Peregrine Pharmaceuticals, Inc. (PPHM), Tustin CA. http://www.peregrineinc.com is committed to improving the lives of patients by delivering high quality pharmaceutical products through its contract development & mfg. organization (CDMO) services and through advancing and licensing its investigational immunotherapy and related products. Peregrine's in-house CDMO services, including cGMP mfg. & dev. capabilities, are provided through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development & biomfg. services for both Peregrine & 3rd-party customers. The company is also working to evaluate its lead immunotherapy candidate, BAVITUXIMAB, in combination with immune stimulating therapies for the treatment of various cancers, and developing its PROPRIETARY EXOSOME TECHNOLOGY for the detection & monitoring of cancer using assays that are able to detect small amts of PS+ Exosomes in a patient's blood sample.
Bavituximab, a phosphatidylserine(PS)-targeting antibody, represents a new approach to treating cancer (3:34 video).
...Bavituximab was invented by UTSW's Dr. Philip Thorpe (1951-2013), and research continues in Dr. Rolf Brekken's UTSW lab.
...PIPELINE for Bavituximab Oncology a/o 5-9-16: http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
• MOA: By blocking the immunosuppressive signal of exposed PS, Bavi mediates multiple immunostimulatory changes in the tumor environment, including a reduction of tumor-promoting immune cells and an increase in tumor fighting (M1) macrophages, dendritic cells, and cytotoxic T-cells (CD8+ CD45+ CD3+) that fight solid tumors. (see: AACR'15 & ASCO'15 & ImVacS’15 & SITC'15 & S.King/1-18-16 & AACR'16)
• COLLABS: In addition to the ongoing UTSW/Brekken research collab., Peregrine began working w/Mem-Sloan-Kettering in Jul'15(see PR) to investigate “Novel PS-Targeting Immunotherapy Combos”, then w/AstraZeneca in Aug'15(see PR) to run human trials evaluating Bavi+Durvalumab in "mult-solid-tumor-types", and w/The Natl. Comprehensive Cancer Network in Jan'16(see PR) via a $2M res. grant to NCCN which will “significantly expand Peregrine's clinical evaluation of bavituximab” at “27 of the world's leading cancer centers”.
• AVID: Peregrine also operates Avid Bioservices, a wholly owned cGMP CMO subsidiary, which provides contract mfg. services on a fee-for-service basis (revs. May'06-Jan'16=$154.8mm), as well as support of Peregrine's own product pipeline.
Summary of Peregrine's New Collaborations a/o 1-2016: 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) - "trial design under evaluation" as of 5-2015 (pending review & analysis of SUNRISE/Ph3 clinical data and collected biomarker samples)
III. Natl-Comprehensive-Cancer-Network (NCCN) – 1-2016/$2mm grant to NCCN, <=9-6-16 NCCN selects 3 Bavi Trials to beg. Early'17/Moffitt/MassGen/JohnHopkins (see PR).
...??Cancer Moonshot 2020 http://www.cancermoonshot2020.org – see S.King's 1-14-16 EP-Vantage comments: http://tinyurl.com/z59pc6a
...??4-13-16: Sean Parker Donates $250mm to Launch Cancer Immunotherapy Inst. (6 key centers: MSKCC Stanford UCLA UCSF MDA UPenn) http://tinyurl.com/gqmmsud
4-2-13: Peregrine Mourns Loss of Dr. Philip E. Thorpe (1951-2013) http://tinyurl.com/l9gqmt5
"Phil will be sorely missed as a colleague and friend. At Peregrine, each of us is pursuing Phil's dream of bringing important drugs to patients who need them based on his basic research. We are more motivated than ever to see this dream through."
…Dr. Thorpe’s successor at UTSW: long-time colleague, co-inventor of 2C3, Dr. Rolf A. Brekken, PhD - http://www.utsouthwestern.edu/labs/brekken
8-2014: UK colleagues from Chester Beatty Labs(ICR/Univ-London), ICRF(IsraelCancerRes), & UTSW create memorial for Dr.Thorpe in London’s Chelsea Physic Garden: http://tinyurl.com/lon73l7
Yahoo Quote & Profile for PPHM: Yahoo.com/PPHM ...Nasdaq Quote: http://www.nasdaq.com/symbol/pphm ...PPHM Tweets: http://stocktwits.com/symbol/PPHM
• IR: firstname.lastname@example.org: Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 email@example.com, Tim Brons (Media) 415-675-7402 firstname.lastname@example.org
UPCOMING EVENTS: http://ir.peregrineinc.com/events.cfm
Sep22: Phacilitate’s "Immunotherapy Europe" (Strategic Partnering Event), Berlin http://tinyurl.com/hwxax88 <=SK Interview transcript: http://tinyurl.com/j8qrekp
...9:50-10:20am - Steve King is Panelist w/BMS/Merck/Agenus: “Analyzing The Business & Partnering Model in Industry & Academia for the Future Dev. of I-O Combination Therapies”
Sep25-28: 2nd AACR-CRI Intl. Cancer Immunotherapy Conf., NYC http://tinyurl.com/hxtbdfm <=9-27-16/PR re: B019*: http://tinyurl.com/zy9yv78 (Bavi+PD1+LAG3 TNBC)
...Sep26 5:15-7:45pm: Michael J. Gray(PPHM Scientist) poster *B019, “LAG3 is an Immunotherapeutic Target in Murine Triple- Breast Cancers, Whose Activity is Significantly Enhanced in Combo with PS-Targeting Antibodies”
...Sep26 5:15-7:45pm: Dr. Raymond Birge(Rutgers) & PPHM poster B119, “Characterization of a PS, TAM Receptor (Tyro3, Axl, Mertk), PDL1 Axis in Breast Cancer”
Oct4-7/Avid/Booth#716: IBC's BioProcess Intl. Conf., Boston http://www.ibclifesciences.com/BPI/overview.xml & http://tinyurl.com/zyblds7
...10-5-16/8-8:30am: Peter Gagnon (Avid's VP/Process-Svcs), “Across the Great Divide: The Upstream Origins & Downstream Ramifications of a Newly Discovered Contaminant Class”
Oct7-11: 41th ESMO European Cancer Congress, Copenhagen, Denmark http://tinyurl.com/jxdppyo (Oral Pres. of Topline Data from Ph3 SUNRISE trial, incl. initial Biomarker analysis)
...10-10-16 9:15-9:30am: David R. Spigel (CSO/Dir./Sarah Cannon Res. Inst., Nashville) Proffered Oral Presentation, “Top-line Results from Ph3/SUNRISE..." (Senior-Author: David Gerber/UTSW)
......10-10-16 ESMO’16 Topline/Ph3.SUNRISE Data: Biomarker B2GPI/200-240(30%pts) StatSig OS 7.7=>13.2mos. http://tinyurl.com/hp73njt
...10-9-16 1:00-2:00pm: Jeff Hutchins(VP/PreClin.Res), “Antibody Mediated Blockade of PS Improves Immune Checkpoint Blockade...”
Oct13/10am: Annual SHM, Avenue of the Arts Hotel, Costa Mesa – Final Proxy: http://tinyurl.com/gsrmgs2 - ATTENDEE Reports: http://tinyurl.com/ztgxwaz
Nov9-13: (SITC) Society for Immunotherapy of Cancer 31st Annual Meeting, Natl-Harbor MD http://tinyurl.com/j4tw5p9
...”First Results” from our collaboration with Jedd Wolchok Lab investigators (MSK) to be presented” (per 9-8-16/Ccall/Hutchins)
...I. “PS Targeting Antibody in Combo w/Checkpoint Blockade & Tumor Rad. Therapy Promotes Anti-Cancer Activity in Mouse Melanoma” - Sadna Budhu, PhD - Ludwig Collaborative Lab, MSKCC
...II. “Antibody Targeting of PS Enhances the Anti-Tumor Responses of Ibrutinib & anti-Pd-1 Therapy in a Mouse Triple Neg. Breast Tumor Model” - Jian Gong, PhD, PPHM
...III. Monoclonal Antibodies Targeting PS Enhance Combinational Activity of the the Immune Checkpoint Targeting Agents LAG3 & PD-1 in Murine Breast Tumors” - Michael Gray, PhD, PPHM
~Dec8: FY'17Q2 (qe 10-31-16) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid/Booth#209: IBC's Antibody Eng. & Therapeutics 2016”, SanDiego http://www.ibclifesciences.com/AntibodyEng/overview.xml
Feb20-22 2017: “CHI’s 5th Translational Models in Oncology & I-O”, SanFran http://www.triconference.com/Pre-Clinical-Oncology-Models
...Bruce Freimark(Dir.Res/Preclin.Oncology), “Blockade of PS-Mediated Tumor Immune Suppression to Enhance Immune Checkpoint Therapies”
SCIENCE: "Evolution has favored pathogenesis that resembles apoptosis."
Dr. Judah Folkman: ”This [Thorpe’s VTA research] is very promising and very elegant work... The whole goal is really 2-part, reducing the harsh side effects of cancer treatment, and reducing the chance that some cancer cells will evade treatment. That would be a big step in the next decade, and anti-vascular therapy will play a major role." (’97 & ’02 http://tinyurl.com/k5qe96g & http://tinyurl.com/n6vh9hp )
Peregrine's Bavituximab Clinical Trials website: http://PeregrineTrials.com
Bavituximab MOA & Clinical Data: http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
...Bavi Publications: http://www.peregrineinc.com/publications/publications.html
...Bavi Posters & Presentations: http://www.peregrineinc.com/publications/posters-and-presentations.html
Bavi MOA: Video (3:34) added ~3-2014 http://vimeo.com/87116642 "Bavituximab: A Novel Immunotherapy Candidate Targeting an Upstream Immune Checkpoint to Fight Cancer"
Bavi MOA: Video (1:33) on Bavi’s Immunotherapeutic MOA added to Youtube on 3-27-14 https://www.youtube.com/watch?v=Esewl35JD8s
7-27-16 Shaul/Brekken/Thorpe/etal PLOS ONE article: Fhu/Bavi vs. APS-related Pregnancy Complications & Thrombosis http://tinyurl.com/jlhrdg2
...”The potential clinical impact of 1N11 (Fhu Bavi) in patients with APS is substantial. Spring-boarding from the present discovery of 1N11 as a highly-effective, mechanism-based treatment for APS in a comprehensive series of mouse models of APS-related disorders, clinical studies of 1N11 now warrant consideration.”
BAVI MOA 9-27-16 AACR-CRI/Dr. Michael Gray: Preclin. Triple-Combo Bavi+PD1+LAG3 TNBC data in TNBC (80% Compl. Regression, Stat-Sig. Incr. in Key Tumor Fighting Immune Cells) http://tinyurl.com/zy9yv78
BAVI MOA 5-11-16 Breast Cancer Res. article, B.Freimark/CW.Hughes-et-al, “PS-Targeting/Bavi Combo w/Anti-PD1/PDL1 in Triple.Neg-MBC” http://tinyurl.com/zxu882y
...”our observations demonstrate that including PS-targeting antibodies such as bavituximab can enhance the anti-tumor activity of anti-PD-1/PD-L1 treatments, not only by increasing TIL responses but also by inhibiting cytokines stimulated by single-agent anti-PD-1 therapy that serve to suppress the immune response & promote tumor progression.”
BAVI MOA 4-20-16/AACR'16 & 4-4-16/Cancer-Immunology-Res.(AACR) article - preclin. data: Bavi combo w/anti-PD-1/anti-CTLA-4 “induces a shift in tumor microenvironment from immunosuppressive to immune active” http://tinyurl.com/jyox458
BAVI MOA 1-18-16: CEO Steve King explains PPHM's direct PS-Targeting advantage vs. the “individual-receptors” PS-binding approach of others like: Axl Mer TIM-3 RAGE Tyro3 GAS6 CD300a BAI1 MFG-E8 etc. http://tinyurl.com/h2h87mc
2-2016: Rutgers' Dr. Raymond Birge's relationship with Peregrine & UTSW's Dr. Rolf Brekken and his 2-26-16 article, “Phosphatidylserine is a Global Immunosuppressive Signal in Efferocytosis, Infectious Disease, and Cancer” http://tinyurl.com/z5d9qt9
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's 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
BAVI MOA 8-28-14: Italy’s Dr. Federico Cappuzzo, Bavi/NSCLC profile article (DovePress OpenAccess, 7pgs) - http://tinyurl.com/n3oa7bc
BAVI MOA 8-11-14: PPHM/VP Dr. Jeff Hutchins’ presentation at ImVacS "Immunotherapies & Vaccine Summit", Boston - PR: http://tinyurl.com/lpjy3u7 ; PDF(31 Slides): http://tinyurl.com/oueldme
...MLV’s Dr. George Zavoico’s 8-27-14 report on Dr. Jeff Hutchins’ 8-11-14 ImVacS/Boston Bavi MOA presentation: http://tinyurl.com/l3tw63c
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)
12-10-13: With recent scientific insights highlighting bavi’s immunostimulatory moa, these additions to PPHM’s SAB: Dimitry Gabrilovich, Scott Antonia, David Carbone**, Hakan Mellstedt http://tinyurl.com/mw776mk
......**A/o 9-2015, Dr. David Carbone (PPHM SAB/KOL) is President of IASLC https://www.iaslc.org/about-us/board
BAVI MOA: 12-2013 Bavi’s Immunotherapeutic MOA overviewed by UTSW’s Brekken/Huang in Pan European Networks Jrnl. http://tinyurl.com/lnb46pq
BAVI MOA 11-9-13: Annual SITC (WashDC) – 2 posters about Bavi’s Immunostimulatory MOA http://tinyurl.com/mjaweu5
...“We are actively working towards initiating a clinical trial in the coming months to further investigate the potential synergistic effects of bavituximab and an approved [anti-CTLA-4] immunotherapy in patients with Melanoma."
10-28-13 IASLC/Sydney: “Immune Checkpoints in the Tumor Environment: Novel Targets & the Clinical Promise of Combined Immunotherapies” http://tinyurl.com/mjaweu5
…Symposium speakers: Scott J. Antonia/MD-PhD(H.Lee Moffitt CC), Dmitry I. Gabrilovich/MD-PhD(Wistar Inst), Rolf A. Brekken/PhD(UTSW), David E. Gerber/MD(UTSW)
BAVI MOA: 8-19-13 Data Supporting Bavituximab’s Immunotherapy MOA Published in “Cancer Immunology Research” (AACR) - http://tinyurl.com/mhjftka (PDF)
…“PS-Targeting Antibody Induces M1 Macrophage Polarization & Promotes Myeloid-Derived Suppressor Cell Differentiation” (Thorpe etal)
BAVI MOA: 8-13-13 PPHM/VP Dr. Jeff Hutchins’ Presentation on the Downstream Immunostimulatory Effects/Moa of PS-targeting antibodies (like Bavi) at CHI’s “Immunotherapies Congress”/Boston http://tinyurl.com/m6h2tvt
BAVI MOA: 10-12-12 NMB article on how Bavi "Induces Innate & Specific Anti-tumor Responses" http://tinyurl.com/cw9odb8
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
BAVI MOA: 5-26-11 Dr.Thorpe's keynoter at Recombinant-Mabs/Barcelona http://tinyurl.com/3klpodc & http://tinyurl.com/3m33h33
BAVI MOA: 4-2010 Thrombosis Research article (Dr.Thorpe) http://tinyurl.com/9reso7s
BAVI MOA: See http://www.peregrineinc.com/technology/bavituximab-oncology/recent-data.html
FTM's 12-2012 post giving links to 46 Cancer & Immunology journals & websites: http://tinyurl.com/agwn2o8
Peregrine's SRB - Links to Profiles & Pubmeds: http://tinyurl.com/2cy3cv
Expert Quotes/Commentary On Bavituximab's Moa/Potential: http://tinyurl.com/nmdw4
Peregrine's Patent Estate - excl. licenses from UTSW MDA U-CALIF USC: http://tinyurl.com/58cn74
7-16-12 Form 10-K (fy/e 4-30-12): License Agreements between PPHM & UTSW/DNA/Avanir/Lonza (pg.10) http://tinyurl.com/agy6hn6
…Royalty %'s payable to UTSW/Dallas on sales of future-approved Anti-PS drugs will be in the "low single digits"
4-2006: Tarvacin (chimeric 3G4) will henceforth be referred to by its generic name, BAVITUXIMAB, to avoid confusion with OSI's anti-cancer drug Tarceva. http://tinyurl.com/2vawjv
- - - -Peregrine's Anti-PS Mabs:
• PGN635 (B2GPI-dep.) is Fully-Human Bavituximab=1N11=AT004 (B2GPI-depen.); Genentech studying 89Zr-PGN635 as a Tumor Imaging Agent, “indep. of cancer type”
• PGN632 (B2GPI-indep.) is the Duke-PPHM-HIV candidate=11.31=AT005; also being studied by PPHM+LSU vs. Ocular Herpes (Acute HSV-1 Keratitis), see http://tinyurl.com/cax9a4p
• PGN650 is a human F(ab’)2 fragment that targets PS expression (1st ref’d in AACR’12 #2452) – see http://tinyurl.com/76nqqkm . 124I-PGN650 is Peregrine’s PS-Imaging candidate (see http://tinyurl.com/7p7jovt )
• BETABODIES (Clipped/Nicked B2GPI - ex: KL15, “2nd-gen. PS-Targeting”) - bind to PS directly, are smaller in size (100 vs. 250KDa) and have a longer serum half-life (~5days) than natural antibodies (Bavi=~1day) – see http://tinyurl.com/khopa3d
…2/17/15: UTSW/PPHM’s BetaBodies patent#8,956,616 Awarded(Granted) http://tinyurl.com/p75uyfu
Examples of anti-PD-1 drugs in development: (PD1=”Programmed Cell Death Protein 1”)
1. Merck’s Keytruda(pembrolizumab=MK-3475, formerly=labrolizumab) <=appr. Sep’14/Melanoma
2. BMS’s Opdivo(nivolumab) <=appr. Dec’14/Melanoma, Mar’15/2L-NSCLC
3. Curetech’s pidilizumab (aka CT-011) ( http://www.curetechbio.com )
4. AZ/MedImmune’s MEDI0680 (formerly=AMP514)
5. GSK’s AMP-224 (collab. with Amplimmune)
Examples of anti-PD-L1 drugs in development: (PD-L1=”PD1 ligand”)
1. BMS’s BMS-936559 (MDX-1105)
2. Roche/DNA’s MPDL3280A (aka RG7446)
3. AstraZeneca's(acq. Medimmune) MEDI4736=durvalumab <=2015 PPHM+AZN collab. & expansion to run trials in Lung & "mult. tumor types"
4. EMD/Serono’s MSB0010718C
7-14-14/CC: Steve Worsley (VP/BusDev) said that Peregrine is “seeking collaborators that build on other checkpoints of pathways such as PD-1, IDO, immune-stimulatory drugs, and even vaccines…” http://tinyurl.com/zor2vjs
...Interesting: PPHM KOL/SRB’r Dr. Scott Antonia’s (Moffitt-CC/Tampa) role in IDO dev: http://tinyurl.com/mol86st <=“1st to report in 2002 that IDO inhibitors delay growth of human lung cancer cells”
• Incyte’s immune checkpoint inhibitor INCB24360 is an oral inhibitor of IDO1 (indoleamine dioxygenase-1) – http://www.incyte.com
• NewLink Genetics’ immune checkpoint inhibitor indoximod is an oral inhibitor of IDO (indoleamine 2,3-dioxygenase) – http://newlinkgenetics.com
...“IDO pathway inhibitors are another class of immune check point inhibitors akin to the recently developed antibodies targeting CTLA-4 & PD-1 that represent potential breakthrough approaches to cancer therapy.”
