Two liver cancer T-cell therapies receive orphan drug designation

The FDA recently granted two orphan drug designations to Lion TCR for T-cell therapy products for the treatment of hepatocellular carcinoma, according to a press release.

“Profiting from U.S. FDA’s well-established regulatory framework and the [orphan drug designation] grant of our [hepatitis B]-specific TCR-T cell products, we aim to develop the clinical program internationally under FDA [investigational new drug Application] covering multiple sites in U.S., Europe and Asia,” Li Lietao, MD, founder and CEO of Lion TCR, said in the release. “It will significantly accelerate our product development and speed up the commercialization of our products to both U.S. and Asian markets.”

The two products under development are an HBV-specific TCR redirected T cell therapy for treating HCC with transient mRNA and a longer lasting DNA transduction technology.

Reference: www.liontcr.com