Avid Bioservices Inc (CDMO)

[cjgaddy]

Per Springer.com, “New-Trial-Records” for the 3 upcoming NCCN/Bavi trials. All 3 dated 9-23-16 – not sure if this means they hit http://ClinicalTrials.gov in some sort of draft status – I just checked and they’re not viewable there as yet.

Phase I/II: “A Study of Bavituximab with Radiation & Temozolomide[Merck’s Temodar] for Patients with Newly Diagnosed Glioblastoma”… This phase I/II study will investigate the safety & efficacy...
http://adisinsight.springer.com/trials/700276383
[MASS-GEN. CANCER CENTER - PI: Elizabeth Gerstner, MD]

Phase II: “A Study Bavituximab & Pembrolizumab[Merck’s KEYTRUDA] for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck”… This phase II study will investigate the safety & efficacy...
http://adisinsight.springer.com/trials/700276389
[JOHN-HOPKINS(Sidney Kimmel CC) - PI: Ranee Mehra, MD]

Phase I: “A Study of Sorafenib[Bayer’s Nexavar] & Bavituximab + Stereotactic Body Radiation Therapy (SBRT) for Unresectable HepC Associated Hepatocellular Carcinoma”… This phase I study will investigate the safety of...
http://adisinsight.springer.com/trials/700276381
[MOFFITT CANCER CENTER - PI: Jessica Frakes, MD]

AdisInsight databases – Springer FAQ http://adisinsight.springer.com/
WHAT SOURCES ARE MONITORED?
Our scientific editors monitor thousands of sources daily including: medical journals, press releases, conference proceedings, company websites and pipelines, trial registries, and regulatory agency websites.

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9-6-16: NCCN to Initiate 3 Bavi-Trials Early’17 (Moffitt,MassGEN,JohnHopkins) http://tinyurl.com/gutgwb5
=> Ph1/HepC-Related-Hepatocellular/MOFFITT, Ph1-2/Glioblastoma/MASS-GEN, Ph2/Head+Neck/JOHN-HOPKINS

NCCN PR: https://www.nccn.org/about/news/newsinfo.aspx?NewsID=785
”NCCN is excited to initiate 3 studies by accomplished investigators at Member Institutions that will explore the effect of this novel immunotherapy in 3 different cancers with significant unmet need,” said Robert C. Young, MD, Interim VP, NCCN ORP.

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3 NCCN Bavituximab Trials Announced 9-6-16 – "Early 2017" (Moffitt, MassGEN, JohnHopkins) :

#1: Ph1/HepC-Related Hepatocellular (Bavi+RAD+Sorafenib), MOFFITT CANCER CENTER - PI: Jessica Frakes, MD
"A Phase I Trial of Sorafenib & Bavituximab + Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma"
=> 9-8-16/CC/JoeShan: “The 1st award is for a Phase I trial of Sorafenib [Bayer’s Nexavar] and bavituximab + radiation in Hepatocellular Carcinoma. This will build on a previously reported investigator sponsored Phase II trial of bavituximab & sorafenib in Liver Cancer. [3-25-15/Dr.Adam.Yopp(UTSW)/Ph2data, N=38: http://tinyurl.com/opkh5qy ]”

#2: P1-2/Newly Diag. Glioblastoma (Bavi+RAD+Merck’s Temodar), MASS-GEN. CANCER CENTER - PI: Elizabeth Gerstner, MD
"Phase I/II Clinical Trial of Bavituximab with Radiation & Temozolomide(Temodar) for Patients with Newly Diagnosed Glioblastoma"
=> 9-8-16/CC/JoeShan: “The 2nd award is for a Phase I/II trial of bavituximab with radiation + temozolomide [Merck’s Temodar] in newly diagnosed Glioblastoma. This trial is supported by some of our most impressive preclinical data demonstrating long-term survival in a lethal brain cancer model and that surviving rats were immune from tumor re-challenge.”

#3: Ph2/Progressive Squamous Head+Neck (Bavi+Merck’s Keytruda), JOHN-HOPKINS(Sidney Kimmel CC) - PI: Ranee Mehra, MD
”Phase II Study of Pembrolizumab & Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck"
=> 9-8-16/CC/JoeShan: “The 3rd award is for a Phase II study of pembrolizumab [Merck’s Keytruda, anti-PD-1] & bavituximab in Head & Neck Cancer. We are particularly excited about this project, as it will be the first clinical trial of bavituximab with a checkpoint inhibitor. In multiple previous preclin. studies, we have observed bavituximab's potential to work synergistically with PD1 inhibitors such as pembrolizumab.”
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Joe Shan 9-8-16/CC: “These 3 studies align with our overall dev. strategy and will add to our knowledge about bavituximab-focused cancer treatment combinations. While we are not directly involved with these studies, we’ll be watching the progress carefully and look forward to providing an updates on the 3 NCCN trials in the coming months.” http://tinyurl.com/jydtkoy

Steve King 9-8-16/CC: “Our collaboration with the NCCN has been an important part of our strategy for advancing the bavituximab clinical program in a cost effective way. We earlier provided NCCN with a $2mm grant to support bavituximab related clinical research with no further financial obligations, and these grant awards represent the outcome of a competitive selection process for the best proposals. These studies will evaluate novel bavituximab combinations in Glioblastoma, Head & Neck Cancer, and Hepatocellular Carcinoma including an immunotherapy combination [Bavi + Merck’s Keytruda], which is a major focus for advancing the program.”

Steve King 9-8-16/CC/Q&A: “I’m very excited about the combinations that were chosen because the Radiation combination is one that in preclinical studies, as was mentioned during the prepared remarks, has always shown a lot of promise. It’s great to be able to now see that put into a clinical setting in a couple of different clinical trials. And the I-O combinations, as Jeff mentioned during his prepared remarks, is a major focus of ours. So to see a Pembro [Keytruda] combination picked as well, we are just really excited that these were the 3 winners out of the NCCN selection process.”