.."As of 4-30-16, we employed 281 full-time emps & 3 part-time emps." ('11=154/2, '12=172/2 '13=182/4 '14=180/4 '15=211/4) http://tinyurl.com/h8eqtg5
...On 3-18-09, CFO P.Lytle (Cowen/Boston) stated, "We have 135 emps, 85 under Avid Bioservices, and the remaining 50 emps reside at the Peregrine corp. level - 35 in R&D & 15 in G&A."
...2009-11: Clinical/Regulatory/CMC hires with BP background: http://tinyurl.com/3k4t3kv & http://tinyurl.com/3lmw22s
…...Genentech(Garnick/Chamow/Suggett/Masten), Abbott(Menender), Novartis(Evilevitch), Pfizer(Ferretti), Amgen(Hansen), Valeant(Dadgostara)
In 10-2009, Dr. Robert Garnick joined Peregrine as Head/Regulatory ( http://tinyurl.com/yga7z4x ). In his 24 years at Genentech (1984-2008; from Feb'01-Oct'08 as Senior V.P. of Regulatory, Quality & Compliance), he was responsible for 17 new product approvals, including most of DNA's top selling monoclonal antibody therapeutics such as Rituxan, Herceptin, Avastin, and Lucentis. He was responsible for all the regulated aspects of Genentech's business, including drug development, commercial production, and promotional & labeling compliance. As CEO Steve King said 6-29-11, "Rob is the ringmaster."
• See this 6-29-11 Minyanville article, "Peregrine Pharma's Secret Weapon" http://tinyurl.com/9jtnano
• Examples of Dr. Garnick's work at Genentech on Avastin (bevacizumab) approvals: http://tinyurl.com/yg7vtqa
• All of Dr. Robert Garnick's public comments (thru 3-7-2014) while at Peregrine: http://tinyurl.com/obvwyuh
• On 7-16-12, RG said this about the ongoing Bavi+Doce randomized 2nd-Line NSCLC Ph.2B n=121 trial (which is going to double+ MOS vs. Doce ctl-arm): "I've seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I've ever seen. So, I'm very comfortable proposing an [EOP2] meeting with the FDA for Q4'12." http://tinyurl.com/cs7spbz
Latest 10K 4-30-16 iss. 7-14-16 http://tinyurl.com/zgognwz PR: http://tinyurl.com/h8eqtg5 (Cash 4-30-16=$61.4mm)
Latest 10Q 7-31-16 iss. 9-8-16 http://tinyurl.com/jmy77g3 PR: http://tinyurl.com/jydtkoy (Cash 7-31-16=$44.2mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
PPHM's Corp. Bylaws (a/o 11-14-14): http://tinyurl.com/jtdlpma
Poison Pill adopted 3-16-06: http://tinyurl.com/yvypvh - 44-pg SEC filing: http://tinyurl.com/5m57ut ...BUNGLER explains in plain language: http://tinyurl.com/mft4nd6
Shares O/S as of 9-2-16=242,381,850 - history since 4-2006: http://tinyurl.com/z9asadj
...A/O 7-31-16: 273,280 warrants o/s with wgt.avg. exercise price of $2.47 -- 29,923,770 stock options outstanding at a wgt.avg. exercise price of $1.27. (pg.14 10Q)
4-13-14: PPHM Registers $30mm of 10.50% Series E Convertible Preferred Stock and $25mm ATM Common Stock in 2 424B5’s: http://tinyurl.com/lth28zj & http://tinyurl.com/kpjloar
12-27-13: S-3 Registration, “up to $100,000,000”, Common & Preferred http://tinyurl.com/ky4ufth
…Of note, this name on the S-3 cover: Michael A. Hedge (Leader, Life Sciences M&A team), K&L Gates LLP, Irvine, CA
...2-5-14: PPHM Announces Public Offering of 10.5% Series E Convertible Preferred Stock http://tinyurl.com/lkxsna6
...2-11-14: PPHM Raises net $16.2mm selling 700k Preferred Shares with 10.5% div. at $25/sh, convertible to common at $3/sh http://tinyurl.com/jwmsnsk (8-K)
...6/14/14-7/14/13: PPHM Raises net $9.5mm selling 400k Preferred Shares with 10.5% div. at $25/sh, convertible to common at $3/sh http://tinyurl.com/mhva3k3 (4-30-14 10-K pg. F-34; $20mm gross remaining)
12-23-14: S-3 Registration, “up to $150,000,000”, Common & Preferred http://tinyurl.com/nhfr55a
A-T-M (At-The-Market) Sales 3/2009 - 9/8/16 ($239,085,000gr./172,041,561sh=$1.39/sh): http://tinyurl.com/z9asadj
...12-29-10: ATM Agreement (up to $75mm) with MLV filed - 8K: http://tinyurl.com/2a6w76g
...3-9-12: PPHM files shelf to sell up to $150mm common stock, warrants, S3: http://tinyurl.com/7dl7pjm
...12-28-12: New ATM Agreement (up to $75mm) with MLV filed - 424B5: http://tinyurl.com/ayny2b3
…8-7-15: New ATM Agreement (up to $20mm) with NOBLE filed - 424B5: http://tinyurl.com/q9zvw6n
…8-7-15: New ATM Agreement (up to $30mm) with MLV filed - 424B5: http://tinyurl.com/oc53ugn
INSIDER-Trans: http://tinyurl.com/ypkow8 & http://tinyurl.com/2yvlj4
Inst. Holdings (Nasdaq.com) - updated qtly, 45-days after each q/e cutoff: http://tinyurl.com/ys7fed
Short Interest, upd. twice a month: http://tinyurl.com/552p6n ...Updates 1 day earlier: http://tinyurl.com/292xyd
Nasdaq Last Sale (NLS) & Official Close for TODAY: http://tinyurl.com/kvplmj DETAIL: http://tinyurl.com/oc58jw
Currenty Halted Stocks: http://www.nasdaqtrader.com/Trader.aspx?id=Tradehalts
Director Eric Swartz's Jan-Feb'10 Buying Streak (100k @ 3.12/sh.): http://tinyurl.com/yegxpvu
6-30-14: SABBY MGT. (led by Hal Mintz) holds 291600/PPHMP a/o 6-30-14 ($email@example.com/sh. common): http://tinyurl.com/kxezbsf
10-30-15: Kenneth Dart (Eastern Capital) acquires 13.1% stake (30,106,945sh.) in PPHM http://tinyurl.com/24qctos
...2-14-12: Kenneth Dart adds 3,460,192, now 7,421,760 (8.55% a/o 12-9-11) http://tinyurl.com/7bb26j4 (13G)
...2-13-13: Kenneth Dart adds 500,000, now 7,921,760 (5.9% a/o 12-31-12) http://tinyurl.com/b25a93j (13G)
...2-13-15: Kenneth Dart PPHM stake now 9,921,760 (5.4% a/o 12-31-14) http://tinyurl.com/k4nsfuu (13G)
...10-30-15: Kenneth Dart adds 18,518,518@$1.08, now 30,106,945 (13.1% a/o 10-30-15) http://tinyurl.com/pexs62e & http://tinyurl.com/ns2s9p6 (13G & Form3)
12-31-14: BlackRock Inc. (Larry Fink, CEO) accums 2.0% stake (4.6mm sh.) in Peregrine.
...12-31-13: BlackRock increases PPHM stake to 10,279,810 http://tinyurl.com/m944oev
...12-31-14: BlackRock increases PPHM stake to 12,130,885 http://tinyurl.com/m3nyvdp
...12-31-15: BlackRock increases PPHM stake to 12,353,101 http://tinyurl.com/hp229dh
...6-30-16: BlackRock decreases PPHM stake to 4,633,699 http://tinyurl.com/h225aey
9-8-11: Roth arranges direct sale of 6,252,252sh.@$1.11 to 3 inst's, net=$6.5mm http://tinyurl.com/3otm3t5
10-19-09 PPHM executes 1:5 R/S to regain Nasdaq $1 min-bid compliance: http://tinyurl.com/ykuw588
Current PPHM Stock Chart: http://stockcharts.com/h-sc/ui?s=pphm
8-6-10: Bavituximab listed #8 in EP-Vantage's 'Biggest Unpartnered Pipeline Assets' chart, with NPV=$1.022b: http://tinyurl.com/34lpt5j
5-22-13: Citigroup analyst Andrew S. Baum’s report, "Immunotherapy - The Beginning of the End for Cancer" http://tinyurl.com/pob7ktc
…”A new wave of medicines that tap the power of the immune system to fight cancer could become the biggest drug class in history… We believe this market will generate sales of up to $35B/yr. over the next 10 years and be used in some way in the mgt. of up to 60% of all cancers…”
Noble Financial/Rahul Jasuja (init. 7-16-15), 7-15-16: Buy/PT=$1.50 http://noblefcm.com/research
Roth Capital /Joe Pantginis (init. 7-15-10), 7-15-16: Neutral/$.50 http://www.roth.com
FBR & Co./ThomasYip http://www.fbr.com 9-9-16: Outperform/PT=$1.00
MLV/George B. Zavoico(Jones Trading?) - init. 2-8-10 Buy/PT=$10, CURR: Buy/$3.50 http://www.mlvco.com <=dropped 2015
. . .9-10-14: MLV maintains PPHM PT=$3.50 ("believe positive results from ongoing ISTs will generate investor & partnering interest") http://tinyurl.com/qgkqm75
. . .8-27-14: G.Zavoico recaps Dr. Jeff Hutchins’ 8-11-14 ImVacS/Boston Bavi MOA presentation: http://tinyurl.com/l3tw63c
Piper Jaffray/Charles Duncan - init. 3-5-13 http://www.piperjaffray.com/3col.aspx?id=103 <=Coverage dropped 12-2015
. . .9-10-14: P-Jaffray reits. PPHM PT=$4.00 ("mgt hinted about data concerning an even broader immunomodulatory role for bavi") http://tinyurl.com/qgkqm75
JMP Securities/Jason Butler - init. 8-30-2011 OutPerf/PT=$5, CURR: OutPerf/$6.50 http://www.jmpg.com <=7-2014: dropped from PeregrineInc.com
. . .9-10-12: JMP ups PT $5=>$6.50 ("2ndLine NSCLC data results could bode well for Ph3 pgm & partnership talks ") http://tinyurl.com/93b34qy
LifeTech-Cap/Steve Dunn - init. 4-14-10 Spec-Buy/PT=$8, CURR: Spec-Buy/$5
. . .4-13-12: LifeTech downgrades PPHM to Neutral/PT=.50 & Terminates Coverage http://tinyurl.com/6n6nqbr
1-2011: PPHM has Exec. Info. Report (EIO) prepared by Crystal Research (Jeffery Kraws): http://tinyurl.com/2dja6uo
12-21-07/Terminated: Rodman&Ren. (Jaikaria/Benjamin) initiate: Mkt-Perform: http://tinyurl.com/624dmd
AVID BIOSERVICES, Inc. (Peregrine's Mfg. Subsidiary): http://www.avidbio.com
9-8-16: PPHM's Revs & Burns By Qtr Table, FY'07/Q1 thru FY'17/Q1 (q/e 7-31-16): http://tinyurl.com/jydtkoy (since 5-2006: Avid=$179.2mm, Total=$205.8mm, incl.Govt)
......Avid FY17 (fye 4-30-17) revs guidance: $50-55mm; committed 9-8-16 backlog: $71mm. Avid III being designed/already secured 25,000sf loc/expect compl=1H/2017. “Expect future sustainable profitability for the co. in 21mos.”
6-2-16: Corp.Update – Avid Expansion & Drug Development - http://tinyurl.com/zvmhqmr
5-23-16: Pete Gagnon (100pubs/presentations, 12+patents, 30 pending patents) Appointed VP/Process-Services of Avid http://tinyurl.com/hg6abdq – See Oct'15: https://www.youtube.com/watch?v=JqJIH33JY8g
3-7-16/Avid II: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) http://tinyurl.com/za2j9mt
12-10-15/Avid II: Avid Expansion into MYFORD Facility now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
6-17-15: Avid’s John Haney (ex-Genentech/Pfizer) speaking at BIO-INTL’5/Philly http://tinyurl.com/pnlquu3 & http://tinyurl.com/nl4vbgk
...”Designing & Implementing Avid’s New State-of-the-Art Single-Use Facility for Late Ph.3 & Commercial Prod.” - SK: "We've seen tremendous interest for production in the new facility, both from new & existing clients"
12-10-14: Avid to Double Mfg. Capacity (“expanding client roster; potential commercial launch of bavituximab”) http://tinyurl.com/mmc3qgy & http://tinyurl.com/kmdgq8t
3-24-15: Avid Receives CMO Leadership Awards for Its Commitment to Innovation & Reliability http://tinyurl.com/psep47f
3-12-13: Avid Q3'FY13 GP=$3.3mm; S.King 3-2012, "We have a profitable CMO, Avid Bioservices" http://tinyurl.com/l97rzm8
2-26-13: Avid Presents QbD/CPPs/CQAs at "BiopharmDev/Prod-Week" http://tinyurl.com/cjzfh73
12-13-12: Avid Completes Facility Upgrades in Resp. to Increased Demand http://tinyurl.com/chu54yo
…Est. $18mm+ for FY'13; $30mm Backlog thru FY'14; RODI & WFI Water Systems Upgrades
9-27-12: Avid to Produce "GP145 HIV Envelope Protein" for Advanced BioScience Labs (ABL) http://tinyurl.com/9gsshel (HHSN272201100021I)
…9-14-11: NIH awards ABL max. $102.5mm 7yr contract to support preclin. dev. of HIV Vaccines - see http://tinyurl.com/pton7e6 & http://tinyurl.com/oxrqysm
6-11-12: Avid to offer Phage Pharma's "Bacteriophage Prod. System" http://tinyurl.com/czfl7v6
4-2-12 AACR'12: Avid presents New Mab-Eng. Process (Fc/ADCC), Client Proj. http://tinyurl.com/7yrwqm7 (see #2510)
8-22-11: Dr. Steven Chamow (Head/Proc.Sci) gives Avid Case Study at CHI Conf./Boston http://tinyurl.com/6ob3o4q
6-17-11: Avid producing "Redectane" (girentuximab) for WILEX/IBA (Germany/Belgium): http://tinyurl.com/3kre928 & http://tinyurl.com/882revm
...SK 9-8-11/Stifel: "Wilex is completing their Ph.3 studies and we're anticipating being their commercial launch facility." http://tinyurl.com/3sbvf2h
12-8-10: Avid signs Biosimilars Services Deal with USA/China firm: http://tinyurl.com/28hryyj
11-1-10: VP R.Richieri presents Avid's S.U.B. at IBC BioProc. Conf. http://tinyurl.com/23yyegk
10-4-10: Avid Wins Bioproduction Contract From Affitech for R84: http://tinyurl.com/27nfs9t
6-14-10: Avid adds 'Line #4 FILL-FINISH' capability, CMOLocator.com http://tinyurl.com/3xgu3ox
5-3-10: PPHM leases addl. 11,000sq adjacent space (Avid exp?): http://tinyurl.com/327dk2j
4-5-10: Avid & Halozyme Expand Commercial Supply Relationship: http://tinyurl.com/yfdgsom
…"the companies extended their existing commercial supply agreement (CSA) for rHuPH20 and signed a new CSA for addl. partnered product candidates such as subcutaneous HERCEPTIN & GAMMAGARD with rHuPH20."
