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Tuesday, March 02, 2021 12:17:32 PM
(1) ATL-DC stands for autologous tumor lysate-pulsed (ATL)-dendritic cell (DC) vaccine. ALT-DC is the generic name, and DCVax-L is the trademarked name.
(2). DCVax-L trademark is owned by NWBio. NWBio is not formally participating in, or putting money in this trial with UCLA. NWBio is devoting its current resources to completing the TLD for the DCVax-L Phase III, and soon getting DCVax-L approved in 4 countries.
(3) The ATL-DC used in the current UCLA trail, is being manufactured by the UCLA GMP lab on its campus. It is not being manufactured by NWBio or its U.S. CMO, Cognate.
(4) The UCLA GMP lab is only authorized by the FDA to make small quantities of ATL-DC (DCVax-L) for small clinical trials. UCLA is not authorized or licensed to make mass commercial quantities of ATL-DC (DCVax-L). That will be done by Cognate (Charles River Laboratories).
I believe that (these are my opinions Jack), if the UCLA Phase I recurrent GBM trial using ATL-DC plus Keytruda proves successful, then UCLA, NWBio & Merck, will conduct a larger Phase II/IIII trial using approved DCVax-L plus Keytruda. Also, I believe they will probably test this combination (DCVax-L + Keytruda) in various other solid tumor cancers.
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