Replies to post #247810 on Avid Bioservices Inc (CDMO)

[stoneroad]

Wonder if MSK encouraged PPHM to pursue a broadened collaboration with NCCN.

[cjgaddy]

Known Upcoming Events...

Jan9: AACR's The Function of Tumor Microenvironment in Cancer Progression Conf., SanDiego http://tinyurl.com/oo37gwr
...Dr. Rolf Brekken (UTSW, PPHM SAB): “Antibody mediated blockade of PS synergizes with immune checkpoint blockade by inhibiting multiple immune suppressive mechanisms”
.....note: the chair in Dr.Brekken's “Actions of Innate & Adaptive Immunity” session is Dr. Joan Massague, DIRECTOR of The Memorial Sloan Kettering Inst.

Jan25: Phacilitate's Immunotherapy World Conf., WashDC http://tinyurl.com/zjd7h4n
...3:40-3:55pm, Dr. Jeff Hutchins (VP/PreClinRes): “Combination Immunotherapies - Opening the Gate: Increasing Tumor Infiltrating Activated T-cells to Optimize & Expand the Benefits of Immune Checkpoint Therapies”

Jan26: GTCbio's Novel Immunotherapeutics Summit, San Diego http://tinyurl.com/z3dyful
...10am, Dr. Bruce Freimark (ResDir./Preclin.Oncology): “Blockade of PS Enhances the Anti-Tumor Activity of Targeted Therapy & Immune Checkpoint Inhibitors by Reducing Immunosuppressive Cells in the Tumor Microenvironment”

Jan26-28/Avid/Booth20: CASSS' 20th Symposium on the Interface of Reg.&Anal. Sciences for Biotech Health Products, WashDC http://www.casss.org/?WCBP1600

Mar8: CHI’s Inaugural Cancer Immunotherapy Conf., SanFran http://tinyurl.com/hlskng8
...3:55pm, Dr. Jeff Hutchins (VP/PreClinRes), Track Chair: “Combination Immunotherapies – Opening the Gate: Increasing Tumor Infiltrating Activated T-Cells to Optimize & Expand the Benefits of Immune Checkpoint Therapies”

~Mar10: FY'16Q3 (qe 1-31-16) Financials & Conf. Call http://ir.peregrineinc.com/events.cfm

Mar14-17/Avid/Booth712: IBC's BioProcess Intl. West, Oakland http://www.ibclifesciences.com/BPIWest/overview.xml

Mar16: Immune Checkpoint Inhibitors Conf., Boston http://tinyurl.com/hzjjs2u (Peregrine is 1 of 8 Corp. Sponsors)
...2pm, Dr. Jeff Hutchins (VP/PreClinRes): “Enhancing the Power of Checkpoint Inhibition by Simultaneously Blocking Upstream & Downstream Targets: The Role of PS, a Novel, Global Immune Checkpoint”

??Apr16-20: AACR 2016, New Orleans http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=63

??Jun3-7: ASCO 2016, Chicago http://am.asco.org

Jun6-9/Avid/Booth5562: BIO Intl. Convention, SanFran http://convention.bio.org

~Jul12: FY'16Q4 (fy/e 4-30-16) Financials & Conf. Call http://ir.peregrineinc.com/events.cfm

[cjgaddy]

Peregrine's Collab. with The NCCN models many others from 2014-2015...
http://www.nccn.org/clinical_trials/news.aspx

NCCN Awarded $2 Million in Research Funding from Peregrine Pharmaceuticals to Study Bavituximab in Various Cancers (01/06/2016)

NCCN Receives $2 Million in Research Funding from Boehringer Ingelheim to Study Targeted Combination Approaches with Afatinib in Lung Cancer (06/11/2015)

NCCN Receives $2-Million Funding Commitment from ImmunoGen to Study Mirvetuximab Soravtansine for Folate Receptor Alpha-Positive Cancers (05/15/2015)

NCCN Receives $2 Million in Research Funding from Boehringer Ingelheim to Study Volasertib in Hematologic Malignancies (05/22/2014)

NCCN Receives $2.2 Million in Research Funding from Astellas & Medivation to Study Enzalutamide in Solid Tumors (04/01/2014)

NCCN Receives $2 Million in Research Funding from Boehringer Ingelheim to Study Nintedanib* in Colorectal and Lung Cancers (03/21/2014)

= = = = = = = = =
1-6-16: Peregrine enters into Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN) http://tinyurl.com/zmxtpsb
...$2mm res. grant to NCCN's Oncology Res. Pgm (ORP), will “significantly expand our clinical evaluation of Bavi and augment Peregrine's IST pgm at 26 of the world's leading cancer centers” [ http://www.nccn.org/members/network.aspx ].