Apr'10: Contract-Pharma article on SUB's quotes 3 Avid execs, Yoshioka/Richieri/Eso: http://tinyurl.com/yk4zbkd
9-21-09: Avid becomes sole U.S. W.Coast CMO in Boehringer Ingelheim's Global Prod. Alliance Network http://tinyurl.com/l9nf4n
11-10-08: Avid expands capacity by adding 100L & 1000L Hyclone bioreactors: http://tinyurl.com/69qgl5
10-27-08: Avid Becomes CMO for Catalyst Biosciences' protease candidate CB-813: http://tinyurl.com/5fg7zg
…5-18-11: Wyeth (now Pfizer) is collaborating with Catalyst for the dev. of CB-813d http://tinyurl.com/6k55bqo
6-25-08: Avid Selected as 1st U.S. CMO for DSM/Crucell's PER.C6 Cell Line: http://tinyurl.com/4geqxw
11-10-14: Avid & Cook remain Halozyme's 2 CMO's (also 12-21-12 HALO/Pfizer rHuPH20 deal): http://tinyurl.com/qbmokuy
7-14-08: Avid is CMO for Arius Research's lead drug, "AR001 Targeting CD44": http://tinyurl.com/6hrwrt
...7-23-08 Roche buys Arius for $190mm: http://tinyurl.com/5fg6jd
EXOSOME-BASED CANCER DETECTION & MONITORING TECHNOLOGY ("Liquid Biopsy") - Excellent Exosome info: http://www.exosome-rna.com
7-14-16: Peregrine Licenses Exosome-based technology from UTSW (Inventors: Alan Schroit/Philip Thorpe) http://tinyurl.com/zszd4fj
...“relates to assays that are able to detect small amts of PS+ Exosomes in a patient's blood sample as a way to detect cancer at a very early stage of development.”
NCCN Bavituximab Trials Announced 9-6-16 - To Begin "Early 2017" http://tinyurl.com/gutgwb5
...#1: Ph1/HepC-Related Hepatocellular (Bavi+RAD+Sorafenib), MOFFITT CANCER CENTER - PI: Jessica Frakes, MD
...#2: P1-2/Newly Diag. Glioblastoma (Bavi+RAD+Merck’s Temodar), MASS-GEN. CANCER CENTER - PI: Elizabeth Gerstner, MD
...#3: Ph2/Progressive Squamous Head+Neck (Bavi+Merck’s Keytruda), JOHN-HOPKINS(Sidney Kimmel CC) - PI: Ranee Mehra, MD
BAVITUXIMAB "SUNRISE" PHASE III TRIAL: http://www.SunriseTrial.com (Start=Dec'13 EstPrimComp=Dec’16)
A. Phase III Bavi+Doce vs. 2nd-Line NSCLC "SUNRISE" (randomized, double-blind, placebo-ctl'd, n=582)
USA Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01999673 <=chgd. to "Active, Not Recruiting." 2-1-16
...2 ARMS: A=BAVI/3mg+DOCE(Weekly), B=Doce+Placebo(Weekly)
...ECOG's: Ph3SUNRISE/0-1, Ph2Bavi+Doce(n=120)/0-1-2, Ph2Bavi+Durva(AZN)/0-1, Ph3Herbst2010/0-1 (2L/NSCLC)
...161 sites a/o 7-9-15 (USA/39 Aus/9 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/9 Rom/6 Rus/8 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/qbemrr2
...EU/EEA Registries: (pts world=582, pts/EU=345, planned EU sites=100) http://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-003953-13
10-10-16 ESMO’16 Topline/Ph3.SUNRISE Data: Biomarker B2GPI/200-240(30%pts) StatSig OS 7.7=>13.2mos. http://tinyurl.com/hp73njt
2-25-16: IDMC Halts SUNRISE at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations” http://tinyurl.com/jbg48vs
...CC Replay: http://edge.media-server.com/m/p/xfa9fy5v 12:22/Q&A: RahulJasuja/Noble, “You said that the performance of the Doce/Ctl arm was higher than ever seen in such a trial?” - SK “Yes, we've never seen these #'s reported. It's quite perplexing… at this point, the performance of the Doce arm was just completely out in left field.”
2-1-16: SUNRISE Trial status updated: “Study ongoing, but not recruiting.” http://www.clinicaltrials.gov/ct2/show/NCT01999673
12-10-15: “Sunrise >90% enrolled; sufficient to allow the 2 planned interim looks (33%/50%) & final readout based on PrimEndPt=OS” http://tinyurl.com/jkp885g
5-31-14 ASCO’14: David Gerber/Joe Shan Poster on Ph3/SUNRISE Trial (#TPS8129) http://tinyurl.com/nv4jloo
3-7-14: PR & Conf-Call: "first patients enrolled and dosed." http://tinyurl.com/kh9cnrg
1-6-14: FDA grants FAST TRACK status to Bavi in 2ndLine NSCLC http://tinyurl.com/l799ukk
12-30-13: Pivotal Ph.3 ‘SUNRISE’ NSCLC Trial Initiated (n=~600, sites=100+) http://tinyurl.com/kdjb9qz
5-20-13: FDA Approves Bavituximab Ph.III Design for 2L/NSCLC; 600-pt trial to begin by y/e’13 http://tinyurl.com/n3dxtm6
...S.King: “We will now focus on starting the Ph.III trial while continuing ongoing partnering discussions.”
…R.Garnick: “This was a highly collaborative effort with the FDA; this trial, when combined with Bavi’s supporting data to date, could be sufficient to support a future BLA submission."
BAVITUXIMAB SOLID CANCERS PHASE1+2 TRIALS: (see http://PeregrineTrials.com)
==> PR=Partial-Resp(30-99% Red.), SD=Stable-Disease(29% Red.-19% Incr.), OR=Obj-Resp(PR+CR)
6-2012: FTM's charts of MOS Data from CtlArms(chemo) of Comp.Trials for 1NSCLC 2NSCLC PANCRE trials http://tinyurl.com/757plm7
11-25-11: Comp. of Bavi+Chemo vs. Avastin & Chemo-Only in 3 completed Ph.2 single-arm trials (ABC/2 & NSCLC): http://tinyurl.com/79b3jcj
O. 6th IST Trial: Bavi+Ipilimumab(Yervoy) vs. Adv.Melanoma (Ph1b, random, open-label, 2arms, n=24)
Protocol (UTSW): http://www.clinicaltrials.gov/ct2/show/NCT01984255 (PI: Dr. Arthur Frankel - see "Researching for Cures" http://youtu.be/0zLAxjFny5Q )
UTSW's listing: http://www.utsouthwestern.edu/research/fact/detail.html?studyid=STU%20102013-007
…Note: Ipilimumab = BMS’s “Yervoy” (anti-CTLA-4) http://www.yervoy.com
...12-10-15: “Due to newly-appr. therapies & chgs in SOC [ex: Keytruda/Opdivo: less-side-effects], enrollment recently stopped by UTSW.” http://tinyurl.com/jkp885g
...4-23-14: Bavi+Yervoy IST trial initiated: http://tinyurl.com/km7krcm
N. 5th IST Trial (Bavi+Capecitabine+RAD) vs. Rectal Cancer (Ph1, open-label, 1arm, n=18)
...Note: Capecitabine (prodrug of 5-FU) = Roche/Genentech's Xeloda - see http://www.xeloda.com
...11-1-15/RadiationOncology – prelim. results/8 evaluables http://tinyurl.com/q3wey2b
…...”Of the 7 pts that proceeded to surgery, 1 demonstrated a pathologic complete response.”
...7-16-12: IST (Rectal) initiated at UTSW (PI=Jeffrey Meyer), ~18 patients - http://tinyurl.com/cr29l6k
M. Tumor Imaging & Dosimetry trial of I124-PGN650 (FH-Bavi) in Adv. Solid Tumors (Ph0, open-label, 1arm, n=12)
..."I124-PGN650 is the Fab end of PS-targeting mab PGN635 (FH-Bavi) joined to the PET imaging radioisotope iodine-124, a new approach to imaging cancer."
5-1-15: Interim Results/8pts (Jrnl Nuclear Med, vol56 suppl#3) http://jnm.snmjournals.org/content/56/supplement_3/1033
…”124I-PGN650 is safe and results in acceptable dosimetry and needs further optimization as an imaging agent based on the level of increased tumor uptake on PET/CT”
...6-28-12: Trial added to Trials.gov, 1st site "recruiting" (Wash.UnivSM/St.Louis)
…4-3-12: Peregrine Launches PS-Targeting Clinical Imaging Pgm (AACR'12 #2452) http://tinyurl.com/7p7jovt & http://tinyurl.com/7yrwqm7
L. 4th IST Trial (Bavi+Cabazitaxel vs. 2nd-Line PROSTATE(CRPC) Cancer, open-label Ph.1B/IIA) *CANCELLED due to chg. in SOC Drugs*
Protocol: http://clinicaltrials.gov/show/NCT01335204 (CRPC=Castration-Resistant Prostate Cancer)
...Note: Cabazitaxel = Sanofi-Aventis' Jevtana - see http://www.jevtana.com
...3-12-13: CRPC IST cancelled (Slow-Enroll/2 New SOC Drugs): http://tinyurl.com/c48osut
...5-25-11: IST (Prostate) initiated at UCI -> moved ot Med.Univ.SCar (PI: Michael Lilly), ~31 patients - http://tinyurl.com/3mtvdvl
K. 3rd IST Trial (Bavi+PemCarbo vs. Frontline NSCLC, open-label Ph.1B, n=25)
…10-30-14: Interim data n=23, MSTO’14: MOS=12.2mos (hist-ctl ~10mos), PFS=4.8mos, ORR=35% http://tinyurl.com/mll62c6
...9-9-14: Stage IV NSCLC IST Enrollment complete. http://tinyurl.com/ktrfswj
...4-2012: Clinicaltrials.gov shows 2nd site added: Univ. of Pittsburg (PI=Liza Villaruz, MD)
...4-2-12 AACR'12: "5pts. to-date, 3 have PR's" http://tinyurl.com/7yrwqm7 (see #1744)
...3-8-11: IST (NSCLC) initiated at UNC (PI= J.Grilley-Olson), ~25 patients - http://tinyurl.com/6b926ku
J. 2nd IST Trial (Bavi+Paclitaxel(Taxol) vs. Her2- Met. Breast Cancer, open-label Ph.1, n=14)
...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
I. Phase II Bavi+GEM vs. Front-Line Adv. PANCREATIC (randomized, unblinded, n=70)
Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01272791 (15 U.S. + 4 Ukraine = 19 as of 6-7-2012)
…1-22-13: FTM's post of 13 Ph3 Gem+Treatment Pancreatic Trials ('02-'13) - Mean MOS: GEM=6.4mos., GEM+TR=7.3mos. http://tinyurl.com/al99hx9
......Another FTM Pancreatic Phase3 trials table showing HR's, P-Values, and ORR% stats: http://tinyurl.com/btzkw4l
…6-3-13 ASCO’13/final data: n=70, Ctl=>Bavi MOS 5.2=>5.6mos, ORR 13%=>28% HR=.75 http://tinyurl.com/kq3uv4e
......Promising ‘immuno-indicative’ 1yr SURVIVAL results: GEM-Only(n=31): 0%, Bavi+GEM(n=32): 24.5% - see: http://tinyurl.com/lz5yg4f
...2-13-13 Topline Data: “Bavi+Gem resulted in more than a doubling of ORR” http://tinyurl.com/aqny7ny
...6-25-12: Enrollment complete. http://tinyurl.com/72tvnfj
...6-20-12: Early data (cutoff=6/6/12 bavi=15 ctl=17) presented at AACR Pancreatic Conf. http://tinyurl.com/77m9fw2
...1-5-11: U.S. Ph.2 randomized trial initiated http://tinyurl.com/26hnuzv "up to 70 front-line patients at ~10 clinical sites."
H. 1st Investigator-Sponsored (IST) Ph.I/II Trial (Bavi+Sorafenib vs. Liver Cancer/HCC, open-label, n=9+38=47)
...Note: Sorafenib = Onyx/Bayer's Nexavar - see http://www.nexavar.com
Protocol: http://clinicaltrials.gov/ct2/show/NCT01264705 UTSW: http://tinyurl.com/mwdc2ql (5 sites: 3/UTSW, Parkland-Hosp, Dallas/VA, PI=Dr. Adam Yopp)
...3-25-15: Dr.Adam.Yopp(UTSW) Oral-pres./SSO (Liver-IST/Ph2-data) http://tinyurl.com/opkh5qy N=38(79%HepC, ECOG/0=34%): MTTP=6.7mos, MOS=6.1, MDSS=8.7, DCR=58%
...1-16-15 ASCO Gastro-Symposium: Ph.2 data/n=38 (Adam Yopp), “These clinical outcomes of TTP=6.7/DCR=58%/PFS=4mo are quite encouraging…” http://tinyurl.com/m9uz9mo
...11-8-14 SITC'14: Ph.2 Correlative Studies data (biopsies B4/After) on 6pts, incl. KOL Dimitry Gabrilovich’s comments: http://tinyurl.com/pchzr6h
...9-9-14 Enrollment complete. http://tinyurl.com/ktrfswj (ph2=38 Ph1=9)
...4-4-12 AACR'12: Dr. Adam Yopp, "promising safety profile to-date" http://tinyurl.com/7yrwqm7 (see #5591)
...Feb'12-Sep'14 10+ times: CEO Steve King hints of future ex-US partner-driven Bavi+Sorafenib/LIVER trial in Asia-Pacific: http://tinyurl.com/nkaxtcc
......Articles & Data describe Liver Cancer challenges in Asian populations: http://tinyurl.com/7z7o8j9 & http://tinyurl.com/7z99cy4
...12-1-10: PPHM's 1st IST (Liver Cancer) initiated at UTSW, ~56 patients - http://tinyurl.com/3xd3e6c
…Per S.King, 5-18-10/R&R, "We've had a lot of interest in running clinical trials with the compound from investigators who have either had prior experience with the drug or would like to study the drug in various settings. Potential IST indications include all the major solid tumor types. Of particular interest is Liver Cancer, in which we have a natural tie-in with our HCV program, Ovarian Cancer and Pancreatic Cancer, also very nicely supported by the prior data."
G. Phase IIb Bavi+PC vs. Front-Line NSCLC (randomized, unblinded, 'confirmatory', n=86)
Protocol: http://clinicaltrials.gov/ct2/show/NCT01160601 (17 U.S. + 9 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 40 as of 8-12-11)
...Also listed in: India's CTRI registry http://tinyurl.com/ljg7aad and WHO's registry http://tinyurl.com/kcp4z89
...6-27-13: Bavi+CP MOS>14mos (“with < 60% of survival events”) http://tinyurl.com/pmcgsgp
…”with less than 60% of survival events, while the Bavi+CP arm currently demonstrates a MOS > 14mos, there was not a meaningful enough diff. in survival between the 2 arms that would support the advancement of this combination. Full results will be presented at a future sci. meeting or thru pub.”
...5-7-13: FTM's Table of 20 prev. Ph.3 Trials in 1st-Line NSCLC (ctl=CP), MOS & HR results (Note Avastin improved CP-Only by 19%): http://tinyurl.com/cho7o29
...3-9-12: Topline ORR & PFS Data (Bavi+PC vs.PC-only) http://tinyurl.com/7m9r6ya
…...LOCAL reads: ORR/32%-31% PFS/5.8-4.6mos , CENTRAL reads: ORR/25%-23% PFS/6.7-6.4mos
...12-6-11 Prelim. Data (n=86, 100% Stage IV's) => ORR=39%, PC/alone=25%: http://tinyurl.com/7ph4tty
......Comp. vs. Avastin+PC/Ph3/n=417(74% Stage IV's): ORR=35% (Sandler/E4599/2006 http://www.nejm.org/doi/pdf/10.1056/NEJMoa061884 )
...9-8-11: Enrollment complete. http://tinyurl.com/3vv9zfx
...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to 30+ sites, expect enroll. comp. "in coming weeks", interim data by Yr-end'11. http://tinyurl.com/6k6y2as
…7-14-10/CC, J.Shan (VP/Clin+RegAffairs): "This trial is intended to confirm in a randomized setting the results from our Ph.2 signal-seeking NSCLC trial which showed 43% ORR, more than double the generally accepted chemo ORR of under 20% in numerous publications. Favorable results could then lead to an end of Ph.2 meeting with the FDA, with possibly a pivotal Ph/3 trial for front-line lung cancer, our 2nd potential regulatory pathway for bavituximab."
