Compugen has entered into a clinical trial collaboration with Bristol-Myers Squibb (BMS) to evaluate the safety and preliminary effectiveness of its investigational immunotherapy COM701 in combination with BMS’ Opdivo (nivolumab), in a Phase 1 trial for patients with advanced solid tumors, including ovarian cancer.
COM701 is an antibody against PVRIG — a new immune checkpoint receptor identified by Compugen with its computational predictive platform — that blocks the interaction with its ligand PVRL2.
While the PVRIG receptor is highly present on the surface of T-cells — white blood cells that play key roles in fighting cancer — that infiltrate the tumor microenvironment, PVRL2 is highly present in several cancers, such as ovarian, breast, endometrial, and non-small cell lung cancer (NSCLC) tumors, suggesting that the PVRIG/PVRL2 interaction may be an important mechanism of immune suppression by these cancers.
Preclinical studies have shown that blocking this interaction strongly boosts the activation of T-cells, which suggests it may activate these cells in the tumor microenvironment to generate anti-tumor immune responses.
Studies in mouse models have also shown that COM701’s anti-tumor effect was even stronger when combined with Opdivo, an antibody against another immune checkpoint receptor called programmed death-1 (PD-1).
The two-part Phase 1 trial (NCT03667716), sponsored by Compugen, will evaluate the safety and preliminary effectiveness of COM701 alone and in combination with Opdivo. The company is currently recruiting patients with advanced ovarian, breast, endometrial or NSCLC tumors, at various sites in the United States.
In the first part of the trial, increasing doses of COM701 will be given intravenously (directly into the blood) to patients as a single therapy or in combination with 360 mg of intravenous Opdivo, every three weeks.
The dose identified as the most appropriate during this dose-escalation part will be given to patients alone or in combination with Opdivo for approximately one year in the trial’s second part.
Preliminary effectiveness of COM701 alone or in combination with Opdivo will be assessed through the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 version, a validated and widely used measure of tumor response.
Compugen and BMS’ collaboration was also created to evaluate the combination of COM701 with BMS’ BMS-986207, a suppressor of an immune checkpoint molecule called TIGIT, in future trials. BMS-986207 is currently being tested as a monotherapy and in combination with Opdivo in a Phase 1/2 study of advanced solid tumors (NCT02913313). The trial is still recruiting.
“This collaboration gives Compugen access to Bristol-Myers Squibb’s Opdivo, enabling the evaluation of COM701 plus a PD-1 inhibitor and potentially accelerating the timeline for clinical testing of COM701 as part of other novel combinations,” Anat Cohen-Dayag, PhD, Compugen’s president and CEO, said in a press release.
Along with this collaboration, BMS will also make a $12 million equity investment in Compugen.
“We look forward to building a strong collaboration with Compugen and addressing significant unmet needs,” said Fouad Namouni, MD, BMS’ head of oncology development.