S. and is currently working to open clinical trial sites.
Bavituximab in Breast Cancer:
Phase II/III HER2-Negative MBC Trial in Combination with Chemotherapy
In December 2015, Peregrine initiated an open-label, randomized Phase II/III study comparing the efficacy and safety outcomes for taxane monotherapy (paclitaxel or docetaxel at investigator discretion) versus taxane therapy in combination with bavituximab in HER2-negative MBC patients. The goal of the Phase II portion of this study is to generate mature data on the combination of bavituximab and chemotherapy in MBC to guide the design and execution of the trial's Phase III component. The primary efficacy endpoint of the Phase II study is ORR, with secondary endpoints including progression free survival (PFS), overall survival (OS), duration of response and safety. The Phase II portion of the study will enroll approximately 150 patients at sites in the U.S. and Europe.
Phase II Trial in Early Stage TNBC in Combination with Chemotherapy
Peregrine is planning to initiate a Phase II trial of bavituximab in combination with neoadjuvant chemotherapy in early stage TNBC. The primary endpoint of this study is to determine the pathologic complete response rate (pCR), an accepted surrogate endpoint in early stage TNBC. The concept for this neoadjuvant setting trial, which will be conducted at a few select U.S. sites, originated from Peregrine's ongoing collaboration with Memorial Sloan Kettering Cancer Center (MSKCC). The company has filed a study protocol to its existing bavituximab IND application in the U.S. and is currently working to open clinical trial sites, including one that will be led by David B. Page [ http://oregon.providence.org/physician-directory/p/page-david-b/ ], M.D., at the Providence Cancer Center in Oregon.
Bavituximab in Other Solid Tumor Indications:
Phase I/Ib Trial in Multiple Solid Tumors in Combination with AstraZeneca's Durvalumab and Chemotherapy
As part of the company's collaboration with AstraZeneca, Peregrine plans to initiate a Phase I/Ib study of bavituximab in combination with durvalumab and chemotherapy in multiple solid tumors in 2016. The Phase I part of the trial is designed to confirm the tolerability of the combination of bavituximab and durvalumab and establish a recommended dose regimen for the Phase Ib part of the trial, which will assess the safety and activity of the combination of bavituximab, durvalumab and chemotherapy.
Multiple Clinical and Translational Studies in Collaboration with NCCN
Peregrine recently announced a new research collaboration with NCCN to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors [1-6-16: http://tinyurl.com/zmxtpsb ]. NCCN, a not-for-profit alliance of 26 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives [ http://www.nccn.org ]. Multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers will be initiated at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant. The company expects results from this collaboration to further support the ongoing development of bavituximab as a key component of various combination cancer treatments.
About Bavituximab: A Targeted Investigational Immunotherapy
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab blocks PS and, in turn, is believed to remove this immunosuppressive signal and send an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in robust anti-tumor immune responses.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer. Bavituximab, the company's lead immunotherapy candidate, is in late-stage clinical development for the treatment of both lung cancer and breast cancer. The company will also evaluate the combination of bavituximab and durvalumab, AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, in a range of cancer types under a clinical collaboration.
In addition to its drug development programs, Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
Safe Harbor *snip*
• Jay Carlson Peregrine Pharmaceuticals, Inc. 800-987-8256 info@peregrineinc.com
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
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1-6-16: Peregrine enters into Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN) http://tinyurl.com/zmxtpsb
...$2mm res. grant to NCCN's Oncology Res. Pgm (ORP), will “significantly expand our clinical evaluation of Bavi and augment Peregrine's IST pgm at 26 of the world's leading cancer centers”.
12-10-15 Qtly. Conf. Call (King/Shan/Worsley/Garnick/Lytle) Transcript http://tinyurl.com/jkp885g
...CEO SK: “Although our SUNRISE enrollment milestone has been reached, we have no intention of slowing down, quite the opposite. We are aggressively moving to initiate new clinical trials [Lung, Breast, Mult-Types] that will allow us to build the most robust oncology business possible… With each of these studies our goal is the same - we are committed to identifying key indications, patient populations, and therapeutics that can benefit from combination treatment with bavituximab. From what we have seen to-date, the opportunity appears vast and we are hard at work converting the most promising prospects into true value.”
10-15-15: Peregrine & AstraZeneca Expand Collab. w/Ph2/2ndLine-NSCLC Trial, Bavi+durvalumab(MEDI4736), squamous or non-squamous. http://tinyurl.com/q79bkam
9-9-15 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/ph22vdn
...CEO S.King: “The Memorial Sloan Kettering & AstraZeneca collaborations are an important part of our announced plans to expand our bavituximab clinical pgm.”
8-24-15: AstraZeneca & Peregrine Collaborate on Bavi+Durvalumab Ph1/1B Trial for “multiple solid tumors” http://tinyurl.com/owlxpsf
...Durvalumab=MEDI4736(anti-PD-L1 immune checkpoint inhibitor). AZN’s Head/I-O(Robert Iannone): “Our partnership with Peregrine provides the opportunity to explore an exciting, novel combination that could deliver important clinical benefit to patients across a range of cancers."
7-14-15 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/nw2v5u6
...CEO S.King: “We recently entered into collaboration with investigators at Memorial Sloan Kettering Cancer Ctr to continue expanding on this important work, as well as to explore other potential applications of bavituximab and other agents that target PS-signaling pathway.”
5-29-15: Peregrine & Sloan Kettering Enter Collab. to “Investigate Novel PS-Targeting Immunotherapy Combos” http://tinyurl.com/qxu4w2x
IMO, anyone that switches “Est./Planned” into “Deadline” either has an agenda or is trying to deceive or gen. unjustified negativity. Just watch out for anybody who ON THEIR OWN likes to switch the term Estimate into Deadline. They're 2 totally different meanings.
I just selected the ones where companies awarded res. grant $$$ to the NCCN. (to the best I could tell). I couldn't really tell how $$$ flowed with the BMS ones.
http://www.nccn.org/clinical_trials/news.aspx
Peregrine's Collab. with The NCCN models many others from 2014-2015...
http://www.nccn.org/clinical_trials/news.aspx
NCCN Awarded $2 Million in Research Funding from Peregrine Pharmaceuticals to Study Bavituximab in Various Cancers (01/06/2016)
NCCN Receives $2 Million in Research Funding from Boehringer Ingelheim to Study Targeted Combination Approaches with Afatinib in Lung Cancer (06/11/2015)
NCCN Receives $2-Million Funding Commitment from ImmunoGen to Study Mirvetuximab Soravtansine for Folate Receptor Alpha-Positive Cancers (05/15/2015)
NCCN Receives $2 Million in Research Funding from Boehringer Ingelheim to Study Volasertib in Hematologic Malignancies (05/22/2014)
NCCN Receives $2.2 Million in Research Funding from Astellas & Medivation to Study Enzalutamide in Solid Tumors (04/01/2014)
NCCN Receives $2 Million in Research Funding from Boehringer Ingelheim to Study Nintedanib* in Colorectal and Lung Cancers (03/21/2014)
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1-6-16: Peregrine enters into Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN) http://tinyurl.com/zmxtpsb
...$2mm res. grant to NCCN's Oncology Res. Pgm (ORP), will “significantly expand our clinical evaluation of Bavi and augment Peregrine's IST pgm at 26 of the world's leading cancer centers” [ http://www.nccn.org/members/network.aspx ].
