18:00 ET 5/23/12 [StreetAccount] CLDX Celldex confirms it will pursue accelerated approval for CDX-011 - conf call ($4.26)
On the call to discuss the preliminary results from the Phase 2B EMERGE study of CDX-011, the company said that it believes accelerated approval is a possibility for the drug, and it plans to discuss the issue and data with the FDA.
Of particular note was the presence - and exuberance - of investigator Linda Vahdat, MD on the call, whom expressed great enthusiasm for the results, and hope for patients with metastatic triple negative breast (TNB) cancer. At one point, she noted that there is "nothing on the horizon, no glimmer. This is the only thing, and I think highly promising." Analysts quickly took to addressing Dr Vahdat directly on the call. Additional responses from Dr Vahdat were similary glowing, such as calling the treatment a "no brainer" and that the drug is "as good as anything out there" in terms of a response.
Diagnostic assay: The company also discussed the diagnostic assay it has developed that identifies GPNMB expression patterns and levels in breast cancer. The company said it would likely not commercialize the assay itself, but would probably partner with a diagnostic manufacturer.
In closing, the company said it is pleased to have defined a patient population, and looks forward to finalizing data from this study in Q4 2012 and to determining the next steps for CDX-011.
StreetAccount notes that the stock is trading down (~8%) to $3.92 in after-hours. A blog post (see reference link) from Forbes' Matthew Herper getting circulation is far more cautious on the results than Dr Vahdat. Herper discusses the relatively small numbers of patients enrolled in the trial (n=122 total) with triple negative breast cancer who also highly express GPNMB (n=11; 4 of 11, or 36% responded).
CLDX Follow-up: Celldex announces preliminary results from ph.2B EMERGE study of CDX-011 (glembatumumab vedotin) antibody drug conjugate in patients with glycoprotein NMB ($4.26)
CLDX announced preliminary results from the company’s randomized Phase 2B EMERGE study of CDX-011 (glembatumumab vedotin) antibody drug conjugate in patients with glycoprotein NMB (GPNMB) expressing, advanced, heavily pretreated breast cancer.
Preliminary results suggest that CDX-011 induces impressive response rates compared to current, available therapies in patients with advanced, refractory breast cancers with high GPNMB expression (expression in =25% of tumor cells).
In this high expressing patient population, treatment with CDX-011 resulted in a 32% overall response rate (ORR; includes confirmed and unconfirmed responses), whereas treatment with Investigator’s Choice (IC) single-agent chemotherapy resulted in a 13% ORR.
CDX-011 also demonstrated strong response rates in patients with triple negative breast cancer across all levels of GPNMB expression (CDX-011 ORR of 21%; IC ORR of 0%), where treatment options are extremely limited.
In addition, in patients with triple negative breast cancer who also highly express GPNMB, greater activity was observed (CDX-011 ORR of 36%; IC ORR of 0%).
The ORR across all levels of GPNMB expression was 19% for the CDX-011 arm and 14% for the IC arm, and a direct, positive correlation was observed between increasing levels of GPNMB expression and increased CDX-011 response rates.
Based on these data, the company believes CDX-011 has significant promise as a targeted therapy for patients with breast cancer and high expression of GPNMB, and especially for those with triple negative disease.