AI
Monday, June 01, 2015 10:02:07 AM
6-1-15/PR’s: ASCO’15 and Planned Expansion of Bavi Clinical-Pgm => Ph2 Bavi+Opdivo/2L-NSCLC(Squamous+NonSquamous), Ph2/3 Bavi+Doce/PAC/Her2-Breast), Sunrise Enrollment anticipated Y/E’15, Avid Exp. s/b done 7-2015, Cash 4-30-15=$68mm…
6-1-15: Peregrine Pharmaceuticals Provides Update on Planned Expansion of Bavituximab Clinical Program
• Phase II Trial to Evaluate Combination of Bavituximab and Opdivo® (Nivolumab) in Non-Small Cell Lung Cancer
• Phase II/III Combination Trial to Advance Bavituximab with Chemotherapy Combinations in HER2 Negative Breast Cancer
• New Studies Expected to be Underway as Phase III SUNRISE Trial in Lung Cancer Completes Enrollment by Calendar Year-End
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915699
TUSTIN, June 1, 2015: Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM, PPHMP), a biopharmaceutical company focused on oncology and the treatment of lung and breast cancers through the development of bavituximab, a novel immunotherapy currently in Phase III, today provided a corporate update on its immuno-oncology pipeline, its wholly-owned contract manufacturing business, Avid Bioservices, as well as anticipated upcoming milestones. This update outlines the expansion of the bavituximab clinical pipeline with a focus on exploring expanded indications and combinations in lung and breast cancers. These new trials build on recently published clinical data of bavituximab in combination with paclitaxel in HER2 negative breast cancer and clinical translational and preclinical data presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting that support the potential combination of bavituximab with the anti-PD-1 checkpoint inhibitor, nivolumab (marketed as Opdivo®). These clinical trials are expected to begin enrollment later this year.
"With many exciting near-term opportunities for Peregrine and Avid, we are pleased to share several strategic decisions aimed at expanding the potential clinical indications for bavituximab. These new trials represent large market opportunities for the bavituximab clinical program that can add significant value," said Steven King, President and CEO of Peregrine. "As we near completion of enrollment in the SUNRISE pivotal Phase III trial by year-end, we are looking to expand bavituximab's market potential and market position in key indications that are supported by strong clinical, translational, and preclinical data. Taken together with the research collaboration we announced last week, we believe we are setting the stage for many significant value driving events throughout 2015 and into 2016."
SUNRISE Phase III Pivotal Trial
The company's Phase III SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) is an approximately 600 patient trial that continues to enroll at over 150 sites worldwide. Completion of enrollment is anticipated by calendar year-end. This Phase III, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety, tolerability and efficacy of bavituximab as a second-line treatment in patients with non-squamous, non-small cell lung cancer (NSCLC). Enrollment is proceeding according to plan with two planned interim efficacy analyses which will be reviewed by the trial's Independent Data Monitoring Committee (IDMC). The first interim analysis, which will be conducted when 33% of the targeted overall survival events are reached, is for futility and the second interim analysis, for futility or superiority, will be conducted at 50% of events. As these analyses are event driven, the exact timing of each is unknown, however the company plans to provide updates as these events are reached. For additional information about the SUNRISE trial, please visit http://www.sunrisetrial.com or ClinicalTrials.gov using the Identifier NCT01999673 [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ].
Beyond SUNRISE: Exploring Checkpoint Inhibitor Combinations in Lung Cancer
Joe Shan said: "Following recent encouraging preclinical data supporting the combination of bavituximab with immune checkpoint inhibitors, today we are supplementing our strategy in lung cancer with the second clinical trial to emerge from our Immuno-Oncology Development Program, a combination trial of bavituximab with nivolumab, an immune checkpoint inhibitor of PD-1. Specifically, recent preclinical data show that the addition of bavituximab could result in turning patients that do not respond to monotherapy into patient responders. This supports our long held knowledge of the synergistic properties of the combination of bavituximab and chemotherapies, thus making this new trial the next logical step."
The company plans to initiate an open-label multi-center, randomized Phase II trial of the anti-PD-1 monoclonal antibody nivolumab (marketed as Opdivo®) versus nivolumab plus bavituximab in patients with previously treated locally advanced or metastatic NSCLC. Enrollment will include patients with squamous and non-squamous NSCLC who have not received a prior PD-L1 or PD-1 inhibitor. The primary endpoint of this trial will be overall response rate (ORR) with secondary endpoints including tumor response and duration, progression free survival, overall survival (OS) and safety. The trial is in the final stages of design and the details of which will be made available once details are completed. Trial initiation is anticipated in the second half of 2015.
Leveraging Positive Data in Breast Cancer
"Today we are pleased to be detailing our strategy in breast cancer which is built upon very promising data which were recently published in the peer-reviewed journal Cancer Medicine," said Joseph Shan, VP of Clinical & Regulatory Affairs at Peregrine Pharmaceuticals. "The clinical development pathway that we are outlining today is based upon the strong clinical experience that supports synergies between bavituximab and docetaxel and paclitaxel, our deep and consistently positive clinical experience in breast cancer to date, as well as the support of leading breast cancer physicians."
The company plans to initiate a Phase II/III open-label trial of physician's choice of either docetaxel or paclitaxel with or without bavituximab in patients with locally advanced or metastatic HER2 negative breast cancer. The primary endpoint for the Phase II trial will be ORR. Results from this trial are expected to inform decisions on future studies in breast cancer and add value to the overall program. The initiation of this trial is anticipated in the second half of 2015.
Fiscal Year End Cash Position
Peregrine today reported $68 million in cash and cash equivalents, as of fiscal year ended April 30, 2015. The company will review full financial results for the fourth quarter and fiscal year 2015 during its quarterly call on Tuesday, July 14, 2015 after the close of markets, details of which will be included in a forthcoming press release.