Dr. Brekken: June2-4 2016: ICDS 2016 Cork, Ireland **Will add, Hutschi**
ICDS = Intl. Cell Death Society
Mtg. Theme: "Translational Implications in Cell Death"
http://www.celldeath-apoptosis.org/extensions/templates/next-meeting-html/speakers-topics.html
*Chair (1 of 9): Ray Birge** (USA)
Speaker (1 of 20): Rolf Brekken/UTSW (USA, PPHM SAB): “Blockade of Phosphatidylserine & Immune Activation in Cancer”
**Recall…
10-29-15: Rutgers' Dr. Raymond Birge, John-Hopkins-Univ/Seminar: “PS is a Global-Immune-Checkpoint In Cancer” (12-1pm) http://tinyurl.com/oks5uo6
...Dr.Birge: PhD, Vice Chair, Professor, Dept of Molecular, Biochemistry & Molecular Genetics, Rutgers Univ.
Known Upcoming Events...
Jan9: AACR's The Function of Tumor Microenvironment in Cancer Progression Conf., SanDiego http://tinyurl.com/oo37gwr
...Dr. Rolf Brekken (UTSW, PPHM SAB): “Antibody mediated blockade of PS synergizes with immune checkpoint blockade by inhibiting multiple immune suppressive mechanisms”
.....note: the chair in Dr.Brekken's “Actions of Innate & Adaptive Immunity” session is Dr. Joan Massague, DIRECTOR of The Memorial Sloan Kettering Inst.
Jan25: Phacilitate's Immunotherapy World Conf., WashDC http://tinyurl.com/zjd7h4n
...3:40-3:55pm, Dr. Jeff Hutchins (VP/PreClinRes): “Combination Immunotherapies - Opening the Gate: Increasing Tumor Infiltrating Activated T-cells to Optimize & Expand the Benefits of Immune Checkpoint Therapies”
Jan26: GTCbio's Novel Immunotherapeutics Summit, San Diego http://tinyurl.com/z3dyful
...10am, Dr. Bruce Freimark (ResDir./Preclin.Oncology): “Blockade of PS Enhances the Anti-Tumor Activity of Targeted Therapy & Immune Checkpoint Inhibitors by Reducing Immunosuppressive Cells in the Tumor Microenvironment”
Jan26-28/Avid/Booth20: CASSS' 20th Symposium on the Interface of Reg.&Anal. Sciences for Biotech Health Products, WashDC http://www.casss.org/?WCBP1600
Mar8: CHI’s Inaugural Cancer Immunotherapy Conf., SanFran http://tinyurl.com/hlskng8
...3:55pm, Dr. Jeff Hutchins (VP/PreClinRes), Track Chair: “Combination Immunotherapies – Opening the Gate: Increasing Tumor Infiltrating Activated T-Cells to Optimize & Expand the Benefits of Immune Checkpoint Therapies”
~Mar10: FY'16Q3 (qe 1-31-16) Financials & Conf. Call http://ir.peregrineinc.com/events.cfm
Mar14-17/Avid/Booth712: IBC's BioProcess Intl. West, Oakland http://www.ibclifesciences.com/BPIWest/overview.xml
Mar16: Immune Checkpoint Inhibitors Conf., Boston http://tinyurl.com/hzjjs2u (Peregrine is 1 of 8 Corp. Sponsors)
...2pm, Dr. Jeff Hutchins (VP/PreClinRes): “Enhancing the Power of Checkpoint Inhibition by Simultaneously Blocking Upstream & Downstream Targets: The Role of PS, a Novel, Global Immune Checkpoint”
??Apr16-20: AACR 2016, New Orleans http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=63
??Jun3-7: ASCO 2016, Chicago http://am.asco.org
Jun6-9/Avid/Booth5562: BIO Intl. Convention, SanFran http://convention.bio.org
~Jul12: FY'16Q4 (fy/e 4-30-16) Financials & Conf. Call http://ir.peregrineinc.com/events.cfm
PPHM's Jeff Hutchins(VP/PreClinRes) speaking 3-16-16 at Immune Checkpoint Inhibitors Conf. (Boston).
Mar15-17 2016: Immune Checkpoint Inhibitors Conf., Boston
http://immune-checkpoint.com (Peregrine is 1 of 8 Corp. Sponsors)
3-16-16: Clinical Stream: “Enhance Combination Strategies to Maximize Efficacy”
11am: Patrick Ott, DANA-FARBER, “Critically Evaluate Mult. CI's in Combination”
11:30am: David Kaufman, MERCK, “Next-Gen.Biomarkers for the Era of Combo Cancer Immunotherapy”
12pm: Jon Wigginton, MACROGENICS, “Releasing the Brake: Enhancing Immunotherapy Through Rational Combos w/CI's”
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2pm: Jeff Hutchins (PEREGRINE/VP-PreClinRes), “Enhancing the Power of Checkpoint Inhibition by Simultaneously Blocking Upstream & Downstream Targets: The Role of Phosphatidylserine (PS), a Novel, Global Immune Checkpoint”
* Inhibiting PS using Bavituximab, a novel PS-signaling pathway inhibitor, blocks the immunosuppressive signal within the tumor microenvironment
* Assessing impact of immune stimulation through Fc?-receptor interaction on immune modulating cells
* Effects on multiple other immune effector cells will be presented
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2:30pm: Dirk Brockstedt, ADURO BIOTECH, “Discovery & Validation of the Next Generation of ICI's”
1-6-16: Peregrine enters Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN), via a $2mm research grant to NCCN's Oncology Research Program (ORP). Will “significantly expand our clinical evaluation of bavituximab and augment Peregrine's internal IST program” at “26 of the world's leading cancer centers”.
1-6-16: Peregrine Pharmaceuticals and National Comprehensive Cancer Network (NCCN) Form Clinical Collaboration to Evaluate Novel Cancer Treatment Combinations With Bavituximab
• NCCN Alliance Includes 26 Leading Cancer Centers and World-Class Thought Leaders on Innovative Cancer Combination Therapies
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=949024
TUSTIN, Jan. 6, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced a new research collaboration with the National Comprehensive Cancer Network (NCCN) [ http://www.nccn.org ] to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors. NCCN, a not-for-profit alliance of 26 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.
Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine's PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight cancer. According to Peregrine, a broad set of preclinical and translational data has been assembled that supports the ability of bavituximab to improve the therapeutic activity of a range of cancer treatments, from traditional approaches, such as chemotherapy and radiation, to novel immuno-oncology agents such as checkpoint inhibitors.
"This collaboration with NCCN will allow us to significantly expand our clinical evaluation of bavituximab and augment Peregrine's internal investigator sponsored trial (IST) program," said Steven W. King, President and CEO of Peregrine. "Importantly, NCCN shares our strong research interest in evaluating unique bavituximab combination therapies for the treatment of cancer, and the group's oversight of the program will allow for the conducting of many more studies than would have been otherwise possible."
"NCCN is very pleased to collaborate with Peregrine Pharmaceuticals on their first-in-class novel targeted monoclonal antibody, bavituximab," said Robert C. Young, MD, Interim Vice President, ORP, NCCN. "We look forward to a productive interaction in both clinical and pre-clinical studies undertaken at the NCCN Member Institutions."
Peregrine expects results from this collaboration to further support the ongoing development of bavituximab as a key component of various combination cancer treatments. Bavituximab is currently being evaluated in combination with docetaxel (chemotherapy) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in the ongoing Phase III SUNRISE trial. In addition, as part of its recently formed collaboration with AstraZeneca, Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in patients with previously treated squamous or non-squamous NSCLC. The company will also be evaluating bavituximab with chemotherapy combinations in HER2-negative breast cancer.
About Bavituximab: A Targeted Investigational Immunotherapy
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab blocks PS, which is believed to remove this immunosuppressive signal and send an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in robust anti-tumor immune responses.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials focused on the treatment of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of previously treated non-small cell lung cancer (the "SUNRISE trial") along with several ongoing and planned company-sponsored trials evaluating other treatment combinations and additional oncology indications. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
About the National Comprehensive Cancer Network [ http://www.nccn.org ]
The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 26 of the nation's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.
The NCCN Member Institutions are: Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.
Clinicians, visit http://NCCN.org . Patients and caregivers, visit http://NCCN.org/patients .
Safe Harbor *snip*
• Jay Carlson Peregrine Pharmaceuticals, Inc. 800-987-8256 info@peregrineinc.com
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
= = = = = = = = =NCCN's 1-6-16 PR:
1-6-16: NCCN Awarded $2 Million in Research Funding from Peregrine Pharmaceuticals to Study Bavituximab in Various Cancers
• The NCCN Oncology Research Program (ORP) was awarded a $2-million grant from Peregrine Pharmaceuticals, Inc. to facilitate studies of bavituximab in various cancers.
http://www.nccn.org/about/news/newsinfo.aspx?NewsID=565
FORT WASHINGTON, PA —The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) has been awarded a $2-million grant from Peregrine Pharmaceuticals, Inc. to study bavituximab, a first-in-class treatment approach for various cancers.
“NCCN is very pleased to collaborate with Peregrine Pharmaceuticals on their first-in-class novel targeted monoclonal antibody, bavituximab,” said Robert C. Young, MD, Interim Vice President, ORP, NCCN. “We look forward to a productive interaction in both clinical and pre-clinical studies undertaken at the NCCN Member Institutions.”
“This collaboration with NCCN will allow us to significantly expand our clinical evaluation of bavituximab and augment Peregrine’s internal investigator sponsored trial (IST) program,” said Steven W. King, President and CEO, Peregrine. “Importantly, NCCN shares our strong research interest in evaluating unique bavituximab combination therapies for the treatment of cancer, and the group’s oversight of the program will allow for the conducting of many more studies than would have been otherwise possible.”
Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine’s PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight canceri. According to Peregrine, a broad set of pre-clinical and translational data has been assembled that supports the ability of bavituximab to improve the therapeutic activity of a range of cancer treatments, from traditional approaches, such as chemotherapy and radiation, to novel immuno-oncology agents such as checkpoint inhibitors.
The first phase of the program will involve the establishment of an NCCN Bavituximab Request for Proposals Development Team to evaluate existing data and to discuss and define the data and type of studies necessary to further characterize the safety and clinical effectiveness of bavituximab.
The NCCN ORP draws on the expertise of the investigators of the NCCN Member Institutions and NCCN Affiliate Research Consortium (ARC) to facilitate all phases of clinical research. This research is made possible by collaborations with pharmaceutical and biotechnology companies in order to advance therapeutic options for patients with cancer.
The NCCN ORP will utilize the grant from Peregrine Pharmaceuticals to support investigator-initiated clinical and correlative studies at NCCN Member Institutions and their affiliate community hospitals for bavituximab. To date, this successful research model has received approximately $58 million in research grants and supported more than 132 studies that have produced a number of publications in peer-reviewed journals.
To learn more about the NCCN ORP and ongoing clinical trials, visit http://NCCN.org/ORP .
*end*
CP, most all the other speakers have pictures too, not just Dr. Hutchins!! (I only POSTED Dr. Hutchins' picture!)
See AGENDA:
http://www.immunotherapyforum.com/Content/Agenda/10/
Jan25-27 2016: “Phacilitate's Immunotherapy World Conf.”, WashDC
http://www.immunotherapyforum.com/Content/Conference
---------
Jan25(Day1): Focus Session1, “Cellular Cancer Immunotherapy: Optimizing Combination Therapy Development Strategy”
2:40-2:55pm: Chair's intro, David Lebwohl, NOVARTIS
2:55-3:10pm: Michael Hanna, VACCINOGEN, “The Provocative Issues of Tumor Heterogeneity on Active Specific Immunotherapy...”
3:10-3:25pm: Laura Benjamin, ELI LILLY, “Challenges/Opportunities for Translational Science to Guide Angiogenesis/Combos w/Immunotherapy”
3:25-3:40pm: Taylor Schreiber, HEAT BIOLOGICS, “Dual-Acting Immunotherapy with ComPACT - Vaccination & Co-Stimulation...”
-------
1-25-16 3:40-3:55pm: Jeff T. Hutchins (PEREGRINE'S VP/PreClinRes), “Combination Immunotherapies - Opening the Gate: Increasing Tumor Infiltrating Activated T-cells to Optimize and Expand the Benefits of Immune Checkpoint Therapies”
* Analyzing complimentary mechanisms in therapeutics and building solid partnerships
* Utilizing scientifically-driven data to build a product value story
* Demonstrating how a product fits within a treatment in combination(s) and against competitive therapies
-------
3:55-4:20pm: Robert Preti, PCT(CALADRIUS), “What Does Commercialization Look Like?”
JJ, they didn't just announce 90+% Enrollment in the CC – it's part of the 12-10-15 Press Release:
12-10-15 PR: ”Peregrine Pharmaceuticals Reports Financial Results for Q2/FY2016 and Recent Developments”
...
