The Food and Drug Administration (FDA) has granted orphan-drug designation to tenalisib (RP6530; Rhizen Pharmaceuticals) for the treatment of cutaneous T-cell lymphoma (CTCL). 

Tenalisib is a highly selective and orally active dual PI3K delta/gamma inhibitor. The treatment has also been granted Orphan and Fast Track status for peripheral T-cell lymphoma (PTCL). 

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Preclinical studies have demonstrated that RP6530 reprograms macrophages from an immunosuppressive M2-like phenotype (pro-tumor) to an inflammatory M1-like state (anti-tumor), which can potentially enhance the activity of checkpoint inhibitors or overcome resistance to these agents. 

“We look forward to advancing the drug into further development for treatment of T-cell lymphoma,” said Swaroop Vakkalanka, PhD, Founder & President of Rhizen Pharmaceuticals.

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