Avid Bioservices' Expansion on Track and Strongly Positioned to Meet Increased Client Demand
In December 2014, the company announced the expansion of Avid's Current Good Manufacturing Practice (cGMP) current manufacturing capacity with a build out that is utilizing an existing 40,000 square foot facility located adjacent to the company's current campus. Designed to more than double Avid's current manufacturing capacity, this state-of-the-art biotechnology facility will employ an innovative and flexible modular clean room design and the latest in single-use technologies to meet the growing needs of Avid's existing and future clients as well as the planned commercialization of bavituximab. Avid's new facility is anticipated to be ready for cGMP production of biotechnology products in July 2015.
Added Steve King: "We are very pleased with the rapid progress by which this expansion is advancing as this is a key component to further demonstrating Avid as a leading provider of high quality biotechnology contract manufacturing services. The design and the features that we have employed in this expansion will truly be an integral part to the future growth of this unique part of our business. We look forward to sharing specific details on the expansion upon its formal unveiling later this year."
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
Safe Harbor <snip>
Opdivo® is a registered trademark of Bristol-Myers Squibb Company
CONTACT: Christopher Keenan, Peregrine Pharmaceuticals, Inc., (800) 987-8256, info@peregrineinc.com
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6-1-15/PR: Peregrine’s 3 ASCO’15 Presentations (NSCLC, Melanoma, Breast, Liver)…
6-1-15: Data Presentations at ASCO Demonstrate the Ability of Peregrine Pharmaceuticals' Bavituximab to Activate Tumor Targeting Immune Cells in PD-L1 Negative NSCLC Tumors
• New Data Show that Bavituximab Alone and in Combination with Docetaxel Elicits a Tumor-Specific Immune Response in PD-L1 Negative Tumors Extracted from NSCLC Patients
• PS-Targeting Antibodies Combined with Anti-PD-1 Reverses Tumor Immunosuppression and Activates Tumor Fighting CD8+ Immune Cells in Models of Melanoma and Breast Cancer
• Encouraging Data in Patients with Advanced Liver Cancer Warrants Further Clinical Study
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915719
TUSTIN, June 1, 2015: Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP), a biopharmaceutical company focused on oncology and the treatment of lung and breast cancers through the development of bavituximab, a novel immunotherapy currently in Phase III, today announced the presentation of preclinical and clinical translation data highlighting its phosphatidylserine (PS) targeting platform and bavituximab at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29-June 2, 2015 in Chicago, Illinois.
"These presentations bridge the preclinical and clinical portions of our Immuno-Oncology Development Program and support our recently announced strategic decision to expand our clinical program aimed at the development of the most promising potential immunotherapy combinations with bavituximab," said Jeff Hutchins, VP of Preclinical Development of Peregrine. "The data generated to date reinforces the potential of bavituximab to enhance current immuno-oncology treatment modalities aimed at creating a greater group of patients responding to currently available therapies."
In poster #385 titled, "Activation of CD8+ Tumor Infiltrating Lymphocytes by Bavituximab in a 3D Ex Vivo System of Lung Cancer Patients", researchers from Nilogen Oncosystems [=Moffit Startup: http://otmc.moffitt.org/startups.aspx ] and H. Lee Moffitt Cancer Center presented initial data from a pilot translation study analyzing tumor tissue from six lung cancer patients to evaluate the immunomodulatory effects of bavituximab in a human ex vivo model of non-small cell lung cancer (NSCLC). New data generated from additional assays further validates previous data showing that ex vivo drug treatment with bavituximab, alone and in combination with docetaxel, elicits an immune response in tumors from NSCLC patients with negative PD-L1 and low PD-1 expression. Specifically, data showed activation of tumor infiltrating lymphocytes (TILs) by polarization of the tumor microenvironment from immunosuppressive to immuno-stimulatory. Results in this pilot translational study also identified PD-L1 and PD-1 expression as a potential biomarker of response to bavituximab treatment, suggesting that the interruption of the PD-1/PD-L1 axis may enhance the bavituximab effect in lung cancer.
[POSTER: http://www.peregrineinc.com/images/stories/pdfs/asco_2015_lung.pdf ]
"These preliminary gene profiling data are consistent with previously published data on bavituximab's immunotherapeutic mechanism of action," said Dr. Soner Altiok, MD, PhD, Chief Scientific Officer at Nilogen Oncosystems and Senior Member at the H. Lee Moffitt Cancer Center. "Building upon encouraging translational findings of a cytokine profile previously reported, these new data support the finding that M1 polarization of tumor associated macrophages is involved in bavituximab-mediated activation of tumor infiltrating lymphocytes in the ex vivo model of lung cancer."
In poster #386 titled, "Phosphatidylserine Targeting Antibody in Combination with anti-PD-1 Antibody Treatment Activates Infiltrating T Lymphocytes of the Spleen and Tumor Microenvironment in Pre-Clinical Models of Melanoma and Breast Cancer", researchers from The University of Texas Southwestern Medical Center in Dallas, Texas led by Xianming Huang, PhD, found that blocking PS with PS-Targeting antibody enhances the anti-tumor activity of combination therapies including anti-PD-1 and anti-CTLA-4 antibodies in an immune competent model of breast cancer and in preclinical models of melanoma. In the breast cancer model, researchers found that the combination of PS blockade and an anti-PD-1 antibody promoted strong and localized anti-tumor responses without the side-effects of systemic immune activation. In models of melanoma, the combination of PS blockade with either an anti-PD-1 or anti-CTLA-4 antibody showed significantly superior tumor growth inhibition over single treatment, with many subjects achieving complete tumor regressions. No toxicity was observed in any of the treatment groups following multiple treatment doses.
[POSTER: http://www.peregrineinc.com/images/stories/pdfs/asco_2015_melanoma_breast.pdf ]
Added Dr. Hutchins: "These data support our view of bavituximab as an immunomodulatory treatment in PD-1 sensitive and anti-PD-1 resistant/unresponsive tumors. We look forward to the execution of additional clinical trials aimed at further exploring these potential combinations."