Clinical Development Highlights
As of today, more than 90% of the planned number of patients have been enrolled in the Phase III SUNRISE trial, representing a sufficient number of patients required to trigger the 2 pre-planned interim analyses as well as the final analysis for trial unblinding. The company expects to reach the trial's estimated enrollment of 582 patients in the coming weeks.
http://tinyurl.com/jkp885g
BTW, TO ME “More than 90%” could easily be 91% or 92% or 93% or even 94% - we don't know. We just know it's enough to trigger both Interims AND FINAL UNBLINDING.
PPHM's Jeff Hutchins(VP/PreClinRes) speaking 3-8-16 at CHI’s Inaugural-Cancer-Immunotherapy Conf. (SanFran). Dr. Hutchins is chairing the “Emerging Strategies For Checkpoint Inhibitor Combination Immunotherapy” track…
Mar6-11 2016: “CHI’s 23rd Molecular Med. TRI-CON 2016”, SanFran http://www.triconference.com
"Attracting over 3,300 drug discovery & dev. professionals from over 40 countries in 2015, the Tri-Conference has grown into a diverse event, focusing on Molecular Medicine, specifically on Discovery, Genomics, Diagnostics, and Info. Technology."
CHI = Cambridge Healthtech Institute http://www.healthtech.com
INAUGURAL CANCER IMMUNOTHERAPY CONF. - Emerging Biology, Targets and Strategies
Mar7–9 2016 (part of the 23rd Intl. Molecular Medicine Tri-Conf.)
http://www.triconference.com/Cancer-Immunotherapy
Track: EMERGING STRATEGIES FOR CHECKPOINT INHIBITOR COMBINATION IMMUNOTHERAPY
Chairperson: Jeff T. Hutchins (PhD, VP/PreclinRes., Peregrine Pharm.)
3-8-16 2pm: Chairperson Jeff Hutchins' Remarks
3-8-16 3:55pm: “Combination Immunotherapies – Opening the Gate: Increasing Tumor Infiltrating Activated T-Cells to Optimize and Expand the Benefits of Immune Checkpoint Therapies” Jeff T. Hutchins (Peregrine)
OVERVIEW: PD-1 & CTLA-4-targeting drugs have significantly improved patient survival in both melanoma and NSCLC, although their efficacy has been limited to a minority of subjects. Phosphatidylserine (PS)-targeting antibodies have demonstrated the ability to override tumor immune suppression and reactivate immune responses when combined with immunotherapies, chemotherapies, radiation, and targeted treatments. Recent translational data demonstrate the potential of PS-targeting antibodies to mediate immune activation and improved anti-tumor responses in low PD-L1 tumor samples.
PPHM's Jeff Hutchins(VP/PreClinRes) speaking 1-25-16 at Immunotherapy World Conf. (WashDC). “750 deal-makers will gather to discuss the direction, future and value of cell, gene and immunotherapy portfolios.”
Jan25-27 2016: “Phacilitate's Immunotherapy World Conf.”, WashDC
http://www.immunotherapyforum.com/Content/Conference
“After years of posting impressive clinical results and pushing analyst projections to greater and greater heights, immuno-oncology has solidified its status as the most exciting development in cancer treatment for a long time. Now that checkpoint inhibitors have uncloaked cancer cells, drug developers are investigating dozens of immune drug cocktails (everything from CAR-T to antibodies, vaccines and other cellular therapies) to find well-tolerated treatments which could become the first-in-line to fight cancer in patients. We have all heard of the stunning breakthroughs at ASCO'15. BMS’ Opdivo + Yervoy study which lead to a 58% shrinkage of tumors and a PFS superiority of 8.6mos. against monotherapies in patients with melanoma. AstraZeneca’s own PD-L1 (MEDI4736/durvalumab) [see 10-15-15 AZN/PPHM Collab. Expansion: http://tinyurl.com/q79bkam ] and CTLA-4 (Tremelimumab) inhibitor combination, which demonstrated an ORR of 27% in the treatment of NSCLC… On Jan25-27 2016, 750 deal-makers will gather in the Grand Hyatt Hotel to discuss the direction, future and value of cell, gene and immunotherapy portfolios.”
---------
Jan25(Day1): Focus Session1, “Cellular Cancer Immunotherapy: Optimizing Combination Therapy Development Strategy”
2:40-2:55pm: Chair's intro, David Lebwohl, NOVARTIS
2:55-3:10pm: Michael Hanna, VACCINOGEN, “The Provocative Issues of Tumor Heterogeneity on Active Specific Immunotherapy...”
3:10-3:25pm: Laura Benjamin, ELI LILLY, “Challenges/Opportunities for Translational Science to Guide Angiogenesis/Combos w/Immunotherapy”
3:25-3:40pm: Taylor Schreiber, HEAT BIOLOGICS, “Dual-Acting Immunotherapy with ComPACT - Vaccination & Co-Stimulation...”
-------
1-25-16 3:40-3:55pm: Jeff T. Hutchins (PEREGRINE'S VP/PreClinRes), “Combination Immunotherapies - Opening the Gate: Increasing Tumor Infiltrating Activated T-cells to Optimize and Expand the Benefits of Immune Checkpoint Therapies”
* Analyzing complimentary mechanisms in therapeutics and building solid partnerships
* Utilizing scientifically-driven data to build a product value story
* Demonstrating how a product fits within a treatment in combination(s) and against competitive therapies
-------
3:55-4:20pm: Robert Preti, PCT(CALADRIUS), “What Does Commercialization Look Like?”
Somebody posted this today to the Bus./Investing section of some gun site (??weird!) – just a very nice, summary of all aspects of Peregrine at the moment. Very professionally done - I don't see a single inaccuracy or stretch. Whoever wrote this follows the company very carefully.
1-4-16/user=CKA, "BIO Stock, 2016 Play Out: Peregrine Pharma": All IMO, please do your own due diligence when inventing your own coin. BIO stocks are high risk/high yield.
I've started following this stock in early 2015. I'm long on this stock and have a positive feel for what could be in store for 2016. It will very likely be making or breaking this year, the company Peregrine Pharmaceuticals (PPHM). Would welcome anyone's thoughts regarding this stock, or just use this as a heads up. The summary below is a bit long (I could easily add more), sorry tl/dr crowd, take it or leave it.
Their lead molecule, Bavituximab, is an immunotherapy MAB that targets PS (phosphatidylserine) exposed on all cancer and most, if not all, viruses (HIV, HepC, Ebola, etc.). Bavi is a checkpoint inhibitor like Opdivo (as see on TV ads recently) and Keytruda (cured Jimmy Carter's Melanoma) in that it blocks PS which causes suppression of the immune system. However, it has a component that none of the others have, an immune stimulating side that generates/promotes cancer killing cells in the tumor environment. For a quick video on the method of action of bavi see here ( https://vimeo.com/84073332 ), a bit wordy on medical speak, but explains much more thoroughly.
In the lab there also have been tests confirmed that due to the immune stimulating component of bavi adaptive immunity is achieved, at least as shown in lab mice where tumors in mice have been stopped after given bavi (complete remission), were reintroduced to the same cancer and "ended up living of old age". In other words the immune system recognized the cancer when it came back and was able to successfully attack it without being given bavi; adaptive immunity (like your body does with a virus; i.e. flu vaccine). Very exciting if proven true in humans with cancer too.
Peregrine is in the 25th month of their stage III clinical trial (named SUNRISE) for non squamous NSCLC (double blind trial; bavi+chemo vs. chemo+placebo), which has been given fast track designation with 2 early look-ins by the FDA. They announced on their last quarterly conference they are more than 90% enrolled in SUNRISE (~582 total patients) and have enough patients enrolled to generate their 1st and 2nd look-ins (huge risk removed), complete enrollment is said to be in the coming weeks.
In addition they have a version of bavi in testing for PET imaging of tumors. They own all their IP and patents targeting PS in U.S. and Europe and are in final stages of patenting their next generation PS targeting molecule, named for now, Betabodies.
Beyond any early collaboration PRs, PPS drivers could come from 1st look-in when the independent monitoring committee checks the SUNRISE trial for safety/futility (estimated Feb/Mar, a trial continue is expected), much more so by 2nd look-in for trial efficacy (estimated mid year) where the trial could be stopped if bavi shows significant extension of overall patient survive vs. the placebo arm, and if not stopped by the 2nd look-in for sure by final trial data unblinding due at the end of 2016 if bavi's arm shows statistically significant overall survival vs. the placebo arm.
Highlights in 2015 were announced collaborations by Peregrine with Memorial Sloan Kettering for combination studies with bavi (ranked 2015's world #1 cancer institute) as well as with AstraZeneca in which they announced 2 trials with their PD-L1 checkpoint inhibitor Durvalumab set to start in 2016. Both big name collaborations should give some degree of confidence for what they have seen behind the curtains in bavi to associate their name with such a small clinical trail company; not forgetting to mention that AstraZeneca is letting small Peregrine run both trials and is providing free Durvalumab ($100K/patient)... A stage III breast cancer trial with bavi and chemo should also be starting in next coming days/weeks, which was recently announced.
If SUNRISE is stopped at either of the early look-ins for efficacy (to start new drug application) it will confirm its MOA (method of action) and its stock price should begin a very interesting and sustained accent due to the likely hood of bavi being a cornerstone molecule with extraordinary safety profile that combines with many others and can be used for many indications due to how universal a target PS is... could it be the perfect suitor for Gilead's ( http://www.fool.com/investing/general/2015/06/30/the-overlooked-reason-why-i-think-gilead-sciences.aspx ) now 20+ billion in cash burning a hole in their pocket shopping for their next cornerstone molecule?
*end*
http://www.ar15.com/forums/t_1_133/1824245_.html
Rolf Brekken (PPHM/SAB) speaking 1-9-16 at Special AACR Tumor Microenvironment Conf. in San Diego. Note that the chair of Session5 that our Dr. Brekken is speaking in is Dr. Joan Massague, who is the DIRECTOR of Memorial Sloan Kettering Institute.
Jan7-10 2016: “AACR's The Function of Tumor Microenvironment in Cancer Progression Conf.”, SanDiego
“This AACR Special Conference will focus on discussing the emerging concepts in stromal cell and ECM heterogeneity, stromal cell metabolism, early events in carcinogenesis involving contributions from tumor cells and their microenvironment, stress responses to oxygen and nutrient gradients, translational impact of targeting the microenvironment, tumor immunity and immunotherapy.”
http://www.aacr.org/Meetings/Pages/Program-Detail.aspx?EventItemID=73&DetailItemID=419
1-9-16 10:30am-12:45pm: Plenary Session 5: “Actions of Innate & Adaptive Immunity”
Chairperson: Joan Massague**, Memorial Sloan Kettering Inst.
1. Tak Mak, Univ./Toronto, “Beyond checkpoint blockade: Emerging strategies”
2. Elizabeth Jaffee, Johns Hopkins, “Tipping the balance from a procarcinogenic to...”
3. Jeffrey Molldrem, MD Anderson, “T cell receptor-like antibody 8F4 targets leukemia...”
4. Joan Massague, MSK-CC, “Latency & immune evasion of metastatic stem cells”
5. Rolf A. Brekken (PPHM SAB), UTSW-MC/Dallas, “Antibody mediated blockade of phosphatidylserine synergizes with immune checkpoint blockade by inhibiting multiple immune suppressive mechanisms”
- - - - - - -
**Dr. Joan Massague is not just some doc from MSK, he is the DIRECTOR OF THE SLOAN KETTERING INSTITUTE and a very well-known scientist.
http://www.mskcc.org/research-areas/programs-centers/ski/director-joan-massague
Here is a video of Dr. Massague talking about the “Next Wave” of cancer research: https://www.mskcc.org/research-areas/programs-centers/ski
= = = = = = = = = =
5-29-15: Peregrine & Sloan Kettering Enter Collab. to “Investigate Novel PS-Targeting Immunotherapy Combos” http://tinyurl.com/qxu4w2x
7-14-15 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/nw2v5u6
...CEO S.King: “We recently entered into collaboration with investigators at Memorial Sloan Kettering Cancer Ctr to continue expanding on this important work, as well as to explore other potential applications of bavituximab and other agents that target PS-signaling pathway.”
9-9-15 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/ph22vdn
...CEO S.King: “The Memorial Sloan Kettering & AstraZeneca collaborations are an important part of our announced plans to expand our bavituximab clinical pgm.”
= = = = = = = = =
BAVI MOA 5-28-14: Dr. Rolf Brekken’s 47min CRI “Cancer Immunotherapy” webinar about Bavituximab as an Upstream/Global Immune Checkpoint Inhibitor – REPLAY: http://tinyurl.com/lxgftyx
. . .CRI=Cancer Research Institute (NYC – Supported by BMS): http://www.cancerresearch.org - Facebook: http://tinyurl.com/pbmhb2z , https://twitter.com/CancerResearch
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
. . .8-12-14: CRI adds Youtube links to the 5-28-14 CRI Immunotherapy webinar, incl. Dr. Brekken's talk "about Bavi and how it works against lung, liver, and other kinds of cancers" http://tinyurl.com/ps5h6h8
BAVI MOA 3-25-14: Dr. Rolf Brekken’s 40min talk at NYAS Lung Cancer Symposium http://tinyurl.com/lq9stnk (45 Slides)
. . .Dr.Brekken’s talk: “Antibody-mediated Inhibition of PS - A Novel Strategy for Immune Checkpoint Blockade” (the 5 speakers: Jessica Donington, Roy Herbst, Balazs Halmos, Suresh Ramalingam, Rolf Brekken)
Thanks, ExW, I remember getting irritated w/you about a year ago about something I thought wasn't right. For that, I apologize, since watching you closely since then, it's become clear to me you're a straight shooter who desires truth, and a valuable asset to this board. Thanks for your contributions.
