Avid Bioservices Inc (CDMO)

[cjgaddy]

Curr. Overview of War on HCC/Liver-Cancer, incl Bavituximab – “Targeted Oncology” pub. 10-6-2014. Recall, at Nov6-9 SITC 2014, Dr. Adam Yopp (UTSW-MC/Dallas, IST PI) will present Bavi+Sorafenib IST/UTSW “correlative studies” data ("translational data showing immune changes"). SITC = The Society for Immunotherapy of Cancer...

Mgt. of Hepatocellular Cancer - Future Directions”
• Renuka Iyer, MD (Roswell Park Cancer Inst., Buffalo, NY)
• Alexander Pomakov (State Univ. at Buffalo)
Pub.Online: Oct6 2014 (Targeted Oncology http://www.targetedonc.com )
http://www.targetedonc.com/publications/targeted-therapies-cancer/2014/august-2014/management-of-hepatocellular-cancer

Hepatocellular cancer (HCC) [LIVER CANCER] is a rapidly fatal malignancy that is often diagnosed at an advanced stage when it is not curable. Despite a rise in incidence, this cancer is not as common in the Western world as it is in Asia & Africa…
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Pg6: Immunomodulatory Therapies (Nivolumab, MK 3475, Bavituximab)
Studies performed by our group have shown that profound immunosuppression exists in patients with HCC compared with healthy normal subjects, and targeted depletion of subsets of immunosuppressive cells can partially restore antitumor immunity, suggesting that this may be a valid target in HCC.4,25 At least 2 anti-PD-1 antibodies (nivolumab & MK 3475) are being evaluated or will soon be evaluated in patients with HCC with careful characterization of the hepatitis status and biomarkers that are eagerly awaited. Phosphatidylserine (PS) is a phospholipid which, unlike other phospholipids that are randomly distributed in the plasma membrane of most cells, is actively maintained by an ATP-dependent. Phosphatidylserine externalizes during apoptosis and can trigger immunosuppressive signals that inhibit autoimmune antitumor responses. Bavituximab is a chimeric PS-targeting antibody that is well tolerated and is being evaluated in combination with sorafenib. It appears to have promising activity thus far.
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Pg6: In summary, although only 2 of the 5 phase III trials recently completed in patients with advanced HCC have been successful, there are a number of promising trials that are ongoing or are soon to begin accrual. These trials have the potential to change the way patients with HCC are treated in the near future.
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Pg7: The novel mechanism of action & safety of bavituximab thus far make this another promising agent in the field of immunotherapy. Studies by our group have shown that profound immune dysfunction exists in HCC and that targeted depletion of immunosupressive cells can restore anti-tumor immunity, providing strong support that immunotherapies may have a large role in HCC.

…Because immune dysfunction from advanced cancer & hepatitis are hallmarks of HCC, newer agents that target immune suppression are currently a major focus of HCC research…
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Nov6-9 2014 SITC 2014 29th Annual-Mtg: http://tinyurl.com/k6q58be (SITC = The Society for Immunotherapy of Cancer http://www.sitcancer.org )
…Bavi+Sorafenib/Liver-Cancer IST(UTSW/Yopp) “correlative studies” data ("translational data showing immune changes"), and 3 posters of followup data from AntiPS+AntiPD1/Melanoma+Breast preclin. studies, specifically how PS-targeting Mabs’ “enhance the activity of immune checkpoint inhibitors”. (4 Peregrine posters total - Freimark Hutchins Yopp Shan Brekken CW.Hughes(UC-Irvine) Menander King Gabrilovich(Wistar) etal)

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H. 1st Investigator-Sponsored (IST) Ph.I/II Trial (Bavi+Sorafenib vs. Liver Cancer/HCC, open-label)
...Note: Sorafenib = Onyx/Bayer's Nexavar - see http://www.nexavar.com
Protocol: http://clinicaltrials.gov/ct2/show/NCT01264705 UTSW: http://tinyurl.com/mwdc2ql (5 sites: 3/UTSW, Parkland-Hosp, Dallas/VA, PI=Dr. Adam Yopp)
...4-4-12 AACR'12: Dr. Adam Yopp, "promising safety profile to-date" http://tinyurl.com/7yrwqm7 (see #5591)
...Feb'12-Sep'14 10+ times: CEO Steve King hints of future ex-US partner-driven Bavi+Sorafenib/LIVER trial in Asia-Pacific: http://tinyurl.com/nkaxtcc
......Articles & Data describe Liver Cancer challenges in Asian populations: http://tinyurl.com/7z7o8j9 & http://tinyurl.com/7z99cy4
...12-1-10: PPHM's 1st IST (Liver Cancer) initiated at UTSW, ~56 patients - http://tinyurl.com/3xd3e6c
…Per S.King, 5-18-10/R&R, "We've had a lot of interest in running clinical trials with the compound from investigators who have either had prior experience with the drug or would like to study the drug in various settings. Potential IST indications include all the major solid tumor types. Of particular interest is Liver Cancer, in which we have a natural tie-in with our HCV program, Ovarian Cancer and Pancreatic Cancer, also very nicely supported by the prior data."