In poster #220 titled: "A phase I/II study of Bavituximab and Sorafenib in Advanced Hepatocellular Carcinoma (HCC)", researchers led by Adam Yopp, M.D., Assistant Professor of Surgery at The University of Texas Southwestern Medical Center in Dallas, Texas found that the combination of bavituximab and sorafenib is associated with an improved time to progression (TTP) of 6.7 months, a disease specific survival (DSS) of 8.7 months, a disease control rate (DCR) of 58% (22 out of 58 patients) and a 4-month progression-free survival (PFS) of 62%. Two patients (5%) achieved a partial response according to Response Evaluation Criteria In Solid Tumors (RECIST). The secondary endpoint of median overall survival (OS) was 6.2 months. The trial's patient population had unfavorable disease biology as demonstrated by a high rate of previous treatment and macrovascular invasion. The combination of bavituximab and sorafenib was well-tolerated in patients with advanced HCC with no indications of autoimmune adverse events that have been seen with other checkpoint immunotherapies.
[POSTER: http://www.peregrineinc.com/images/stories/pdfs/asco_2015_hcc_utsw_y_.pdf ]
A link to copies of these presentations can be found on the home page of Peregrine's website at http://www.peregrineinc.com .
Webcast Replay: Roundtable Discussion "Raising the Immuno-Oncology Bar"
Last night, Peregrine hosted a roundtable discussion of immunotherapy thought leaders in conjunction with the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois. A link to the replay of this event titled: "Raising the Immuno-Oncology Bar: The Next Wave of Immune Modulating Checkpoint Inhibitors" can be found on the home page of Peregrine's website at http://www.peregrineinc.com . [ http://edge.media-server.com/m/p/h2toyjv4 ]
About Bavituximab: A Targeted Investigational Immunotherapy
Scientific research has shown that tumors evade immune detection due partly to the expression of phosphatidylserine, or PS, a highly immunosuppressive molecule. Peregrine's immuno-oncology development program has developed bavituximab, an investigational monoclonal antibody that targets and binds to PS, blocking its immunosuppressive effects while activating tumor fighting immune cells, thus enabling the immune system with the ability to better recognize and fight cancer. Bavituximab's immune-stimulatory mechanism-of-action data is the subject of a manuscript published in the October 2013 issue of the American Association for Cancer Research's (AACR) peer-reviewed journal, Cancer Immunology Research. Bavituximab is currently being evaluated in several solid tumor indications, including non-small cell lung cancer (the SUNRISE Phase III trial), breast cancer, liver cancer, rectal cancer and advanced melanoma. In January 2014, bavituximab received Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential second-line treatment of patients with non-small cell lung cancer.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
CONTACT: Christopher Keenan, Peregrine Pharmaceuticals, Inc., 800-987-8256, info@peregrineinc.com
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Event Brochure for Peregrine’s 5-31-15 ASCO’15 I-O Roundtable – sent to me my CK@IR…
Sunday 5-31-15 6pmCT: "Raising the Immuno-Oncology Bar: The Next Wave of Immune Modulating Checkpoint Inhibitors"
…7 panel members, incl. 3 Mem. Sloan Kettering researchers – recall the 5-29-15 announced collab. with MSK “to Investigate Novel PS-Targeting Immunotherapy Combinations”…
WEBCAST Replay: http://edge.media-server.com/m/p/h2toyjv4
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5-27-15/PR: Peregrine Pharmaceuticals Announces Webcast of Immunotherapy Roundtable at ASCO Annual Meeting
• Immunotherapy Thought Leaders to Discuss Next Wave of Therapies Aimed at Increasing the Number of Patients That Respond to Immuno-Oncology Combination Therapies
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915098
TUSTIN, May 27, 2015: Peregrine Pharmaceuticals (Nasdaq:PPHM, PPHMP), a biopharmaceutical company focused on advancing bavituximab, a novel immuno-oncology (I-O) agent in Phase III development for the treatment of lung cancer, invites investors and the general public to listen to a webcast of its roundtable discussion in conjunction with the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting [ http://am.asco.org ]. This roundtable is comprised of key opinion leaders in the field of Immunotherapy who will discuss novel I-O combination therapies that may improve patient outcomes.
Title: "Raising the Immuno-Oncology Bar: The Next Wave of Immune Modulating Checkpoint Inhibitors"
Date/Time: Sunday, May 31, 2015 from 6:00-7:00pm CT
The event is being hosted by Peregrine Pharmaceuticals and will be webcast live and archived for 60 days. The event may be accessed from the home page of Peregrine Pharmaceuticals' website at http://www.peregrineinc.com . For the live event, listeners are encouraged to login 5-10 minutes ahead of the scheduled start in order to verify system requirements and complete registration.
Lori Kunkel, MD will moderate this event. Dr. Kunkel serves on the Board of Directors of Loxo Oncology [ http://www.loxooncology.com ], where she held the position of Acting Chief Medical Officer. Previously, Dr. Kunkel was Chief Medical Officer at Pharmacyclics and Proteolix and has also held senior roles at ACT Therapeutics, Syndax, Xencor, and Genitope. Dr. Kunkel received her MD from the Univ. of Southern California and her BA degree from the Univ. of California San Diego.
