FDA fast tracks Carisma cell therapy for solid tumors
Cell TherapyPhase 1License out/inFast TrackImmunotherapy
The FDA has awarded Fast Track designation to CT-0525, a cellular therapy developed by Carisma Therapeutics, to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).
CT-0525 works by modifying monocytes, a type of white blood cell, to target and kill cancer cells. This therapy is based on the chimeric antigen receptor (CAR) technology, but instead of modifying T-cells, as in traditional CAR-T therapies, CT-0525 adapts monocytes to express CAR that recognizes and binds to HER2 on the surface of tumor cells. This binding initiates the destruction of the tumor cells, particularly targeting those solid tumors prevalent in conditions where current treatments are insufficient.
The drug is currently in phase 1, with results expected later this year. The trial includes patients with advanced or metastatic solid tumors that are unresectable and have shown progression despite existing therapies. The study design incorporates escalating doses to optimize the therapeutic effect while monitoring safety outcomes.
Recently, the HER2 target has garnered attention from drugmakers in the cancer field, with many establishing partnerships with Chinese biotech companies. In May, Roche acquired the global rights to Chinese biotech Zion Pharma's lead program, a drug designed to treat or prevent the onset of brain metastases in patients with HER2-positive metastatic breast cancer. Back in April, BioNTech signed a $1.5 billion deal with China-based biotech DualityBio to co-develop and commercialize two cancer ADCs candidates, including DualityBio’s lead candidate, DB-1303, which is a topoisomerase-1 inhibitor-based ADC directed against HER2. Eisai and China-based Bliss Biopharmaceutical just announced a clinical trial collaboration agreement — with the option to license — for BlissBio's ADC candidate directed against HER2 for the treatment of cancers.
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