Replies to post #267237 on Avid Bioservices Inc (CDMO)

[stoneroad]

SOOOOO, this is what Jake was referring to. Nice to see.

[volgoat]

The recently completed SUNRISE trial was a randomized phase 3 study of the same combination, but was closed for futility at interim analysis

Funny, NCCN didnt sugar coat it and PPHM paid them $2m to get trials and so far nobody has even applied for the grant?

Specific exclusions from this RFP include:•
Phase 3 studies
Studies in pediatric populations
Studies in unselected immunotherapy
naïve patient populations where
immunotherapy is already approved
(NSCLC,renal cancer, bladder cancer
melanoma)
Combination studies with chemotherapeutic agents;
Single agent studies unless the study is a proposed window study evaluating mechanistic endpoints utilizing multiple tumor biopsies

Studies evaluating bavituximab in combination with pembrolizumab in hepatocellular carcinoma

Proposals focusing solely on preclinical studies

http://cancer.ucsf.edu/intranet/sm_files/NCCN%20Bavituximab%20RFP.pdf

[Couch]

Quote:
Planned studies include bavituximab in combination with pembrolizumab in hepatocellular carcinoma, and durvalumab in NSCLC.

Anybody have any info on when the "planned studies" are to move forward???

AND am I to assume a study in less than a phase trial???

[sunstar]

“Planned studies include bavituximab in combination with pembrolizumab in hepatocellular carcinoma, and durvalumab in NSCLC.”

“7.0 Drug Supply”

“Bavituximab will be supplied for all approved and funded studies by Grantor.
If bavituximab is studied in combination with an investigational agent from another pharmaceutical company, or an agent is used outside of its indication, the investigator must provide documentation of that company’s commitment to provide drug for the investigation as well as the agreement of that company to allow presentation and publication of results, and allow cross-filing or filing of a new IND. If pharmacokinetic studies of investigational agents other than bavituximab are planned, the investigator must provide documentation of that company’s commitment to or alternative mechanism for performing PK studies for that agent. This documentation must be provided to NCCN along with the proposal.”

“Diagnostic assays and other correlative study assays will be supplied for all approved and funded studies by Peregrine Pharmaceuticals.”

http://cancer.ucsf.edu/intranet/sm_files/NCCN%20Bavituximab%20RFP.pdf

sunstar

[biopharm]

Looks like Peregrine will have control over the final call on these RFP's...

Scientific Review Committees (SRC): The NCCN ORP establishes qualified Scientific Review Committees (SRCs) to conduct the peer review of research proposals received in response to RFPs. SRC members are from NCCN Member Institutions and have expertise in the specific therapeutic areas relevant to the research project. The NCCN ORP SRC review process meets the general NIH standards of peer review and funding by meeting the following three criteria:

the peer review system uses external reviewers and is free of conflict-of-interest
the ranking or rating system in the review process is based on the scientific merit of the proposed research
the funding system is based primarily on the peer review ranking or rating of the research application.

The NCCN ORP requires major reviews by two (2) members of the SRC with discussion and ranking of proposals by all members of the SRC. Grantor representatives serve in an advisory capacity to these committees and are given the opportunity to review each of the proposals prior to the formal review. Grantors may request elimination of particular proposals from scientific review if they duplicate already well-studied concepts or raise safety concerns.

https://www.nccn.org/clinical_trials/research_boards.aspx