[biopharm]

Jan. 6, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced a new research collaboration with the National Comprehensive Cancer Network (NCCN) [ www.nccn.org ] to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors. NCCN, a not-for-profit alliance of 26 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.
..
..

I see a good opportunity for Peregrine Pharmaceuticals over the next month, leading up to this NCCN 2016 Congress Series, especially since Peregrine was just at the 2015 San Antonio Breast Cancer Symposium and possibly played a key role in helping NCCN choose Peregrine Pharmaceuticals in further collaborations...

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=118955009

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NCCN 2016 Congress Series™: BREAST CANCER with Updates from 2015 San Antonio Breast Cancer Symposium
Overview

Friday Feb 12, 2016

Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. The clinical evaluation and therapeutic options for patients with noninvasive or invasive breast cancer are complex and varied. Healthcare professionals need to be educated on current and emerging scientific data to make evidence-based treatment decisions, to communicate treatment options to patients effectively in order to make shared treatment decisions, and to provide optimal care for patients with breast cancer.

As the complexity and importance of screening, testing, and individualized treatment strategies for breast cancer have increased, so has clinicians’ reliance on the National Comprehensive Cancer Network (NCCN) Breast Cancer Guidelines and NCCN’s educational interventions to increase knowledge and bridge the gaps between knowledge and competence.

The NCCN 2016 Congress Series™: Breast Cancer will present a comprehensive summary of the most up-to-date research and clinical data presented at the 2015 San Antonio Breast Cancer Symposium®. According to William J. Gradishar, MD (Betsy Bramsen Professor of Breast Oncology; Professor of Medicine; Director, Maggie Daley Center for Women’s Cancer Care; Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Northwestern Hospital), “Health care providers caring for patients with breast cancer are increasingly challenged by new developments in disease management. The optimal treatment of breast cancer is becoming increasingly complex requiring an understanding of the biology of the disease, which, in turn, can inform treatment recommendations both locally and systemically. The SABCS Updates will review data-driven changes to the breast cancer practice guidelines affecting decisions regarding risk reduction strategies, local therapy options including surgical management, local-regional radiation therapy recommendations, and optimal systemic therapy for early-stage breast cancer and advanced disease. Defining risk of recurrence and potential benefit from specific treatment modalities for patients with early-stage disease has been the promise of genomic profile signatures and will be considered within the context of practice guidelines. Additionally, key emerging data from SABCS will be reviewed that may influence practice in the future.”

http://www.cvent.com/events/nccn-2016-congress-series-breast-cancer-with-updates-from-2015-san-antonio-breast-cancer-symposium/event-summary-47dede2a064643ed9baca863a2a490a4.aspx

[cjgaddy]

1-11-16/PR: Update on 4 New Bavi Clinical Trials (Lung/AZN, Breast/1Co./1MSKCC, Other Cancers/AZN). SUNRISE estimates: Interim1=Early'16, Interim2=Mid'16, FinalUnblinding=End'16…

1-11-16: Peregrine Pharmaceuticals Provides Update on Planned Expansion of Bavituximab Clinical Program in Lung, Breast and Other Cancers
– Phase II Study in NSCLC in Collaboration with AstraZeneca Evaluating Bavituximab Plus Durvalumab to Expand Lung Cancer Program in Q1 2016
– Phase II/III Study in HER2-Negative Metastatic Breast Cancer is Now Underway with a Second Phase II Study in Early Stage Triple Negative Breast Cancer to Begin in Q1 2016
– Additional Studies to Broaden Evaluation of Bavituximab Immunotherapy and Standard of Care Combinations in Multiple Solid Tumors Planned for 2016

TUSTIN, Jan. 11, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today provided a clinical development update for bavituximab, the company's investigational phosphatidylserine (PS)-targeting immunotherapy. In the first quarter of 2016, Peregrine plans to initiate two new Phase II clinical trials in breast and lung cancer in combination with current standard of care treatments including both chemotherapy and immuno-oncology agents. In addition, the company has entered into a collaboration with the National Comprehensive Cancer Network (NCCN) to evaluate bavituximab in other tumor types and combinations. Additionally, the company is nearing completion of enrollment of an ongoing Phase III trial in non-small cell lung cancer (NSCLC) named SUNRISE.

