The US Food and Drug Administration (FDA) has granted Fast Track designation for Carisma Therapeutics’ CT-0525 for the treatment of solid tumours overexpressing human epidermal growth factor receptor 2 (HER2).

An ex vivo gene-modified autologous chimeric antigen receptor-monocyte cellular therapy, CT-0525 is being analysed in a Phase I clinical trial.

The open-label trial is designed to assess the safety, tolerability, and manufacturing feasibility of the therapy.

Participants enrolled in the trial will include those with locally advanced (unresectable) or metastatic solid tumours that overexpress HER2 and have advanced following treatment with standard therapies approved presently.

The trial will also feature two dose escalation cohorts to determine the optimal dose of CT-0525.

With the receipt of FDA Fast Track status, CT-0525 is now poised for an accelerated review process.

Carisma Therapeutics CMO Eugene Kennedy said: “Receiving Fast Track designation for CT-0525 from the FDA marks a significant milestone for Carisma, highlighting the FDA’s recognition of the serious and life-threatening nature of these malignancies and the potential of CT-0525 to meet this critical medical need.

“We are committed to working closely with the FDA to accelerate the development of CT-0525. Currently, we are enrolling patients in the Phase I clinical trial and remain on track to report initial clinical data by the end of 2024.”

This designation is a significant milestone, intended to expedite the development and review of therapies for serious conditions with unmet medical needs.

In 2022, Carisma Therapeutics and Sesen Bio signed a definitive merger agreement to combine businesses and create a clinical-stage biotechnology company in an all-stock deal.