Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced the initiation of a Phase 1/2 safety pilot and expansion study examining the investigational combination of varlilumab and ipilimumab (Yervoy®; Bristol-Myers Squibb) in patients with Stage III or IV metastatic melanoma. Varlilumab is Celldex's fully human monoclonal antibody that targets CD27, a critical co-stimulatory molecule in the immune activation cascade. Ipilimumab, a recombinant, human monoclonal antibody that blocks CTLA-4, is FDA approved for the treatment of unresectable or metastatic melanoma. In the Phase 2 portion of the study, patients with tumors that express NY-ESO-1 will also receive CDX-1401, Celldex's off-the-shelf antibody-based dendritic cell vaccine that targets tumors expressing the NY-ESO-1 oncoprotein.
The three agents in this study were specifically selected because they uniquely intervene at key points of immune regulation and because Celldex has observed enhanced activity in preclinical studies when varlilumab is combined with either checkpoint inhibitors or with vaccines. In addition, this study will also build on previous clinical data from the CDX-1401 experience that suggests that CDX-1401 may predispose patients to better outcome on checkpoint inhibitors, including ipilimumab.
"We believe sophisticated combination approaches centered on immunotherapy hold significant promise for the treatment of cancer and, to this end, are committed to exploring novel combinations across a broad array of mechanisms and indications. This latest trial marks the third Phase 1/2 combination study that varlilumab has entered and the first three-drug combination study," said Thomas Davis, MD, Executive Vice President and Chief Medical Officer of Celldex Therapeutics.
The Phase 1 portion of the study will assess the safety and tolerability of varlilumab at 0.3 and 3.0 mg/kg in combination with ipilimumab at 3 mg/kg administered every three weeks to identify a recommended dose for the Phase 2 portion of the study. The Phase 2 study will include two cohorts—one comprised of patients who are NY-ESO-1 positive and one comprised of patients who are NY-ESO-1 negative. Patients who are NY-ESO-1 positive will also receive CDX-1401 dosed at 1 mg (with poly-ICLC at 2 mg given as an adjuvant) every three weeks in addition to varlilumab and ipilimumab. In total, up to four doses of study treatment will be administered. The primary objective for both cohorts is objective response rate up to 24 weeks (ORR6) using standard, modified World Health Organization response criteria. Secondary objectives for the Phase 2 study include safety and tolerability, immunogenicity, pharmacokinetics and further assessment of anti-tumor activity across a broad range of endpoints. (Original Source)
Shares of Celldex Therapeutics closed last Thursday at $26.43. CLDX has a 1-year high of $32.82 and a 1-year low of $10.76. The stock's 50-day moving average is $27.22 and it's 200-day moving average is $19.80.
On the ratings front, Celldex has been the subject of a number of recent research reports. In a report issued on March 11, Cowen analyst Boris Peaker reiterated a Buy rating on CLDX, with a price target of $33, which represents a potential upside of 24.9% from where the stock is currently trading. Separately, on February 24, Wedbush's David Nierengarten reiterated a Buy rating on the stock and has a price target of $32.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Boris Peaker and David Nierengarten have a total average return of 34.1% and 43.5% respectively. Peaker has a success rate of 63.6% and is ranked #31 out of 3568 analysts, while Nierengarten has a success rate of 64.0% and is ranked #20.
The street is mostly Bullish on CLDX stock. Out of 4 analysts who cover the stock, 4 suggest a Buy rating . The 12-month average price target assigned to the stock is $35.75, which implies an upside of 35.3% from current levels.
Celldex Therapeutics Inc is a biopharmaceutical company. The Company is engaged in the development, manufacturing and commercialization of immunotherapy technologies for the treatment of cancer and other difficult-to-treat diseases.