FDA grants fast track designation to BNT111 for advanced melanoma
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The FDA granted fast track designation to BNT111 for the treatment of advanced melanoma.
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.
“The fast track designation underlines the potential of our FixVac platform to address current treatment challenges of pretreated and immune checkpoint blocker experienced melanoma with limited standard of care therapy options left,” Özlem Türeci, MD, co-founder and chief medical officer of BioNTech, said in a company-issued press release. “This is an important step to pave the way for this versatile new treatment approach in a high medical need setting.”
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