David Greene's  Instablog

Celldex Therapeutics Inc. (Nasdaq:CLDX) has a full plate at the American Society of Clinical Oncology (ASCO) Annual Meeting June 5-8--with four abstracts being presented:

CDX-011 in Advanced Melanoma
CDX-011 in Breast Cancer
CDX-1307 in Muscle-invasive Bladder Cancer --Trials in Progress Poster Session

and the most awaited "Interim data for ACT III: Phase II trial of PF-04948568 (CDX-110) in combination with temozolomide (TMZ) in patients (pts) with glioblastoma (GBM)".

The data showed that CLDX's brain cancer vaccine exhibited efficacy with 70% of patients surviving with no progression of cancer tumor growth 5.5 months after being treated.  Looked at another way, the 70% rate is about 40% better versus standard care. The trial protocol involved a particular challenge in clinical trials--patients recruited for the trial had to have completed their chemotherapy without their brain cancer tumor progressing, which usually resulted in a two to three month delay from starting. As the abstract conclusions stated,  "Vaccination with PF-04948568 was well tolerated in combination with maintenance TMZ in pts with newly diagnosed, fully resected GBM. PFR of 70% at 5.5 months reported from this multicenter experience is similar to that reported from the previous Duke/MDACC trial. Difficulties retaining control arm pts in this open label US trial, suggest that additional study of the vaccine would require a placebo controlled trial." So the results are consistent with the previous trial, but did not offer any better results. One patient exhibited an allergic reaction which necessitated the discontinuation of that patient from receiving CDX-110. 

Pfizer (NYSE:PFE), Celldex's partner in developing CDX-110, and CLDX will be conducting a randomized  Phase III study with international clinical sites later.

On a more general note, with the turmoil in the markets in general, it will be difficult to assess how investors react to the posted ASCO abstracts today (May 21). Investors that may have taken positions in companies that were to present at ASCO may make decisions based on preservation of capital versus holding for the ASCO meeting, regardless the strength of any clinical results.



Disclosure: No positions