Compugen (CGEN) Announces Data Update from COM701 Phase 1 Clinical Trial

Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported today updated data from its Phase 1 dose escalation and expansion study of COM701 as a monotherapy, and in a dose escalation combination study with Opdivo® (nivolumab). COM701 is a first-in-class investigational therapeutic antibody targeting PVRIG, a novel immune checkpoint discovered computationally by Compugen.

"The data generated to date across our COM701 clinical program suggest that PVRIG may be an important immune checkpoint in patients who are unresponsive or refractory to currently available immunotherapies," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We are highly encouraged by our updated results from the COM701 plus Opdivo® combination dose escalation, which now include a confirmed complete response in a patient with prior progression on Opdivo® and a previously reported patient with a durable confirmed partial response for almost a year. Combined with a disease control rate of 66.7% and ongoing durable signals of activity beyond or approaching one year in multiple patients and across indications, these results leave us increasingly confident that dual blockade of PVRIG and PD-1 may be key to driving anti-tumor immune responses in certain patient populations. Based on these encouraging results, we will be further evaluating this dual combination regimen in patients with ovarian, breast, endometrial and microsatellite-stable colorectal cancers with the initiation of the COM701 and Opdivo® cohort expansion study in the second quarter of 2021, as part of our collaboration with Bristol Myers Squibb."

Dr. Cohen-Dayag continued, "Our monotherapy cohort expansion study was an important milestone in our COM701 monotherapy evaluation. This data, together with data from our previously reported dose escalation study, which includes a confirmed partial response with treatment ongoing for over one year as of our new data cutoff date, demonstrate durable signals of antitumor activity in tumor types typically unresponsive to immune checkpoint inhibitors, including patients with prior progression on these treatments. We will leverage these data, along with future data from our ongoing correlative assessments of biological samples from patients, to inform our clinical approach and next steps as we execute across our broad combination strategy, which includes dual and triple blockade regimens of COM701 with TIGIT and PD-1. Importantly, as the only company with wholly owned clinical candidates targeting both PVRIG and TIGIT, we are uniquely capable and on track to conduct this comprehensive evaluation of the synergistic blockade of the DNAM axis with PD-1, and we look forward to continued progress in potentially expanding the reach of immunotherapy."

Data highlights from the Phase 1 dose escalation studies as of the data cutoff of December 14, 2020 include:

COM701 and Opdivo® combination dose escalation arm:

• In 15 patients with a median of five prior anticancer therapies (range of 2-10), COM701 in combination with Opdivo® was well-tolerated with no reported dose-limiting toxicities up to the fifth and final dose cohort of COM701 20 mg/kg and Opdivo® 480 mg, both IV Q4 weeks.
• The disease control rate (DCR) was 66.7% (N=10) with best responses of complete response (CR) 6.7% (N=1), partial response (PR) 6.7% (N=1) and stable disease (SD) 53.3% (N=8).
• A patient with anal squamous cell carcinoma with confirmed SD as reported at American Association for Cancer Research (AACR) 2020, now with confirmed CR and remains on treatment at 79 weeks. This patient progressed on Opdivo® prior to enrolling in our study.
• A patient with microsatellite stable (MSS)-colorectal cancer with durable confirmed partial response previously reported at AACR 2020 remained on study treatment at 44 weeks.
• Durable responses of confirmed SD of six months or more in three patients. One patient with renal cell carcinoma remains on treatment at 58 weeks, and one patient with non-small cell lung cancer (NSCLC) (squamous) who failed prior treatment with immune checkpoint inhibitors remained on treatment at 36 weeks, and one patient with endometrial cancer remained on treatment at 46 weeks.

COM701 monotherapy arm dose escalation update since AACR 2020:

• The patient with primary peritoneal cancer (platinum resistant, MSS) with durable confirmed partial response remains on study treatment at 62 weeks.
• The patient with pancreatic cancer, refractory to all three prior lines of standard of care (SOC) therapy with durable confirmed SD was on study treatment for 31 weeks.

Data highlights from the monotherapy expansion cohort as of the data cutoff of December 14, 2020 include:

• 20 patients enrolled in biomarker and data informed indications; four patients of each: endometrial cancer, NSCLC, ovarian cancer, breast cancer and colorectal cancer.
• Six of the 20 patients (30%) had best responses of SD, one patient with endometrial cancer, three patients with NSCLC and two patients with ovarian cancer.
• Two patients with SD remain on treatment as of the data cutoff date; one patient with NSCLC who had >3 prior lines of SOC therapy; including prior treatment with immune checkpoint inhibitors with treatment ongoing at 26 weeks, and one patient with ovarian cancer with treatment ongoing at 20 weeks.
• Two additional patients remain on treatment as of the data cutoff date.
• No new safety findings were observed.

Additional clinical data and initial correlative assessments of biological samples from patients are planned to be presented at the American Society of Clinical Oncology 2021 annual meeting, to which an abstract was submitted.

Opdivo® is a registered trademark of Bristol Myers Squibb.

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