FDA grants fast track designation to BNT111 for advanced melanoma

Source: Healio, November 2021

BNT111 (BioNTech) — an investigational cancer immunotherapy — uses a fixed combination of mRNA-encoded, tumor-associated antigens designed to activate a precise and strong immune response against cancer.

Preclinical and clinical data showed BNT111 has the potential to overcome treatment limitations for inoperable, therapy-resistant advanced-stage melanoma, according to a BioNTech-issued press release.

A phase 1 trial showed the agent induced responses and exhibited a favorable safety profile alone and in combination with immune checkpoint inhibitor therapy among patients with advanced melanoma.

A phase 2 trial is underway to evaluate the vaccine candidate in combination with the anti-PD-1 antibody cemiplimab-rwlc (Libtayo; Regeneron, Sanofi Genzyme) for patients with unresectable stage III or stage IV melanoma who are refractory to or relapsed after anti-PD-1 therapy.

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