The panel includes:
Scott J. Antonia[PPHM SAB], MD, PhD, Department Chair, Program Leader, Thoracic Oncology Dept Associate Professor Dept of Interdisciplinary Oncology and Program Leader of the Immunology Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida
[ http://moffitt.org/research--clinical-trials/individual-researchers/scott-j--antonia-md-phd ]
Dmitry I. Gabrilovich, MD, PhD, Christopher M. Davis Professor in Cancer Research and Program Leader, Translational Tumor Immunology, The Wistar Institute, Philadelphia, PA
[ http://www.wistar.org/our-science/scientists/dmitry-gabrilovich-md-phd ]
Kathy D. Miller, MD, Ballve Lantero Scholar in Oncology, Professor, Dept of Medicine, Co-Director, Simon Cancer Center Breast Cancer Program, Indiana University School of Medicine, Indianapolis, IN
[ http://www.bcrfcure.org/researchers/kathy-d-miller ]
Dmitriy Zamarin, MD, PhD, Assistant Attending Physician, Gynecologic Medical Oncology & Immunotherapeutics, Memorial Sloan Kettering Cancer Center, NYC
[ http://www.mskcc.org/research-areas/labs/members/dmitriy-zamarin http://www.youtube.com/watch?v=hGL__YKuOLY ]
Matthew D. Hellman, MD, Assistant Attending Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, NYC
[ http://www.mskcc.org/cancer-care/doctors/matthew-hellmann “History of Immunotherapy”: http://www.youtube.com/watch?v=2KWsYmXhclw ]
Alexander M. Lesokhin, MD, Assistant Member, Assistant Attending Physician, Memorial Sloan Kettering Cancer Center, NYC
[ http://www.mskcc.org/research-areas/labs/members/alexander-lesokhin-01 ]
Rolf A. Brekken[PPHM SAB], PhD, Effie Marie Cain Research Scholar in Angiogenesis Research, Professor, Depts of Surgery & Pharmacology, Univ. of Texas Southwestern Medical Center, Dallas, TX
[ http://profiles.utsouthwestern.edu/profile/10808/rolf-brekken.html ]
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
CONTACT: Christopher Keenan, Peregrine Pharmaceuticals, Inc., 800-987-8256, info@peregrineinc.com
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5-29-15: Peregrine Pharmaceuticals Enters Into Research Collaboration [with Mem. Sloan Kettering] to Investigate Novel PS-Targeting Immunotherapy Combinations
• Research Collaboration to Focus on Exploring Potential Combinations of PS-Targeting Agents Including Bavituximab With Other Immune Modulators
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=114118480
"The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said (Sloan’s) Dr. Jedd D. Wolchok.
. . .
As part of the collaboration, researchers at MSK will conduct research to further explore the combination of PS-targeting agents, including bavituximab, that block a primary immunosuppressive pathway thereby allowing anti-tumor immune responses with other immuno-stimulatory agents that enhance immune responses. Specifically, MSK researchers will examine the combination of bavituximab alongside models of checkpoint blockade that are unresponsive to inhibition or co-stimulation given the ability of bavituximab to reprogram myeloid derived suppressor cells (MDSC) and increase tumoricidal T-cells in tumors, a mechanism of action that is complementary to checkpoint blockade and T-cell activation.
. . .
"A key focus of the Wolchok Lab's research is studying novel immunotherapy combinations that work together to enable the immune system to recognize and destroy cancer. This collaboration will allow us to focus on the role and contribution of PS blockade therapy in determining which combination of the current and next generation of immune modulators is likely to increase the extent and amplitude of anti-tumor response. This important pre-clinical and translational work will potentially guide the design of the next generation of clinical studies with bavituximab," said (Sloan’s) Dr. Taha Merghoub.
. . .
"We are delighted to be working with a world-renowned pioneer and leader in the immuno-oncology space, recognizing that there remains significant research in order for more cancer patients to realize the benefits of combination immune therapy," said Jeff T. Hutchins, PhD, VP of Preclin. Research at Peregrine. "Our internal & collaborative research presented over the last year has established a robust foundation of PS-targeting activity on which to initiate this next chapter in PS research and development."
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5-30-15: PD-1/PD-L1 blockade therapies like Opdivo+Keytruda benefit ~20% of patients. Peregrine’s objective with Bavi is to “increase the extent & amplitude” of such therapies…
“Although PD-1/PD-L1 blockade therapy [ex: Opdivo, Keytruda ] provides clinical benefits to approx. 20% of patients with advanced NSCLC, about 80% of patients still remain refractory to this treatment. Therefore, new molecules & combinations are urgently needed to address primary & secondary resistance to these new agents.
From 3-2015 ClinCancerRes. article, “Immune Checkpoint Modulation for Non–Small Cell Lung Cancer”:
http://clincancerres.aacrjournals.org/content/21/10/2256.abstract
http://www.ncbi.nlm.nih.gov/pubmed/25979932
=> Enter BAVI, stage left, whose objective is to Extend The Range of patients that would benefit from the anti-PD1 mabs, in addition to helping the 20% that do benefit get Better Results.
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BAVITUXIMAB PHASE III TRIAL: see http://PeregrineTrials.com => 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
Geo/Map view of Worldwide Ph3 SUNRISE Sites: http://www.medbravo.org/study?study=NCT01999673
...159 sites a/o 5-6-15 (USA/39 Aus/8 Bel/7 Fr/9 Ger/15 Greece/9 Hungary/7 Italy/10 Korea/9 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/nrpbqhl
...EU/EEA Registries: (pts world=582, pts/EU=345, planned EU sites=100) http://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-003953-13
• GER: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/DE (planned sites=14, pts=43)
• SPAIN: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/ES (planned sites=16, pts=100)
• HUNGARY: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/HU (planned sites=9, pts=28)
• GREECE: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/GR (planned sites=9, pts=120)
• ITALY: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/IT (planned pts=55)
• BELGIUM: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/BE (planned sites=7 pts=31)
...EU= European Union (29 countries – see http://www.gov.uk/eu-eea ), EEA=European Economic Area (all the EU, plus Iceland, Liechtenstein, Norway)
…Regions where sites are planned: Australia, Belgium, France, Germany, Greece, Hungary, Italy, Korea, Romania, Russia., Spain, Taiwan, Ukraine, USA
...3-2014: Eur.Med.Assoc.(EMA) appears to approve Bavi/2L-NSCLC for possible future trial in Children: http://tinyurl.com/lqsjfj2
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."
