Agenus Inc., an immunotherapy company, engages in discovering and developing innovative treatments for patients with cancer and other diseases. The company has a portfolio of programs in pre-clinical and clinical stages, including a series of checkpoint modulators (CPMs) in investigational new drug (IND)-enabling studies, its Prophage Series vaccine, a Phase 3 ready heat shock protein (HSP) based autologous vaccine for glioblastoma multiforme (GBM), a form of brain cancer, and a number of advanced QS-21 Stimulon-containing vaccine candidates in late stage development by its partner, GlaxoSmithKline (GSK). Retrocyte Display and the Checkpoint Antibody Program The company acquired its Retrocyte Display platform in 2014 when it acquired 4-Antibody AG (4-AB), a private European-based biopharmaceutical company. Retrocyte Display (Retroviral B Lymphocyte Display) is a proprietary antibody discovery platform designed for the rapid discovery and optimization of fully-human and humanized monoclonal antibodies against a range of molecular targets. The Retrocyte Display platform is designed to rapidly screen and generate quality therapeutic antibody drug candidates using a high-throughput approach incorporating human antibody libraries expressed in mammalian B-lymphocytes. The company has pre-clinical programs exploring fully human and humanized monoclonal antibodies against six important checkpoint targets: GITR, OX40, CTLA-4, PD-1, TIM-3, and LAG-3. The company is working to discover and develop monoclonal CPM antibodies to modulate the activity of these targets and selectively reactivate the immune system and thwart attempts by cancer to evade destruction. The company has selected product candidates targeting GITR, OX40, CTLA-4 and PD-1 to advance into IND-enabling studies. In addition, it plans to identify development candidates for TIM-3 and LAG-3 during 2015. Partnered Retrocyte Display and CPM Programs In February 2015, the company entered into a broad, global alliance with Incyte Corporation to pursue the discovery and development of CPMs, initially targeting GITR, OX40, TIM-3 and LAG-3 in the fields of hematology and oncology. The company also began collaborating with Merck Sharpe & Dohme in April 2014 to discover antibodies against two undisclosed CPM targets. The company also continues to collaborate with Recepta SA on the development of antibodies targeting CTLA-4. The HSP based Vaccine Platform The company’s HSP-based vaccine platform includes its Prophage Series vaccine candidates for the treatment of cancer and its HerpV vaccine candidate for the treatment of genital herpes. The Prophage Series Vaccine Candidates The company’s Prophage Series cancer vaccine candidates are autologous therapies derived from cancer tissues that are surgically removed from each patient. The company’s Prophage Series vaccines are also being studied in stage III and IV metastatic melanoma. GBM GBM is a cancer affecting the central nervous system arising from glial cells that become malignant. GBM, the most common primary malignant brain tumor, is currently a rapidly fatal disease. Melanoma In 2014, the company announced the initiation of an investigator-sponsored, randomized Phase 2 clinical trial of the Prophage Series vaccine in combination with ipilimumab in patients with stage III and IV metastatic melanoma. Other Indications The company completed various Phase 1 and 2 trials with Prophage across many different tumor types, including colorectal cancer, gastric cancer, glioma, lung cancer, melanoma, pancreatic cancer, renal cell carcinoma and lymphoma. Strategy The company’s strategy includes identifying opportunities to advance the emerging portfolio of CPMs as single agents and in optimized combinations, including potential combinations with Prophage and other agents. Intellectual Property Portfolio The company has rights, through outright ownership or through exclusive licenses, to approximately 60 issued United States patents and approximately 100 issued foreign patents. It also has rights to approximately 9 pending United States patent applications and approximately 40 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 2015 and 2030. 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. In particular, the company owns patents and patent applications relating to Retrocyte Display technology platform. This patent family is projected to expire between 2029 and 2031. The company’s issued patents include those that cover its core technologies, including HSP-based vaccines for the treatment of cancers and treatment/prevention of infectious diseases, and saponin adjuvants, in combination with other agents. The company’s QS-21 Stimulon composition of matter patent family expired in 2008. Additional protection for QS-21 Stimulon in combination with other agents is provided by its other issued patents which expire between 2017 and 2022. Research and Development The company’s research and development expenses were $22.3 million for the year ended December 31, 2014. 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. 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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