Avid Bioservices Inc (CDMO)

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Mar28’15: UTSW’s Dr.AdamYopp Ph1/2 Liver Data at SSO’15/Houston (oral presentation)

Mar25-28 2015: “Society of Surgical Oncology's 68th Annual Cancer Symposium (SSO 2015)”, Houston
http://events.jspargo.com/SSO15/public/enter.aspx
…12/10/14/PR: “• Data from a Phase I/II IST that evaluated bavituximab in combination with sorafenib in patients with advanced hepatocellular carcinoma (Liver cancer) has been accepted for poster presentation at the 2015 Gastrointestinal Cancers Symposium to be held Jan15-17, 2015 in San Francisco, California [ http://tinyurl.com/q5dyruw ] and for an oral presentation at the Society of Surgical Oncology's 68th Annual Cancer Symposium to be held Mar25-28, 2015 in Houston."
Schedule: http://djgcreate.com/ssocalendar2/public/
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Mar28 2015 12:45-2:15pm: Hepatobiliary Parallel Session/Gastrointestinal Track
#GBCC-310
”A Phase II Study of Bavituximab & Sorafenib in Advanced Hepatocellular Carcinoma (HCC)”
Presenter: Adam C. Yopp (MD, Assist.Prof.Surgery, UTSW/Dallas, PI, Bavi+Sorafenib Liver IST http://clinicaltrials.gov/ct2/show/NCT01264705 )
…Authors: Adam Yopp*, H. Zhu, J. Mansour, A. Singal, Y. Arriaga, S. Beg, UTSW-MC/Dallas
ABSTRACT:
BACKGROUND: Bavituximab is a first-in-class immunomodulator targeting phosphatidylserine (PS), a membrane lipid externalized on tumor and endothelial cells. Preclinical and phase I studies demonstrated that sorafenib upregulates PS externalization and can be given safely with bavituximab. We thus evaluated the safety and clinical activity of bavituximab + sorafenib in HCC.
METHODS: Patients with locally advanced or metastatic HCC deemed ineligible for curative therapy with no previous systemic treament, ECOG score = 2, Child Pugh score A or B7 received bavituximab, 3 mg/kg IV weekly, and sorafenib, 400 mg PO BID until disease progression or intolerable toxicity. 38 patients were accrued providing a power of 80% and 2-sided significance level of 10% to show an 8.2mo. time to progression compared to historical control, 5.5mos. Secondary endpoints included safety and tolerability, 4-mo. PFS, OS, and response rates. Correlative studies using tissue from pre- and post-treatment tumor biopsies included IHC analysis of regulatory, cytotoxic, and helper T cells in addition to macrophage infiltrates.
RESULTS: 38 patients were accrued, 7 still on treatment. Patient characteristics: median age: 60.5 years, male 74%, HCV: 79%, Black: 47%/Hispanic: 29%/White: 21%, previous treatment 37%, and metastases: 24%. Median follow-up is currently 6.1 months with current median TTP of 6.8 months (95% CI 3,10). Four month PFS is 76% and there are no partial or complete responses. Treatment related adverse events were observed in 53% of patients, one grade 3 (GI bleed), four grade 2 (DVT, anorexia, diarrhea, and infusion reaction). Most common grade 1 events were diarrhea (18%), fatigue (16%), and anorexia (16%). Six patients had tissue analyzed pre- and post-treatment, 2 of 6 demonstrated increase tumor infiltration of CD4+, CD8+, and macrophages with a corresponding decrease in Tregs.
CONCLUSIONS: Bavituximab & sorafenib were well tolerated in patients with advanced HCC. When compared with historical controls, combination therapy demonstrated an improvement in TTP and PFS at 4 months. Combination therapy increases immune tumor infiltrates.
ID: 86

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H. 1st Investigator-Sponsored (IST) Ph.I/II Trial (Bavi+Sorafenib vs. Liver Cancer/HCC, open-label, n=47)
...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)
11-8-14: SITC'14 Ph.2 Correlative Studies data (biopsies B4/After) on 6pts, incl. KOL Dimitry Gabrilovich’s comments: http://tinyurl.com/pchzr6h
...9-9-14 Enrollment complete. http://tinyurl.com/ktrfswj (ph2=38 Ph1=9)
...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."