...7-14-10: U.S. Ph.2b randomized trial initiated http://tinyurl.com/27kxksl
……up to 86 front-line patients at ~20 clinical sites; goal: enrollment comp. by mid'11.
F. LEAD IND: Phase IIb Bavi+Doce vs. 2nd-Line NSCLC (randomized, double-blinded, placebo-ctl'd, n=120, 'registrational')
Protocol: http://clinicaltrials.gov/ct2/show/NCT01138163 (24 U.S. + 15 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 53 as of 8-12-11)
Enrolled Oct2010 - Oct2011 at 40 global sites (per J.Shan 9-7-12 webcast ( http://tinyurl.com/8cn87la )
8-2012: Compare Bavi+Doce's MOS=11.7mos (Bavi/3mg) to the 4 Curr-Approved 2Line/NSCLC Drugs http://tinyurl.com/cgnkvpa
• Taxotere/docetaxel => MOS=6.3mos (meta-analysis of 5 trials, 865 pts)
• Altima/pemetrexed => No diff. vs. Docetaxel (Ph.3 non-inferiority vs. Doce, 571 pts)
• Tarceva/erlotinib => MOS=5.3mos (TITAN Ph.III n=424 trial - see http://tinyurl.com/8w8lo93 )
• Iressa/gefitinib => "Iressa does not improve OS"
2-19-16/Clin-Lung-Cancer-Jrnl: Ph2 Final Data, Dr. David Gerber et al http://tinyurl.com/z5a7fwu
9-8-15: CMS SETTLEMENT EXECUTED (CSM pays PPHM only $600k for their “breach of contract, negligence & constructive fraud”, due to “limitation of liability contract clauses”) http://tinyurl.com/pemub47 (10Q/pg.17)
6-23-14: PPHM files Opposition to CSM’s Motion For Partial Summary Judgment - excerpts: http://tinyurl.com/q8xwd4v
. . .Declaration of Joseph Shan (VP/Clin+RegAffairs): http://tinyurl.com/kdgllxn
. . .Declaration of Jeffery Masten (VP/Quality): http://tinyurl.com/oru9p5q #6: “up to 25%" of CTL had 1mg, and “up to 25%" of 1mg had CTL(DoceOnly).
3-28-14: Peregrine files 1st Amended Complaint vs. CSM (13pgs) http://tinyurl.com/lsgf5lz
...Pg6: ”[as of 4-15-10], CSM had already secretly & unilaterally swapped the A & B arms so that those patients that were randomized in the A arm (CTL) and supposed to receive placebo treatments, were actually receiving 1MG Bavi treatments, and vice-versa. Peregrine’s Fall’12 investigation revealed that CSM committed other labeling & distribution errors affecting the A & B arms above & beyond the swap of the A& B arms noted above.”
6-3-13/ASCO’13: Final Data Ph.II 2L/NSCLC http://tinyurl.com/my8qxw7
…60% improvement in MOS: Bavi/3mg=11.7mos. vs. 7.3mos. for CTL-arm(combined Bavi/1mg + DoxyOnly arms), HR=.662, P=.113
5-20-13: FDA Approves Bavituximab Ph.III Design for 2L/NSCLC; 600-pt trial to begin by y/e’13 http://tinyurl.com/n3dxtm6
...S.King: “We will now focus on starting the Ph.III trial while continuing ongoing partnering discussions.”
…R.Garnick: “This was a highly collaborative effort with the FDA; this trial, when combined with Bavi’s supporting data to date, could be sufficient to support a future BLA submission."
2-19-13: Topline Data Update from 2nd-Line NSCLC Trial after data discrepancies review http://tinyurl.com/ansqcea
…60% improvement in MOS: 3mg=11.7mos. vs. 7.3mos. for CTL-arm(combined 1mg & Doxy+placebo arms), HR=.73, p=.217
6-5-13: FTM's table of MOS data in 15 prior Doxy 2nd-Line NSCLC trials (Bavi's 60% MOS Improvement is Tops) http://tinyurl.com/m886ctb
1-25-13: MLV's George Zavoico recaps 2ndLine/NSCLC data errors & current status of PPHM's review http://tinyurl.com/b9u4pk8
...GZ: "This means that patients randomized into the high dose arm were administered Bavi correctly, whereas some of the patients in the placebo arm were administered low dose Bavi and some in the low dose Bavi arm were administered placebo. More importantly, the findings suggested that the MOS of 13.1 mos. in the high dose arm was likely to be valid. Even by historical measures, this is a remarkable result, since docetaxel's product insert lists the MOS of NSCLC patients receiving this widely used drug as 2nd-Line therapy in 2 trials as 5.7 & 7.5 mos. In effect, adding Bavi doubled the MOS. In our view, this was an extraordinary stroke of luck. If the high dose arm had been affected by the coding discrepancy, Peregrine would have been in a completely different & unfortunate position… Moreover, Peregrine must determine how best to present its case to the FDA. Will the historical controls be sufficient to justify moving Bavi into a Phase III pivotal trial, or will Peregrine have to pool the results of the placebo & low-dose arms and use that as a comparator to argue for moving ahead? A simple average of the placebo & low-dose arms results in a new control MOS of about 8.4 mos., still several months less than that of the high dose arm. This quick analysis results in about a 5-mo. survival advantage, a substantial prolongation for patients with second-line NSCLC and likely to justify moving Bavi into a pivotal Phase III trial in 2013, in our view."
1-7-13 PPHM PR - Review Update: "discrepancies are isolated to the placebo and 1 mg/kg arms; no evidence of discrepancies in the 3 mg/kg arm… Peregrine is taking a very conservative approach toward analyzing the results by combining the placebo & 1mg/kg arms into one treatment arm (control arm), and comparing to the 3mg/kg arm. This analysis indicates that the 3 mg/kg arm continues to show favorable TRR's, PFS, and OS over the new combined control arm. Peregrine expects to announce more detailed results from the analysis in the near term when it is completed." http://tinyurl.com/asup54d
9-24-12: Major Discrepancies found in 2nd-Line NSCLC Ph.2B Treatment Group Coding by Indep. 3rd-Party Vendor CMS/FargoND http://tinyurl.com/8r9zcqy
…"Investors should not rely on clinical data that the company disclosed on or before Sept. 7, 2012 from its Ph.2 Bavi trial in patients with 2nd-Line NSCLC or any presentations or other documents related to this Ph.2 trial."
9-24-12: Peregrine sues CSM Over Bavi Ph.2B 2nd-Line NSCLC Clinical Trial Mix-Up http://tinyurl.com/8fpgngu
…CSM = Clinical Supplies Management Inc., Fargo ND http://www.csmondemand.com
...1-17-13: Peregrine's lawsuit against CSM for "breach of contract & negligence" SERVED http://tinyurl.com/a7zrgys
…9-10-12 CEO Steve King, QtlyCC ( http://tinyurl.com/8nkwrml )
……"These are truly remarkable results (statistically doubling MOS) that are not only great for the pgm… but also great news for the NSCLC patients in the trial…"
…9-10-12 Robert Garnick (Head/Reg), QtlyCC ( http://tinyurl.com/8nkwrml )
……"The NSCLC data we announced 9-7-12 has far exceeded our expectations, and I hope that you're as excited as I am with bavituximab's potential. I feel strongly that Peregrine should be recognized for having the corporate courage to conduct the rigorous, randomized placebo-controlled Phase II trial that provided these robust data and that provide the basis for us to plan for a pivotal Phase III program."
...9-7-12: PPHM Press Release about Dr. Gerber's plenary at ASTRO/Thoracic/Chicago: http://tinyurl.com/96wrrso
…"The interim data showed a statistically significant improvement in OS (Hazard Ratio 0.524, p-value .0154) and a doubling of MOS (11.1/13.1mos. vs. 5.6mos.) in the Bavituximab-containing arms compared to the [Docetaxel] ctl-arm."
......VP Joe Shan's 15min. Webcast & Slideshow recapping Dr. David Gerber's 9-7-12 ASTRO/Chicago Plenary: http://tinyurl.com/96wrrso
…8-15-12 CEO Steve King, Wedbush/NYC ( http://tinyurl.com/8mhrtld )
......"As we're sitting here today, we have still not reached the # of events for MOS in either of the Bavituximab arms - and, in fact, we still have patients that are on treatments." Q&A: "it's going to be a very positive MOS result, it's just a matter now of magnitude."
…7-16-12 CEO Steve King, QtlyCC ( http://tinyurl.com/cs7spbz )
......"The strength of this 2nd-Line NSCLC data (esp. MOS trends) in this large area of high unmet medical need has also sparked a surge in partnering discussions that has included over 15 in-person partnering meetings since that time with major players in oncology, with all discussions ongoing and addl. parties showing interest. Our goal for the program is to position ourselves, along with a potential partner, to initiate Ph3 by mid-2013, which means an EOP2 meeting by yr-end'12. It would be ideal to have a partner on board to participate in the EOP2 meeting, and we have communicated this to interested parties and they agree."
…7-16-12 Robert Garnick (Head/Reg), QtlyCC ( http://tinyurl.com/cs7spbz )
……"We've been working very hard and very actively on the next steps in our Bavi 2nd-Line NSCLC pgm, given the favorable data that we've seen. As you can imagine, with data like this, there are many things that we need to consider. One consideration is that, should the data continue to trend the way it is, particularly in survival, this opens a door for potential discussions around a pathway for Accelerated Approval. At this point, all options are being considered, with Peregrine working towards the most efficient path forward from a regulatory standpoint." Q&A: "…all in all, I think the data is extremely compelling and I think it makes a really good case. Certainly, I think, I've seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I've ever seen. So, I'm very comfortable proposing a meeting with the FDA for Q4'12."
…7-12-12 CEO Steve King, JMP-Conf/NYC ( http://tinyurl.com/csdclwb )
……"Re: 2nd-Line/NSCLC trial, the most thrilling thing is the fact that, even though we'd reached MOS for the ctl-arm(Doce) at end of Apr'12 of LESS THAN 6MOS, the majority of patients are still alive (today) in both Bavi arms, and we expect that to continue for some period of time still. Ph3 planning is underway already; our goal is to start this Ph3 by mid'13, meaning an EOP2 meeting with the FDA in Q4'12; our goal is to bring a partner on board, ideally in time for that EOP2 meeting, certainly before the beg. of the Ph3 trial."
…5-21-12: TopLine data n=117 for Bavi/3mg+Doce arm: ORR=17.9%/PFS=4.5mos (vs. CTL 7.9%/3mos) http://tinyurl.com/73aeyxj
......Importantly, MOS for CTL-arm "< 6 mos", but not yet reached in both Bavi arms.
...10-6-11: Enrollment complete. http://tinyurl.com/3m9re39
...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to ~45 sites, expect enroll. comp. "early in Q4/2011", data unblinding 1H'12. http://tinyurl.com/6k6y2as
…3-17-10/Roth, CEO S.King: "We refer to this trial as a Registrational Phase II Study, because we believe that if we have results anywhere near approaching what we saw in the earlier [India] study, it could be a conduit for Accelerated Approval."
...6-4-10: Ph.2b randomized reg. trial Open for enrollment: http://tinyurl.com/25v22qk
……"up to 120 refractory patients at ~30 clinical sites; goal: fully-enroll by mid'11, topline data by y/e'11."
COMPLETED BAVI CANCER TRIALS:
These 5 completed Ph.1 & Ph.2 Bavituximab Cancer Trials archived to: http://tinyurl.com/72dnkfg
1. Ph.1A Bavi/Mono vs. Solid Cancers (USA n=26, 6/2005-6/2009)
2. Ph.1B Bavi+Chemo vs. Solid Cancers (India n=12, 11/2006-5/2007)
3. Ph.2 Bavi+Doce/BREAST/Refractory (RepGA n=46, 1/2008-5/2009): ORR=61%(Her2+=86%), PFS=7.4mos, MOS=20.7mos *
4. Ph.2 Bavi+PC/BREAST/Frontline (India n=46, 8/2008-9/2009): ORR=74%(Her2+=100%), PFS=6.9mos, MOS=23.2mos %
5. Ph.2 Bavi+PC/NSCLC/Frontline (India n=49, 6/2008-10/2009): ORR=43%, PFS=6.1mos, MOS=12.4mos #
......* BAVI+DOCE/Refract-MBC N=46: Compare *MOS=20.7mos to 11.4mos for Doce/alone (Nabholtz/JCO1999 Ph3/n=203 http://tinyurl.com/3rxqqtk )
......% BAVI+PC/FrontLine-MBC N=46: Compare %MOS=23.2mos to 16.0mos for P+C/alone (Loesch/JCO2002 Ph2/n=95 http://tinyurl.com/6wazs9p )
......# BAVI+PC/Frontline-NSCLC N=49: Compare #MOS=12.4mos to P+C/alone=10.3, Avastin+PC=12.3 (E4599/n=434), achieved using less Chemo (175-v-200 & AUC5-v-AUC6), treating 16% (8/49) more-difficult Squamous in Bavi trial (excluded totally from E4599), and treating higher % of sicker ECOG1 pts than in E4599 (96%-v-60%). See 6-15-11/PR http://tinyurl.com/3fcz5ok , ASCO'10 http://tinyurl.com/2g5cqof , and a discussion of differentiating factors between patient demographics & baselines treated in the 2 trials: http://tinyurl.com/6k5uuf7 .
BAVITUXIMAB HEP-C PHASE1+2 TRIALS: (see http://PeregrineTrials.com)
9-9-11: PPHM is positioning Bavi as potential Interferon replacement in HCV cocktails: http://tinyurl.com/3novgzk
12-2011: Nature Medicine article lists Peregrine among 11 co's dev. interferon-free treatments for HCV: http://tinyurl.com/87ltkmt
7-2011: Nature Biotechnology article quotes Dr. Thorpe on Bavi's goal to elim. IFN-A: http://tinyurl.com/3n8qluq
6-2011: Flying Publisher 'Guide to HepC Treatment' highlights Bavituximab: http://tinyurl.com/3srbzl5
D. Phase II Bavi+Riba vs. Frontline-HEPC (randomized, open-label):
Protocol (init=1-2011): http://clinicaltrials.gov/ct2/show/NCT01273948
12-29-11: HCV Ph.2 Trial Update http://tinyurl.com/coq2969
……SK: " this is a good time to seek partners for the antiviral pgm. which has shown promise in this study."
9-26-11: Enrollment Complete in Bavi+Riba/HCV trial http://tinyurl.com/3j9bba8
1-10-11: Bavi+Ribavirin/HepC Ph.2 trial initiated http://tinyurl.com/4uz97tv
......"~66 patients with previously untreated genotype-1 chronic HCV, 1 of 3 arms (.3Bavi+R / 3.0Bavi+R / PEGIFN+R) for 12 wks, testing for safety & antiviral activity."
C. Phase 1B HCV-HIV Co-Infected's Mono Repeat-Dose Trial:
Protocol (init=7-2007): http://clinicaltrials.gov/ct/show/NCT00503347
…4-2-11: Ph.1B trial data presented at EASL-2011/Berlin on 4-2-11 http://tinyurl.com/3mmwy5d
…1-31-11: Enrollment Complete in HCV-HIV trial http://tinyurl.com/4tagpz2
...7-10-07: Enrollment begins at St.Michaels (Peter Ho Mem. Clinic, NJ) http://tinyurl.com/2g7rdp
......Ascending dose levels of Bavi weekly for 8 wks; ~24 pts; designed to assess Safety & PK, but "HCV & HIV viral titers & other biomarkers will be evaluated".
...5-17-07: New Clinical Protocol filed with FDA: http://tinyurl.com/2lpacm
These 2 completed Ph.1 Bavituximab Hep-C Trials archived to: http://tinyurl.com/27f58fc
1. Phase 1A Bavi/Mono Single-Dose HCV Trial: (init=8-2005 comp=2-2006 n=30)
2. Phase 1B Bavi/Mono Repeat-Dose HCV Trial: (init=6-2006 comp=1-2007 n=24)
COMPANY UPDATES & ARTICLES: [ PPHM News: http://finance.yahoo.com/q/h?s=PPHM ]
9-8-16 Qtly. Conf. Call (King/Shan/Garnick/Hutchins/Lytle) Transcript http://tinyurl.com/jydtkoy
...CEO SK: “Our ultimate goal remains to reach overall profitability within the next 21mos, and Avid will be an important driver for achieving that goal, in combination with making strategic investments in our R&D while pursuing partnerships to help advance our programs.”
