Avid Bioservices Inc (CDMO)

[cjgaddy]

Robert Garnick’s 9-8-16 comments re: upcoming ESMO’16/SUNRISE/Biomarker data, to be presented 10-10-16 in a proffered late-breaking oral presentation by lead author Dr. David R. Spigel (CSO/Dir. Lung Cancer Res. Pgm. at Sarah Cannon Res. Inst., Nashville)...

9-8-16/CC: ROBERT GARNICK (Head of Reg. Affairs):
“I’d like to emphasize the strategic importance of the biomarker study, which, as Joe said, was built into the SUNRISE trial. The identification of a positive biomarker or relevant biomarker pattern with clinical efficacy is an important facet of clinical trial design that can be used to inform addl. new studies that in turn might be used to select patients who would best benefit from bavituximab therapy. For example, the identification of the HER2 biomarker was critical in the development of Herceptin. Its importance was only critically established based on the results of a Phase II clinical trial. As Steve previously described, the critical role of the PD-L1 biomarker is emerging as a major factor in the selection of patients for the clinical use of Opdivo & Keytruda. In the case of bavituximab, once a promising biomarker or biomarker pattern is identified, we strategically plan to include these results into potential new clinical trials...” http://tinyurl.com/jydtkoy

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Oct7-11 2016: “41st ESMO European Cancer Congress”, Copenhagen, Denmark
http://www.esmo.org/Conferences/ESMO-2016-Congress
ESMO = European Society for Medical Oncology, ECCO = European CanCer Organization
PPHM EXHIBITING: Booth #418 (Floorplan: http://tinyurl.com/zqhv88v )
Pgm: http://www.esmo.org/Conferences/ESMO-2016-Congress/Programme
10-10-16 Type: Proffered Paper Session* - “NSCLC/Metastatic2”
*Proffered Paper Session = Oral presentations by authors presenting original data of superior quality, followed by expert discussion and perspectives.
Chairs: Fiona Blackhall(GB); Tony S.K. Mok(Hong Kong)
10-10-16 9:15-9:30am #LBA45: “Top-line Results from SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Ctl’d Multicenter Trial of Bavituximab + Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous NSCLC”
David R. Spigel###(LEAD AUTHOR: CSO/Dir. Lung Cancer Res. Pgm. at Sarah Cannon Res. Inst., Nashville) 1, I. Bondarenko 2, G. Losonczy 3, J. Mezger 4, H. Kalofonos 5, M. Reck 6, R. Palmero 7, T. Jang 8, R. Natale 9, R. Sanborn 10, J. Lai 11, N. Kallinteris 12, M. Tang 11, J. Shan 13, David E. Gerber***(SENIOR AUTHOR: UTSW/Dallas) 14
1=Nashville TN; 2=Dnepropetrovsk, UA, 3=Budapest, HU, 4=Karlsruhe, DE, 5=Patras, GR, 6=Grosshansdorf, DE, 7=Barcelona, ES, 8=Busan, KR, 9=Los Angeles CA, 10=Portland OR, 11/12/13=Tustin CA; 14=UTSW/Dallas
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###6-1-16: “Sarah Cannon Appoints David Spigel, MD to CSO… For more than 10yrs, Dr. Spigel, has been instrumental in bringing the latest targeted therapies to patients through our lung cancer research program...” - see: http://tinyurl.com/jgxhjdn . Many Dr. David Spigel interviews on lung cancer here: https://www.youtube.com/results?search_query=David+Spigel – esp. interesting, the 4th one down: “Dr. David Spigel on Fox News Discussing Novel Therapies at ASCO 2015” https://www.youtube.com/watch?v=eb2L5xRedhQ (at 1:45 he discusses the emergence of I-O therapies: “It’s a very exciting time in oncology.”)