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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
BAVI MOA 5-21-15: NYAS: Emerging Approaches to Cancer Immunotherapy, NYC http://tinyurl.com/lfdoksl
…3:10pm: Dr. Rolf Brekken, “Lifting the Veil of Immune Suppression and Inducing Immune Activation through Antibody-mediated Blockade of Phosphatidylserine Signaling”
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/VP Dr. Bruce Freimark’s presentation at KEYSTONE "Tumor Immunology Meeting", Banff/CN – PR & Slides: http://tinyurl.com/q6cx4w6
. . .MORE/iBox: http://investorshub.advfn.com/boards/show_ibox.aspx?boardid=2076
6-1-15: Peregrine Pharmaceuticals Provides Update on Planned Expansion of Bavituximab Clinical Program
• Phase II Trial to Evaluate Combination of Bavituximab and Opdivo® (Nivolumab) in Non-Small Cell Lung Cancer
• Phase II/III Combination Trial to Advance Bavituximab with Chemotherapy Combinations in HER2 Negative Breast Cancer
• New Studies Expected to be Underway as Phase III SUNRISE Trial in Lung Cancer Completes Enrollment by Calendar Year-End
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915699
TUSTIN, June 1, 2015: Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM, PPHMP), a biopharmaceutical company focused on oncology and the treatment of lung and breast cancers through the development of bavituximab, a novel immunotherapy currently in Phase III, today provided a corporate update on its immuno-oncology pipeline, its wholly-owned contract manufacturing business, Avid Bioservices, as well as anticipated upcoming milestones. This update outlines the expansion of the bavituximab clinical pipeline with a focus on exploring expanded indications and combinations in lung and breast cancers. These new trials build on recently published clinical data of bavituximab in combination with paclitaxel in HER2 negative breast cancer and clinical translational and preclinical data presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting that support the potential combination of bavituximab with the anti-PD-1 checkpoint inhibitor, nivolumab (marketed as Opdivo®). These clinical trials are expected to begin enrollment later this year.
"With many exciting near-term opportunities for Peregrine and Avid, we are pleased to share several strategic decisions aimed at expanding the potential clinical indications for bavituximab. These new trials represent large market opportunities for the bavituximab clinical program that can add significant value," said Steven King, President and CEO of Peregrine. "As we near completion of enrollment in the SUNRISE pivotal Phase III trial by year-end, we are looking to expand bavituximab's market potential and market position in key indications that are supported by strong clinical, translational, and preclinical data. Taken together with the research collaboration we announced last week, we believe we are setting the stage for many significant value driving events throughout 2015 and into 2016."
SUNRISE Phase III Pivotal Trial
The company's Phase III SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) is an approximately 600 patient trial that continues to enroll at over 150 sites worldwide. Completion of enrollment is anticipated by calendar year-end. This Phase III, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety, tolerability and efficacy of bavituximab as a second-line treatment in patients with non-squamous, non-small cell lung cancer (NSCLC). Enrollment is proceeding according to plan with two planned interim efficacy analyses which will be reviewed by the trial's Independent Data Monitoring Committee (IDMC). The first interim analysis, which will be conducted when 33% of the targeted overall survival events are reached, is for futility and the second interim analysis, for futility or superiority, will be conducted at 50% of events. As these analyses are event driven, the exact timing of each is unknown, however the company plans to provide updates as these events are reached. For additional information about the SUNRISE trial, please visit http://www.sunrisetrial.com or ClinicalTrials.gov using the Identifier NCT01999673 [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ].
Beyond SUNRISE: Exploring Checkpoint Inhibitor Combinations in Lung Cancer
Joe Shan said: "Following recent encouraging preclinical data supporting the combination of bavituximab with immune checkpoint inhibitors, today we are supplementing our strategy in lung cancer with the second clinical trial to emerge from our Immuno-Oncology Development Program, a combination trial of bavituximab with nivolumab, an immune checkpoint inhibitor of PD-1. Specifically, recent preclinical data show that the addition of bavituximab could result in turning patients that do not respond to monotherapy into patient responders. This supports our long held knowledge of the synergistic properties of the combination of bavituximab and chemotherapies, thus making this new trial the next logical step."
The company plans to initiate an open-label multi-center, randomized Phase II trial of the anti-PD-1 monoclonal antibody nivolumab (marketed as Opdivo®) versus nivolumab plus bavituximab in patients with previously treated locally advanced or metastatic NSCLC. Enrollment will include patients with squamous and non-squamous NSCLC who have not received a prior PD-L1 or PD-1 inhibitor. The primary endpoint of this trial will be overall response rate (ORR) with secondary endpoints including tumor response and duration, progression free survival, overall survival (OS) and safety. The trial is in the final stages of design and the details of which will be made available once details are completed. Trial initiation is anticipated in the second half of 2015.
Leveraging Positive Data in Breast Cancer
"Today we are pleased to be detailing our strategy in breast cancer which is built upon very promising data which were recently published in the peer-reviewed journal Cancer Medicine," said Joseph Shan, VP of Clinical & Regulatory Affairs at Peregrine Pharmaceuticals. "The clinical development pathway that we are outlining today is based upon the strong clinical experience that supports synergies between bavituximab and docetaxel and paclitaxel, our deep and consistently positive clinical experience in breast cancer to date, as well as the support of leading breast cancer physicians."
The company plans to initiate a Phase II/III open-label trial of physician's choice of either docetaxel or paclitaxel with or without bavituximab in patients with locally advanced or metastatic HER2 negative breast cancer. The primary endpoint for the Phase II trial will be ORR. Results from this trial are expected to inform decisions on future studies in breast cancer and add value to the overall program. The initiation of this trial is anticipated in the second half of 2015.
Fiscal Year End Cash Position
Peregrine today reported $68 million in cash and cash equivalents, as of fiscal year ended April 30, 2015. The company will review full financial results for the fourth quarter and fiscal year 2015 during its quarterly call on Tuesday, July 14, 2015 after the close of markets, details of which will be included in a forthcoming press release.
Avid Bioservices' Expansion on Track and Strongly Positioned to Meet Increased Client Demand
In December 2014, the company announced the expansion of Avid's Current Good Manufacturing Practice (cGMP) current manufacturing capacity with a build out that is utilizing an existing 40,000 square foot facility located adjacent to the company's current campus. Designed to more than double Avid's current manufacturing capacity, this state-of-the-art biotechnology facility will employ an innovative and flexible modular clean room design and the latest in single-use technologies to meet the growing needs of Avid's existing and future clients as well as the planned commercialization of bavituximab. Avid's new facility is anticipated to be ready for cGMP production of biotechnology products in July 2015.