The planned trials include a Phase II NSCLC trial in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), and a Phase II trial in early stage triple negative breast cancer (TNBC). These are in addition to the recently initiated Phase II/III study in combination with chemotherapy in human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). The company expects that initial data from these trials may be available in late 2016 or early 2017. Additionally, the company looks forward to the initiation of additional trials of bavituximab combinations through its ongoing collaborations with AstraZeneca and NCCN.

"As we wrap up enrollment in the SUNRISE trial, we recognize that we are at an ideal juncture to continue expanding the potential of bavituximab with standard of care and immunotherapy combinations in multiple solid tumor types. Combined with the SUNRISE trial, the new studies we have planned can help solidify the potential of bavituximab in NSCLC while significantly expanding the market opportunity in breast cancer," said Steven W. King, President and CEO of Peregrine. "Driving our strategy is the goal of further demonstrating that bavituximab can provide therapeutic benefit to available cancer treatments, regardless of whether those are traditional therapies such as chemotherapy and radiation, or the emerging novel class of immuno-oncology agents. In today's update, it is evident that we are moving aggressively to compile a significant body of clinical evidence to support bavituximab's utility in multiple cancers and across a range of treatment regimens. By doing so, we hope to optimally position bavituximab for success."

Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine's PS targeted inhibitor, bavituximab, is thought to reverse the immunosuppressive environment that many tumors establish in order to proliferate and spread, while also fighting cancer by activating immune cells that target and fight cancer.

Updated details on Peregrine's expanded bavituximab clinical development program include:

Bavituximab in NSCLC:

Phase III SUNRISE Trial
Peregrine's Phase III SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) trial is evaluating the use of bavituximab and docetaxel in patients with previously treated locally advanced or metastatic non-squamous NSCLC. Peregrine expects that the first interim analysis (33% of targeted number of deaths) will be conducted in early 2016 and the second interim analysis (50% of targeted number of deaths) in mid-2016. The final analysis, which will trigger the unblinding of the study data, is currently projected to occur at the end of 2016.

Phase II NSCLC Trial in Combination with AstraZeneca's Durvalumab
Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca's durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with previously treated squamous or non-squamous NSCLC during the first quarter of 2016. The goal of this trial is to generate data on the combination of bavituximab and durvalumab to inform the potential advancement of this treatment regimen into later stage clinical trial. The study's primary endpoints are overall response rate (ORR) and safety. The trial is also designed to retrospectively evaluate patients for the correlation between their PD-L1 levels and clinical outcomes, providing further critical data to guide future development.

The randomized, open-label trial will evaluate approximately 200 patients at sites in the U.S. and Europe. The company has filed a study protocol to its existing investigational new drug (IND) application for bavituximab in the U.S. and is currently working to open clinical trial sites.

Bavituximab in Breast Cancer:

Phase II/III HER2-Negative MBC Trial in Combination with Chemotherapy
In December 2015, Peregrine initiated an open-label, randomized Phase II/III study comparing the efficacy and safety outcomes for taxane monotherapy (paclitaxel or docetaxel at investigator discretion) versus taxane therapy in combination with bavituximab in HER2-negative MBC patients. The goal of the Phase II portion of this study is to generate mature data on the combination of bavituximab and chemotherapy in MBC to guide the design and execution of the trial's Phase III component. The primary efficacy endpoint of the Phase II study is ORR, with secondary endpoints including progression free survival (PFS), overall survival (OS), duration of response and safety. The Phase II portion of the study will enroll approximately 150 patients at sites in the U.S. and Europe.

