) -- The
American Society of Clinical Oncology
(ASCO) annual meeting -- the Super Bowl of cancer drug research -- is in full swing. For those that missed all the action captured on my two ASCO live blogs
, here's a recap of the news that will be moving biotech and drug stocks Monday:
On Celldex Therapeutics(CLDX - Get Report):
I just met with Celldex. Data from the Act III study of CDX-110 is consistent with previous studies in Gioblastoma (brain tumors.) The big question -- what's next for CDX-110? A randomized controlled pivotal study needs to be designed and run. Celldex and Pfizer (Celldex's CDX-110 partner) are working on making that happen but Celldex could not give me any firm timeline. The ultimate decision seems to rest with Pfizer.
Celldex does have an interesting and overlooked pipeline. Two cancer drugs entering phase 2 studies this year -- and the studies are going to be randomized and controlled! Hallelujah!!!
I want to dig more into the pipeline but what I saw briefly looks interesting. Celldex is more than CDX-110, which is good. And yes, Celldex CEO Tony Marucci seems like a straight shooter. He'd love to start the CDX-110 phase III study today but he has to work through Pfizer. Investors need to be realistic with timelines.
Celldex is down 30 percent since the ASCO abstracts were released in late May. Is this a buy opportunity? Perhaps with realistic expectations of timelines. I really like the fact that Celldex plans randomized, controlled phase II studies of the pipeline drugs. Data from those studies will not be ready until end of next year, however.
On ImmunoCellular Therapeutics(IMUC.OB) and its ICT-107 "vaccine" for glioblastoma (GBM):
To recap the company's release, treatment with ICT-107 in newly diagnosed GBM, this phase I study showed a 2-year survival of 80%. Median overall survival (OS) not yet reached. Median progression-free survival (PFS) was reported as 17.7 months after surgery.
Interesting data, but it's a single-center study so be wary of patient selection bias. An immune response to the ICT-107 vaccine was only detected in 35 percent of patients, which seems low to me. The investigator at the poster agreed but said that immune response may have been measured at too early a time point.