On April 28, 2016 Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company developing checkpoint antibodies and cancer vaccines, reported a corporate update and reported financial results for the first quarter ended March 31, 2016 (Press release, Agenus, APR 28, 2016, View Source [SID:1234511561]).
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"In the first quarter we advanced our checkpoint antibodies by gaining FDA clearance for the Investigational New Drug applications for our CTLA-4 antagonist antibody AGEN1884, and for our GITR agonist antibody partnered with Incyte, INCAGN1876," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "Earlier this week, we commenced a Phase 1 trial of AGEN1884 in solid tumors with the first patient in the trial having been dosed. During the remainder of 2016, we expect to begin clinical trials for additional checkpoint antibody candidates. Our plans this year and into next include initiating one or more randomized trials with Prophage, including combination trials with approved and/or experimental immunotherapeutic agents. Within the next 12 months we also plan to initiate a Phase 1 trial of our AutoSynVax or ASV vaccine, a synthetic autologous vaccine candidate that targets cancer neoantigens. Finally, we expect to consummate non-dilutive funding strategies and evaluate additional strategic alliances and partnerships to strengthen our immuno-oncology capabilities."
First Quarter 2016 and Recent Corporate Highlights
April: Initiated Phase 1 trial of AGEN1884, a CTLA-4 antagonist antibody, in solid tumors. AGEN1884 is the first of a series of checkpoint antibodies the Company is developing. AGEN1884 was developed using Agenus’ powerful in-house antibody technology platform.
April: Presented preclinical data for three checkpoint antibody programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference: INCAGN1949 (an OX40 agonist antibody, partnered on a 50/50 financial basis with Incyte), INCAGN1876 (an agonist antibody for the glucocorticoid-induced TNFR-related protein, or GITR, also partnered on a 50/50 basis with Incyte), and our anti-CTLA-4 program (AGEN1884 and AGEN2041, partnered with Recepta for certain South American territories). The poster presentations covered preclinical pharmacology for each antibody, including detailed studies to support potential in vivo mechanism(s) of action. Data from the INCAGN1949 and INCAGN1876 programs will also be presented at the upcoming Protein and Antibody Engineering Summit (PEGS) in Boston tomorrow, April 29.
January: Investigational New Drug applications received clearance from the U.S. Food and Drug Administration for two checkpoint antibodies: AGEN1884 (CTLA-4 antagonist) and INCAGN1876 (GITR agonist partnered with Incyte).
January: Began integration efforts for our antibody manufacturing facility acquired from Xoma in December 2015. The facility will enable the Company to manufacture checkpoint antibodies for its own programs and those of its collaborators. The facility is expected to provide Agenus’ antibody supply requirements for most programs through clinical proof-of-concept studies.
First Quarter 2016 Financial Results
For the first quarter ended March 31 2016, Agenus reported a net loss attributable to common stockholders of $31.8 million, or $0.37 per share, basic and diluted, including $9.6 million in non-cash expenses. This compares to a net loss attributable to common stockholders for the first quarter of 2015 of $18.8 million, or $0.28 per share, basic and diluted. The increase in net loss attributable to common stockholders for the three months ended March 31, 2016, compared to the net loss attributable to common stockholders for the same period in 2015, was primarily due to the advancement of our checkpoint programs.
Cash, cash equivalents and short-term investments were $148.2 million as of March 31, 2016.