7-14-16 Qtly. Conf. Call (King/Garnick/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/h8eqtg5 (Avid revs guidance for FY17=$50-55mm, curr. committed B/L=$68mm)
...CEO SK: “The recent licensing of Novel PS Exosome Tech. for detection/monitoring of cancer from UTSW will allow the co. to continue its R&D activities with significant upside coming from partnering as we move towards profitability.”
6-2-16: Corp.Update – Avid Expansion & Drug Development - http://tinyurl.com/zvmhqmr
...Avid Revs for FY16(fye 4-30-16) will be $44mm; B/L=$56M; FY17/guidance=$50-55mm(3 curr. clients). Avid III being designed/already secured 25,000sf loc/expect complete=1H/2017. “Expect future sustainable profitability for the company in 24mos.”
3-9-16 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/gom7md5
...CEO SK: “Peregrine remains a strong company with a valuable clinical asset and a rapidly growing biomfg. business... We believe our relationships with AstraZeneca, Mem. Sloan Kettering, UTSW, & NCCN will be invaluable as we establish & execute our overall strategy for advancing the bavituximab I-O combination plans in a range of cancers.”
3-7-16: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) http://tinyurl.com/za2j9mt
2-25-16: IDMC Halts Ph.3/NSCLC SUNRISE Trial at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations” http://tinyurl.com/jbg48vs
1-18-16: CEO Steve King's 1-18-16 presentation at Noble-Financial's Investor Conf. (21min replay, 31 slides) http://tinyurl.com/j9dkekm
1-11-16: Update on 4 New Bavi Clinical Trials (Lung/AZN, Breast/1Co./1MSKCC, Other Cancers/AZN). SUNRISE est's: Look1=Early'16, Look2=Mid'16, FinalUnblind=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/o3k9ux8
3-12-15 Qtly. Conf. Call (King/Garnick/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/q78oxvm
...CEO S.King: “Bavituximab represents the most clinically advanced agents that target the immunosuppressive PS signaling pathway, and we are driven to bring this product to the market and believe it has the potential to help change the way cancer patients are treated. Our Ph.3 SUNRISE NSCLC trial continues to make great progress & is on track to complete enrollment in the study by YrEnd’15.”
3-9-15: CEO Steve King’s 24min. talk at ROTH Conf. (DanaPT CA) - SLIDES http://tinyurl.com/p873grw
12-10-14 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/kmdgq8t
...CEO S.King: “We believe Peregrine is in a unique position with an immune-oncology program already in Phase III, with what has been a positive safety profile and a target that is ideal for combining with other IO agents.”
10-16-14 Peregrine's ASM: Slides(42), Audio-Replay-Link, Attendee-Reports http://tinyurl.com/oyc3e5v
9-9-14 Qtly. Conf. Call (King/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/ktrfswj
...CEO S.King: “In addition to our clinical trials, many of which have also have translational data points built in to tie together pre-clin. data with the clinic, we have also continued to build momentum in our pre-clin. collaborations which now number in the dozens. We are evaluating new combinations & dosing strategies combining bavituximab with chemotherapy, radiation, and immune-oncology approaches, including those targeting CTLA-4, PD-1, as well as other downstream immune checkpoints."
7-14-14 Qtly. Conf. Call (King/Shan/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/o2e4a4g
...CEO S.King: “Partnering remains a priority with the goal being to use partnerships to continue expanding the bavituximab program, while we continue to execute the SUNRISE Phase III trial.”
3-10-14: CEO Steve King’s 22min. talk at ROTH Conf. (DanaPT CA) - SLIDES http://tinyurl.com/n65myfk
3-7-14 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/kh9cnrg
...CEO S.King: “I don't want to overuse the word ‘excitement’, but these are truly exciting times that have positioned us for success on all fronts.”
12-10-13 Qtly. Conf. Call (King/Shan/Garnick/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/mw776mk
...With recent scientific insights highlighting bavi’s immunostimulatory moa, these additions to PPHM’s SAB: Dimitry Gabrilovich, Scott Antonia, David Carbone, Hakan Mellstedt
...CEO S.King: “We believe that Peregrine is uniquely positioned among the companies developing immunotherapies… and that because of our current valuation, we represent a unique investment opportunity.”
11-2013: Stephen Worsley joins Peregrine as VP of Bus.Dev. http://tinyurl.com/mmet4eb
11-12-13: CEO Steve King's 23min. talk at Credit-Suisse Conf. (Scottsdale) http://tinyurl.com/nu3vxgt
9-9-13 Qtly. Conf. Call (King/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/q3zooj6
...CEO S.King: “In addition to the immunotherapy research, there has been significant interest in the results presented at ASCO showing an 84% tumor response rate in HER2- breast cancer patients.”
8-14-13: CEO Steve King's 26min. talk at Wedbush/NYC http://tinyurl.com/m22n9pl - SK. "We have very active partnering discussions [ongoing] around our 2 lead programs.”
7-11-13 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/khpokw6
...CEO S.King: “This [new bavi] moa insight has opened the door to completely new combinations not previously explored. Bavi acts on an upstream immune checkpoint, and thus, makes a potentially ideal combination with downstream-acting immune checkpoint inhibitors such as anti PD1 antibodies & CTLA-4 targeted approaches… Preclinical studies are well underway to explore these combinations, and we look forward to generating and reporting data later this year that could support moving these concepts into the clinic.”
6-27-13: Updates on Bavituximab Pgm. & Cash Position http://tinyurl.com/pmcgsgp
…“primary focus remains on the init. of the PhIII trial in 2nd-Line NSCLC by y/e; recent data supporting an immunotherapy moa for bavituximab opens many new development opportunities including new combinations not previously planned and has created a lot of excitement around the potential of bavituximab in combination with other immunotherapeutic agents…"
4-2-13: Peregrine Mourns Loss of Dr. Philip E. Thorpe (1951-2013) http://tinyurl.com/c5zhd4q
3-18-13: CEO Steve King's 27min. talk at Roth Conf.(DanaPT CA) - Excerpts & SLIDES http://tinyurl.com/cebtwen
…CEO S.King: "Our goal is to initiate the Phase III trial (2ndLine NSCLC) by the end of 2013."
3-12-13 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/c48osut
...Rob Garnick (Head/Reg.): "Re: 2nd-Line NSCLC: …the 3rd piece, which is important, is the efficacy piece, and as I point out to many people, there are very few and far between Phase II trials that ever show statistical significance in efficacy - that's an absolutely unbelievable hurdle for a Phase II product. And, what you're really looking for is an ability to describe that you do have clinical efficacy, and as Joe has said, showing 11.7 mos. for the 3mg arm and a difference in the pooled dataset for the product of 7.3 mos. when you combine the control & the placebo, definitely gives you the indication that in overall survival, we have a potentially highly efficacious product… we're going to discuss the entire situation of the investigation with the agency, as well as all the data I just described, and we feel pretty confident that we have enough data to move the product effectively into Phase III."
3-5-13: CEO Steve King's 24min. talk at Cowen HC Conf.(Boston) - Excepts & SLIDES http://tinyurl.com/bczyfb3
12-10-12 Qtly. Conf. Call (King/Garnick/Shan/Lytle) Transcript http://tinyurl.com/a954bmw
...CEO Steve King: "The goal of this (2nd-Line NSCLC ) review is to be able to generate a final data set that we believe could be used in discussions with the FDA to support advancing the program into a pivotal trial. Our partnering phase for Bavi has not changed. The partnering discussions are still ongoing, with potential partners remaining engaged, and like all of us, awaiting the outcome from this review…"
...Rob Garnick (Head/Reg.): "(Re: Cotara FDA-Approved Ph3 Design), we're pivoting right now and following the discussions with the FDA to discuss the same trial design plan with the Eur. agency and as well as potentially other global regulatory authorities. So, it's going to take a lot of effort and a lot of time, but we're very confident that we're going to be able to come up with one unified trial that will accomplish all of our goals."
10-17-12: Corp-Update ($14.3mm/ATM, Avid, Mult-Milestones, ASM Webcast Oct18) http://tinyurl.com/c7gax7y
…PDF of 10-18-12 ASM Presentation/S.King http://tinyurl.com/8e5p6m5 (19 slides), Attendee Reports: http://tinyurl.com/9b2xfzu
9-24-12: Peregrine sues CSM Over Bavi Ph.2B 2nd-Line NSCLC Clinical Trial Mix-Up http://tinyurl.com/8fpgngu
…CSM = Clinical Supplies Management Inc., Fargo ND http://www.csmondemand.com
9-25-12: Peregrine Pays Off $15mm Loan from Oxford, triggered by 3rd-party data error: http://tinyurl.com/9pucqn8
……"we will have sufficient capital to fund our operations into Q4'13 based on current projections."
...8-30-12: $30mm Loan ($15mm/immed, $15mm/option) from Oxford Fin. http://tinyurl.com/cm2lkgs 8K: http://tinyurl.com/9hedbaf
9-2012 PPHM's 2012 Annual Report: Theme => "Transformation" http://tinyurl.com/8myww6w
9-10-12 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/8nkwrml
...CEO Steve King: "These are truly remarkable results that are not only great for the pgm… but also great news for the NSCLC patients in the trial…"
...Rob Garnick (Head/Reg.): "The NSCLC data we announced 9-7-12 has far exceeded our expectations, and I hope that you're as excited as I am with bavituximab's potential. I feel strongly that Peregrine should be recognized for having the corporate courage to conduct the rigorous, randomized placebo-controlled Phase II trial that provided these robust data and that provide the basis for us to plan for a pivotal Phase III program.."
...CFO Paul Lytle: "As you can imagine, given the Bavi results that we shared with you on Friday [9-7-12 2nd-Line NSCLC], our partnering activities are continuing at a very active pace as we move closer towards the EOP2 meeting with the FDA. Our stated goal is to have a partner on board before we start the Phase III trial and, preferably, before the EOP2 meeting with the FDA, as we would like our future partner to be a part of that important meeting."
9-5-12: CEO Steve King's 26min. talk at Stifel-Nicolaus/Boston http://tinyurl.com/cr65pug
8-30-12: $30mm Term-Loan Secured ($15mm/immed, $15mm/option) + 273k 6yr firstname.lastname@example.org http://tinyurl.com/cm2lkgs 8K: http://tinyurl.com/9hedbaf
8-15-12: CEO Steve King's 29min. talk at Wedbush/NYC http://tinyurl.com/8mhrtld
…SK: "As we're sitting here today, we have still not reached MOS in either of the Bavi arms in the 2nd-Line NSCLC trial - and, in fact, we still have patients that are on treatments." Q&A: "it's going to be a very positive MOS result, it's just a matter now of magnitude. We've laid out our strategy for financing the company; we've not been raising money thru the capital markets in any way. We're not currently planning on going out for, nor have we been actively involved in any other fund-raising activities. Right now, our stated goal is to pursue a debt-arrangement - with an asset like Avid Bioservices, we can get very preferential rates on raising debt-type funding right now, which we feel is the least-dilutive for the company."
7-16-12 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/cs7spbz
...Steve King: "The strength of this 2nd-Line NSCLC data (esp. MOS trends) in this large area of high unmet medical need has also sparked a surge in partnering discussions that has included over 15 in-person partnering meetings since that time with major players in oncology, with all discussions ongoing and addl. parties showing interest. Our goal for the program is to position ourselves, along with a potential partner, to initiate Ph3 by mid-2013, which means an EOP2 meeting by yr-end'12. It would be ideal to have a partner on board to participate in the EOP2 meeting, and we have communicated this to interested parties and they agree."
...Robert Garnick: "We've been working very hard and very actively on the next steps in our Bavi 2nd-Line NSCLC pgm, given the favorable data that we've seen. As you can imagine, with data like this, there are many things that we need to consider. One consideration is that, should the data continue to trend the way it is, particularly in survival, this opens a door for potential discussions around a pathway for ACCELERATED APPROVAL. At this point, all options are being considered, with Peregrine working towards the most efficient path forward from a regulatory standpoint." Q&A: "…all in all, I think the data is extremely compelling and I think it makes a really good case. Certainly, I think, I've seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I've ever seen. So, I'm very comfortable proposing a meeting with the FDA for Q4'12."
7-12-12: CEO Steve King's 26min. talk at JMP/NYC http://tinyurl.com/csdclwb
…SK: "Re: 2L/NSCLC trial, the most thrilling thing is the fact that, even though we had reached the MOS by the cutoff point at the end of April of less than 6mos. for the Doce ctl-arm, the majority of patients are still alive in both Bavi arms, and we expect that to continue for some period of time still."
6-20-12: PPHM hires Securities, Financing, and M&A Attorney Mark Ziebell as VP, General Counsel http://tinyurl.com/7ze229a
3-12-12: CEO Steve King's 24min. talk at ROTH-OC(DanaPT) http://tinyurl.com/7837qym
…SK: "I think the best-case result is, if we have just phenomenal results out of this study (2ndLine-NSCLC), that we would obviously talk to the FDA about Accelerated Approval; that was our intention to begin with."
3-9-12 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/7t2xsks
…Rob Garnick, "re: 1st-Line NSCLC, I personally don't read a lot into ORR data nor PFS and really go for the std. that really counts that's unequivocal & relatively straightforward to measure, which is MOS, and I think we have to wait for those results in order to make any judgment. And on top of that, I'd like to point out that our primary goal is in 2nd-line NSCLC, which is a disease with very low response rates in general (10% or 11%), and what we're expecting to show there is a real increase ultimately in survival. And, if we see that, that's what we'll take forward into a Phase III pivotal trial."
2-14-12: CEO Steve King's 24min. talk at BIO-CEO/2012 (NYC) - slides & excerpts http://tinyurl.com/86wque8
…SK: "Our pipeline is completely unencumbered, so as we look into 2012 & beyond, we think we can bring in significant monies thru partnering deals which will help us move the programs forward."
12-12-11 Qtly. Conf. Call (King/Shan/Lytle) Transcript http://tinyurl.com/75rfwrv
…SK, "Our goal is to secure regional partners for our Bavi oncology program, and we look forward to seeing addl. data points from our randomized trials as we advance these discussions. [re: Cotara/GBM Ph3], the FDA has agreed to provide specific feedback to us in writing on our proposed pivotal trial design that we submitted to them."
9-27-11: JMP Securities Healthcare Conf./NYC - SK's Slideshow Capture http://tinyurl.com/3qqslkb
9-9-11 Qtly. Conf. Call (King/Garnick/Shan/Lytle) Transcript http://tinyurl.com/3bx8eat
...Robert Garnick: "As we saw over the last couple of weeks, the most recently approved therapy for NSCLC drugs (Pfizer's crizotinib=Xalkori) can in fact receive Accelerated Approval based on ORR data gen'd from single-arm studies, and we're very eager to assess bavituximab's potential in our ongoing trials."
9-8-11: CEO Steve King presents at Stifel Nicolaus HC/Boston - a few slides, incl. milestones: http://tinyurl.com/3sk8rba
7-14-11 Qtly. Conf. Call (King/Shan/Garnick/Masten/Eso/Lytle) Transcript http://tinyurl.com/6k6y2as
...Robert Garnick: "It's really easier to approach regulatory agencies with promising survival data and a consistent safety profile, which is exactly what we have seen from both bavituximab & Cotara in our clinical trials to date."
6-29-11 Minyanville article, "Peregrine Pharma's Secret Weapon [Robert Garnick]" http://tinyurl.com/3lgoras
…CEO Steve King considers his company fortunate to have someone with Garnick's long history with the FDA. "Rob is the ringmaster," King says.
11-8-11: April Loui (ex-Genentech Sr.Mgr/QA) joins Peregrine as Director/QA http://tinyurl.com/6tzbfkt
5-31-11: Jeff Masten (ex-Genentech Sr.Dir. of Quality) joins Peregrine as VP/Quality http://tinyurl.com/3qxuvso
..."This is an exciting time to join Peregrine, as bavituximab advances through numerous Phase II clinical trials and Cotara's registrational path is being outlined. I look forward to working with CEO Steve King, head of regulatory affairs Rob Garnick, and the extended teams at Peregrine and Avid to drive industry-leading quality programs and facilitate regulatory agency inspections as we support Avid's third-party clients and prepare for potential launch of Peregrine's products."
5-26-11: Dr. Steven Chamow (ex-Genentech) joins Peregrine as Head of Process Science http://tinyurl.com/3bgglxj
5-19-11: Nuclear-Med. & Oncology Specialist Dr. Vladimir Evilevitch (ex-Parexel, ex-Novartis) joins PPHM as Med.Director http://tinyurl.com/3av4red
…"to execute Cotara Regulatory & Clinical strategy"
4-2011: Peregrine adds 2 more "Regulatory" people, Kathryn Hansen (ex-Amgen) & Soheila Dadgostari (ex-Valeant) http://tinyurl.com/3wy4sxm
3-14-11: S.King at Roth-OC/DanaPT - slides & excerpts: http://tinyurl.com/4d2voyy
...SK: "Cotara/GBM Ph.2/40pt enrollment completed in Dec'10; expect top-line by mid'11, We've already begun preparing for an FDA meeting in 2H'11, in which the goal is to get an SPA ("Special Protocol Assessment") approved; at that point, the drug is highly partnerable." [Per David Miller, "the idea is if you sign an SPA with the FDA and conduct the trial as agreed, good results from the trial will be sufficient for marketing approval."]
