This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Biotech Stock Mailbag: Celldex, Hep C Bubble, Al Mann Anger

BOSTON ( TheStreet) -- Welcome to this week's Biotech Stock Mailbag. @WilliamPShelley kicks it off with a tweet concerning Celldex Therapeutics (CLDX - Get Report).

"What do you think about $CLDX. Volume is up in these 2 days and over $4!"

Celldex was once forgotten but, apparently, no longer. I highlighted Celldex and its breast-cancer drug CDX-011 in my wrap-up of the JPMorgan Healthcare Conference. Data from a phase II breast cancer study of CDX-011 in the spring is Celldex's next important catalyst. A few more details:

CDX-011 is a monoclonal antibody drug conjugate. The antibody portion targets cancer cells that express a protein known as GPNMB shown to correlate with poorer outcomes in breast cancer patients. When the CDX-011 antibody attaches to GPNMB-expressing tumor cells, it releases a toxic chemotherapy payload. This "drug conjugate" was licensed from Seattle Genetics (SGEN) and is the same one used in the newly approved lymphoma drug Adcetris.

CDX-011 was previously studied in a phase I/II study of advanced and metastatic breast cancer patients, with data reported at the 2010 American Society of Clinical Oncology annual meeting. Forty-two breast cancer patients were enrolled in the study, all heavily pre-treated with a median of seven prior breast-cancer therapies.

In the phase II portion of the study, nine of 26, or 35%, of patients were progression-free after 12 weeks of treatment. Two patients were excluded from the analysis because they discontinued the study without tumor progression prior to 12 weeks.

Twelve percent (4/33) of patients in the phase II portion of the study had a partial response to CDX-011 therapy, although just two, or 6%, of those partial responses were independently confirmed. Another 19 patients, or 58%, were stable following treatment with CDX-011.

The study enrolled 10 breast cancer patients with so-called triple negative disease, which is very difficult to treat. Two of the patients, or 20%, responded to CDX-011 therapy, with one partial response independently confirmed.

Importantly, researchers analyzed tumor samples from some patients in the study to measure the level of GPNMB expression. They found that patients with tumors over-expressing GPNMB responded more strongly to CDX-011 therapy, with response rates ranging from 20% to 33%, depending on the level of GPNMB expression. No patients responded if their tumors didn't express GPNMB.
1 of 5

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
ONXX $0.00 0.00%
AVNR $16.96 0.00%
IDIX $24.50 0.20%
ACHN $8.55 0.00%
CLDX $4.00 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs