Seems like 3 lots of good news to me, the bottom line being (pre-clinically at least) that onCARlytics will work with a variety of CD19 directed therapies.
It will be interesting now to see the phase 1 plan(s). Or will it be 3 separate Phase 1's?
Personally I think CYCART-19 is behind the 8 ball and is potentially even a non-starter. The last clinical update from Celularity said this :
Celularity submitted an investigational new drug application (IND) for CYCART-19 in the first quarter of 2022 and in May 2022, the FDA requested additional information before Celularity can proceed with the planned first-in-human Phase 1/2 clinical trial of CYCART-19. Celularity is in the process of working with the FDA to resolve the agency’s questions as promptly as possible, and, if the IND is cleared, plans to commence a Phase 1/2 clinical trial of CYCART-19 in B-cell malignancies in 2023.
Seems unlikely CYCART-19 could start in a combo phase 1 trial with onCARlytics if it can't run in one as a monotherapy. Although I guess that could all change pretty quickly if the FDA decide to give it the OK.
Question : Is it in any way relevant that Amgen currently own the only FDA approved oncolytic virus in TVEC?
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- Ann: onCARlytics to be showcased in three abstracts at SITC
Ann: onCARlytics to be showcased in three abstracts at SITC, page-70
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