• COM701 in combination with nivolumab demonstrated encouraging 12% ORR in 3L+ MSS-CRC patients with liver metastases, compared to 0% ORR historically for other immunotherapies in a U.S. patient population
  • Translational data showed potent immune activation in the tumor microenvironment (TME) in patients responding to treatment, atypical of immunotherapy in cold tumors like MSS-CRC
  • Further clinical evaluation of COM701 + anti-PD-1 in combination with COM902 planned in MSS-CRC patients

HOLON, Israel I November 7, 2022 ICompugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, announced today publication of an abstract on preliminary data showing anti-tumor activity and potent immune modulation with the combination of COM701 and nivolumab in metastatic MSS-CRC patients. The data will be presented as an oral presentation by Michael Overman, M.D., University of Texas MD Anderson Cancer Center at the annual meeting of the Society for Immunotherapy of Cancer (SITC) on November 10, 2022 in Boston, MA.

“MSS-CRC is a cold tumor that is typically not responsive to immunotherapy, especially in MSS-CRC patients with liver metastases representing about 70% of all CRC patients,” said CRC expert and presenting author, Dr. Michael Overman. “The data we will present at SITC, are encouraging and address this non-immune responsive subset of CRC. Adding COM701 to nivolumab resulted in a response rate of 9% in 22 MSS-CRC patients with two partial responses occurring in 17 patients with liver metastases. This stands in contrast to other novel immunotherapy combinations where responses in MSS-CRC patients with liver metastases have been extremely rare to non-existent. I was particularly excited to see that the responses were supported by robust translational data, clearly showing immune activation that reflects the mechanism of action from the addition of COM701 to nivolumab. While the numbers of patients were small, the data are encouraging and warrant further evaluation. I look forward to investigating COM701 and an anti-PD-1 in triple combination with Compugen’s anti-TIGIT, COM902 in a similar patient population.”

Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen, added, “This data increase our confidence that what we are seeing is a COM701 driven effect. We have shown that adding COM701 to nivolumab in patients with MSS-CRC, results in both anti-tumor activity and potent tumor microenvironment immune activation in a tumor type that typically does not respond to immunotherapy. Our data suggest that blocking PVRIG with COM701 is making the tumors more sensitive to anti-PD-1 alone. This is further exemplified by encouraging anti-tumor activity seen with COM701 in combination with nivolumab with or without BMS-986207 (anti-TIGIT) in another cold or checkpoint non-responsive tumor, platinum resistant ovarian cancer, which we are excited to be presenting this coming December at ESMO-IO.”

Dr. Cohen-Dayag, continued, “We are excited to be pursuing the further clinical evaluation of MSS-CRC patients blocking the full DNAM-1 axis with our fully owned COM701 and COM902 in combination with an anti-PD-1.  Based on the suggested COM701 mechanism of action and the totality of our preclinical and clinical findings showing more potent immune activation with triple blockade of the DNAM-1 axis, we are hoping to further enhance the overall response rate already achieved with dual blockade.”

Key findings from the abstract, “COM701 plus nivolumab demonstrates preliminary antitumor activity and immune modulation of tumor microenvironment in patients with metastatic MSS-CRC and liver metastases” (NCT03667716), with a data cut-off date of June 17, 2022, include:

  • COM701+ nivolumab combination is well tolerated with a favorable safety profile
  • ORR 2/22 (9%) higher than ORR (1-2%) reported for SOC- regorafenib or TAS-102
  • Encouraging preliminary antitumor activity in the subset of MSS-CRC patients with liver metastases, ORR 2/17 (12%), compared to 0% ORR historically for other immunotherapies in a U.S. patient population 
  • Translational data demonstrated potent TME immune activation, in the majority of patients based on 13 paired biopsies, most notable in responders and consistent with COM701 mechanism of action. Such modulation is not typical of checkpoint inhibitors in cold indications.

Planned Next Steps

  • Further clinical investigation of COM701 and anti-PD-1, triple combination with COM902 in MSS-CRC patients
  • ESMO-IO presentation on December 8, 2022, of new encouraging clinical data from the fully enrolled dual and triple combination cohorts of COM701+nivolumab ± BMS-986207 in platinum resistant ovarian cancer patients

The abstract is published today in a supplement of the Journal for Immunotherapy of Cancer (JITC). The presentation and poster will be available on the publications section of Compugen’s website following presentation at SITC on November 10, 2022.

About Compugen

Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has developed two proprietary product candidates: COM701, a potential first-in-class anti-PVRIG antibody and COM902, a potential best-in-class antibody targeting TIGIT for the treatment of solid tumors. Partnered programs include bapotulimab, an antibody targeting ILDR2, in Phase 1 development, licensed to Bayer under a research and discovery collaboration and license agreement, and a TIGIT/PD-1 bispecific derived from COM902 (AZD2936) in Phase 1/2 development by AstraZeneca through a license agreement for the development of bispecific and multi-specific antibodies. In addition, the Company’s therapeutic pipeline of early-stage immuno-oncology programs consists of programs aiming to address various mechanisms of immune resistance, including myeloid targets. The most advanced program, COM503 is about to enter pre-IND enabling studies. COM503 is a potential first-in-class, high affinity antibody targeting cytokine biology to enhance anti-tumor immunity in a differentiated manner. 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.

SOURCE: Compugen