Replies to post #272242 on 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.”
- - - - - - - - - -
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.”

[cjgaddy]

Thx/CP: 1st (of 3) NCCN Trial hits ClincalTrials.gov.
That’s this one:
#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 ]”
- - - - - - -
9-6-16: NCCN to Initiate 3 Bavi-Trials Early’17 (Moffitt,MassGEN,JohnHopkins) http://tinyurl.com/gutgwb5
1. Ph1/HepC-Related-Hepatocellular/MOFFITT (Bavi+RAD+Sorafenib)
2. Ph1-2/Glioblastoma/MASS-GEN (Bavi+RAD+Merck’s Temodar)
3. Ph2/Head+Neck/JOHN-HOPKINS (Bavi+Merck’s Keytruda)
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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12-12-16: First Bavituximab clinical trial with NCCN on ClinicalTrials.gov:
Sorafenib & Bavituximab Plus SBRT in Unresectable Hepatocellular Carcinoma”
Entered 12-8-16: NCT02989870 https://clinicaltrials.gov/ct2/show/NCT02989870
This study involves a course of radiation to up to 5 tumors in the participant's liver followed by systemic therapy. (Treatment using substances that travel through the bloodstream, reaching and affecting cells all over the body.) The type of radiation is called stereotactic body radiation therapy (SBRT). The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given along with the systemic therapies, sorafenib and bavituximab. The researchers want to see which dose of radiation will work best in stimulating the immune response and provide local control to the participant's liver. The usual treatment for hepatocellular carcinoma that is unresectable can be transarterial therapy, sorafenib alone and/or clinical trial.
Sponsor: H. Lee Moffitt Cancer Center & Res. Institute
Collaborator: National Comprehensive Cancer Network
Info provided by (Responsible Party): H. Lee Moffitt Cancer Center & Res. Institute

[asmarterwookie]

Is there info on the selection process or how many proposals were submitted?

we are just really excited that these were the 3 winners out of the NCCN selection

Winner and Peregrine

Ever shall the two meet?

wook