Agenus Inc., a biopharmaceutical company, develops a portfolio of immuno-oncology candidates, including checkpoint modulators, heat shock protein (HSP) vaccines, and adjuvants. The company is focused on immunotherapeutic products based on its core platform technologies with multiple product candidates advancing through the clinic, including various product candidates that have advanced into late-stage clinical trials through corporate partners. Products and Technologies Under Development The company’s core technology portfolio consists of its Checkpoint Antibody Program, HSP Platform (based on its HSP technologies), and Saponin Platform (based on its saponin adjuvant technologies). The Checkpoint Antibody Program Effective February 2014, the company acquired 4-Antibody AG (4-AB), a private European-based biopharmaceutical company, providing the company with a technology platform for the discovery and optimization of fully-human antibodies against a range of molecular targets. The company is applying this antibody platform to discover and optimize checkpoint modulators that regulate immune response to cancers and other diseases. Its proprietary discovery engine within the platform, Retrocyte Display, is designed to generate therapeutic antibody drug candidates using an approach incorporating human antibody libraries expressed in mammalian B-lineage cells. The company has pre-clinical checkpoint antibody programs targeting GITR, OX40, CTLA-4, PD-1, TIM-3, and LAG-3 from 4-AB’s technologies, and has selected two GITR agonists and one CTLA-4 antagonist to advance into pre-clinical development. The company was targeting to identify development candidates for the other four checkpoint programs during 2014. The HSP Platform The Prophage Series Vaccines: Within the company’s HSP Platform, it is developing its Prophage Series cancer vaccines. The company’s Prophage Series cancer vaccines are autologous therapies derived from cells extracted from the patient’s tumor. Its Prophage Series G vaccines are being studied in two different settings of glioblastoma multiforme (GBM), newly diagnosed and recurrent disease. GBM: GBM is a cancer affecting the central nervous system arising from glial cells, which become cancerous. The company has investigator-sponsored Phase 2 trials fully enrolled in the United States testing the Prophage Series vaccine candidates G-100 (HSPPC-96) and G-200 in newly diagnosed and recurrent GBM, respectively. Melanoma: In January 2014, the company announced the initiation of an investigator-sponsored, randomized Phase 2 clinical trial of the Prophage vaccine in combination with ipilimumab in patients with stage III and IV metastatic melanoma. Renal Cell Carcinoma: The company granted NewVac LLC a license to manufacture, market, and sell Oncophage, as well as pursue a development program in the Russian Federation and certain other CIS countries. HerpV: HerpV is an investigational therapeutic vaccine candidate directed at the virus that causes genital herpes (herpes simplex virus-2 (HSV-2)) and is the first potential recombinant (off-the-shelf) application of the company’s HSP technology. HerpV includes its proprietary QS-21 Stimulon adjuvant. HerpV is a polyvalent ‘off-the-shelf’ vaccine consisting of recombinant human HSP-70 associated with a total of 32 antigens representative of genital herpes virus (HSV-2) genome. The Saponin Platform and QS-21 Stimulon QS-21 Stimulon, from the company’s Saponin Platform, is an adjuvant, or a substance added to a vaccine or other immunotherapy that is intended to improve immune response. QS-21 Stimulon has become a major component in the development of investigational preventive vaccine formulations across various infectious diseases, including various investigational therapeutic vaccines intended to treat cancer and degenerative disorders. The primary licensees of QS-21 Stimulon are GlaxoSmithKline (GSK) and JANSSEN Alzheimer Immunotherapy (JANSSEN AI). QS-21 Stimulon is being studied in 21 vaccine indications, which include GSK's Phase 3 vaccine programs for RTS,S for malaria, MAGE-A3 cancer immunotherapeutic for non-small cell lung cancer and melanoma and HZ/su for shingles. In addition, JANSSEN AI’s QS-21 Stimulon adjuvant-containing vaccine candidate is in Phase 2 trials for the treatment of Alzheimer’s disease. Intellectual Property Portfolio The company has rights, through outright ownership or through exclusive licenses, to approximately 60 issued United States patents and approximately 99 issued foreign patents. It also has rights to approximately 13 pending United States patent applications and approximately 43 pending foreign patent applications. The issued patents that cover the Prophage Series vaccines expire at various dates between 2015 and 2024. The issued patents relating to HerpV expire at various dates between 2014 and 2029. Additional protection for QS-21 Stimulon in combination with other agents is provided by its other issued patents, which expire between 2017 and 2022. Oncophage, Stimulon, and Retrocyte Display are registered trademarks of the company and its subsidiaries. Regulation The company is subject to regulation under the Occupational Safety and Health Act; the Toxic Substances Control Act; the Resource Conservation and Recovery Act; and other current and potential future federal, state, or local regulations. It conducts its activities in compliance with the National Institutes of Health Guidelines for Recombinant DNA Research. The company is also subject to current Good Manufacturing Practices, Good Clinical Practices, and Good Laboratory Practices compliance obligations, and is subject to inspection by international regulatory authorities. Research and Development The company’s research and development expenses were $13.0 million for the year ended December 31, 2013. History The company was founded in 1994. It was formerly known as Antigenics Inc. and changed its name to Agenus Inc. in 2011.
agenus inc (AGEN:NASDAQ CM)
3 Forbes Road
Lexington, MA 02421
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