beartrap, to market a new drug or biologic, regulations require adequate and well-controlled studies that distinguish the effect of a drug from other influences. And for regulatory approval of combination regimens, it is necessary to demonstrate the contribution effect of each monotherapy to the overall combination. This is why I believe that Northwest Bio’s first marketing application did not include other adjuvants.
ATLnsider has speculated that Northwest Bio is using poly-ICLC as a maturation and activation agent in the manufacturing process of DCVax-L and therefore, thinks it will be included in the marketing application. While I believe this manufacturing method may have been studied, I believe it was with DCVax-Direct, and not DCVax-L. Northwest Bio did not use this manufacturing method for the clinical trials with DCVax-L, so I do not believe the first marketing application includes poly-ICLC as a maturation/activation agent either.
As I’ve said, other than a few potential anecdotal cases, I don’t think Northwest Bio has enough (real-world) data to seek regulatory approval with Poly-ICLC at this time. I’m not aware of ANY actual evidence that studies with a significant number of patients were performed using this combination (or manufacturing method) for compassionate use, so this seems to be complete speculation. As far as Dr. Ashkan using it for compassionate use and collecting real-world data; I’ve seen a number his presentations about DCVax, and not once was poly-ICLC mentioned. The only data that I’m aware of with poly-ICLC, is the UCLA data, which I believe Northwest Bio intends to confirm through their own clinical studies,(both DCVax-L and Direct) as soon as possible. (after the first regulatory approval and in-licensing agreements are finalized) They might even run studies to determine the optimal method of combining poly-ICLC with DCVax; as a separate adjuvant, or as a maturation/activation agent in the manufacturing process.
BTW - I’ve read some of dstock’s posts, and in my opinion, his speculation seems rather far-fetched and not based in reality. For example, I don’t believe Merck or any Big Pharma company (except NW Bio’s CDMO, Advent) is constructing a manufacturing facility to manufacture DCVax, nor did Merck and Northwest Bio secretly run the combination trial for colorectal cancer. I highly doubt that any Big Pharma companies are currently hiring positions related to Northwest Bio, nor do I think that Northwest Bio is secretly applying for approval with poly-ICLC. Everyone is free to speculate and believe whatever they wish, so I mean no disrespect, but I’m just stating my personal opinion on this because you asked.
I think the extremely slow pace of DCVax development, and lack of communication, has led many of us to speculate that certain developments have occurred or could be happening behind the scenes. This very rarely proves true, and in most cases, Northwest Bio at least mentions, or alludes to their development plans in SEC filings or press releases, and announces significant milestones when they are achieved.
