Infinity to Present Data from Phase 1 Trial of IPI-549 as Treatment for Advanced Solid Tumors

Infinity to Present Data from Phase 1 Trial of IPI-549 as Treatment for Advanced Solid Tumors

Infinity Pharmaceuticals plans a presentation next month of new data from a Phase 1 clinical trial of the PI3K gamma inhibitor IPI-594, either alone or in combination with Opdivo (nivolumab), as a treatment for advanced solid tumors.

The presentation, in the form of a clinical trial poster session, will be April 4 at the American Association for Cancer Research (AACR) annual meeting in Washington. The event runs from April 1-5.

Jedd Wolchok, MD, PhD, chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center, will make the presentation, titled “IPI-549-01 – A Phase 1/1b, First-in-Human Study of IPI-549, a PI3K-Gamma Inhibitor, as Monotherapy and in Combination with Nivolumab in Patients with Advanced Solid Tumors.

Wolchok is also director of the Parker Institute for Cancer Immunotherapy and associate director of the Ludwig Center for Cancer Immunotherapy. Both are also part of Memorial Sloan Kettering.

IPI-549 is an investigational, orally administered drug that selectively inhibits PI3K-gamma. The protein plays an important role in immune cell function and migration, and seems to support myeloid cells in the tumor microenvironment. Myeloid cells are a type of immune cells that, in tumors, suppress the activity of tumor-killing immune cells.

Researchers reported in a preclinical study last year that blocking PI3k-gamma with IPI-549 pushed myeloid cells into a pro-inflammatory state, enhancing the recruitment and activation of cancer-killing cytotoxic T-cells. The study was published in Nature in November.

The finding suggested that in tumors with considerable myeloid cell infiltration, IPI-549 could enhance the activity of immunotherapies such as Opdivo that boost anti-tumor immune surveillance.

The first-in-human, dose-escalation Phase 1 and 1b trial (NCT02637531) was designed to evaluate the safety and tolerability of IPI-549 alone, or in combination with Opdivo, in up to 175 patients. The participants had advanced solid tumors and had shown resistance to PD-1 or PD-L1 therapy.

The study included dose escalations of  IPI-549 alone and in combination with Opdivo. The aim was to determine the best dose for a Phase 2 clinical trial. The main objective of the Phase 2 trial will be to assess the effectiveness of IPI-549 alone or in combination with Opdivo.

An expansion part of the Phase 1 trial, which will test the dose that researchers determined should be given in the Phase 2 trial, is set to include patients with non-small cell lung cancer, melanoma, and head and neck squamous cell carcinoma. Those three types account for nearly 17 percent of all new cancer cases in the United States.