Celldex Therapeutics, Inc. Message Board

Roth adds Celldex to focus list
January 22, 2013 by stephenkilmer · Leave a Comment

Roth Capital Partners has added “buy-rated” Celldex Therapeutics (NASDAQ:CLDX) to its “focus list as a biotech Top Pick for 2013” and raised its price target to $16 from $11, saying the company is solidifying its position as a premier cancer immunotherapy company with a broad pipeline.

Shares of Celldex closed at $7.32 on Monday.

Analyst Joseph Pantginis cited Celldex’s broad approach to immunotherapy, with promising clinical data in hand for its two key late-stage assets, CDX-011 and rindopepimut, and a stream of anticipated data readouts in 2013.

“We believe that CDX-011 represents an attractive partnering opportunity,” he said, adding that in addition to an end-of-Phase 2 meeting with the FDA, Celldex should announce plans for a pivotal CDX-011 study in metastatic breast cancer in March 2013.

At the San Antonio Breast Cancer Symposium last month, Celldex presented randomized Phase 2b results, indicating that highly pre-treated GPNMB+ patients with triple-negative breast cancer achieved improvement in response rates following treatment with CDX-011, compared with investigator’s choice therapy.

Mr. Pantginis also is looking for updates from the rindopepimut program in brain cancer, with results expected in the second half this year from the ReACT study in combination with Avastin in the recurrent setting.

The Phase 3 ACT IV study of rindopepimut in frontline GBM patients with EGFRvIII is ongoing. The study is enrolling in line with management expectations, with full accrual expected by year-end 2013.
He said a Phase 1 study of CDX-1135 in dense deposit disease (DDD) is set to begin in the first quarter this year, with potential data readout by year end. The dose escalation Phase 1 study of CDX-1127 is ongoing, with no tolerability issues seen to date.

In addition, a pilot study of CDX-301 in patients undergoing transplantation is planned by year end, with results from a Phase 1 study of CDX-301 expected in February at the BMT meeting. A collaborative study with the NCI is set to test CDX-1401 in combination with CDX-301.