Thank Ye, Sir Loofman!! Undeserved, but who in their right mind would ever turn down a jug of Kentucky's BEST!! Can't Wait!
The REAL WINNER here, is of course, (((Our Brother Krakonos))). Our Thoughts & Prayers constantly go out to you, Krak.
Thanks, Loofman - very much appreciated. Hic!
3 Types of Interim Analyses: SAFETY, FUTILITY, EFFICACY. (SAFETY being a continuous DMC concern).
During a clinical trial, we can perform interim analysis (or DMC, DSMB review) for 3 different reasons:
Interim analysis for SAFETY:
1) with pre-specified stopping rule (for example stop the trial if we see # of cases of Serious Adverse Events)
2) without pre-specified stopping rule (rely on DMC members to review the overall safety)
Interim analysis for FUTILITY ["INFERIORITY"]: To see if the new treatment is unlikely to beat the control – then stop the trial for futility - this is called ‘futility analysis’.
Interim analysis for EFFICACY ["SUPERIORITY"]: To see if the new treatment is overwhelmingly better than control - then stop the trial for efficacy.
In situations 2 & 3, the criteria for stopping rule for efficacy could be different from the stopping rule for futility, but need to be pre-specified.
More: http://onbiostatistics.blogspot.com/2012/03/futility-analysis-in-clinical-trials.html
= = = = = = =
6-1-15 PR: BAVI CLINICAL TRIALS EXPANSION http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915699
SUNRISE Phase III Pivotal Trial
The company's Phase III SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) is an approximately 600 patient trial that continues to enroll at over 150 sites worldwide. Completion of enrollment is anticipated by calendar year-end. This Phase III, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety, tolerability and efficacy of bavituximab as a second-line treatment in patients with non-squamous NSCLC. Enrollment is proceeding according to plan with 2 planned interim efficacy analyses which will be reviewed by the trial's Independent Data Monitoring Committee (IDMC). The 1st interim analysis, which will be conducted when 33% of the targeted overall survival events are reached, is for futility and the 2nd interim analysis, for futility or superiority [Superiority=EFFICACY], will be conducted at 50% of events. As these analyses are event driven, the exact timing of each is unknown, however the company plans to provide updates as these events are reached. For additional information about the SUNRISE trial, please visit http://www.sunrisetrial.com or ClinicalTrials.gov using the Identifier NCT01999673. => http://www.clinicaltrials.gov/ct2/show/NCT01999673
12-10-15: “Sunrise >90% enrolled; sufficient to allow the 2 planned interim looks (33%/50%) and final readout based on PrimEndPt=OS”
“The next milestones are the interim analyses that will be conducted when 33% & 50% of the targeted number of deaths are reached. While these are event driven, it is our expectation that the 1st interim analysis will read out in early 2016 and the 2nd interim analysis around mid-2016. The final analysis, which will trigger study unblinding, is currently projected to occur at the end of 2016.
http://tinyurl.com/jkp885g
Rolf Brekken (PPHM/SAB) speaking 1-9-16 at Special AACR Tumor Microenvironment Conf. in San Diego…
Jan7-10 2016: “AACR's The Function of Tumor Microenvironment in Cancer Progression Conf.”, SanDiego
“This AACR Special Conference will focus on discussing the emerging concepts in stromal cell and ECM heterogeneity, stromal cell metabolism, early events in carcinogenesis involving contributions from tumor cells and their microenvironment, stress responses to oxygen and nutrient gradients, translational impact of targeting the microenvironment, tumor immunity and immunotherapy.”
http://www.aacr.org/Meetings/Pages/Program-Detail.aspx?EventItemID=73&DetailItemID=419
1-9-16 10:30am-12:45pm: Plenary Session 5: Actions of Innate & Adaptive Immunity
Chairperson: Joan Massague, Memorial Sloan Kettering CC
1. Tak Mak, Univ./Toronto, “Beyond checkpoint blockade: Emerging strategies”
2. Elizabeth Jaffee, Johns Hopkins, “Tipping the balance from a procarcinogenic to...”
3. Jeffrey Molldrem, MD Anderson, “T cell receptor-like antibody 8F4 targets leukemia...”
4. Joan Massague, MSK-CC, “Latency & immune evasion of metastatic stem cells”
5. Rolf A. Brekken (PPHM SAB), UTSW-MC/Dallas, “Antibody mediated blockade of phosphatidylserine synergizes with immune checkpoint blockade by inhibiting multiple immune suppressive mechanisms”
= = = = = = = = =
BAVI MOA 5-28-14: Dr. Rolf Brekken’s 47min CRI “Cancer Immunotherapy” webinar about Bavituximab as an Upstream/Global Immune Checkpoint Inhibitor – REPLAY: http://tinyurl.com/lxgftyx
. . .CRI=Cancer Research Institute (NYC – Supported by BMS): http://www.cancerresearch.org - Facebook: http://tinyurl.com/pbmhb2z , https://twitter.com/CancerResearch
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
. . .8-12-14: CRI adds Youtube links to the 5-28-14 CRI Immunotherapy webinar, incl. Dr. Brekken's talk "about Bavi and how it works against lung, liver, and other kinds of cancers" http://tinyurl.com/ps5h6h8
BAVI MOA 3-25-14: Dr. Rolf Brekken’s 40min talk at NYAS Lung Cancer Symposium http://tinyurl.com/lq9stnk (45 Slides)
. . .Dr.Brekken’s talk: “Antibody-mediated Inhibition of PS - A Novel Strategy for Immune Checkpoint Blockade” (the 5 speakers: Jessica Donington, Roy Herbst, Balazs Halmos, Suresh Ramalingam, Rolf Brekken)
AZN is providing durvalumab “free of charge” for the upcoming PPHM/AZN collab. Ph2/2ndLine-NSCLC Trial. To me, that's CASH to Peregrine.
12-15-15/BioWorld: “If You Can't Beat 'em, Join 'em; Looking for Immuno-onc Boost”
By Brian Orelli, BioWorld Staff Writer
...
Earlier this year, Peregrine partnered up with Astrazeneca to test the pharma's anti-PD-L1 immune checkpoint inhibitor, durvalumab, with bavituximab, after preclinical data suggested that the combination might help even if tumors don't initially express PD-L1. By removing the phosphatidylserine checkpoint, the immune system is activated, but the tumor can then use PD-L1 to inhibit the immune system. Durvalumab should help perpetuate the bavituximab-induced immune response, while boosting the opportunity for durvalumab in tumors that are not expressing PD-L1 until the bavituximab treatment. "It's sort of a win-win situation," King said. ...
