About Compugen

Compugen Ltd. (Compugen) operates as a clinical-stage therapeutic discovery and development company. The company is utilizing its broadly applicable predictive computational discovery capabilities to identify novel drug targets and new biological pathways to develop therapeutics in the field of cancer immunotherapy. The company's innovative immuno-oncology pipeline consists of three clinical stage programs, targeting immune checkpoints it discovered computationally by COM701, COM902, and rilvegostomig. Its lead product candidates, COM701, a potential first-in-class anti-PVRIG antibody, and COM902, a potential best-in-class therapeutic anti-TIGIT antibody, are in Phase 1 clinical trials and have been evaluated for the treatment of solid tumors as a monotherapy and in combination of dual (PVRIG/PD-1, PVRIG/TIGIT) and triple (PVRIG/PD-1/TIGIT) blockade. Based on the data from the Phase 1 trials and as part of its corporate focus on two specific tumor types for the further clinical evaluation of COM701 and COM902, it intends to initiate two clinical trials evaluating the triple combination treatment of COM701, COM902 and pembrolizumab, one in metastatic microsatellite stable colorectal cancer patients and one in platinum resistant ovarian cancer patients. As part of Phase 1 clinical trials for the company's lead product candidates, COM701, it evaluated COM701 as a monotherapy and under clinical collaboration with Bristol Myers Squibb Company in combination with nivolumab ± Bristol Myers Squibb investigational anti-TIGIT, BMS-986207. Following the termination of its collaboration with Bristol Myers Squibb Company, these combination studies are being wound down while the monitoring of patients on study treatment is ongoing. Rilvegostomig, a novel anti PD-1/TIGIT bispecific antibody with a TIGIT-specific component that is derived from the company's COM902 antibody, is being developed by AstraZeneca pursuant to an exclusive license agreement between the company and AstraZeneca and is in Phase 2 clinical trial in patients with advanced or metastatic non-small cell lung cancer and locally advanced or metastatic gastric cancer. Its therapeutic pipeline of early-stage immuno-oncology programs consists of programs aiming to address various mechanisms of immune resistance. The company's most advanced early-stage program, COM503, is a potential first-in-class high affinity antibody, which blocks the interaction between IL-18 binding protein and IL-18, thereby releasing the natural IL-18 into the tumor microenvironment to inhibit cancer growth. COM503 is being advanced into IND enabling studies and the company plans to file an IND in 2024. Strategy The company's pipeline strategy for the development of potentially first-in-class cancer immunotherapies is differentiated in the competitive landscape of immuno-oncology in the following manner: discovering novel drug targets and biological pathways with the potential to address the unmet need of patients non-responsive to current cancer immunotherapies; integrating its cutting-edge computational capabilities with its ground-breaking immuno-oncology research and drug development expertise to inform its target discovery and drug development process; and identifying drug combinations and design biomarker strategy for potential future patient selection. In the company's clinical therapeutic pipeline, its most advanced programs are: COM701 is the company's lead immuno-oncology pipeline program. COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint target candidate discovered by the company that blocks the interaction with its ligand, PVRL2. The company's data suggests that the PVRIG pathway is parallel and complementary to TIGIT, an immune checkpoint discovered computationally by it in 2009. These two pathways intersect with DNAM-1, a costimulatory receptor on T cells and NK cells. The PD-1 pathway also intersects with DNAM-1. In certain tumors, the blockade of both TIGIT and PVRIG may be required to stimulate an antitumor immune response, with or without additional PD-1 pathway blockade. Phase 1 trials for COM701 were initiated in September 2018. COM902 is a high affinity, fully human antibody developed by the company, targeting TIGIT, an immune checkpoint. COM902 blocks the interaction of TIGIT with PVR, its ligand. The company's preclinical data suggests that in certain tumor indications the blockage of both TIGIT and PVRIG, two coinhibitory arms of the DNAM-1 axis, may be required to stimulate an anti-tumor immune response with or without the blockade of the PD-1 pathway. Phase 1 trials for COM902 were initiated in March 2020. Rilvegostomig is a novel PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from COM902 and is being developed by AstraZeneca pursuant to an exclusive license agreement with AstraZeneca. AstraZeneca initiated its Phase 2 trial in patients with advanced or metastatic non-small cell lung cancer in September 2022. In February 2023, AstraZeneca announced that it plans to initiate a Phase 3 trial for rilvegostomig and that expanded Phase 2 for rilvegostomig is in development. In