On March 9, 2020 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported updated data from its ongoing Phase 1 dose escalation study of COM701 in patients with advanced solid tumors who have exhausted all available standard therapies (Press release, Compugen, MAR 9, 2020, View Source [SID1234555300]). COM701 is a first-in-class investigational therapeutic antibody targeting PVRIG, a novel immune checkpoint discovered computationally by Compugen and part of the DNAM axis, which also includes the TIGIT inhibitory pathway.
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"We continue to be encouraged by the updated data which further supports our focus on the indications we previously selected for our planned expansion cohorts, based on our biomarker-informed approach and our predictive discovery capability," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We look forwad to presenting the full data at a future scientific conference."
As of February 9, 2020, the data cutoff date, a total of 28 patients with a variety of tumor types who had failed all available standard therapies were enrolled onto the study, 16 patients in the COM701 monotherapy dose escalation arm and 12 patients in the COM701 in combination with nivolumab dose escalation arm.
At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2019, we reported antitumor activity (stable disease) in 9 of the 13 patients enrolled in the first seven cohorts of the COM701 monotherapy dose escalation arm.
The updated data reported today is from the eighth cohort of the COM701 monotherapy dose escalation arm treated with a dose of 20 mg/kg on a Q4 weekly dosing schedule and from the dose escalation arm of COM701 in combination with nivolumab.
A summary of key data is presented below:
COM701 was well-tolerated and with no reported dose-limiting toxicities in both treatment arms.
Encouraging signals of preliminary antitumor activity in two patients with confirmed partial responses:
A confirmed partial response in a patient from the COM701 monotherapy dose escalation arm with microsatellite stable primary peritoneal cancer, a type of challenging-to-treat ovarian cancer that was selected as a tumor type for the COM701 monotherapy expansion study based on our preclinical biomarker prediction of likely response to treatment with COM701; the patient is one of the three patients enrolled in the eighth cohort and is continuing on study treatment (more than 18 weeks).
A confirmed partial response in a patient from the dose escalation arm of COM701 in combination with nivolumab with microsatellite stable colorectal cancer (MSS-CRC); the patient is continuing on study treatment (more than 36 weeks).
At SITC (Free SITC Whitepaper) Annual Meeting 2019, we reported antitumor activity (stable disease) in 5 of 6 patients with MSS-CRC in the COM701 monotherapy dose escalation arm.
About COM701
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.