Rare Lymphoma Drug Gets Fast Tracked by FDA

This morning, it was announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for RP6530 (Tenalisib). Rhizen Pharmaceuticals S.A. is developing the drug for the treatment of patients with relapsed and/or refractory cutaneous T-cell lymphoma (CTCL).

Earlier this week, Rhizen was granted an orphan drug designation for the drug in the same indication.

RP6530 is a selective and orally active dual PI3K delta/gamma inhibitor with efficient translation of activity through enzyme, cell, and whole blood-based studies.

The new designation comes after preclinical data has shown the drug to reprogram macrophages from an immunosuppressive M2-like phenotype to an inflammatory M1-like state, which has the potential to enhance the activity of checkpoint inhibitors or overcome drug resistance.

“We are pleased that Tenalisib (RP6530) has been granted Fast Track Designation, demonstrating the FDA’s commitment to facilitate the development and expedite the review of our highly selective and orally active dual PI3K delta/gamma inhibitor as an important therapy for patients with relapsed and/or refractory Cutaneous T-cell Lymphoma (R/R CTCL),” said Swaroop Vakkalanka, Ph.D., Founder & President of Rhizen Pharmaceuticals S.A. in a press release.

Aside from its ability to inhibit the growth of immortalized cancerous cell lines and primary patient leukemic/lymphoma cells, RP6530 plays a meaningful role in modulation of tumor microenvironment at concentrations that are clinically achievable.

A Phase 1 study (NCT02567656) is expected to be initiated later this month, and intends to evaluate the safety, pharmacokinetics and efficacy of the drug in patients with relapsed and refractory T-cell lymphoma. It is also the hope of the Rhizen that maximum tolerated dose (MTD) for RP6530 in combination with Pembrolizumab will be established in the study.

“We look forward to advancing the drug into further development for treatment of T-cell lymphoma,” said Vakkalanka.

RP6530 has also previously been granted both Fast Track and orphan drug designations for the treatment of peripheral T-cell lymphoma (PTCL).

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