Benzinga | Nov 12, 2021 07:04AM EST

Compugen Reports Prelim. Results From Phase 1 Dose Escalation Monotherapy Study Of COM902

- COM902, high affinity, IgG4, reduced Fc effector function, anti-TIGIT antibody was well tolerated with a favorable safety profile

- Encouraging preliminary anti-tumor activity with 9 of 18 patients (50%) with a best response of stable disease, 3 patients with stable disease of at least 6 months

- Treatment with COM902 avoided depletion of major TIGIT positive expressing lymphocytes including CD4, CD8 and NK cells, supporting Compugen's rationale for choosing an IgG4, reduced Fc effector function anti-TIGIT antibody

- COM902 in combination with COM701 cohort expansion in a PD-(L)1 free regimen Phase 1 has been initiated

- Management will discuss the preliminary results as part of the Q3 earnings call, today at 8:30am ET

HOLON, Israel, Nov. 12, 2021 /PRNewswire/ -- Compugen Ltd. (NASDAQ:CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, today announced the presentation of preliminary results from its ongoing Phase 1 dose escalation study evaluating COM902, Compugen's anti-TIGIT antibody, in patients with advanced solid tumors at the 36th Annual Meeting of the Society for Immunotherapy of Cancer, being held on November 10-14, 2021.

"The primary objective of this Phase 1 dose escalation study of COM902 monotherapy was to evaluate safety and tolerability and we were pleased to see that COM902 was well tolerated with a favorable safety profile. A maximum tolerated dose of COM902 was not reached." said principal investigator and presenting author, Ecaterina Elena Dumbrava, M.D., Assistant Professor of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center. "It is encouraging to achieve a disease control rate of 50% in these heavily pretreated patients who typically do not respond to PD- (L)1 inhibitors. I look forward to enrolling patients in the combination study with COM701 to continue exploring new therapeutic options for patients in need."

Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, added, "COM902 high- affinity anti-TIGIT antibody was well tolerated, showed early signs of anti-tumor activity in heavily pretreated patients with advanced solid tumors and as we expected avoided depletion of major TIGIT positive expressing lymphocytes, supporting our rationale for choosing a reduced Fc effector function anti-TIGIT antibody. These data are encouraging, in line with our science suggesting that TIGIT is a combination agent and serves as the basis for exploring our differentiated TIGIT combination strategy. In addition to our triplet study blocking PVRIG, TIGIT and PD-1 pathways, we are already enrolling patients in our Phase 1 study of COM902 in combination with COM701 for the first clinical evaluation of dual blockade of TIGIT and PVRIG in a PD-(L)1-free regimen."

Key findings from the poster presentation titled, "COM902 (Anti-TIGIT antibody) monotherapy -- preliminary evaluation of safety, tolerability, pharmacokinetics and receptor occupancy in patients with advanced solid tumors," (NCT04354246) with a cutoff of September 3, 2021, include:

Key findings from the study

* The study enrolled 18 patients with advanced solid tumors who exhausted all available standard therapies

* The study population was heavily pretreated with the median number of prior therapies was 7, with a minimum of 2 and maximum of 16

* COM902 administered IV Q3W was well tolerated with a favorable safety profile. A maximum tolerated dose of COM902 was not reached. o One patient in the 0.01 mg/kg dose cohort reported a dose limiting toxicity (DLT) of Grade 2 vomiting, and one patient in the 1 mg/kg dose cohort had a DLT of Grade 3 atrial fibrillation; these were assessed by the investigator as possibly related to study treatment with COM902 o No DLTs were reported at any other COM902 doses including higher doses (3 mg/kg, 10 mg/kg)

* COM902 3 mg/kg IV Q3W has been selected as the recommended dose for expansion

* Best response of stable disease (SD) was reported in 9 patients (50%), with 6 patients (67%) having confirmed SD and 3 patients (17%) with SD of at least 6 months

* No depletion of major lymphocyte populations expressing TIGIT (NK, CD4 and CD8 T cells) in the peripheral blood analysis

Study Progress

* COM902 monotherapy expansion cohort is enrolling up to 10 patients

* A PD-(L)1-free regimen of COM902 cohort expansion in combination with COM701 has been initiated

The poster is available to conference attendees for the duration of the SITC Congress and will be archived on the Publications section of Compugen's website.