Great News for Seattle Genetics...and also for Celldex

February 28, 2011

* Analysis by: GLG Expert Contributor
* Analysis of: Seattle Genetics Submits BLA to FDA for Brentuximab Vedotin in Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL
* Published at: phx.corporate-ir.net

Summary

* The regulatory piping being laid with Seattle Genetics' brentuximab vedotin is excellent for the company's second leading drug candidate, CDX-011, a Celldex collaboration, that potentially treats a much larger market

Analysis

Background
Seattle Genetics submitted its biologics license application (BLA) to the FDA only about three months after reporting very robust results at the American Society of Hematology (ASH) meeting for its drug candidate brentuximab vedotin. The drug is an antibody drug-conjugate that targets anaplastic large cell lymphoma and Hodgkin’s lymphoma that had very robust results in the pivotal trial. It is proof-of-concept that the company’s core technology, antibody-drug conjugation, works. The company’s next furthest along drug candidate is CDX-011 (anti-GPNMB), in which it is partnered with Celldex.

Discussion
Celldex looks like it has a very promising treatment with Rindopepimut (CDX-110) -- the company has a real-time observable biological marker to know that their vaccine is working, good progression-free survival data, and a safety profile consistent with any standard vaccination. What I believe will make the company though is CDX-011.

Many industry scientists, even as recently as a year ago, did not believe that antibody-drug conjugation would work in the clinic. With Seattle Genetics submission of the BLA, what the CEO called a “very strong package”, the regulatory piping is being laid for the new class of drugs. Celldex's CDX-011, the initial indication of which will all but certainly be refractory metastatic breast cancer, has tremendous market expansion opportunities. Significantly more patients express the GPNMB marker than the HER2 breast cancer marker, the biomarker that essentially made Genentech. The data suggests the drug may be particularly efficacious in triple-negative (ER, PR, HER2 negative) patients, where current treatment modalities are limited.

http://glgroup.com/News/Great-News-for-Seattle-Genetics...an d-also-for-Celldex-52752.html