***UTSW’s Dr. David Gerber presented Prelim. SUNRISE Data 5-31-14 at ASCO’14 – see http://tinyurl.com/nv4jloo

9-21-16/PR About ESMO’16/Copenhagen:
Peregrine Pharmaceuticals Provides Update on Oral Presentation of Top-Line Data from Phase III SUNRISE Trial of Bavituximab at European Society for Medical Oncology (ESMO) 2016 Congress
“Ongoing Biomarker Analysis Has Identified a Biomarker that is Associated with a Statistically Significant Improvement in Overall Survival for Patients Receiving the Bavituximab Combination”
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=990296
TUSTIN, Sept. 21, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, today announced that top-line data from the Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) will be presented as a late-breaking oral presentation at the upcoming European Society for Medical Oncology (ESMO) 2016 Congress. Presented data will include a biomarker in the SUNRISE trial that correlated with a statistically significant improvement in overall survival for patients treated with bavituximab in combination with docetaxel compared to patients treated with docetaxel alone. Peregrine will file a new patent application directed to the use of the biomarker prior to the presentation of results at the ESMO 2016 Congress, which is being held October 7-11, 2016 in Copenhagen, Denmark.

Details of the Phase III SUNRISE trial data presentation are as follows:
Presentation #LBA45
Presentation Title: “Top-line results from SUNRISE: A Phase III Randomized Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous NSCLC”
Date: Monday, October 10, 2016 Time: 9:15am (local time in Copenhagen)

"I want to start by thanking the patients, investigators and scientists involved in the SUNRISE trial that have made possible the continuing collection and analysis of important data from the study. While the current interim analysis is still ongoing, it is exciting to already see that a biomarker associated with positive outcomes for patients receiving the combination of bavituximab with docetaxel has been identified. In the evolving cancer therapeutic space, biomarker identification is playing an increasingly critical role in guiding clinical development strategies and trial designs," said Steven W. King, President and CEO of Peregrine. "It is important to note that we are undertaking a broad biomarker analysis effort as part of the SUNRISE trial and this initial set of data is just the first of what we hope will be several findings that will help guide the bavituximab clinical program going forward. We look forward to presenting results from this ongoing analysis effort at the ESMO 2016 Congress, as well as other medical conferences as the additional data becomes available."

The primary goal of the biomarker analysis is to identify a biomarker profile for patients that receive the most benefit from a bavituximab-containing therapeutic regimen. As specified in the study protocol, thousands of patient samples were collected to potentially identify biomarkers associated with improved outcome for patients receiving bavituximab. Peregrine is in the process of filing a new patent application directed to the use of the initial biomarker discovery which will be presented at the ESMO 2016 Congress. Additional patient sample testing and analysis is ongoing and may result in other biomarkers of importance.

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 is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses.

Peregrine's clinical development strategy for bavituximab is currently focused on small, early-stage proof-of-concept trials evaluating the drug in combination with other cancer treatments. The intent behind this strategy is to control research and development costs, while continuing to generate clinical data to further validate bavituximab's combination potential that will be critical to bringing onboard a partner to help advance the program.
ABOUT PEREGRINE PHARMACEUTICALS, INC. *snip*
Safe Harbor *snip*
Contacts: Vida Strategic Partners - Stephanie Diaz (Investors) 415-675-7401
[e-mail], Tim Brons (Media), 415-675-7402

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9-8-16/CC/Steve King: “Topline data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation [10-10-16, Dr. David Gerber, UTSW, Lead Author – see below] at the upcoming European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October [Oct7-11]. ESMO is the premier European oncology meeting, attended by thousands of oncologists. The presentation at ESMO will be a great opportunity to share clinical data from the study in conjunction with initial results from ongoing biomarker analysis, which are already highly encouraging. Biomarker analysis was built into the SUNRISE trial from the beginning, including the collection of thousands of patient samples that could be analyzed once of the trial was unblinded. The primary goal the biomarker analysis is to identify a biomarker pattern, present in patients that receive the most benefit from a bavituximab containing therapeutic regimen, and we look forward to sharing the results of the ongoing analysis, with more data expected later in the year. The impact of the effective biomarker identification is already quite evident in oncology drug development, with the latest evidence being PD1/PD-L1 in the development of Keytruda. These types of biomarkers can only be identified through analysis of larger patient populations, such as in the SUNRISE trial. The results of identifying effective biomarkers can potentially have a huge impact on clinical development, potentially reducing the size of future trials, including making possible biomarker-driven clinical designs which could provide even more rapid readouts. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017.” http://tinyurl.com/jmy77g3