Compugen Doses First Patient in Phase 1 Combination Study of COM902 and COM701 in Patients with Advanced Malignancies
- Category: Antibodies
- Published on Thursday, 15 July 2021 17:00
- Hits: 909
Combination study evaluates dual blockade of PVRIG and TIGIT, parallel and distinct DNAM axis checkpoint pathways
Phase 1 COM902 monotherapy dose escalation study is complete with initial results on track for Q4 2021
HOLON, Israel I July 15, 2021 ICompugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery today announced that the first patient has been dosed in its Phase 1 clinical study evaluating the dual combination of COM902, the Company's potential best-in-class, high-affinity anti-TIGIT antibody and COM701, Compugen's first-in-class anti-PVRIG antibody in patients with advanced malignancies who have exhausted all available standard therapies.
"This Phase 1 combination study is an important component in our clinical strategy, evaluating the dual blockade of DNAM axis members PVRIG and TIGIT," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "Our belief is that dual blockade of these distinct checkpoint pathways has the potential to expand the number of patients who respond to treatment with immunotherapy. We continue to move forward as leaders in the DNAM axis space with ongoing single, dual and triple combination clinical studies. We look forward to initial results of the COM902 monotherapy dose escalation study expected in Q4 2021".
The COM902 monotherapy dose escalation arm of this Phase 1 open-label study is complete. The Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of COM902 alone and in combination with COM701 in patients with advanced malignancies who have exhausted all available standard therapies. The COM902 monotherapy dose expansion study, will be in subjects with select tumor types, preferably multiple myeloma. The COM902 in combination with COM701 dose expansion arm is expected to be in select tumor types, PD1 refractory or relapsing HNSCC, NSCLC and CRC (MSS). The study is being conducted in multiple leading oncology clinical centers in the United States with an estimated enrolment of 90 participants across all arms. (NCT04354246).
COM902 is a high affinity, fully human antibody that blocks the interaction of TIGIT with PVR, its ligand, and consequently enhances T cell function. Data suggests that COM902 has in vitro activity comparable or superior to TIGIT antibodies in clinical development. It is currently being evaluated in a Phase 1 clinical studies in patients with advanced malignancies who have exhausted all available standard therapies. Compugen has demonstrated in preclinical studies that simultaneous inhibition of TIGIT and PVRIG, the two coinhibitory arms of the DNAM axis, can increase antitumor immune responses, which may be further enhanced with the addition of PD-1 blockade. These data suggest that treatment with COM701 and COM902, targeting PVRIG and TIGIT, respectively, alone or in combination with a PD-1 inhibitor, has the potential to expand immuno-oncology treatment to patient populations who are non-responsive or refractory to existing immunotherapies. The discovery of TIGIT, using the Company's computational discovery platform, was published by Compugen in October 2009 in the Proceedings of the National Academy of Sciences (PNAS).
COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. Blockade of PVRIG by COM701 has demonstrated in preclinical studies potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. PVRIG and TIGIT, also discovered by Compugen's computational discovery platform in 2009, constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory molecule on T cells and NK cells. As such, preclinical data suggest that the inhibition of PVRIG together with TIGIT and/or PD-1 has the potential to further enhance anti-tumor immune response and improve patient outcomes in a broad variety of tumor types.
Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop therapeutics in the field of cancer immunotherapy. Compugen's lead product candidate, COM701, a first-in-class anti-PVRIG antibody, for the treatment of solid tumors, is undergoing Phase 1 single, dual and triple combination studies. In addition, COM902, Compugen's antibody targeting TIGIT, is in a Phase 1 clinical study. Compugen's therapeutic pipeline also includes early stage immuno-oncology programs focused largely on myeloid targets. Compugen is headquartered in Israel, with offices in South San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. For additional information, please visit Compugen's corporate website at www.cgen.com.