U.S. Food and Drug Administration grants Breakthrough Therapy Designation to Multitude Therapeutics’ AMT-253

CAR-T Digest - August 2020

04 August 2026: U.S. Food and Drug Administration grants Breakthrough Therapy Designation to Multitude Therapeutics’ AMT-253

Multitude Therapeutics announced that the U.S. FDA has granted Breakthrough Therapy Designation to AMT-253, a MUC18-directed antibody-drug conjugate, for patients with unresectable locally advanced or metastatic melanoma whose disease has progressed or recurred following prior immunotherapy
The BTD is based on the ongoing AMT-253-02 Phase 1/2 study, which is evaluating AMT-253 in patients with unresectable or metastatic malignant melanoma and other advanced solid tumors through dose escalation and dose expansion
The designation addresses a significant unmet need in advanced melanoma, where patients who progress after immunotherapy have limited treatment options and available approaches, including targeted therapy, immunotherapy and chemotherapy, provide limited overall efficacy

AMT-253 comprises a proprietary high-affinity MUC18 antibody, a protease-cleavable linker and an exatecan topoisomerase I inhibitor payload, with a drug-to-antibody ratio of approximately 8. Its design provides high ADC stability, avoids BCRP/P-gp-mediated drug efflux and has demonstrated a strong bystander effect in preclinical studies
Strategically, the FDA BTD strengthens Multitude Therapeutics’ position in the emerging MUC18 ADC landscape, accelerates the development and regulatory pathway of AMT-253 in melanoma, and further validates the company’s strategy of developing ADCs against novel, potentially first-in-class targets

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