addition to the company's clinical therapeutic pipeline, bapotulimab, an antibody targeting ILDR2, licensed to Bayer, under a research and discovery collaboration and license agreement has been evaluated in Phase 1 clinical trials in naïve head and neck squamous cell carcinoma patients. This research and discovery collaboration and license agreement expired on February 27, 2023, and the company is in the process of obtaining certain rights from Bayer to allow it to continue the development and commercialization of bapotulimab, should it choose to do so. Research Focus - Immuno-Oncology The company's research and development efforts focus on identifying novel drug targets and developing first-in-class therapeutics in the field of cancer immunotherapy. The company's discovery strategy is focused on the discovery of new drug targets involved in mechanisms of immune resistance and which may consequently provide new cancer immunotherapies for enhancing anti-tumor immune responses in cancer patients. Business Strategy and Partnerships The company's business strategy includes entering into various forms of revenue-sharing collaborations with pharmaceutical or biotechnology partners for its novel drug targets and product candidates at various stages of research and development. Such collaborations or other types of partnering arrangements might include one or more of the company's therapeutic pipeline programs. Through these collaborations the company seeks to create, further develop, and commercialize its therapeutic product candidates. Additionally, its discovery capabilities designed to feed its internal pipeline may allow for research and discovery collaborations aimed at harnessing its capabilities towards a potential partner's pipeline needs. The company may also seek co-development arrangements pursuant to which it would further advance partnered programs under any such partnership in order to retain higher share from future sales revenues. AstraZeneca License In March 2018, the company entered into an exclusive license agreement with AstraZeneca, to enable the development of bi-specific and multi-specific immuno-oncology antibody products. In February 2023, AstraZeneca announced that it plans to initiate a Phase 3 trial for rilvegostomig and that expanded Phase 2 for rilvegostomig is in development. Subject to termination rights for material breach, bankruptcy or by the company for patent challenge by AstraZeneca, the term of the license agreement continues until the expiration of the last Royalty Term in the Territory, each as defined in the license agreement. In addition, AstraZeneca may terminate the agreement for convenience upon prior written notice. Intellectual Property Rights As of February 1, 2023, the company had a total of 52 issued and allowed patents, of which 14 are U.S. patents, 8 are European patents and additional 30 patents in other territories. Its issued and allowed patents expire between 2028 and 2037. As of February 1, 2023, the company had over 168 pending patent applications that have been filed in the United States, Europe, and in other territories, as well as pending patent applications that have been filed under the Patent Cooperation Treaty for which it has not yet designated the countries of filing. The patents issued in the U.S. and Europe for COM701 and COM902 were issued between 2017 and 2022 and should expire no earlier than 2036. These patents include issued claims directed to, among others, the composition of these product candidates and/or methods of using the same to treat cancer by activating T cells and/or NK cells, and/or combinations of its product candidates with other checkpoint inhibitors. In October 2020, two parties, one being GSK (following an assignment), filed oppositions in the European Patent Office, or EPO, requesting revocation of the company's granted European patent relating to anti-PVRIG antibodies, that expires in 2036. It responded to this opposition in March 2021. Research and Development Expenses The company's research and development expenses totaled approximately $30.6 million during 2022. Government Regulation In the United States, the FDA regulations describe good laboratory practices, or GLPs, for various types of nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA, including INDs. Nonclinical animal studies conducted by the company or third parties on its behalf may be subject to the U.S. Animal Welfare Act, the U.S. Public Health Service Policy on Humane Animal Care and Use, U.S. Department of Agriculture regulations for certain animal species or applicable laws and regulations of other countries where the company or third parties on its behalf conduct these studies. In Israel, the Council on Animal Experimentation has regulatory and enforcement powers, including the ability to suspend, change or withdraw approvals, among other powers. To the company's knowledge, it and the third-party service providers the company works with, as applicable, substantially comply with these regulatory requirements. History Compugen Ltd. was incorporated in 1993 as an Israeli corporation.