King said he thinks that bavituximab will likely work with any of the drugs targeting the PD-1 pathway, but decided to work with London-based Astrazeneca rather than one of the FDA-approved drugs, in part, because Astrazeneca was willing to provide the drug free of charge. ”We save probably as much as we're spending because of the cost of these drugs," King said.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=119200003
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10-15-15: Peregrine & AstraZeneca Expand Collab. w/Ph2/2ndLine-NSCLC Trial, Bavi+durvalumab(MEDI4736), squamous or non-squamous. http://tinyurl.com/q79bkam
8-24-15: AstraZeneca & Peregrine Collaborate on Bavi+Durvalumab Ph1/1B Trial for “multiple solid tumors” http://tinyurl.com/owlxpsf
...Durvalumab=MEDI4736(anti-PD-L1 immune checkpoint inhibitor). AZN’s Head/I-O(Robert Iannone): “Our partnership with Peregrine provides the opportunity to explore an exciting, novel combination that could deliver important clinical benefit to patients across a range of cancers."
5-29-15: Peregrine & Sloan Kettering Enter Collab. to “Investigate Novel PS-Targeting Immunotherapy Combos” http://tinyurl.com/qxu4w2x
Bruce Freimark (Dir/PreClin-Oncology) speaking 1-26-16 at GTCbio's Novel-Immunotherapeutics-Summit, SanDiego
Jan25-26 2016: “GTCbio's Novel Immunotherapeutics Summit”, San Diego
https://www.gtcbio.com/conferences/immunotherapeutics-summit-overview
GTC = Global Technology Community https://www.gtcbio.com/about-us
4 Sub-Conferences, including: 8TH IMMUNOTHERAPEUTICS & IMMUNOMONITORING
1-26-15: SESSION: ”Combinatorial Immunotherapies” - Moderator: Bruce Freimark, Peregrine Pharm.
4 Speakers:
*9:35am “DNA Vaccines with T-Cell Checkpoint Blockade”, Douglas McNeel, UNIV./WISCONSIN
*10:00am “Blockade of Phosphatidylserine Enhances the Anti-Tumor Activity of Targeted Therapy & Immune Checkpoint Inhibitors by Reducing Immunosuppressive Cells in the Tumor Microenvironment”, Bruce Freimark (Res.Dir./Preclin.Oncology), PEREGRINE PHARMACEUTICALS
Abstract: The underlying cause for the failure of immune checkpoint blockade is persistent, multifocal immune suppression in the tumor microenvironment. This is due to the absence of pre-existing antitumor Teff because of the action of immune checkpoints that induce immunosuppressive cytokines and recruit tumor infiltrating myeloid-derived suppressor cells (MDSCs), regulatory T cells (Treg), and M2 macrophages. Phosphatidylserine (PS) is segregated to the inner leaflet of the plasma membrane but becomes externalized to the outer leaflet in tumor cells where it contributes as an upstream checkpoint inhibitor to an immunosuppressive environment. Antibody blockade of PS reprograms the immune cells in the tumor microenvironment to support immune activation. Antibody-mediated PS blockade reduces the levels of MDSCs, TGF-beta, and IL-10 and increases the levels of TNF-alpha and IL-12. PS blockade also re-polarizes tumor-associated M2 macrophages to a M1 phenotype which promotes the maturation of dendritic cells and induces of adaptive T-cell responses. PS targeting antibodies enhance the anti-tumor activity of anti-CTLA-4 and anti-PD-1 antibodies in models of melanoma and breast cancer and correlates with an increase in the infiltration of activated T cells and the induction of adaptive immunity. In summary, PS blockade in combination with targeted therapy and other immune checkpoint inhibitors promotes a localized, anti-tumor response and represents a promising strategy to enhance cancer immunotherapy.
*10:25am “Cancer Vaccines in the Era of Checkpoint Blockade”, Willem Overwijk, MD.ANDERSON
*11:20am “Myeloid-Derived IL-10 & PD-1 Create a Vicious Immune...”, Keith Knutson, MAYO CLINIC
= = = = = = = = = = =OTHER KNOWN UPCOMINGS (2016):
Jan26: “GTCbio's Novel Immunotherapeutics Summit”, San Diego http://tinyurl.com/z3dyful
...10am, Dr. Bruce Freimark(ResDir./Preclin.Oncology): “Blockade of Phosphatidylserine Enhances the Anti-Tumor Activity of Targeted Therapy & Immune Checkpoint Inhibitors by Reducing Immunosuppressive Cells in the Tumor Microenvironment”
Jan26-28/Avid/Booth20: CASSS' 20th Symposium on the Interface of Reg.&Anal. Sciences for Biotech Health Products, WashDC http://www.casss.org/?WCBP1600
Mar6-11: CHI’s 23rd Molecular Med TRI-CON 2016, SanFran http://www.triconference.com (Speaker: Dr. Jeff Hutchins, VP/Preclin.Res.)
~Mar10: FY'16Q3 (qe 1-31-16) Financials & Conf. Call http://ir.peregrineinc.com/events.cfm
Mar14-17/Avid/Booth712: IBC's BioProcess Intl. West, Oakland http://www.ibclifesciences.com/BPIWest/overview.xml
Mar15-17: Immune Checkpoint Inhibitors Conf., Boston http://immune-checkpoint.com (Peregrine is 1 of 4 Corp. Sponsors; Speaker: Dr. Jeff Hutchins, VP/Preclin.Res.)
Jun6-9/Avid/Booth5562: BIO Intl. Convention, SanFran http://convention.bio.org
= = = = = = = = = =PREVIOUS BAVI MOA PRESENTATIONS:
11-9-15 SITC'15: New Bavi+Checkpoint Inhibitors preclin. data (UTSW/DUKE's Herbert K. Lyerly) http://tinyurl.com/pbof95w
...Also, collab. with Dr. Bernard Fox (Immunotherapist/Earle A. Chiles Res.Inst.) on new Immuno-Profiling Clinical Test (Opal 6-plex quantitative IF Assay), PPHM roundtable with Raymond Birge (Rutgers), Douglas Graham (Emory), Dmitry Gabrilovich (Wistar), Rolf Brekken (UTSW), Maria Karasarides (AstraZeneca) - ”Combining Bavi w/anti-PD-1 significantly enhanced O/S… significant incr. CD45+, CD8+ and CD3+ T-cells… led a prolonged anti-tumor immune response which protected the animals against a re-challenge w/same tumor.”
