November 28, 2021

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FDA Fast Track: BioNTech mRNA cancer vaccine for advanced melanoma

FDA Fast Track: BioNTech mRNA cancer vaccine for advanced melanoma



 

FDA Fast Track: BioNTech mRNA cancer vaccine for advanced melanoma. 

The mRNA cancer vaccine is here! FDA grants BioNTech Fast Track qualification for mRNA cancer vaccine for the treatment of advanced melanoma.

On November 19, 2021, mRNA vaccine giant BioNTech issued an announcement announcing that the US FDA has granted its mRNA cancer vaccine BNT111 fast track qualification .

 

BNT111 is an investigational cancer immunotherapy for the treatment of advanced melanoma.

It is one of the four product candidates of BioNTech’s FixVac platform. The platform uses a combination of tumor-associated antigens encoded by mRNA to trigger powerful and precise cancer Immune response to cancer treatment .

 

FDA Fast Track: BioNTech mRNA cancer vaccine for advanced melanoma

 

 

The BNT111 vaccine is currently undergoing phase 2 clinical trials for the treatment of PD-1 inhibitor refractory/relapsed unresectable stage III or IV melanoma, clinical trial number: NCT04526899.

It is reported that BNT111 encodes four tumor-associated antigens that appear in more than 90% of melanoma patients- NY-ESO-1 , MAGE-A3 , tyrosinase and TPTE , which can be prevented by combining with PD-1 inhibitors Depletion of T cells improves the prognosis of patients with advanced melanoma.

 

Fast Track aims to promote the development and review of new drugs and vaccines designed to treat or prevent serious diseases that may solve unmet medical needs.

The FDA’s approval this time is based on existing preclinical and clinical data. On July 29, 2020, BioNTech published the interim analysis of the Phase 1 clinical trial in Nature , showing that BNT111 has the potential to overcome the currently inoperable advanced melanin The limitations of the tumor.

 

FDA Fast Track: BioNTech mRNA cancer vaccine for advanced melanoma

 

 

BioNTech co-founder and chief medical officer Özlem Türeci said that BNT111’s fast track approval by the FDA demonstrates the potential of the FixVac platform.

With the support of the FDA, BioNTech will accelerate the further development of the BNT111 project to provide life-threatening and difficult-to-treat melanoma patients New treatment options.

 

 

 

 

Reference materials:
https://www.nature.com/articles/s41586-020-2537-9
https://investors.biontech.de/news-releases/news-release-details/biontech-receives-fda-fast-track-designation-its-fixvac

FDA Fast Track: BioNTech mRNA cancer vaccine for advanced melanoma

(source:internet, reference only)


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