3-11-11 Qtly. Conf. Call (King/Shan/Thorpe/Lytle) Transcript http://tinyurl.com/4p4hqr5
3-9-11: Dr. Kerstin B. Menander (ex-Abbott) appointed Head of Medical Oncology http://tinyurl.com/4cjlbzn
3-4-11: Reuters' Deena Beasley Interviews Steve King http://tinyurl.com/4c9um52
...SK: "The study [ongoing Ph.2b Bavi+Doce/Refract-NSCLC] could provide the basis for seeking U.S. regulatory approval… This is easily a $1B+ potential drug in NSCLC alone."
12-9-10 Qtly. Conf. Call (King/Shan/Eso/Lytle) Transcript http://tinyurl.com/23kassc
…S.King: "our next planned virus therapy trial will evaluate Bavi+Ribavirin vs. HCV patients… we are planning to initiate addl. Co-sponsored trials & ISTs in the very near future."
11-2-10: Peregrine Awarded $977,917 Therapeutic Discovery Grant http://tinyurl.com/2funn26
10-21-10: Carlton Johnson appointed Chairman of BOD & SHM Results http://tinyurl.com/269zqn5
10-3-10/OCBJ: PPHM Repeats as #1 Growth Co. in OrangeCo. http://tinyurl.com/27cuv7o
...Last-12mos-Rev: $27.9mm, 3yr-Sales-Growth: +358.6%
9-13-10, CEO S.King, R&R/NYC: http://tinyurl.com/23fagxw
…S.King re:TMT: "We're at the point where we're getting into more advanced models of the disease, as well as starting to look at some combination-therapy potential of the drug. The plan now is to complete that evaluation, to firmly establish that pgm going forward - then at that point it'll be a contract modification, and from everything we hear, we s/b moving fwd with addl. animal studies."
9-9-10 Qtly. Conf. Call (King/Eso/Lytle) Transcript http://tinyurl.com/8megkre
…S.King: "[On the AV side], so far every type of virus we have looked at does induce PS exposure on infected cells. And that creates a vast number of opportunities, everything from immunocytokines, which we're currently evaluating as part of our UC Discovery grant work, all the way to targeting nanoparticles, in which you could basically take these nanoparticles, load them with different antivirals depending on the particular type of antiviral indication, and specifically deliver your drugs to the infected cells, reducing the toxicity of the agent and taking advantage of our technology platform. And, there's actually interest in all of those from both funding agencies as well as potential partners down the road. So, I think there's a lot of great utility of that technology platform and the group here is looking at a number of different areas that we really think have pretty dramatic potential from a market standpoint, but also just can build & build on what really is a platform that has so much utility."
9-7-10 PS Patents Granted: 7790860/Imaging 7790159/Antiviral http://tinyurl.com/27zlc8a
8-2010/IF LINKEDIN IS RIGHT: Dr. Shelley Suggett (ex-Genentech Sr.Product.Dir/Regulatory) joins PPHM as Director, Regulatory Affairs http://tinyurl.com/3lmw22s
7-14-10 Qtly. Conf. Call (King/Garnick/Shan/Eso/Lytle) Transcript http://tinyurl.com/3a4p66c
…Robert Garnick: "I like to end by again saying how optimistic I am about bavituximab's potential. The growing body of research points to bavituximab potentially providing a unique & valuable new approach for the treatment of cancer. The clinical results we have to date support moving forward with our regulatory strategy to advance this novel antibody."
6-14-10: PPHM set to join Russell 3000 - reconstitution occurs 6-28-10: http://tinyurl.com/2d87y3z
6-9-10 CFO Paul Lytle's 26min. talk at Needham HealthCare Conf./NYC http://tinyurl.com/2wt2gc7
...See slide5: considerable discussion of possible addl. Gov't Contracts & Grants, like new IRS "Therapeutic Discovery Proj. Pgm" (max=$5mm).
5-18-10: CEO Steve King's 20min. talk at R&R HealthcareConf/London http://tinyurl.com/23wqam9
…SK: "based on these [Bavi Ph.2] clinical data and our interactions with the FDA, we're in the process of operationalizing a Phase IIb Registrational Trial [Bavi+Doce 2nd-line NSCLC]. We're referring to this as a "registrational trial" because one potential is if we anywhere close to approximate the results we've seen in a prior study, this could be an opening for Accelerated Product Approval."
3-17-10: CEO Steve King's 23min. talk at ROTH Stock Conf. (DanaPT CA) http://tinyurl.com/ye9v7jq
…SK: "And then we have a real interesting part of the portfolio, which is our Bavi VHF pgm. This is completely funded by the DOD… evaluating Bavi for the treatment or prevention of VHF. What's interesting about this compound is this would not take a typical Phase1-2-3 approval approach, but rather likely go thru the FDA's "Animal Rule", which means that it basically would have animal efficacy data, combined with human safety data, which we're obviously generating a lot of, and then it would be applied for approval based on those 2 things. So this could be a much shorter entry point into an actual product that could be acquired by the gov't to stockpile as part of its biodefense efforts."
3-11-10 Qtly. Conf. Call (King/Lytle/Shan/Eso) Transcript http://tinyurl.com/yl4befh
…SK (resp. to Joe Pantginis question re: bus.dev. strategy for Bavi): "Clearly there is a lot of interest in the bavituximab pgm - novel monoclonal antibody therapies with an interesting target that has broad-spectrum capabilities in multiple indications - clearly there are not a lot of those out there… we have a lot of interested parties; we will continue to keep those potential partners updated on our clinical trial progress."
2-9-10: CEO Steve King's 23min. talk at BIO-CEO/2010 (NYC) http://tinyurl.com/ykxznha
…SK: "what we're most intrigued about is Bavi's potential in Refractory Disease, which of course is the fastest route to product approval."
1-13-10: CEO Steve King's 16min. talk at OneMedForum2010 (SanFran) http://tinyurl.com/yb7v2u4
…SK: "The [next] study we have discussed with the FDA is Bavi+Doce in 2nd-line NSCLC. In this patient population, they have about a 6% resp. rate; so, a high unmet medical need, and we think an excellent opportunity for development. The trial design we've agreed to with the FDA is essentially a registrational Ph.2 design; it's going to be about a 120 patient study, double-blinded, placebo-controlled… the goal being, if we see positive results & excellent results, that we really want to be able to take advantage of that and potentially approach the agency about Accelerated Approval."
1-11-10: Dr. Marvin Garovoy (Ex-XOMA VP) joins PPHM as Head/Clin.Science http://tinyurl.com/yz4fwyv
…Dr. Garovoy will have primary responsibility for establishing & supervising an Investigator-Sponsored Trials (IST) pgm, as well as expanding scientific outreach & assisting with clinical trial design for the Bavi & Cotara pgms.
…CEO SK: "These ISTs can be a very important part of our overall clinical dev. pgm, potentially providing invaluable info. that might not otherwise be obtained from our company-initiated trials."
…Dr. Garovoy, "Bavituximab is a promising new approach with broad potential for the treatment of solid cancers and other diseases. Based on the encouraging results seen in early clinical trials, I welcome the opportunity to collaborate with clinical researchers to establish the investigator-sponsored studies that will enhance our understanding of the clinical potential of this exciting new agent."
ARTICLES, ANNUAL SHM'S, & CC'S - Archive 2005-2009: http://tinyurl.com/6pjqt27
BAVITUXIMAB ANTI-CANCER NEWS (see above for Trials Info):
4-20-16 AACR'16 & 4-4-16/Cancer-Immunology-Res.(AACR) article - preclin. data: Bavi combo w/anti-PD-1/anti-CTLA-4 “induces a shift in tumor microenvironment from immunosuppressive to immune active” http://tinyurl.com/jyox458
6-1-15 ASCO’15: 3 Bavi/AntiPS Posters (NSCLC, Melanoma, Breast, Liver) & Plans to add Ph2/3 Bavi Trials (NSCLC/Optivo, Her2- Breast) http://tinyurl.com/qxu4w2x
4-20-15 AACR’15: 3 Abstracts/2 PR’s - Bavi Clinical TransData/Lung & PreClinData/Melanoma/Breast – Moffitt/S.Antonia, UTSW/R.Brekken, UC-Irvine/CW.Hughes, Peregrine http://tinyurl.com/n7e7r7p
4-2014 AACR'14: Peregrine's 3 preclin. posters http://tinyurl.com/k4fl8z6
...about Bavi as an “Upstream PS Checkpoint Inhibitor”; notably, “when combined with downstream immune checkpoint inhibitors such as anti-CTLA-4 and anti-PD-1, PS targeting mediates an improved protective tumor-specific immunity following tumor rechallenge”, and, “combination of bavituximab with the anti-PD-1 checkpoint blockade should synergistically induce potent long-lasting antitumor immunity.”
4-2013 AACR'13: Peregrine's 3 preclin. posters http://tinyurl.com/cnqx9oh
..."data on the immune stimulating moa of Bavi, anti-tumor & imaging potential of other PS-targeting constructs"
10-31-12, New PS-Targeting Preclin. Data - Mabs Stimulate Cancer-Fighting Immune Responses & Specifically Target Tumors http://tinyurl.com/cw9odb8
…10-25-12 SITC Poster describes Bavi's 3-pronged MOA, and 10-10-12 Nuclear Medicine & Biology article on "ImmunoPET Imaging of PS" using 89Zr-PGN635.
8-2-12: Texas CPRIT grants Philip Thorpe $1.4mm in $4.1mm Lung Cancer Project (SRBT/Rad+AntiPS) http://tinyurl.com/clhzbx2
. . .Dr. Thorpe's Project4 "Lay Summary" => http://www.cprit.state.tx.us/files/funded-grants/RP120670-P4.pdf
5-1-12 Audio replays of the NYAS Anti-PS Symposium (NYC) now at NYAS.org: http://tinyurl.com/7w3kpuc
…The 5 Speakers were: Alan Schroit, David Ucker, Ari Helenius, Chris Reutelingsperger, Philip Thorpe => Dr.Thorpe's 46min talk: http://tinyurl.com/d6vtsrr
4-2012: UPenn & Dr.Thorpe Neoplasia article on PGN635 vs. Lung Cancer http://tinyurl.com/7dynlzr
…on the potential benefits of treating with fhBavi+Chemo (PGN635+cis) AFTER Surgery - an approach offering "significant promise to prevent lung cancer recurrences."; also contrasts Bavi vs. Avastin on side effects.
4-2012 AACR'12: 7 Posters (3 Bavi/IST's, 3 Bavi/antiPS pre-clin, 1 TNT-Imaging) http://tinyurl.com/7yrwqm7 (see #2452)
…Peregrine Launches PS-Targeting Clinical Imaging Pgm. (fully-human 124I-PGN650), IND recently filed.
8-2011: Gerber/Thorpe IMMUNOTHERAPY article on Bavi+Chemo/NSCLC http://tinyurl.com/3gzd6g5
...Obviously resulting from: 6-10-09 ASCO $200k Grant to UTSW's David Gerber for New Bavi/NSCLC Study: http://tinyurl.com/nt4na9
6-2011 Dr. Philip Thorpe article in VACCINE on the "Anti-PS Fusion Protein" 2aG4-IL2: http://tinyurl.com/3o6aq7p
…"Enhancing The Potency of a Whole-Cell Breast Cancer Vaccine in Mice with an Antibody-IL-2 Immunocytokine that Targets Exposed PS"
5-26-11: Dr. Philip Thorpe Keynotes Bavi/PS MOA at Recombinant-Antibodies Conf. in Barcelona http://tinyurl.com/3klpodc
…Dr. Thorpe, "What is especially exciting is that administration of PS-targeting antibodies like bavituximab breaks the grip of the tumor on the immune system."
...A few of the more illustrative slides from Dr. Thorpe's 5-26-11 talk: http://tinyurl.com/3m33h33 . . .PT's entire 53-pg PDF: http://tinyurl.com/3ck56gr
4-5-11 AACR'11 #3643: Sorafenib Enhances Anti-tumor Effects of Bavi in Liver Cancer (HCC) http://tinyurl.com/3fzubz3
…Dr.Thorpe: "These data suggest that the growth-blocking mechanisms of sorafenib combined with the vascular-targeting & immune-reactivation mechanisms of bavituximab may offer additive anti-tumor effects for patients with HCC."
4-6-11 AACR'11: Peregrine's 4 PS-Targeting Presentations http://tinyurl.com/68p9zs4
…#621/ADT-Prostate, #3651/AntiPS-MOA, #3643/Sorafenib-Liver, #4880/FH-Bavi-Imaging
3-24-11: Phil Thorpe, E.Ward, R.Ober, R.Mason awarded $6.0mm by Texas CPRIT http://tinyurl.com/4c2sm4k & http://tinyurl.com/65fjmpw
…"to develop a new class of [Anti-PS] therapeutics to treat cancers involving the brain & nervous systems, breast, liver, interhepatic bile duct, lung, bronchs, and prostate."
...…8-2011: UTSW Article about 3-2011 $6.0mm CPRIT Award to Thorpe/etal for AntiPS dev. http://tinyurl.com/4339hwp
......11-2011: UT-Dallas Article about Dr. Raimund Ober's role in 3-2011 $6.0mm CPRIT Award for AntiPS dev. http://tinyurl.com/3prrkm3
12-1-10: Dr. Phil Thorpe co-author of J.Clin.Investigation article about "novel therapies" for APS thrombus issues http://tinyurl.com/24ddq8h
…APS (antiphospholipid syndrome) can cause life-threatening clotting disorders. One of the mabs tested was 2aG4 (mouse model of Bavi).
4-12-10: IST program (Investigator Sponsored Trials) launched: http://tinyurl.com/y3yh5h3 & PeregrineInc/IST's
AACR'10 #1919 4-19-10: PS-Targeting Mabs Can Reverse Tumor-Induced Immune Suppression http://tinyurl.com/y266azk
…Dr. Thorpe, "This study shows that the immunosuppressive effects of PS exposed on apoptotic tumor cells can be reversed by PS-targeting antibodies, specifically by reversing the suppression of DC maturation caused by the exposed PS. This finding is important since reactivation of the immune system after the primary tumor has been removed is a critical line of defense in fighting cancer recurrence. Additionally, we showed that PS-targeting antibodies have the ability to confer tumor-specific immunity, which could lead to the future development of new cancer vaccine regimens."
4-21-10, AACR'10, 3 Wed. Posters (#5337,5330,5232) http://tinyurl.com/y65nyfc
BAVITUXIMAB ANTI-CANCER NEWS - Archive 2004-2009: http://tinyurl.com/6pjqt27
IMAGING APPLICATIONS Of PS-TARGETING MABS:
5-25-16/OncoTarget, “PS-Targeted Liposome [PGN635=Fhu-Bavi] For Enhanced Glioma-Selective Imaging” - Wake Forest's Dawen Zhao & UTSW's Liang Zhang http://tinyurl.com/z6lzkqm
6-2014: Two Bavi-Imaging abstracts by UTSW at Society of Nuclear Med+Molecular Imaging (SNMMI) Annual Mtg http://tinyurl.com/kemdu2d
11-26-13: PGN635 (Fhu-Bavi) Imaging article in Molecules2013 by UTSW’s Liang Zhang & Dawen Zhao http://tinyurl.com/mxzodta
10-31-12, New PS-Targeting Preclin. Data - Mabs Stimulate Cancer-Fighting Immune Responses & Specifically Target Tumors http://tinyurl.com/cw9odb8
…10-25-12 SITC Poster on Bavi's MOA, and 10-10-12 NMBA article on "ImmunoPET Imaging of PS" using 89Zr-PGN635 (see Genentech below)
10-12-12: Genentech studying Imaging using PGN635(Fhu-Bavi) for the potential "detection of tumor response to therapy". http://tinyurl.com/8wvem9y
…Nuclear Medicine & Biology, Genentech's Jan Marik, "ImmunoPET Imaging of PS in Pro-Apoptotic Therapy Treated Tumor Models"
4-3-12: Peregrine Launches PS-Targeting Clinical Imaging Program (AACR'12 #2452) http://tinyurl.com/7p7jovt & http://tinyurl.com/7yrwqm7
…PPHM "recently filed an IND" with FDA for an Imaging trial using 124I-PGN650, ~12pts.
...6-28-12: Trial added to trials.gov: http://clinicaltrials.gov/ct2/show/NCT01632696 - see CANCER TRIALS ABOVE for more details.
12-2011: Thorpe Article on FH-Bavi/Optical-Imaging in Translational Oncology http://tinyurl.com/7vcnbz2
11-14-11: Dr. Bruce Freimark presents PS IMAGING poster at AACR-NCI-EORTC Conf./SanFran http://tinyurl.com/89hpydn
9-12-11: Drs. Thorpe & Freimark present PS IMAGING posters at World Imaging Congress/S.Diego http://tinyurl.com/3uv5rgr
9-9-11: PS IMAGING potential discussed in Qtly. Conf. Call: http://tinyurl.com/3q7hzjh
4-2011/Neoplasia: Dr. Thorpe 9-pg. article on Exposed-PE/Imaging http://tinyurl.com/5uoy6fh
…Dr. Thorpe: "PE also has potential as a marker for Imaging human malignancies."