BAVI MOA 8-26-15: Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar” - 7 panel members, incl. 3 Sloan Kettering researchers http://tinyurl.com/qxu4w2x
BAVI MOA 3-25-15: PPHM/VP Dr. Jeff Hutchins’ presentation at "Immune Checkpoint Inhibitors Conf.", Boston - PDF(34 Slides): http://tinyurl.com/ooxkhq7
BAVI MOA 2-9-15: PPHM/ResDir. Dr. Bruce Freimark’s presentation at KEYSTONE "Tumor Immunology Meeting", Banff/CN – PR & Slides: http://tinyurl.com/q6cx4w6
BAVI MOA 12-12-14 San Antomio Breast Cancer Symposium, Dr. Bruce Freimark, Bavi+anti-PD-1 vs. Breast Cancer http://tinyurl.com/p5ng6vs
BAVI MOA 11-2014 SITC’14: 3 posters on preclin. Bavi+aCTLA4/aPD1 combo data (Hutchins Freimark Brekken Huang etal) http://tinyurl.com/pchzr6h
PTL, those were an excerpt from Rob Garnick's prepared remarks, not in the Q&A. Don't forget, a big part of FDA Approval is have a GMP-compliant Mfg. facility ready to produce for market - that's a very important part of the overall "Bavi Approval" process to RG.
These are All of RG's prepared remarks 12-10-15:
12-10-15 CC: Rob Garnick (Head of Regulatory Affairs): http://tinyurl.com/jkp885g
As we reported in our press release today, our new facility has just been commissioned for the initial phase of GMP manufacturing. I’d like to reiterate that this facility, currently named the Myford facility, is state-of-the-art and its construction was completed for a fraction of the cost of building of comparable facilities. This in and of itself is a major accomplishment and I am very proud of our team for their success in this achievement. Going forward, we expect this facility will be a highly valuable asset for Peregrine & Avid. Initial engineering runs, which will be initiated tomorrow, will be followed by GMP runs prior to process validation for products entering into the facility. GMP material produced in the new facility can be used either in clinical trials or for commercial sale once Peregrine or Avid’s business partners make the appropriate regulatory filings in the territories where they intend to use the product. This generally requires several runs and demonstrating that the product produced in the Myford facility is comparable to product produced in our Franklin facility or in other production facilities. With the Myford site now in the initial phase of GMP manufacturing, we have seen a significant increase in demand for production capacity. Although, we have just opened the doors at Myford, we are already contemplating our options to increase further mfg. capacity. Although no decisions have been made, we are pleased to have what appears to be a growing opportunity in this important area of our business.
On the regulatory side, we are busy to taking the steps necessary to initiate up the new clinical trials that Joe described. To this end, we successfully filed the new IND supporting expanding the bavituximab breast cancer program and subsequently received FDA clearance to commence the study. We have also taken important steps to de-risk our bavituximab/durvalumab combination trials by requesting and receiving critical guidelines from the FDA. It’s been a busy time for the regulatory affairs team, but our recent efforts have put us on track to grow our mfg. business and initiate our newest clinical programs. This concludes my comments and I will now turn the call over to CFO Paul Lytle, who will discuss the company’s financial performance and our Avid Bioservices business.
12-10-15 ROB GARNICK: “With the Myford site (Avid II) now in the initial phase of GMP manufacturing, we have seen a significant increase in demand for production capacity. Although, we have just opened the doors at Myford, we are already contemplating our options to increase further mfg. capacity. Although no decisions have been made, we are pleased to have what appears to be a growing opportunity in this important area of our business.”
12-10-15 STEVE KING(Q&A): “The [further Avid] expansion really is driven by our existing and new clients that have come in, and so obviously primarily that’s driven in the bulk drug substances area not necessarily the fill/finish area. So that'll probably be the primary focus; we have considered and eventually would like to move into the fill/finished business, it's just we’ve been so busy expanding our drug substances business, we really haven’t had the option to do that. For the question of space, there’s space in the current buildings that we’re in, but we’re also looking at other opportunities nearby that fit the same model as we did for the Myford facility and allows us to most efficiently grow the business. At the end of the day it will be a business decision and we’ll take on space as needed to expand the business [Avid III]. Again, it’s all really right now supported by the client base, which has had an extremely positive response to the Myford facility and that’s really driving we think even beyond what we expected going into it.
...G.Zavoico: ”Would you finance that further expansion as sort of debt against the revenue coming in or are you just keeping all your options open for that?”
STEVE KING: “We’re keeping our options wide open. At this point, we’ll do what’s best for the business itself. It’s a nice growing backlog of future revenue, it’s really a change in the way the Avid business can be viewed, as more a long-term go-forward business. So, we just need to make the right business decision based on the cost of capital, whatever avenue that takes, and then we’ll make the right decision.”
http://tinyurl.com/jkp885g
12-10-15/BioPharma: Avid Expansion into MYFORD Facility (Avid II) now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
You said, "The company doesn't even mention partnership discussions anymore." (PPHMVERYLONG 12-19-15 #246187).
On the Dec. 10 2015, Conf.Call PPHM's VP of Business Development, STEVE WORSLEY said,
“We continue our dialog with a number of other world leading pharmaceutical organizations and believe that bavituximab will continue to generate partnering interest. I will now turn the call over to Rob Garnick...”
http://tinyurl.com/jkp885g
"The company doesn't even mention partnership discussions anymore." (PPHMVERYLONG 12-19-15 #246187)... This 9 days ago...
Dec.10 2015/CC: STEPHEN WORSLEY (PPHM's VP/Business Dev.): http://tinyurl.com/jkp885g
SW: “Peregrine’s goal in partnering with these immuno-oncology leaders is to define the broader scope of utility for bavituximab. Through these collaborations, we are actively identifying a range of indications & treatments that will benefit from combination therapy with bavituximab. This will undoubtedly yields important findings in the near-term that will continue to build shareholder value. We continue our dialog with a number of other world leading pharmaceutical organizations and believe that bavituximab will continue to generate partnering interest. I will now turn the call over to Rob Garnick, Peregrine’s Head of Regulatory Affairs, who’ll discuss our drug mfg. & regulatory activities.”
===Preceded by:
SW: “We were very pleased to announce our collaboration with AstraZeneca in August [8-24-15: http://tinyurl.com/owlxpsf ] and were even more delighted to announce the expansion of that agreement in October [10-15-15: http://tinyurl.com/q79bkam ]. We believe that AstraZeneca’s enthusiasm for this program is based on the promise & potential of bavituximab. Copious amounts of positive data have consistently demonstrated bavituximab’s therapeutic value & ability to provide solutions to the limitations of currently available treatments. Today, checkpoint inhibitors are primarily effective in patients with high PD-L1 expression, a minority of all patients being treated. However, translational findings have demonstrated that bavituximab is effective in patients with the lowest PD-L1, PD-1 expressions, highlighting the potential bavituximab to convert patients with the low expression levels who do not respond to anti-PD-1 treatments into responders.”
SW: “In addition to AstraZeneca, such data have also been the impetus for our ongoing collaboration with Memorial Sloan Kettering Cancer [5-21-15: http://tinyurl.com/qxu4w2x ], which is evaluating combinations of bavituximab with other checkpoint inhibitors & immune stimulatory agents for the purpose of developing new & increasingly effective anti-cancer treatments. It has also been the driver for our ongoing work with the Univ. of Texas SW, as well as a number of other ISTs.”