FDA Grants Fast Track Status to Carisma Therapeutics’ New Cancer Therapy

Carisma Therapeutics

PHILADELPHIA, PACarisma Therapeutics Inc. (Nasdaq: CARM) has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its innovative cancer treatment, CT-0525. This therapy targets solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).

The FDA’s Fast Track program is designed to speed up the development and review of treatments for serious conditions with significant unmet medical needs. This designation allows Carisma to expedite the development of CT-0525, a gene-modified cellular therapy.

“Receiving Fast Track designation for CT-0525 from the FDA marks a significant milestone for Carisma,” said Eugene P. Kennedy, Chief Medical Officer of Carisma. “We are committed to working closely with the FDA to accelerate the development of CT-0525.”

Currently, Carisma is enrolling patients in a Phase 1 clinical trial for CT-0525. This open-label study aims to evaluate the safety, tolerability, and manufacturing feasibility of the therapy. The trial will include participants with advanced or metastatic solid tumors that overexpress HER2 and have not responded to standard treatments. The study will begin with two dose escalation cohorts to determine the optimal dosage.

“[We] remain on track to report initial clinical data by the end of 2024,” added Kennedy.

CT-0525 represents a new approach in cancer treatment, utilizing CAR-Monocyte technology to target and destroy cancer cells. If successful, this therapy could provide a much-needed option for patients with limited alternatives.

Further details about the trial can be found under the identifier NCT06254807 on clinicaltrials.gov.

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