Added Steve King: "We are very pleased with the rapid progress by which this expansion is advancing as this is a key component to further demonstrating Avid as a leading provider of high quality biotechnology contract manufacturing services. The design and the features that we have employed in this expansion will truly be an integral part to the future growth of this unique part of our business. We look forward to sharing specific details on the expansion upon its formal unveiling later this year."
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
Safe Harbor <snip>
Opdivo® is a registered trademark of Bristol-Myers Squibb Company
CONTACT: Christopher Keenan, Peregrine Pharmaceuticals, Inc., (800) 987-8256, info@peregrineinc.com
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6-1-15/PR: Peregrine’s 3 ASCO’15 Presentations (NSCLC, Melanoma, Breast, Liver)…
6-1-15: Data Presentations at ASCO Demonstrate the Ability of Peregrine Pharmaceuticals' Bavituximab to Activate Tumor Targeting Immune Cells in PD-L1 Negative NSCLC Tumors
• New Data Show that Bavituximab Alone and in Combination with Docetaxel Elicits a Tumor-Specific Immune Response in PD-L1 Negative Tumors Extracted from NSCLC Patients
• PS-Targeting Antibodies Combined with Anti-PD-1 Reverses Tumor Immunosuppression and Activates Tumor Fighting CD8+ Immune Cells in Models of Melanoma and Breast Cancer
• Encouraging Data in Patients with Advanced Liver Cancer Warrants Further Clinical Study
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915719
TUSTIN, June 1, 2015: Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP), a biopharmaceutical company focused on oncology and the treatment of lung and breast cancers through the development of bavituximab, a novel immunotherapy currently in Phase III, today announced the presentation of preclinical and clinical translation data highlighting its phosphatidylserine (PS) targeting platform and bavituximab at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29-June 2, 2015 in Chicago, Illinois.
"These presentations bridge the preclinical and clinical portions of our Immuno-Oncology Development Program and support our recently announced strategic decision to expand our clinical program aimed at the development of the most promising potential immunotherapy combinations with bavituximab," said Jeff Hutchins, VP of Preclinical Development of Peregrine. "The data generated to date reinforces the potential of bavituximab to enhance current immuno-oncology treatment modalities aimed at creating a greater group of patients responding to currently available therapies."
In poster #385 titled, "Activation of CD8+ Tumor Infiltrating Lymphocytes by Bavituximab in a 3D Ex Vivo System of Lung Cancer Patients", researchers from Nilogen Oncosystems [=Moffit Startup: http://otmc.moffitt.org/startups.aspx ] and H. Lee Moffitt Cancer Center presented initial data from a pilot translation study analyzing tumor tissue from six lung cancer patients to evaluate the immunomodulatory effects of bavituximab in a human ex vivo model of non-small cell lung cancer (NSCLC). New data generated from additional assays further validates previous data showing that ex vivo drug treatment with bavituximab, alone and in combination with docetaxel, elicits an immune response in tumors from NSCLC patients with negative PD-L1 and low PD-1 expression. Specifically, data showed activation of tumor infiltrating lymphocytes (TILs) by polarization of the tumor microenvironment from immunosuppressive to immuno-stimulatory. Results in this pilot translational study also identified PD-L1 and PD-1 expression as a potential biomarker of response to bavituximab treatment, suggesting that the interruption of the PD-1/PD-L1 axis may enhance the bavituximab effect in lung cancer.
[POSTER: http://www.peregrineinc.com/images/stories/pdfs/asco_2015_lung.pdf ]
"These preliminary gene profiling data are consistent with previously published data on bavituximab's immunotherapeutic mechanism of action," said Dr. Soner Altiok, MD, PhD, Chief Scientific Officer at Nilogen Oncosystems and Senior Member at the H. Lee Moffitt Cancer Center. "Building upon encouraging translational findings of a cytokine profile previously reported, these new data support the finding that M1 polarization of tumor associated macrophages is involved in bavituximab-mediated activation of tumor infiltrating lymphocytes in the ex vivo model of lung cancer."
In poster #386 titled, "Phosphatidylserine Targeting Antibody in Combination with anti-PD-1 Antibody Treatment Activates Infiltrating T Lymphocytes of the Spleen and Tumor Microenvironment in Pre-Clinical Models of Melanoma and Breast Cancer", researchers from The University of Texas Southwestern Medical Center in Dallas, Texas led by Xianming Huang, PhD, found that blocking PS with PS-Targeting antibody enhances the anti-tumor activity of combination therapies including anti-PD-1 and anti-CTLA-4 antibodies in an immune competent model of breast cancer and in preclinical models of melanoma. In the breast cancer model, researchers found that the combination of PS blockade and an anti-PD-1 antibody promoted strong and localized anti-tumor responses without the side-effects of systemic immune activation. In models of melanoma, the combination of PS blockade with either an anti-PD-1 or anti-CTLA-4 antibody showed significantly superior tumor growth inhibition over single treatment, with many subjects achieving complete tumor regressions. No toxicity was observed in any of the treatment groups following multiple treatment doses.
[POSTER: http://www.peregrineinc.com/images/stories/pdfs/asco_2015_melanoma_breast.pdf ]
Added Dr. Hutchins: "These data support our view of bavituximab as an immunomodulatory treatment in PD-1 sensitive and anti-PD-1 resistant/unresponsive tumors. We look forward to the execution of additional clinical trials aimed at further exploring these potential combinations."
In poster #220 titled: "A phase I/II study of Bavituximab and Sorafenib in Advanced Hepatocellular Carcinoma (HCC)", researchers led by Adam Yopp, M.D., Assistant Professor of Surgery at The University of Texas Southwestern Medical Center in Dallas, Texas found that the combination of bavituximab and sorafenib is associated with an improved time to progression (TTP) of 6.7 months, a disease specific survival (DSS) of 8.7 months, a disease control rate (DCR) of 58% (22 out of 58 patients) and a 4-month progression-free survival (PFS) of 62%. Two patients (5%) achieved a partial response according to Response Evaluation Criteria In Solid Tumors (RECIST). The secondary endpoint of median overall survival (OS) was 6.2 months. The trial's patient population had unfavorable disease biology as demonstrated by a high rate of previous treatment and macrovascular invasion. The combination of bavituximab and sorafenib was well-tolerated in patients with advanced HCC with no indications of autoimmune adverse events that have been seen with other checkpoint immunotherapies.
[POSTER: http://www.peregrineinc.com/images/stories/pdfs/asco_2015_hcc_utsw_y_.pdf ]
A link to copies of these presentations can be found on the home page of Peregrine's website at http://www.peregrineinc.com .
Webcast Replay: Roundtable Discussion "Raising the Immuno-Oncology Bar"
Last night, Peregrine hosted a roundtable discussion of immunotherapy thought leaders in conjunction with the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois. A link to the replay of this event titled: "Raising the Immuno-Oncology Bar: The Next Wave of Immune Modulating Checkpoint Inhibitors" can be found on the home page of Peregrine's website at http://www.peregrineinc.com . [ http://edge.media-server.com/m/p/h2toyjv4 ]
About Bavituximab: A Targeted Investigational Immunotherapy
Scientific research has shown that tumors evade immune detection due partly to the expression of phosphatidylserine, or PS, a highly immunosuppressive molecule. Peregrine's immuno-oncology development program has developed bavituximab, an investigational monoclonal antibody that targets and binds to PS, blocking its immunosuppressive effects while activating tumor fighting immune cells, thus enabling the immune system with the ability to better recognize and fight cancer. Bavituximab's immune-stimulatory mechanism-of-action data is the subject of a manuscript published in the October 2013 issue of the American Association for Cancer Research's (AACR) peer-reviewed journal, Cancer Immunology Research. Bavituximab is currently being evaluated in several solid tumor indications, including non-small cell lung cancer (the SUNRISE Phase III trial), breast cancer, liver cancer, rectal cancer and advanced melanoma. In January 2014, bavituximab received Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential second-line treatment of patients with non-small cell lung cancer.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
CONTACT: Christopher Keenan, Peregrine Pharmaceuticals, Inc., 800-987-8256, info@peregrineinc.com
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Event Brochure for Peregrine’s 5-31-15 ASCO’15 I-O Roundtable – sent to me my CK@IR…
Sunday 5-31-15 6pmCT: "Raising the Immuno-Oncology Bar: The Next Wave of Immune Modulating Checkpoint Inhibitors"
…7 panel members, incl. 3 Mem. Sloan Kettering researchers – recall the 5-29-15 announced collab. with MSK “to Investigate Novel PS-Targeting Immunotherapy Combinations”…
WEBCAST Replay: http://edge.media-server.com/m/p/h2toyjv4
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5-27-15/PR: Peregrine Pharmaceuticals Announces Webcast of Immunotherapy Roundtable at ASCO Annual Meeting
• Immunotherapy Thought Leaders to Discuss Next Wave of Therapies Aimed at Increasing the Number of Patients That Respond to Immuno-Oncology Combination Therapies
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915098
TUSTIN, May 27, 2015: Peregrine Pharmaceuticals (Nasdaq:PPHM, PPHMP), a biopharmaceutical company focused on advancing bavituximab, a novel immuno-oncology (I-O) agent in Phase III development for the treatment of lung cancer, invites investors and the general public to listen to a webcast of its roundtable discussion in conjunction with the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting [ http://am.asco.org ]. This roundtable is comprised of key opinion leaders in the field of Immunotherapy who will discuss novel I-O combination therapies that may improve patient outcomes.
Title: "Raising the Immuno-Oncology Bar: The Next Wave of Immune Modulating Checkpoint Inhibitors"
Date/Time: Sunday, May 31, 2015 from 6:00-7:00pm CT
The event is being hosted by Peregrine Pharmaceuticals and will be webcast live and archived for 60 days. The event may be accessed from the home page of Peregrine Pharmaceuticals' website at http://www.peregrineinc.com . For the live event, listeners are encouraged to login 5-10 minutes ahead of the scheduled start in order to verify system requirements and complete registration.
Lori Kunkel, MD will moderate this event. Dr. Kunkel serves on the Board of Directors of Loxo Oncology [ http://www.loxooncology.com ], where she held the position of Acting Chief Medical Officer. Previously, Dr. Kunkel was Chief Medical Officer at Pharmacyclics and Proteolix and has also held senior roles at ACT Therapeutics, Syndax, Xencor, and Genitope. Dr. Kunkel received her MD from the Univ. of Southern California and her BA degree from the Univ. of California San Diego.
