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Agreements

Date: 2018-08-16

Type of information: Development agreement

Compound: mRNA-based flu vaccines

Company: BioNTech (Germany) Pfizer (USA - NY)

Therapeutic area: Infectious diseases

Type agreement: research - development - R&D

Action mechanism:

  • mRNA vaccine. BioNtech is developing a self-amplifying RNA-based Ribological® RNA Amplicon vaccine platform against Infectious Diseases (A.I.R® - Amplified Immune Response). A.I.R® vaccines are based on pharmacologically optimized in vitro transcribed, self-amplifying RNA derived from an alphaviral genome. Compared to non-amplifying RNA, self-amplification and subgenomic transcription of self-amplifying RNA results in higher antigen expression; since innate immunity effectively prevents persistent replication, the self-amplifying RNA is considered comparable to non-amplifying mRNA in terms of safety.
  • Upon delivery of mRNA into a patient‘s target cell, the encoded protein is produced as a pharmacologically active product that induces protective neutralizing antibody and cytotoxic T-cell responses (humoral and cellular immune response). Due to an intrinsic adjuvant activity of the A.I.R® vaccines, no additional adjuvant is required to drive an effective immune response.

Disease: influenza (flu)

Details:

  • • On August 16, 2018, BioNTech, a rapidly growing biotechnology company focused on precise immunotherapies for the treatment of cancer and infectious disease announced that it has entered into a multi-year research and development collaboration with Pfizer to develop mRNA-based vaccines for prevention of influenza.
  • Under the terms of the agreement, BioNTech and Pfizer will jointly conduct research and development activities to help advance mRNA-based flu vaccines. Pfizer will assume sole responsibility for further clinical development and commercialization of mRNA-based flu vaccines, following BioNTech’s completion of a first in human clinical study.

Financial terms:

  • BioNTech will receive $120 million in upfront, equity and near-term research payments and up to an additional $305 million in potential development, regulatory and commercial milestone payments.
  • In addition, BioNTech will receive up to double-digit tiered royalty payments associated with worldwide sales if the program reaches commercialization.

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