FDA Approves Investigational Drug Application for Bi-Functional Fusion Protein

In a recent announcement, the Simcere Pharmaceutical Group — a global pharmaceutical company with origins in China — revealed that the FDA approved its investigational new drug application for SIM0237, an anti-PD-L1/IL-15 bi-functional fusion protein drug for treating advanced solid tumors. This follows the approval of the investigational new drug application of this drug in China by the National Medical Products Administration.

According to the press release, the drug is an anti-PD-L1 monoclonal antibody. The medication can bind to PD-L1, blocking the PD-1/PD-L1 immunosuppressive pathway. The press release notes, “the attenuated IL-15 part of SIM0237 prolongs its PK, increases MTD, and avoids overstimulation and accompanied anergy of NK and CD8+ T cells. In the meantime, fusion of attenuated IL-15 to full anti-PD-L1 mAb further enhances the half-life of attenuated IL-15 and delivers IL-15 directly to the tumor microenvironment avoiding notorious CRS toxicity induced by systemic IL-15 exposure.”

The approval follows a phase I open-label, multicenter clinical trial. Researchers looked at the safety, tolerability, and pharmacokinetics of the drug. Additional upcoming trials will test how varying the medication dosage can impact the pharmacokinetics and pharmacodynamics. Researchers will be able to determine the safest recommended dose of the drug.

"There is demonstrated history of PD-1/PD-L1 immune checkpoint inhibitors (ICIs) showcasing strong efficacy in a variety of cancers, but there is a large percentage of oncology patients who are either refractory these therapeutics or develop resistance," said Dr. Bijoyesh Mookerjee, MD, Chief Medical Officer, Oncology of Simcere, in the press release. "By developing this compound as a bi-functional fusion protein that combines an anti-PD-L1 antibody with an IL-15 cytokine, we can direct therapeutic activity to the tumor microenvironment, enabling us to potentially limit toxicity while improving tolerability and enhancing efficacy in patients with metastatic or locally advanced solid tumors."

As the study progresses, researchers will have to determine the best use of this investigational drug. Additional research may consider comparing the use of this drug with other existing medications to determine which has the most beneficial impact on the overall survival rate.

Editor's Note: The header and the subheader of this article have been corrected to clarify that it was an investigational new drug application.