Avid Bioservices Inc (CDMO)

[cjgaddy]

Quick overview of Gerber Bavi/2L-NSCLC Talk Sept7 in Chicago… Great find, RRdog.

Sept6-8 2012: “2012 Chicago Multidisciplinary Symposium in Thoracic Oncology”
http://www.thoracicsymposium.org
“This meeting will bring together physician specialists from around the world for interdisciplinary discussions on the latest research and state-of-the-art care for thoracic cancers. Speakers will address a variety of strategies to treat lung and esophageal cancer, malignant mesothelioma and metastatic cancers of the chest. In addition, the symposium will highlight the translation of novel clinically significant discoveries into clinical practice. Other educational topics to be discussed include the relation of molecular diagnoses, pathology and the clinical significance of targeted therapies in molecularly defined patient subpopulations for clinical trials and clinical practice.”
Symposium Supporters: Genentech, Lilly, Amgen, Astellas, Pfizer
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Per Roth/Pantginis 8-9-12 update (see RRDog’s #86253), “PPHM is a ‘late breaking’ entry for presentation on Sept 7th. The implication in the report is that PPHM will discuss the Bavi 2nd line Phase II trial developments.”
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Agenda: http://www.thoracicsymposium.org/MeetingProgram/Agenda.htm
Sept 7 12:30-2:40 Plenary Session
Moderators:
• Pasi A. Janne, MD, PhD, Program, Chairman Dana-Farber Cancer Inst., Boston
• Fadlo R. Khuri, MD, Winship Cancer Inst., Atlanta
SEPT7 1:40-1:50PM
#LBPL2 “Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients with Previously Treated Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer (Top-line Results)” - Dr. David Gerber
Notes: [Dr. David Gerber: MD, UTSW, Asst.Professor, Medical Oncology – see http://www.aafp.org/afp/2008/0201/p311.html
2nd-Line Bavi+Doce trial protocol: http://clinicaltrials.gov/ct2/show/study/NCT01138163 ]

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A couple of David Gerber pubs from http://www.peregrineinc.com/technology/publications/111-ps-targeting-oncology-publications-.html

David E. Gerber, Alison T. Stopeck, Lucas Wong, Lee S. Rosen, Philip E. Thorpe, Joseph S. Shan, and Nuhad K. Ibrahim, ”Phase I Safety and Pharmacokinetic Study of Bavituximab, a Chimeric Phosphatidylserine-Targeting Monoclonal Antibody, in Patients with Advanced Solid Tumors”, Clinical Cancer Research: 2011, 11-1074
http://clincancerres.aacrjournals.org/content/early/2011/08/12/1078-0432.CCR-11-1074.abstract

Paul DeRose, Philip E. Thorpe, David E Gerber, ”Development of Bavituximab, a Vascular Targeting Agent with Immune-Modulating Properties, for Lung Cancer Treatment”, Immunotherapy: 2011, Vol. 3, No. 8, Pages 933-944
http://www.futuremedicine.com/doi/abs/10.2217/imt.11.87?journalCode=imt

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F. Phase IIb Bavi+Doce vs. 2nd-Line NSCLC (randomized, double-blinded, placebo-controlled, n=120, 'registrational')
Protocol: http://clinicaltrials.gov/ct2/show/NCT01138163 (24 U.S. + 15 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 53 as of 8-12-11)
...Also listed in: India's CTRI registry ctri.in#2191 (12 sites a/o 3-20-11)
6-2011 WJCO article lists 2ndLine NSCLC hist. results (Doce/Tarceva/Pemetrexed) http://tinyurl.com/7jdtpto
. . . . .see pg.266, 2ndLine comparator results: ORR=6.7-9.1%, PFS=2.2-6.0mo, MOS=5.7-8.3mo
…7-16-12 QTLY. CONF. CALL - COMMENTS ON 2ND-LINE NSCLC PROGRAM... ( http://tinyurl.com/cs7spbz )
……Steve King 7-16-12: "The strength of this data (esp. MOS trends) in this large area of high unmet medical need has also sparked a surge in partnering discussions that has included over 15 in-person partnering meetings since that time with major players in oncology, with all discussions ongoing and addl. parties showing interest. Our goal for the program is to position ourselves, along with a potential partner, to initiate Ph3 by mid-2013, which means an EOP2 meeting by yr-end'12. It would be ideal to have a partner on board to participate in the EOP2 meeting, and we have communicated this to interested parties and they agree."
……Rob Garnick 7-16-12: "We've been working very hard and very actively on the next steps in our Bavi 2nd-Line NSCLC pgm, given the favorable data that we've seen. As you can imagine, with data like this, there are many things that we need to consider. One consideration is that, should the data continue to trend the way it is, particularly in survival, this opens a door for potential discussions around a pathway for ACCELERATED APPROVAL. At this point, all options are being considered, with Peregrine working towards the most efficient path forward from a regulatory standpoint." Q&A: "…all in all, I think the data is extremely compelling and I think it makes a really good case. Certainly, I think, I've seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I've ever seen. So, I'm very comfortable proposing a meeting with the FDA for Q4'12."
…7-12-12 CEO Steve King, JMP-Conf/NYC ( http://tinyurl.com/csdclwb )
……Steve King 7-12-12: "Re: 2nd-Line/NSCLC trial, the most thrilling thing is the fact that, even though we'd reached MOS for the ctl-arm(Doce) at end of Apr'12 of LESS THAN 6MOS, the majority of patients are still alive (today) in both Bavi arms, and we expect that to continue for some period of time still. Ph3 planning is underway already; our goal is to start this Ph3 by mid'13, meaning an EOP2 meeting with the FDA in Q4'12; our goal is to bring a partner on board, ideally in time for that EOP2 meeting, certainly before the beg. of the Ph3 trial."
…5-21-12: TopLine data n=117 for Bavi/3mg+Doce arm: ORR=17.9%/PFS=4.5mos (vs. CTL 7.9%/3mos) http://tinyurl.com/73aeyxj
......Importantly, MOS for CTL-arm "< 6 mos", but not yet reached in both Bavi arms.
...10-6-11: Enrollment complete. http://tinyurl.com/3m9re39
...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to ~45 sites, expect enroll. comp. "early in Q4/2011", data unblinding 1H'12. http://tinyurl.com/6k6y2as
…3-17-10/Roth, CEO S.King: "We refer to this trial as a Registrational Phase II Study, because we believe that if we have results anywhere near approaching what we saw in the earlier [India] study, it could be a conduit for Accelerated Approval."
...6-4-10: Ph.2b randomized reg. trial Open for enrollment: http://tinyurl.com/25v22qk
……"up to 120 refractory patients at ~30 clinical sites; goal: fully-enroll by mid'11, topline data by y/e'11."