Bristol-Myers Squibb Company (BMY) and Infinity Pharmaceuticals will collaborate to conduct a clinical study of Bristol-Myers Squibb’s Opdivo in combination with Infinity’s IPI-549 to treat advanced solid tumours.
The dose-escalation portion exploring IPI-549 as a monotherapy in Infinity’s Phase 1 study is proceeding, while the first dose-escalation cohort studying IPI-549 in combination with Opdivo, a PD-1 immune checkpoint inhibitor, is expected to commence.
IPI-549 is an oral immuno-oncology development candidate designed to selectively inhibit phosphoinositide-3-kinase (PI3K)-gamma, and is the only investigational PI3K-gamma inhibitor in clinical development.
Preclinical data indicate that IPI-549 may boost the impacts of checkpoint inhibitors and may also reverse tumour resistance to checkpoint inhibitors by targeting immune cells and changing the immune-suppressive microenvironment, promoting an anti-tumour immune response.
Opdivo is intended to overcome immune suppression.
The combination phase of this ongoing Phase 1 study in patients with advanced solid tumours will explore the potential of combining these two agents to boost improved and sustained efficacy and drive tolerability above the present standard of care by targeting the immune-suppressive cells in the tumour microenvironment.
Bristol-Myers Squibb head of oncology development Fouad Namouni said: “Targeting the tumour 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: "We are excited to explore the potential clinical benefits of combining IPI-549 with Opdivo in the next phase of our ongoing Phase I study, which is expected to begin this fall.
"Our preclinical research demonstrates that IPI-549 may enhance the effects of and reverse tumour resistance to checkpoint inhibitors, providing a strong rationale for evaluating this combination in patients with advanced forms of solid tumours."
The ongoing Phase 1 clinical study of IPI-549 is intended to explore the activity, safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 175 patients with advanced solid tumours.
When the dose-escalation phase evaluating Opdivo and IPI-549 is completed, an expansion phase will begin to evaluate the combination in patients with selected solid tumours, including non-small-cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN).
IPI-549 is an orally administered, immuno-oncology development candidate that selectively inhibits PI3K-gamma.
Opdivo is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1, which is used by the cancer cells to take refuge from the immune system and block the tumour from being exposed to the immune system.