Celldex Therapeutics, Inc. (NASDAQ:CLDX) presented new preclinical data on varlilumab, a fully human monoclonal agonist antibody that binds and activates CD27, a critical co-stimulatory molecule in the immune activation cascade. Results suggest that cancers may respond to CD27 immune modulation by independent mechanisms, such as immune co-stimulation and regulatory T cell (Treg) depletion. Varlilumab has the unique ability to act through both of these mechanisms. The new data were presented in a poster entitled “The mechanism of anti-tumor immunity induced by varlilumab, a CD27 agonist mAb, is model dependent” at the Society for the Immunotherapy of Cancer(SITC) Annual Meeting.

“Our data show that CD27 modulation through varlilumab results in immune activation and suppression of Treg activity, either of which can be independently responsible for a therapeutic effect, depending on the cancer model,” said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. “Because individual human cancers are also likely to have different sensitivities to these anti-tumor activities, varlilumab’s ability to act through both mechanisms provides the broadest potential for therapeutic benefit. Our collection of preclinical and clinical results to date support Celldex’s broad clinical development program across tumor types and in combinations with other anti-tumor agents.”

To better understand each mechanism separately, scientists engineered varlilumab to possess either strong co-stimulatory activity (varli-mG1) or strong Treg suppression activity (varli-mG2a) and analyzed their efficacy in several preclinical tumor models. The data indicated that potent co-stimulation activity was required for therapeutic activity in a BCL1 lymphoma model, whereas control of Tregs was required for activity in several other models, such as E.G7 thymoma, CT26 colorectal and colon 26. Importantly, varlilumab has a combination of immune co-stimulation and Treg depleting activity and demonstrated potent anti-tumor activity in all the models.

The immune stimulating and Treg depleting effects of varlilumab were also observed in Celldex’s Phase 1, single-agent clinical trial of varlilumab in patients with refractory, advanced cancers. Specifically, varlilumab administration was associated with a rapid and transient induction of pro-inflammatory cytokines, activation of T cells as assessed by increased HLA-DR expression and a significant decrease in circulating Tregs. The study also demonstrated promising clinical activity. Two patients experienced durable objective responses including a complete response in Hodgkin lymphoma (18.9+ months) and a partial response in renal cell carcinoma (13.6+ months). Thirteen patients experienced stable disease (3-36.2+ months). Varlilumab was very well tolerated and demonstrated minimal toxicity, even in elderly patients. There was no indication of immune-mediated adverse events often seen with other immunotherapies. Varlilumab is currently being studied in multiple ongoing Phase 1/2 clinical trials with several anti-tumor agents, including nivolumab (Opdivo®), ipilimumab (Yervoy®) and sunitinib (Sutent®) in advanced-stage cancers. Efforts are underway for additional Phase 2 studies with varlilumab, including a combination with atezolizumab (Roche’s anti-PDL1 antibody), and the Company will provide updates on these studies as they are initiated. (Original Source)

Shares of Celldex Therapeutics closed yesterday at $12.51. CLDX has a 1-year high of $32.82 and a 1-year low of $10.11. The stock’s 50-day moving average is $12.81 and its 200-day moving average is $20.40.

On the ratings front, Celldex has been the subject of a number of recent research reports. In a report issued on September 15, Cowen analyst Boris Peaker maintained a Buy rating on CLDX, with a price target of $28, which implies an upside of 123.8% from current levels. Separately, on August 11, Brean Murray Carret’s Jonathan Aschoff reiterated a Buy rating on the stock and has a price target of $31.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Boris Peaker and Jonathan Aschoff have a total average return of 21.8% and -2.9% respectively. Peaker has a success rate of 48.5% and is ranked #107 out of 3827 analysts, while Aschoff has a success rate of 41.3% and is ranked #3556.

Overall, 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $28.00 which is 123.8% above where the stock closed yesterday.

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.