Phase II Trial in Early Stage TNBC in Combination with Chemotherapy
Peregrine is planning to initiate a Phase II trial of bavituximab in combination with neoadjuvant chemotherapy in early stage TNBC. The primary endpoint of this study is to determine the pathologic complete response rate (pCR), an accepted surrogate endpoint in early stage TNBC. The concept for this neoadjuvant setting trial, which will be conducted at a few select U.S. sites, originated from Peregrine's ongoing collaboration with Memorial Sloan Kettering Cancer Center (MSKCC). The company has filed a study protocol to its existing bavituximab IND application in the U.S. and is currently working to open clinical trial sites, including one that will be led by David B. Page [ http://oregon.providence.org/physician-directory/p/page-david-b/ ], M.D., at the Providence Cancer Center in Oregon.

Bavituximab in Other Solid Tumor Indications:

Phase I/Ib Trial in Multiple Solid Tumors in Combination with AstraZeneca's Durvalumab and Chemotherapy
As part of the company's collaboration with AstraZeneca, Peregrine plans to initiate a Phase I/Ib study of bavituximab in combination with durvalumab and chemotherapy in multiple solid tumors in 2016. The Phase I part of the trial is designed to confirm the tolerability of the combination of bavituximab and durvalumab and establish a recommended dose regimen for the Phase Ib part of the trial, which will assess the safety and activity of the combination of bavituximab, durvalumab and chemotherapy.

Multiple Clinical and Translational Studies in Collaboration with NCCN
Peregrine recently announced a new research collaboration with NCCN to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors [1-6-16: http://tinyurl.com/zmxtpsb ]. NCCN, a not-for-profit alliance of 26 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives [ http://www.nccn.org ]. Multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers will be initiated at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant. The company expects results from this collaboration to further support the ongoing development of bavituximab as a key component of various combination cancer treatments.

About Bavituximab: A Targeted Investigational Immunotherapy
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab blocks PS and, in turn, is believed to remove this immunosuppressive signal and send an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in robust anti-tumor immune responses.

About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer. Bavituximab, the company's lead immunotherapy candidate, is in late-stage clinical development for the treatment of both lung cancer and breast cancer. The company will also evaluate the combination of bavituximab and durvalumab, AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, in a range of cancer types under a clinical collaboration.

In addition to its drug development programs, Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
Safe Harbor *snip*
• Jay Carlson Peregrine Pharmaceuticals, Inc. 800-987-8256 [e-mail]
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 [e-mail]
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 [e-mail]

= = = = = = = = = =
1-6-16: Peregrine enters into Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN) http://tinyurl.com/zmxtpsb
...$2mm res. grant to NCCN's Oncology Res. Pgm (ORP), will “significantly expand our clinical evaluation of Bavi and augment Peregrine's IST pgm at 26 of the world's leading cancer centers”.

12-10-15 Qtly. Conf. Call (King/Shan/Worsley/Garnick/Lytle) Transcript http://tinyurl.com/jkp885g
...CEO SK: “Although our SUNRISE enrollment milestone has been reached, we have no intention of slowing down, quite the opposite. We are aggressively moving to initiate new clinical trials [Lung, Breast, Mult-Types] that will allow us to build the most robust oncology business possible… With each of these studies our goal is the same - we are committed to identifying key indications, patient populations, and therapeutics that can benefit from combination treatment with bavituximab. From what we have seen to-date, the opportunity appears vast and we are hard at work converting the most promising prospects into true value.”

10-15-15: Peregrine & AstraZeneca Expand Collab. w/Ph2/2ndLine-NSCLC Trial, Bavi+durvalumab(MEDI4736), squamous or non-squamous. http://tinyurl.com/q79bkam

9-9-15 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/ph22vdn
...CEO S.King: “The Memorial Sloan Kettering & AstraZeneca collaborations are an important part of our announced plans to expand our bavituximab clinical pgm.”

8-24-15: AstraZeneca & Peregrine Collaborate on Bavi+Durvalumab Ph1/1B Trial for “multiple solid tumors” http://tinyurl.com/owlxpsf
...Durvalumab=MEDI4736(anti-PD-L1 immune checkpoint inhibitor). AZN’s Head/I-O(Robert Iannone): “Our partnership with Peregrine provides the opportunity to explore an exciting, novel combination that could deliver important clinical benefit to patients across a range of cancers."

7-14-15 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/nw2v5u6
...CEO S.King: “We recently entered into collaboration with investigators at Memorial Sloan Kettering Cancer Ctr to continue expanding on this important work, as well as to explore other potential applications of bavituximab and other agents that target PS-signaling pathway.”