The panel includes:
Scott J. Antonia[PPHM SAB], MD, PhD, Department Chair, Program Leader, Thoracic Oncology Dept Associate Professor Dept of Interdisciplinary Oncology and Program Leader of the Immunology Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida
[ http://moffitt.org/research--clinical-trials/individual-researchers/scott-j--antonia-md-phd ]
Dmitry I. Gabrilovich, MD, PhD, Christopher M. Davis Professor in Cancer Research and Program Leader, Translational Tumor Immunology, The Wistar Institute, Philadelphia, PA
[ http://www.wistar.org/our-science/scientists/dmitry-gabrilovich-md-phd ]
Kathy D. Miller, MD, Ballve Lantero Scholar in Oncology, Professor, Dept of Medicine, Co-Director, Simon Cancer Center Breast Cancer Program, Indiana University School of Medicine, Indianapolis, IN
[ http://www.bcrfcure.org/researchers/kathy-d-miller ]
Dmitriy Zamarin, MD, PhD, Assistant Attending Physician, Gynecologic Medical Oncology & Immunotherapeutics, Memorial Sloan Kettering Cancer Center, NYC
[ http://www.mskcc.org/research-areas/labs/members/dmitriy-zamarin http://www.youtube.com/watch?v=hGL__YKuOLY ]
Matthew D. Hellman, MD, Assistant Attending Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, NYC
[ http://www.mskcc.org/cancer-care/doctors/matthew-hellmann “History of Immunotherapy”: http://www.youtube.com/watch?v=2KWsYmXhclw ]
Alexander M. Lesokhin, MD, Assistant Member, Assistant Attending Physician, Memorial Sloan Kettering Cancer Center, NYC
[ http://www.mskcc.org/research-areas/labs/members/alexander-lesokhin-01 ]
Rolf A. Brekken[PPHM SAB], PhD, Effie Marie Cain Research Scholar in Angiogenesis Research, Professor, Depts of Surgery & Pharmacology, Univ. of Texas Southwestern Medical Center, Dallas, TX
[ http://profiles.utsouthwestern.edu/profile/10808/rolf-brekken.html ]
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
CONTACT: Christopher Keenan, Peregrine Pharmaceuticals, Inc., 800-987-8256, info@peregrineinc.com
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5-29-15: Peregrine Pharmaceuticals Enters Into Research Collaboration [with Mem. Sloan Kettering] to Investigate Novel PS-Targeting Immunotherapy Combinations
• Research Collaboration to Focus on Exploring Potential Combinations of PS-Targeting Agents Including Bavituximab With Other Immune Modulators
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=114118480
"The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said (Sloan’s) Dr. Jedd D. Wolchok.
. . .
As part of the collaboration, researchers at MSK will conduct research to further explore the combination of PS-targeting agents, including bavituximab, that block a primary immunosuppressive pathway thereby allowing anti-tumor immune responses with other immuno-stimulatory agents that enhance immune responses. Specifically, MSK researchers will examine the combination of bavituximab alongside models of checkpoint blockade that are unresponsive to inhibition or co-stimulation given the ability of bavituximab to reprogram myeloid derived suppressor cells (MDSC) and increase tumoricidal T-cells in tumors, a mechanism of action that is complementary to checkpoint blockade and T-cell activation.
. . .
"A key focus of the Wolchok Lab's research is studying novel immunotherapy combinations that work together to enable the immune system to recognize and destroy cancer. This collaboration will allow us to focus on the role and contribution of PS blockade therapy in determining which combination of the current and next generation of immune modulators is likely to increase the extent and amplitude of anti-tumor response. This important pre-clinical and translational work will potentially guide the design of the next generation of clinical studies with bavituximab," said (Sloan’s) Dr. Taha Merghoub.
. . .
"We are delighted to be working with a world-renowned pioneer and leader in the immuno-oncology space, recognizing that there remains significant research in order for more cancer patients to realize the benefits of combination immune therapy," said Jeff T. Hutchins, PhD, VP of Preclin. Research at Peregrine. "Our internal & collaborative research presented over the last year has established a robust foundation of PS-targeting activity on which to initiate this next chapter in PS research and development."
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5-30-15: PD-1/PD-L1 blockade therapies like Opdivo+Keytruda benefit ~20% of patients. Peregrine’s objective with Bavi is to “increase the extent & amplitude” of such therapies…
“Although PD-1/PD-L1 blockade therapy [ex: Opdivo, Keytruda ] provides clinical benefits to approx. 20% of patients with advanced NSCLC, about 80% of patients still remain refractory to this treatment. Therefore, new molecules & combinations are urgently needed to address primary & secondary resistance to these new agents.
From 3-2015 ClinCancerRes. article, “Immune Checkpoint Modulation for Non–Small Cell Lung Cancer”:
http://clincancerres.aacrjournals.org/content/21/10/2256.abstract
http://www.ncbi.nlm.nih.gov/pubmed/25979932
=> Enter BAVI, stage left, whose objective is to Extend The Range of patients that would benefit from the anti-PD1 mabs, in addition to helping the 20% that do benefit get Better Results.
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BAVITUXIMAB PHASE III TRIAL: see http://PeregrineTrials.com => 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
Geo/Map view of Worldwide Ph3 SUNRISE Sites: http://www.medbravo.org/study?study=NCT01999673
...159 sites a/o 5-6-15 (USA/39 Aus/8 Bel/7 Fr/9 Ger/15 Greece/9 Hungary/7 Italy/10 Korea/9 Rom/6 Rus/7 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/nrpbqhl
...EU/EEA Registries: (pts world=582, pts/EU=345, planned EU sites=100) http://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-003953-13
• GER: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/DE (planned sites=14, pts=43)
• SPAIN: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/ES (planned sites=16, pts=100)
• HUNGARY: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/HU (planned sites=9, pts=28)
• GREECE: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/GR (planned sites=9, pts=120)
• ITALY: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/IT (planned pts=55)
• BELGIUM: http://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/BE (planned sites=7 pts=31)
...EU= European Union (29 countries – see http://www.gov.uk/eu-eea ), EEA=European Economic Area (all the EU, plus Iceland, Liechtenstein, Norway)
…Regions where sites are planned: Australia, Belgium, France, Germany, Greece, Hungary, Italy, Korea, Romania, Russia., Spain, Taiwan, Ukraine, USA
...3-2014: Eur.Med.Assoc.(EMA) appears to approve Bavi/2L-NSCLC for possible future trial in Children: http://tinyurl.com/lqsjfj2
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."
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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
BAVI MOA 5-21-15: NYAS: Emerging Approaches to Cancer Immunotherapy, NYC http://tinyurl.com/lfdoksl
…3:10pm: Dr. Rolf Brekken, “Lifting the Veil of Immune Suppression and Inducing Immune Activation through Antibody-mediated Blockade of Phosphatidylserine Signaling”
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/VP Dr. Bruce Freimark’s presentation at KEYSTONE "Tumor Immunology Meeting", Banff/CN – PR & Slides: http://tinyurl.com/q6cx4w6
. . .MORE/iBox: http://investorshub.advfn.com/boards/show_ibox.aspx?boardid=2076
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