Bristol-Myers, Infinity partner for Opdivo- IPI-549 combo trial in advanced solid tumors

The companies formed a clinical trial collaboration to evaluate the combination treatment.

The dose-escalation part assessing IPI-549 as a monotherapy in Infinity’s phase 1 trial is continuing, and

The first dose-escalation cohort studying IPI-549 in combination with Opdivo is anticipated to start this fall.

IPI-549 is designed to selectively inhibit PI3K-gamma. In preclinical studies, it inhibited immune suppressive macrophages within the tumor microenvironment.

The combination phase of the ongoing phase 1 study in patients with advanced solid tumors will evaluate the potential of combining the two agents by targeting the immune-suppressive cells in the tumor microenvironment to drive enhanced and sustained efficacy and tolerability above the existing standard of care.

Bristol-Myers Squibb head of oncology development Fouad Namouni said: “Targeting the tumor microenvironment is an important part of our Immuno-Oncology strategy as we continue to advance research for cancers with limited treatment options.

“Our agreement with Infinity builds on our continued focus to bring forward potential novel combination treatment options for patients with cancer.”

Infinity research and development president Julian Adams said: “Our preclinical research demonstrates that IPI-549 may enhance the effects of and reverse tumor resistance to checkpoint inhibitors, providing a strong rationale for evaluating this combination in patients with advanced forms of solid tumors.”

Opdivo is a PD-1 immune checkpoint inhibitor which has regulatory approval in 54 countries including the US, Japan, and in the European Union.

Image: Bristol-Myers Squibb facility in New Brunswick, New Jersey, US. Photo: courtesy of Bristol-Myers Squibb Company.