5-29-15: Peregrine & Sloan Kettering Enter Collab. to “Investigate Novel PS-Targeting Immunotherapy Combos” http://tinyurl.com/qxu4w2x

[cjgaddy]

CEO Steve King quoted in 1-13-16 EP-Vantage article about advancing cancer immunotherapy combinations... “in an interview on the sidelines of the JP Morgan meeting.”…

1-13-16: “JP Morgan - Jumping In Front Of The Cancer Immunotherapy Parade”
EP Vantage Newsletter Provider (biotech, healthcare)
http://seekingalpha.com/article/3807976-jp-morgan-jumping-in-front-of-the-cancer-immunotherapy-parade
NantWorks’ Patrick Soon-Shiong has a very good idea about advancing cancer immunotherapy combinations - but this work is already being done. The billionaire’s Cancer Moonshot 2020 initiative is pushing for thousands of patients to be enrolled in trials combining such agents as checkpoint inhibitors with chemotherapies and other approaches in four years. Surely Dr Soon-Shiong must know that the sector looks like it might already be at least halfway there without his help. EP Vantage noted the first emergence of combination PD-1 trials two years ago, and the space has mushroomed since, counting no fewer than 170 combination studies of PD-1/PD-L1agents along as of last September (Merck & Co shows the way in immuno-oncology combinations, Nov. 23, 2015 http://epvantage.com/Universal/View.aspx?type=Story&id=609107 ).

PRIME OPPORTUNITY
Dr Soon-Shiong and his collaborators took the annual JP Morgan healthcare meeting in San Francisco as an opportunity to launch the National Immunotherapy Coalition, comprising big cap biotechs like Amgen and Celgene, smaller players like NantWorks, and insurers and employers. Fresh from a Dec. meeting with Joe Biden, whose son died of brain cancer last year, the coalition wants 20,000 patients to be enrolled in immunotherapy combination trials in 20 cancer types within 36mos. Absent from the scene were Bristol-Myers Squibb, Merck & Co and Roche, the undisputed leaders in the field of immunotherapies and combination trials. EP Vantage’s report, PD-1/PD-L1 Combination Therapies, found that these companies and others have already launched combination trials of their immunotherapies in at least 10 cancer types, and new indications seem to be added frequently.

Steven King, CEO of Peregrine Pharmaceuticals, sees the potential for this initiative to offer an opportunity for smaller companies to run more combination trials. While Peregrine is planning a trial in combination of its immuno-oncology agent bavituximab with AstraZeneca’s durvalumab and is collaborating with the National Comprehensive Cancer Network for other combination trials, this coalition might serve to stimulate an expansion of clinical work. “It’s often access to drugs. If you want to run a combination with Keytruda or Opdivo, you’re going to have to buy the drug,” he told EP Vantage in an interview on the sidelines of the JP Morgan meeting. “It becomes a cost issue. You’re not going to be able to run as many studies.”

WHERE THE RUBBER MEETS THE ROAD
Merck & Co’s (NYSE:MRK) Keytruda and Bristol’s Opdivo already accounted for around 96 separate combination trials, as of last September, covering such burdensome diseases as breast and lung cancer. AstraZeneca’s durvalumab and Roche’s atezolizumab added another 46. Where the Moonshot initiative is innovative is in what it calls the quantitative integrative lifelong trial (QUILT) approach, in which academic centers, oncologists, government agencies like the NIH and pharma groups will co-ordinate trials in patients who have undergone genome, transcriptome and quantitative proteomic analysis. While the strength in this approach will no doubt deliver some of the most robust analysis of immunotherapy combinations, the weakness is that these consortia studies often take more time to deliver their data than commercial counterparts. In the pursuit of a cure for cancers, having more allies, particularly in the payer community and at the highest levels in government, cannot be said to be a bad thing. However, while Dr Soon-Shiong has been busy talking and organising, Merck, Bristol and others have been doing the heavy lifting. As an elaborate public relations event for Dr Soon-Shiong’s companies this might have been a success. But the sector was already well on its way.
*end*
EP Vantage's report on the landscape for anti-PD-1/PD-L1 combination therapeutics is available for free by download. To contact the writer of this story email Jonathan Gardner in San Francisco at [e-mail] or follow @ByJonGardner on Twitter