Company Update (NASDAQ:AGEN): Agenus Inc Announces Clearance of Investigational NDA by the FDA for anti-CTLA-4 and anti-GITR Antibodies

Agenus Inc (NASDAQ:AGEN), an immuno-oncology company developing checkpoint modulator antibodies and cancer vaccines, announced today that the U.S. Food and Drug Administration (FDA) cleared the company’s investigational new drug (IND) application for AGEN1884, an immune checkpoint modulator (CPM) antibody that binds to cytotoxic T-lymphocyte antigen-4 (CTLA-4). Clearance was also received for a second CPM antibody partnered with Incyte (NASDAQ: INCY) for INCAGN1876, which targets glucocorticoid-induced TNFR-related protein (GITR). Clinical trials for both candidates are expected to begin in the first half of 2016.

“We are pleased with the prospects of both CTLA-4 and GITR moving rapidly into and through the clinic, and in our efforts to bring profoundly effective medicines to cancer patients,” said Garo Armen, PhD, Chairman and CEO of Agenus. “We are also diligently advancing several other product candidates into the clinic and are aiming to begin a number of clinical trials in 2016.”

These two compounds were developed utilizing Agenus’ state-of-the-art monoclonal antibody platform capabilities and leverage the company’s world-class expertise in immuno-oncology and related drug discovery and development. The antibodies were discovered during an earlier collaboration with Ludwig Cancer Research. Recepta, a Brazilian biotech company, was also involved in the collaboration that led to the discovery of AGEN1884, which is partnered with Recepta for certain South American rights. INCAGN1876 is now being co-developed with Incyte.

“CTLA-4 is emerging as an important foundational target for immuno-oncology combination regimens, showing terrific promise when used with other CPMs and cancer vaccines. Our CTLA-4 antagonist antibody, AGEN1884, is a natural potential fit with our expanding vaccine portfolio. This includes Prophage™, slated to enter a randomized placebo-controlled study in newly diagnosed GBM in the second half of 2016, and AutoSynVax™, which we also plan to take into the clinic in the second half of 2016,” said Robert B. Stein, MD, PhD, Agenus’ President, Research & Development. “I would like to acknowledge the research and development teams at Agenus, and Incyte for GITR, for their tireless efforts to achieve our goal of filing these INDs by the end of 2015.” (Original Source)

Shares of Agenus closed yesterday at $3.17. AGEN has a 1-year high of $10.16 and a 1-year low of $2.74. The stock’s 50-day moving average is $4.18 and its 200-day moving average is $5.85.

On the ratings front, Agenus has been the subject of a number of recent research reports. In a report issued on January 6, H.C. Wainwright analyst Swayampakula Ramakanth reiterated a Buy rating on AGEN, with a price target of $10, which represents a potential upside of 215.5% from where the stock is currently trading. Separately, on December 16, Jefferies Co.’s Biren Amin initiated coverage with a Buy rating on the stock and has a price target of $8.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Swayampakula Ramakanth and Biren Amin have a total average return of -31.6% and 2.8% respectively. Ramakanth has a success rate of 9.8% and is ranked #3558 out of 3579 analysts, while Amin has a success rate of 44.9% and is ranked #777.

Overall, one research analyst has assigned a Hold rating and 3 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 $11.00 which is 247.0% above where the stock closed yesterday.

Agenus Inc along with its subsidiaries is a biopharmaceutical company. The Company is engaged in developing and commercializing technologies to treat cancers and degenerative disorders.



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