FDA Accelerates Carisma Cell Therapy for Solid Tumors

The FDA has granted Fast Track designation to CT-0525, a novel cellular therapy devised by Carisma Therapeutics, aimed at combating solid tumors that overexpress the human epidermal growth factor receptor 2 (HER2).

CT-0525 operates by modifying monocytes, a kind of white blood cell, to target and eradicate cancer cells. Unlike traditional CAR-T therapies that alter T-cells, CT-0525 employs chimeric antigen receptor (CAR) technology to adapt monocytes. These monocytes are engineered to express a CAR that identifies and binds to HER2 present on the surface of tumor cells. This attachment triggers the destruction of the tumor cells, specifically addressing solid tumors that are prevalent in cases where current treatments are inadequate.

Presently, CT-0525 is in phase 1 of clinical trials, with results anticipated later this year. The trial involves patients with advanced or metastatic solid tumors that cannot be surgically removed and have continued to progress despite available treatments. The study is designed to escalate doses to determine the optimal therapeutic effect while closely observing safety outcomes.

The HER2 target has recently attracted significant interest from pharmaceutical companies in the oncology sector, leading to numerous collaborations with Chinese biotech firms. For instance, in May, Roche obtained the global rights to Zion Pharma's leading program, a medication aimed at treating or preventing brain metastases in patients with HER2-positive metastatic breast cancer. In April, BioNTech entered into a $1.5 billion partnership with China-based biotech company DualityBio to co-develop and commercialize two cancer antibody-drug conjugates (ADCs) candidates. Among these candidates is DualityBio’s leading compound, DB-1303, a topoisomerase-1 inhibitor-based ADC targeting HER2. Additionally, Eisai and Bliss Biopharmaceutical from China recently announced a clinical trial collaboration agreement, which includes an option for licensing, for BlissBio's ADC candidate targeting HER2 for cancer treatment.