Replies to post #153489 on Biotech Values

[bladerunner1717]

CLDX presentations this week.


NEEDHAM, Mass.--(BUSINESS WIRE)-- Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced upcoming data presentations on two of the Company's fully human monoclonal antibody programs—CDX-1127 and CDX-011.
Tibor Keler, PhD, Senior Vice President and Chief Scientific Officer, will present a review of the CDX-1127 program at the IBC's Antibody Engineering & Antibody Therapeutics Meeting on Thursday, December 6, 2012 at 3:15 pm PT (6:15 pm ET) at the Hilton San Diego Bayfront Hotel in San Diego, California. The presentation will include a comprehensive review of preclinical results. CDX-1127 binds CD27, an important co-stimulatory molecule on T cells, and is designed to activate patients' immune cells against their cancer. The Company is currently conducting a two-arm, multi-dose, Phase 1 study in patients with selected malignant solid tumors or hematologic malignancies to determine a Phase 2 dose for further development. The solid tumor arm is completing accrual in the final dose cohort and, to date, has been well tolerated, including at the highest dose level. The Company continues to enroll patients in the hematologic arm and expects to complete enrollment in this arm in the first half of 2013. Clinical results from both studies will be presented at a future medical meeting.
Denise A. Yardley, MD, Senior Investigator in the Breast Cancer Research Program at the Sarah Cannon Research Institute and a lead investigator in the Phase 2b EMERGE study of CDX-011 in metastatic breast cancer, will present mature results in a poster session at the San Antonio Breast Cancer Symposium on Saturday, December 8, 2012 at 7:00 am CT (8:00 am ET) at the Henry B. Gonzalez Convention Center in San Antonio, Texas. The Company anticipates the presentation will include overall survival and duration of response data and updated patient response and progression free survival data. The Company will issue a press release at the time of the presentation and will make a copy of the poster available on their website in the "Product Pipeline, Scientific Presentations" section. CDX-011 targets and binds to GPNMB, a specific protein expressed in breast cancer that promotes the migration, invasion and metastasis of the disease. In May of 2012, the Company reported preliminary positive results from the Phase 2b study, noting particularly impressive response rates in patients with triple negative breast cancer who also have high (= 25%) levels of GPNMB expression.


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[mcbio]

I suppose the potential good news is it implies there is at least strong survival trend from ph2 data for this subgroup [high-expressors of GPNMB in triple-negative breast cancer].

That's a big part of why I'm willing to gamble and hold my position through the results tomorrow. I don't think Mariucci makes those comments just 5 days before the presentation at SABCS if there's not at least an encouraging trend in the data. It would be a moot point if he doesn't have the data at that time; but how likely is that just 5 days in front of the conference and presentation?

FWIW, someone on the YMB posted to note the changes made to the clinicaltrials.gov entry for the 011 trial and how it was edited on 12/3 to eliminate the language that patients would be monitored "for survival information" (
http://finance.yahoo.com/mbview/threadview/?&bn=ef145a6a-8faa-3c06-9031-7248813df2f0&tid=1354821299910-9487150b-259d-4087-8129-de34926d0b11&tls=la%2Cd%2C9 ). They also note that OS was removed as secondary measure on 11/27/12. They then try to spin that as a positive sign, although I don't really follow the logic. I'm not sure this means much of anything but curious to hear any others' thoughts on this. I'm still willing to gamble given the aforementioned comments from the CEO so shortly before the conference.

[bladerunner1717]

jq,

In the ongoing 011 trial PFS is a secondary endpoint with IC as the comparator.


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