4-6-11/AACR'11: Tumor Imaging Applications of PS-Targeting Antibodies http://tinyurl.com/68p9zs4
…Steve King: "Molecular imaging is a growing field and represents an entirely new development opportunity for our first-in-class PS-targeting antibody platform… our antibodies labeled with imaging tracers hold potential for illustrating exposed PS in a clinical oncology setting, imaging PS as a companion diagnostic with bavituximab therapy, as well as ultimately assessing patient response to a range of cancer therapies."
3-14-11: Dr. Thorpe discusses PS IMAGING in Conf. Call: http://tinyurl.com/4p4hqr5
…Dr. Thorpe: "The quality of the images is quite extraordinary. The antibody homes to tumor blood vessels beautifully in all tumors that we've seen with really very, very little of a staining seen in other tissues, and that's just what you'd like to see in a diagnostic - we are looking at that very seriously. And also, that binding is correlated to response, both with radiotherapy & chemotherapy. So again, we have the possibility of making a diagnostic that would be predictive of response. We are evaluating that possibility at this time... Duramycin binds PE; binding PE expands our coverage of our broad aminophospholipid-targeting platform, so it really dovetails very beautifully with the existing antibody portfolios. It's expanding our desire to explore different phospholipids as potential targets for therapy & diagnosis… PE is phosphatidylethanolamine and it is the brother of PS. So where PE goes, so does PS and vice versa. So the 2 lipids co-segregate normally on the inside surface of the plasma membrane, but in activated cells or apoptotic cells or stress cells, both lipids flip, and both are potential targets for therapeutics or diagnostics… Duramycin is a little peptide, that's a small molecule and has quite different qualities from an antibody in terms of penetrants. So we're intrigued to see how it plays out, too."
6-24-09 U.S. Patent #7,550,141 granted: Anti-PS for Tumor Imaging: http://tinyurl.com/ln9ub8
3-3-08: Thorpe/Mason C.C.R. (AACR) article on Arsenic-labeled Bavi for Imaging Tumors: http://tinyurl.com/32jbfl
…3-5-08 Chemistry World followup article on CCR Bavi+Arsenic/IMAGING: http://tinyurl.com/4m4lbse
2006/SMI: Thorpe/Mason, "Optical Imaging of Exposed PS in Tumors" http://tinyurl.com/42nh7d9
…"We believe optical imaging with Bavituximab holds great promise for assessing PS expression, and therapeutic activity in vivo and optimizing treatment protocols."
OCULAR APPLICATIONS Of PS-TARGETING MABS:
11-1-15-UTSW/Mayo/Tulane/PRC: “PS-Targeting Mabs Inhibit Choroidal Angiogenesis InVivo & ExVivo” [CNV/Macular Degen] http://www.ncbi.nlm.nih.gov/pubmed/26529048
5-2012: Two Anti-PS (PGN632 + PGN635) Ocular posters at ARVO'12 Annual Mtg./FtLaud http://tinyurl.com/cax9a4p
..5-6-12/Thorpe+Mayo, "Anti-PS (PGN632 & PGN635) as Potential New Therapy Against Choroidal Neovascularization (CNV) - AMD"
..5-10-12/PPHM+LSU, "Efficacious Clinical Outcome of an Ophthalmic Formulation of PS-binding mab (PGN632) in a Rabbit Model of Acute HSV-1 Keratitis"
BIOSIMILARS INITIATIVE - History & Update thru 9-9-10 CC: http://tinyurl.com/3xwoq8y (S.King, 9-9-10, "we're currently evaluating a number of different potential targets to go after.")
12-8-10: Avid signs Biosimilars Services Deal with USA/China firm: http://tinyurl.com/28hryyj
BAVITUXIMAB ANTI-VIRAL NEWS:
I: THE 2008-2011 DTRA/TMT Gov't Contract for Anti-PS vs. Hemorrhagic Fevers http://tinyurl.com/5dxpup
DTRA: www.dtra.mil FPDS.gov: http://tinyurl.com/4jbmkcg
3-11-11: TMT/DTRA will not extend VHF Contract - expires 3-15-11 (total revs. rec'd=$24.2mm): http://tinyurl.com/4p4hqr5
…Steve King (3-11-11 CC): "While this news is certainly disappointing, we are grateful to the TMT & DTRA for the opportunity to work together to evaluate bavituximab in this unique potential indication. We received nearly $24mm in funding over the past 33 mos… In the studies we have conducted to date under this contract, our antibodies have demonstrated a significant increase in survival in advanced preclinical models of the highly lethal Ebola virus. However in these specific studies, we weren't able to achieve an adequate dose response correlation to support advancing the program to the next stage. In no way does this dampen our enthusiasm for bavituximab and the PS-targeting platform for infectious diseases, where we believe there is still significant unrealized potential."
11-16-11: Two AntiPS posters presented at DTRA's 2011 CBD S&T/Vegas http://tinyurl.com/7pc76qd
...1) Argentine Hemorrhagic Fever/UTexas. . .2) Bacteria Infections/DSTL Porton Down/UK & Thorpe/King/C.Empig/PPHM
11-16-10: PPHM Presents AntiPS/VHFs pre-clin. data at CBDS&T BioDef Conf./Orlando http://tinyurl.com/4ve6xcl
10-2009: U-Pitt report for DARPA on Biologics Demand references Bavi http://tinyurl.com/yaefb4j
11-18-09: PPHM Presents AntiPS/VHFs pre-clin. data at DTRA/TMT Conf. http://tinyurl.com/ycrrwub
7-3-08 BioWorld Today article on PPHM's DTRA Deal: http://tinyurl.com/5kr6xk
...FULL ARCHIVE OF 2008-2011 DTRA GOV'T CONTRACT: http://tinyurl.com/6pjqt27
II: THE DUKE/HAYNES/CAVD/GATES/CHAVI/NIAID HIV COLLABORATION:
Duke's B.Haynes CAVD-Reports outline Thorpe's Role in the CAVD-Gates HIV-Vaccine Initiative: http://tinyurl.com/5xwjk4
…"Philip Thorpe is determining the role of lipid binding of anti-HIV antibodies and anti-phosphatidylserine (PS) autoantibodies to protection from HIV infection."
3-2014: Keystone Conf./Alberta PS-Targeting/HIV Poster by PPHM’s Cyril Empig & Duke/Peregrine Co-Authors Haynes/Moody/etc http://tinyurl.com/m6kuqpr
…”We expanded the characterization of PGN632 in the current study; PGN631 & PGN633, “sister clones” of PGN632, are also able to inhibit HIV-1 in the PBMC assay.”
12-29-11: Duke patent app#20110318360 "Anti-Lipid Antibodies" describes using PGN632 to inhibit HIV infection http://tinyurl.com/84vluj7
Sept'10: LWW article by Barton Haynes ref's 4-2010 Duke/PPHM JEM antiPS article: http://tinyurl.com/2bsgv8m
......"HIV vaccines after STEP: Strategies for Eliciting HIV-1 Inhibitory Antibodies"
4-11-10: CHAVI Newsletter highlights PPHM-Duke JEM article http://tinyurl.com/35eelvw
..."The study is significant because it shows that components of the adaptive immune system can activate antiviral innate immunity. Investigators believe that a vaccine that elicits polyreactive anti-PS antibodies could potentially be used to engage both the innate and adaptive immune response against HIV."
4-5-10: DukeHealth announces the 1st Duke/PPHM HIV Collab. article in JEM: http://tinyurl.com/yzr2tax
...Duke's Bart Haynes: "While the findings still have to be tested clinically, they do suggest a new way the immune system might be manipulated to thwart HIV."
...The full 4-5-10 JEM Duke-PPHM HIV article (23pgs) posted to PPHM's homepage: http://tinyurl.com/ydqdk59
2005-July2009: All Peregrine Public Statements on the Duke HIV Collab: http://tinyurl.com/m4aggy
10-14-08: "The AIDS Vaccine 2008 Conference", CapeTown, So.Africa http://tinyurl.com/7dnmpe
...Duke's B.Haynes & T.Moody present Anti-PS data for 1st time publicly: "The most potent mAb, PGN632 [11.31], inhibited 7/7 B & C clade HIV-1 isolates & SHIV SP162P3... Studies showed the mAbs acted at host cell surfaces to inhibit HIV-1 infection."
...Dr. Ralph Pantophlet's summary of T.Moody's Talk, incl. two PGN632=11.31 test data graphs: http://tinyurl.com/7w4udz
.....1-6-09: NIAID reviews CapeTown AIDS'08, commenting on the Tony Moody Anti-Lipids/PGN632 talk: http://tinyurl.com/7dnmpe
...FULL ARCHIVE OF DUKE-PPHM-CHAVI-CAVD HIV COLLABORATION: http://tinyurl.com/6pjqt27
III. OTHER ANTI-PS ANTI-VIRAL NEWS:
10-15-14: Public-Health-England/PPHM article on Bavi/Ebola in Hindawi’s Jrnl-of-Immunology-Res http://tinyurl.com/mg3va35 (also see: http://tinyurl.com/ofa5zlt )
6-2013: NIAID is “particularly interested how PS & PE expression… which is key to regulation of the immune response.” http://tinyurl.com/mvzqn26
…the above from John Coligan’s (PhD, Chief, Receptor Cell Biology Section) NIAID lab webpage.
11-16-12: 'Antiviral-Research' article by Bavi-AV collaborator HPA/UK & PPHM researchers on Bavi vs. EBOLA http://tinyurl.com/aa98xl3
…"Virus induced externalization of PS raises the possibility that PGN401 (Bavi) has broad spectrum antiviral activity."
11-16-12: 'Parasite Immunology' article by Dr. Phillip Thorpe & Brazilian Bavi-AV collaborators on AntiPS vs. Leishmania http://tinyurl.com/a8xtmny
..." This study provides new information regarding the mechanism of immune suppression in Leishmania infection."
8-2011: Brazilian collab's (INCA) studying PS-targeting vs. Leishmaniais, a protozoan parasitic disease http://tinyurl.com/435j8u2
11-4-09: 2nd Patent (7,611,704) Granted for AntiPS Broad AV apps http://tinyurl.com/y9jmsod
..."noteworthy since it includes methods for treating all viruses in humans & animals."
10-7-09: PPHM forms 'Anti-Viral Research Group' http://tinyurl.com/yan3fws
…"Peregrine's broad-spectrum PS-targeting antibodies are being assessed in anti-infective applications by more than a dozen leading research institutions… Peregrine and its collaborators have already secured over $60 million in research funding to evaluate the potential of the company's PS-targeting platform in a wide range of viral infections…"
9-10-09: PPHM's 7 Anti-PS Collaborators (S.King, R&R Healthcare Conf/NYC) http://tinyurl.com/nn4w8t
8-26-09: $763k NIAID Grant to Dr. Thorpe to Expand Anti-PS/VHF Studies: http://tinyurl.com/lxtuo3
…"The objective of the newly funded research is to evaluate a panel of new fully human anti-PS antibodies with different binding & functional properties as potential 2nd-gen. treatments."
8-5-09: 'New Scientist' Article Highlights Peregrine/Thorpe/BaviAV http://tinyurl.com/mp2aku
...Dr. Thorpe, "We were doing something that was quite extraordinary. We had let the animals progress in their disease until they were heavily symptomatic, and then started treatment. It was a major accomplishment to knock that disease back."
...7-11-09 Dr. Thorpe Interview on Bavi-AV in BMED Report: http://tinyurl.com/ltudso
3-31-09: 3rd (Conjugated) Anti-PE Patent (#7,511,124) Granted: http://tinyurl.com/dmkw6y
1-6-09: New 'Anti-PS Anti-viral Factsheet' on the PPHM Website: http://tinyurl.com/759qyw
11-24-08: Dr.Thorpe publishes in Dec.2008 NATURE Medicine on BaviAV vs. Lassa/CMV: http://tinyurl.com/9ktvsb
...Dr. Thorpe, "This is a whole new strategy for making antiviral drugs." . . . CEO S.King, "We think it has tremendous potential."
...Dr. B.Haynes, "Targeting a host cell lipid such as PS as an anti-viral strategy is an intriguing concept that may have relevance for new therapeutic and possibly prophylactic innovations in a number of virus infections."
...ARCHIVE OF OTHER ANTI-PS ANTI-VIRAL NEWS (2005-6/2008): http://tinyurl.com/6pjqt27
TUMOR NECROSIS THERAPY (TNT/COTARA/VEA's) NEWS: (see http://PeregrineTrials.com)
Highlights of Cotara/GBM Trials History 1998-2009: http://tinyurl.com/y8fyl2r
12-5-12: FDA OK's Ph3 Pivotal Trial Design for Cotara/GBM (single-infustion, dual catheters) http://tinyurl.com/czjy6mf
…SK: "We can now escalate our business development activities to secure a partnership, recognizing the great interest by companies in drug candidates within the orphan and rare disease space."
5-3-10: PPHM Licenses TNT rights in "Certain APEC Countries" to STASON(Stonsa Biopharm) http://tinyurl.com/29x433b
Stonsa's website: http://stonsabio.com
...Harry Fan/CEO/Stason, "This agreement represents a unique opportunity to acquire a novel, cutting-edge pharmaceutical technology package and bring innovative & promising treatments to millions of cancer patients in Asia & the Pacific Rim. We will also continue developing new applications & bioproducts based on TNT technologies to complement Peregrine's activities in the glioblastoma arena and will aggressively pursue new, diverse biotechnology markets. To advance these efforts, a new spin-off biopharmaceutical company (Stonsa Biopharm Inc.) headed by Dr. Eugene Mechetner will be formed which will focus on commercializing TNT technologies."
7-20-11: Dr. Missag Parseghian now VP/R&D at Stonsa Biopharm; pub's article in Jrnl/Chromatography http://tinyurl.com/m3c69w
…6-2010: More on PPHM-Stason Collab., "TNT For Tumors", Lloyd Dunla, Drug Disc. News http://tinyurl.com/28vmkzm
…5-27-10: Stonsa's CEO Dr. Eugene Mechetner presents TNT at Taiwanese Bio-Seminar http://tinyurl.com/29r7one
...12-16-10: "Stason Inks Deal to use Lonza's GS Gene Expression System with TNT Antibody Platform" http://tinyurl.com/2dzz4b5
7-1-09 Eur. Patent #1638989 for 'In-Line Labeling' (used in Cotara GBM trials) & JNM Article: http://tinyurl.com/mlgz8p
India (expanded Jan'10 to U.S.) Cotara/Brain Ph.2 Trial (40 patients, 1st relapse):
India's DCGI protocol (init=7-2007): http://clinicaltrials.gov/ct2/show/NCT00677716
7-2011 BRIT (India Radiolabelling co.) says: "(Cotara) Ph2 completed; another order is expected from Peregrine to enable them to go ahead with Ph3" http://tinyurl.com/43vb4ax
10-11-11: SIRO Clinpharm is Peregrine's Indian CRO for GBM/Cotara Ph.2 Trial: http://tinyurl.com/3eobdca
6-3-11 ASCO'11: Dr. William Shapiro (Barrow) presents Cotara N=41 Data http://tinyurl.com/3g7oz55
…"Interim MOS=8.8mos(38wks); we are eager to meet with the FDA in Q4'11 to determine the optimal registration pathway for Cotara."
...NOTE: In 12-12-2011 QtlyCC, S.King reported MOS at 9.3 mos., up from in "interim" 8.8mos reported at ASCO'11. http://tinyurl.com/75rfwrv
…Dr. Shapiro's Cotara Poster #2035 (PDF & Images) http://tinyurl.com/3wetx5r
5-19-11: ASCO'11 preview; Dr. Vladimir Evilevitch (ex-Novartis) hired as Med.Dir. "to execute Cotara Reg&Clin. strategy" http://tinyurl.com/3av4red
12-20-10: Treatment Complete in Cotara/GMB Ph.2 Trial http://tinyurl.com/2844wrq
…J.Shan: "We expect top-line data by mid-year 2011 and plan to meet with the FDA to define the optimal registration pathway for Cotara."
10-18-10: Interim Ph.2 update (n=14) at CNS'10: http://tinyurl.com/349kvca
...PI Dr. Deepak Gupta, "MOS of 86 weeks far exceeded our expectations in this very difficult to treat patient pop. where treatment options are few and rarely extend med.survival beyond 6mos."
…Roth's Joe Pantginis: "Physicians know how long these patients are expected to survive on avg. and that's why these data are very, very promising. Because there is a huge unmet medical need for new treatments for this type of brain cancer, Peregrine may seek an accelerated approval that could avoid lengthy Phase III clinical trials."
...Link to Dr. Gupta's CNS'10 Poster (6pg PDF): http://tinyurl.com/26b8sp9
...6-3-10/ASCO: Cotara/Ph.2 Trial 75% enrolled; 3 more U.S. sites added: http://tinyurl.com/33z8ggo
...1-28-10 U.S. site (Barrow/Phoenix) added formerly India-Only Ph.2 trial: http://tinyurl.com/yk565jy
…Per 3-11-10 QtlyCC, VP/ClinAffairs J.Shan said also exp. UPenn & Univ. of S.Car. http://tinyurl.com/yl4befh
…9-2-09 Interim Ph.2 data (10 pts) presented at AANS Annual Mtg/Boston: http://tinyurl.com/mxzbzm
……P.I. Dr. A.K. Mahapatra: "Most importantly, Cotara has demonstrated promising signs of efficacy."
...8-2-07 1st Patient Dosed in Indian Cotara/Brain Ph.2 Trial: http://tinyurl.com/296mcj
...The obvious desire is to compare Cotara vs. SOC Temodar for GBM therapy: http://tinyurl.com/yttt99
USA Cotara/Brain 'Dosimetry & Dose Confirmation Trial' (originally funded by NABTT):
U.S.A. Cotara Brain Cancer trial protocol (added 8-14-07): http://clinicaltrials.gov/show/NCT00509301
6-6-10/ASCO: Final Results of Cotara/GBM Ph.1/Dosimetry trial (n=12): http://tinyurl.com/24qjxxh
......"Final data confirm Cotara's targeting capabilities, delivering 300-fold higher radiation levels to the tumor than to normal organs."
...2-11-10: "Current Cancer Therapy Reviews" article on Cotara/GMB http://tinyurl.com/yg2on8f
......the cases of "2 patients who have survived more than 9 years" are also reviewed.
...12-2-09: U.S. Trial Enrollment Complete http://tinyurl.com/yez7lzd
...6-16-09: Cotara/Brain Oral-Pres. at SNM Annual Meeting http://tinyurl.com/lmhkw2
......Dr. Sui Shen (U-Alabama), "With a mean dose ratio showing 300-fold greater delivery of radiation to the tumor as compared to other organs, Cotara represents a potentially valuable new therapy for GBM patients."
…9-23-08: Article in Cleveland paper - comments by P.I. Dr. Andrew Sloan (Case Western/CLEV) http://tinyurl.com/3mkmas
...5-31-08: Cotara USA Ph.1B data presented at ASCO/2008: http://tinyurl.com/68apro
...8-29-05: NABTT Initiates Cotara/Brain Trial (28 patients/4 sites): http://tinyurl.com/9w3cr
...Orig. NABTT protocol, "6-2007, completed": http://www.clinicaltrials.gov/ct/show/NCT00128635
...The Phil (Marfuta) Bannister Story (NABTT Cotara/GBM patient #1, diag. 2-4-06): http://tinyurl.com/24gkml
......4-22-10: Phil reports on YASG that his GBM was misdiagnosed; he has a GrIII Oligodendroglioma, which carries a MLE of 12yrs! http://tinyurl.com/23mhboa
Previous USA Cotara/Brain Ph.1-2 Trials, completed in 2003:
...Slides showing correlation between Cotara dosage levels and MST vs. Temodar(curr.SOC): http://tinyurl.com/26s265
...4-27-08 update: The Jerod Swan Cotara/Brain Success Story (10 years after diag.): http://tinyurl.com/68ofsv
...5-22-07 update: The Freddie Sanford Cotara/Brain Success Story (7 years after diag.): http://tinyurl.com/2du2e5
...6-1-05: Cotara w/CED Brain Delivery pub. in Neurosurgery Jrnl: http://tinyurl.com/anmaa
..."Cotara Holds Promise for Treating Brain Cancer - P1/P2 Data Suggests Extended Survival in a Number of Patients"
PRIOR COTARA/GBM PH.3 FDA NEGOTIATIONS (2 INFUSIONS, SINGLE-CATHETER)
…12-13-01: FDA OK's Ph3 Design for Cotara/GBM (2 doses, single interstitial catheter) http://tinyurl.com/a7m3xjw
…7-1-02: Peregrine Provides Update on Status of Cotara Phase III http://tinyurl.com/bac9rtr
......"Peregrine FDA have been in close consultation regarding the Cotara Ph3 trial. Peregrine is confident that the Ph3 will adequately address all regulatory, drug safety & efficacy requirements for such a large multi-national trial."
…11-19-02: Peregrine Provides Update on Status of Cotara Phase III http://tinyurl.com/a4mw5yj
......ELegere: "Although many issues have been finalized, there are several important issues that remain to be negotiated prior to Ph3 approval. We will request an expedited meeting with the FDA so we can clarify & finalize the remaining issues…"
…11-25-02: Peregrine Receives Orphan Drug Designation for Cotara in Europe http://tinyurl.com/b7wr9at
…2-24-03: Peregrine Receives FDA Approval for its Cotara Phase III Registration Trial Design for GBM http://tinyurl.com/bjowgh6
......"Peregrine has received approval from the FDA to start its Cotara Ph3 registration clinical study in GBM."
TNT3 (Vivatuxin) Lung Cancer Approval/Launch in China:
...Shanghai MediPharm Biotech's TNT/China website: http://www.vivatuxin.com
...8-2010 Profile of Shanghai MediPharm Biotech by WallStreetResearch (Alan Stone): http://tinyurl.com/2fn3nvk
...3-2010: New Vivatuxin+MicrowaveAblation NSCLC trial (n=2000) http://tinyurl.com/2ccghvr
...1-16-07: Medipharm Launches TNT in China for Lung Cancer http://tinyurl.com/ttlne
...6-19-02: TNT Interim Lung Data from China: http://tinyurl.com/ggcba & http://tinyurl.com/em6da
Peregrine v. CTL Lawsuit - Settled 6-19-09:
...6-19-09: Form 8-K, Peregrine & CTL Settle: http://tinyurl.com/mhgcg7
...3-29-07 CTL countersues PPHM over TNT/China licensing dispute: http://tinyurl.com/39k8sx
...3-30-07 PPHM comments on CTL's 3-29-07 countersuit: http://tinyurl.com/33xzzq
...1-12-07: New China Subsidiary; Suit Filed Against Cancer Therapeutics Labs (CTL) http://tinyurl.com/y4vzbj
Eur. Licensee Merck-KGaA's TNT/Cytokine Fusion Protein Ph.1 Trial:
...4-3-12: NHS-IL2-LT (EMD 521873) poster at AACR'12 http://tinyurl.com/7bm4lpx
...4-2009: 2nd SELECTIKINE Ph.1 trial added: SELECTIKINE+RAD/NSCLC: http://tinyurl.com/pzl9j8
...5-2007: 2nd SELECTIKINE Ph.1 site added, Univ. of Lausanne, Switz: http://tinyurl.com/2l933s
...Ph.1 Trial Protocol (Merck KGaA/Germany, PI=Dr. R.Stupp): http://tinyurl.com/2f4u2t
...2-22-07: TNT-based European Cancer Trial initiated by 'Licensee': http://tinyurl.com/2zcjqr
...Clearly, it's Merck-KGaA's 'SELECTIKINE' (NHS-IL2-LT/EMD521873): http://tinyurl.com/yud7pw
...5-1-08 Dr. Missag Parseghian (Dir/R&D) presents VEAs at PEGS/2008: http://tinyurl.com/66onj2
AFFITECH-PPHM Collab: Fully-Human Mabs, Anti-PS & Anti-VEGF/2C3
• AT001 is Fully-Human 2C3 = R84 = PGN311
• AT004 is Fully-Human BAVI=PGN635=1N11
• AT005 is the Duke-PPHM-HIV candidate PGN632=11.31
4-28-09 Affitech comments on PGN635 & PGN632 presented at AACR'09: http://tinyurl.com/cxkcb4
...All Affitech Press Releases: http://www.affitech.com/investors-news/press-releases-english
ANTI-ANGIOGENESIS AGENT '2C3' [Fhu: R84=At001] ANTI-VEGF MAB:
8-20-12: 1st patient dosed in R84 (AT001) Ph.1 "Various Cancers" Trial in Russia/CIS http://tinyurl.com/8ahaw3l
3-12-12 Affitech's Board rec's S/H's approve Trans Nova's buyout offer (7.85mm Euros for rem. 60%) http://tinyurl.com/6qwh4zb
6-16-11: Affitech partners with IBC Generium for R84 dev. in Russia/CIS http://tinyurl.com/6hezkux
…Affitech rec. $2.5mmEURO from IBC; PPHM re-invests $1.6mm payment into "further advancement of R84."
5-26-11 Affitech update on R84 progress: "trial matl. mfg. (by Avid)" http://tinyurl.com/3hu5nqe
4-28-11: Affitech's Annual SHM (32pg. PDF) - much on R84 progress/plans: http://tinyurl.com/3h47nqa
..Affitech's 12-31-10 10-K iss. 4-28-11 - much info on R84 as well: http://tinyurl.com/3dcnefa
…$1mm milestone to PPHM for pre-clin-pkg forthcoming? Also, Avid "1st-GMP-Mfg" => http://tinyurl.com/3hc6bw9
4-28-11: Affitech signs with UTSW/Dr. Rolf Brekken for further AT001/R84 research: http://tinyurl.com/4ybh2l2
...Dr. Rolf Brekken's research at UTSW: http://www4.utsouthwestern.edu/brekkenlab/research.htm
2-18-11 Interview with Affitech CEO Dr. Martin Welschof discusses R84 Progress/Plans http://tinyurl.com/5rhmlog
Nov/Dec'10: Affitech Reiterates R84 (FH-2C3) Dev. Project Plans http://tinyurl.com/2fhyzxz
9-30-10: PPHM & Affitech Amend 7-2009 R84 Licensing Agreement http://tinyurl.com/2cn77c2
…following Affitech/NTS+ Collab for dev. in Russia/Brazil. Also, Avid gets contract to mfg. R84 for clinical studies.
8-6-10/PLoS: PPHM-Brekken/UTSW/Affitech article on pre-clin. R84=AT001 (Fhu 2C3): http://tinyurl.com/2unp4j3
…"Extended r84 therapy controls tumor growth without induction of toxicity"
6-30-10: NTS-Plus to run 2C3/R84 clinical trial(s) in Russia: http://tinyurl.com/26hhln4
…"AT001/r84 differs from Avastin in a number of ways… more selective… may have a better side effect profile."
4-21-10: Affitech sub-licenses Anti-VEGF mabs (incl. R84) to Russian partner NTS-Plus: http://tinyurl.com/29tzen9
11-3-09/PLoS: R.Brekken (PPHM SRB) on R84, increases "immune cell infiltration" in Breast Cancer: http://tinyurl.com/y8ooxah
7-22-09: Peregrine Licenses Anti-VEGF mabs (incl. R84) to Affitech: http://tinyurl.com/n67v57
6-30-09: R.Brekken article in Mol-Cancer-Ther on 2C3/R84+Avastin vs. Breast Cancer: http://tinyurl.com/mqv5ol
12-11-08: Dr. Brekken (PPHM SRB) presents F.H. 2C3 (R84/PGN311) at TX Breast-Cancer Conf. http://tinyurl.com/63utya
11-3-07: Dr. Brekken presents 'R84' (F.H. 2C3, aka PGN311) data at IBC-Conf: http://tinyurl.com/yp459d
4-16-07 AACR2007: Brekken [PPHM SRB] presents fully-human 2C3 ('R3') http://tinyurl.com/2udkgr
"The anti-tumor activity of 2C3, which only blocks VEGFR2 compared favorably to that of Avastin, which blocks both VEGFR1+2"
2-14-05: Humanized 2C3 Pre-Clin. data presented at "Anti-Angio. Symposium" http://tinyurl.com/85qy3
2-10-05: VEGF Pioneer Dr. Donald Senger joins PPHM's SRB to assist with 2C3 pgm: http://tinyurl.com/yul72w
OTHER PEREGRINE DRUG CANDIDATES:
5-6-12: Dr. Phil Thorpe's poster on PGN632 vs. AMD/CNV at ARVO-2012/FtLaud http://tinyurl.com/6q6kuwa
1-9-07 PR: VTA Microbubbles as Contrast Agents (AACR/CCR article) http://tinyurl.com/v7mf9 & http://tinyurl.com/w4pe9
9-26-06: VTA+Combo Patent Granted; Expands VTA Licensing Opportunities http://tinyurl.com/er4hh & http://tinyurl.com/ry5a4
8-25-05: PPHM Licenses Conjugated Anti-PSMA VTA Technolody to Medarex: http://tinyurl.com/dv6rt
"These types of deals should add considerable value to the company as our partners move their VTA dev. programs forward."
4-19-05: VEGF121/rGel presented at AACR (50% Survival vs. Prostate Cancer): http://tinyurl.com/8gazv
###SUPG moving VEGF121/rGel (lic. from PPHM) fwd. via Targa/Rosenblum: http://tinyurl.com/ylevod
...Rosenblum 11-15-06, "Ph.I human trials of VEGF121/rGel are expected to open shortly at M. D.A."
BACKGROUND ON 3G4/BAVITUXIMAB(formerly Tarvacin):
Thorpe 10-25-04 SHM Presentation: "Understanding Tarvacin", incl. his first-ever public comments about Tarvacin's ANTI-VIRAL capabilities:
"OK, this is Tarvacin.. the cleanest tumor vessel marker of which we are aware.. If you look here at the 3G4 slide, you'll see, most remarkably, that it's absolutely chock full with macrophages; they're beginning to outnumber the tumor cells... . So, the conclusions with Tarvacin are that it has a unique mechanism of action, there's nothing else like it out there; it homes specifically to tumor blood vessels and induces white blood cells to attack the tumor."
Dr. Thorpe's APT (AntiPS/3G4/BAVITUXIMAB patent app #20040161429 (pub. USPO 8-19-04):
"Compositions for treating Viral Infections using Immunoconjugates to Aminophospholipids": http://tinyurl.com/6pdny
 "the 3G4 antibody has enormous potential as a broad spectrum anti-viral agent."
 "...The inhibitory activities of 3G4 on cell division, angiogenesis, tumor growth & viral infectivity, taken together with lack of apparent toxicity, show broad therapeutic indications for this antibody, including in the treatment of angiogenic disorders, cancer, diabetes and viral infections."
 "the anti-viral methods and uses of the invention are suitable for treating all viruses... as exemplified by treating CMV, RSV, arenavirus and HIV infections, and the diseases hepatitis, influenza, pneumonia, Lassa fever and AIDS."
 "The 3G4 antibody has also been administered to monkeys in safety studies and no side effects have been observed."
Thorpe's Aug03-Jan08 $1.68mm NIH/NIAID Grant for research using PPHM's APTs (Anti-PS/3G4) as "Novel Anti-Viral Agents for Treating Lassa Fever":
Thorpe: "We are developing drugs to use against Lassa fever that operate on a new principle in virology. They exploit the fact that viruses coat themselves with an outer membrane where some of the lipids are inside-out. The drugs direct our immune responses to the inside-out components of the viral membrane, or envelope. These drugs potentially could be effective against numerous viruses that have similar outer membranes… We have raised mabs to PS and other anionic phospholipids that block the spread of several viruses to uninfected cells in vitro, essentially completely. The phospholipids that they recognize have the same structure & cellular distribution in different mammalian species, simplifying the transition from experimental animals into humans. The antibodies are not toxic to mice, even when administered in high doses for prolonged periods of time."
GRANT LINK: http://tinyurl.com/5ntcm . . .11-3-03 Grant PR: http://tinyurl.com/5aulds
###8-26-09: $763k 2yr expansion NIAID grant (8/14/09-7/31/11) to Dr. Thorpe for 2nd-gen. anti-PS/VHF studies: http://tinyurl.com/lxtuo3
The Inventor of the PS-Targeting Mabs, like 3G4/bavituximab, is Dr. Philip E. Thorpe of UTSW-MC/Dallas.
4-2-13: Peregrine Mourns Loss of Dr. Philip E. Thorpe (1951-2013) http://tinyurl.com/l9gqmt5
Dr. Thorpe's LAB TEAM (UTSW Hamon Center): http://tinyurl.com/yuxemu
…2013: Dr. Thorpe’s lab taken over by UTSW’s Dr. Rolf A. Brekken: http://www.utsouthwestern.edu/labs/brekken
Dr. Thorpe's Patents: GRANTED: http://tinyurl.com/m232k PENDING: http://tinyurl.com/845p2
…Dr. Thorpe's Articles: http://tinyurl.com/csjsl Also see: http://www.researchgate.net/profile/Philip_Thorpe
Dr. Brekken’s Patents: GRANTED: http://tinyurl.com/q2joy3v PENDING: http://tinyurl.com/l5jngmw
…Dr. Brekken’s Articles: http://tinyurl.com/oyf5r9p Also see: http://www.researchgate.net/profile/Rolf_Brekken
Dr. Alan Schroit's Patents (MDA, PPHM SRB, “Clipped B2GP1”): GRANTED: http://tinyurl.com/n4pnk8p PENDING: http://tinyurl.com/mrf2nsb
…Dr. Schroit’s Articles: http://tinyurl.com/lqbd8kt Also see: http://tinyurl.com/lx2p32b (MDA profile)
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