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BNT 162

Drug Profile

BNT 162

Alternative Names: BNT-162; COVID-19 mRNA vaccine programme - BioNTech; PF-07302048

Latest Information Update: 10 May 2020

At a glance

  • Originator BioNTech
  • Developer BioNTech; Pfizer
  • Class RNA vaccines; Viral vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II COVID 2019 infections

Most Recent Events

  • 29 Apr 2020 Phase-I/II clinical trials in COVID-2019 infections (Prevention, In volunteers, In adults, In the elderly) in USA (IM, Injection) (NCT04368728)
  • 29 Apr 2020 BioNTech awaits for regulatory approval in USA to conduct phase I/II trial in COVID-19 infections (Prevention)
  • 29 Apr 2020 BioNTech and Fosun Pharma plans to conduct clinical trial in China for COVID-19 infections

Development Overview

Introduction

BNT 162 is an mRNA vaccine project, being conducted by BioNTech, for the prevention of COVID-2019 infections. The four BNT 162 vaccine candidates belong to the company's Lightspeed project, and represent different mRNA formats and target antigens. Clinical evaluations are underway in the US and Germany.

Lightspeed is BioNTech’s accelerated development program, encompassing the prevention and treatment of COVID-19 infections, which leverages the company’s proprietary mRNA platform for infectious diseases.

Company Agreements

In March 2020, BioNTech SE and Pfizer agreed to a letter of intent regarding the co-development and distribution (excluding China) of an mRNA-based coronavirus vaccines including BNT 162, for the prevention of COVID-2019 infections. Under the collaboration terms, BioNTech will be entitled to receive $US185 million in upfront payments, including a cash payment of $US72 million and an equity investment of $US113 million from Pfizer. BioNTech is also eligible to receive future milestone payments of up to $US563 million for a total consideration of $US748 million. Both the parties agreed to share development costs equally. Initially, Pfizer will fund 100 percent of the development costs, and BioNTech will repay Pfizer its 50 percent share of these costs during the commercialisation of the vaccine. BioNTech and its partners will manufacture the vaccine candidates including BNT 162 for clinical studies from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech and Pfizer will work together to scale-up manufacturing capacity later for commercialisation. BioNtech and Pfizer together commercialise the approved vaccines worldwide (excluding China). The companies executed a material transfer and collaboration agreement to enable the parties to start working together on vaccines for COVID-2019 infections. Earlier, in August 2018, the former entered into a multi-year research and development agreement with Pfizer to develop mRNA-based vaccines for prevention of influenza. Under the terms of the agreement, both the companies will jointly contribute to research and development activities to advance the vaccines. Pfizer will be solely responsibility for further clinical development and commercialisation of the flu vaccines, following BioNTech's completion of a first in human clinical study. BioNTech will receive $US120 million in upfront, equity and near-term research payments and up to an additional $US305 million in potential development, regulatory and commercial milestone payments. BioNTech will also receive up to double-digit tiered royalty payments based on worldwide sales, once the drug program is commercialised. [1] [2] [3]

In March 2020, BioNTech entered into a research and development agreement with Shanghai Fosun Pharma, to jointly develop BNT 162 vaccine, for the prevention of COVID-2019 infections, in China. Under the terms of the agreement, the two companies will work jointly on the development of BNT162 in China. The companies will collaborate to conduct clinical trials in China leveraging Fosun Pharma’s extensive clinical development, regulatory, and commercial capabilities in the country. If approved, Fosun Pharma will commercialise the vaccine in China. BioNTech will supply the mRNA vaccine for clinical trials from GMP manufacturing facilities in Europe along with its partner Polymun. BioNTech will retain full rights to develop and commercialise the vaccine in the rest of the world. Under the terms of the agreement, Fosun Pharma agreed to make an equity investment of $US50 million for 1,580,777 ordinary shares in BioNTech, subject to execution of share subscription documentation and approval from regulatory authorities in China. [4] [5]

Key Development Milestones

In April 2020, BioNTech in collaboration with Pfizer initiated and dosed first participant in a phase I/II trial, designed to evaluate the safety, tolerability, immunogenicity, and potential efficacy of up to four different BNT 162 vaccines candidates, for the prevention of COVID-2019 infections in healthy volunteers (C4591001; NCT04368728). The dose level escalation portion (Stage 1) of the Phase 1/2 trial in the U.S. will enroll up to 360 healthy volunteers into two age cohorts (18-55 and 65-85 years of age). The first participant immunized in Stage 1 of the study will be healthy adults 18-55 years of age. Older adults will only be immunized with a given dose level of a vaccine candidate once testing of that candidate and dose level in younger adults has provided initial evidence of safety and immunogenicity. The randomised, placebo-controlled, observer-blind, dose-finding, and vaccine candidate-selection study will enrol approximately 7600 participants in the US [6] [7] .

BioNTech, in April 2020, initiated a phase I/II study, to evaluate the safety and immunogenicity of four BNT 162 vaccines, using different regimens, for the prevention of COVID-2019 infection (EudraCT2020-001038-36; BNT162-01). Approximately 200 subjects are expected to be enrolled in Germany. The study will assess the effects of repeated vaccination following a prime injection for the three vaccine candidates that contain uridine containing mRNA (uRNA) or nucleoside modified mRNA (modRNA). A fourth vaccine candidate, which contains self-amplifying mRNA (saRNA) will be evaluated after a single dose of vaccine. Patinets with a higher risk of severe COVID-19 disease will be included in the second part of the study. In May 2020, first patients were dosed [8] . The German regulatory authority, the Paul-Ehrlich-Institut, had granted approval to conduct the study, earlier in the same month. BioNTech completed dosing in first cohort (n = 12) in Germany. Company also intends to extend the trial in the US upon regulatory approval [9] [10] [11]

In March 2020, BioNTech reported that the company has intended to manufacture the vaccine for clinical trials, along with it's partner Polymun, in Europe [4] .

Drug Properties & Chemical Synopsis

  • Route of administration IM
  • Formulation Injection
  • Class RNA vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E9 (All other viral vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - In adults, In the elderly, In volunteers, Prevention Phase I/II USA IM / Injection BioNTech, Pfizer 29 Apr 2020
COVID 2019 infections - Prevention Phase I/II Germany IM / Injection BioNTech 20 Apr 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
BioNTech Originator Germany
BioNTech Owner Germany
Shanghai Fosun Pharmaceutical Collaborator China
Pfizer Collaborator USA

Future Events

Expected Date Event Type Description Updated
31 Dec 2020 Regulatory Status Pfizer and BioNTech plan to launch the vaccine for COVID-2019 infections by the end of 2020, subject to technical success of the development program and approval of regulatory authorities [12] 15 Apr 2020

Development History

Event Date Update Type Comment
29 Apr 2020 Phase Change - I/II Phase-I/II clinical trials in COVID-2019 infections (Prevention, In volunteers, In adults, In the elderly) in USA (IM, Injection) (NCT04368728) Updated 10 May 2020
29 Apr 2020 Regulatory Status BioNTech awaits for regulatory approval in USA to conduct phase I/II trial in COVID-19 infections (Prevention) [9] Updated 05 May 2020
29 Apr 2020 Trial Update BioNTech and Fosun Pharma plans to conduct clinical trial in China for COVID-19 infections [9] Updated 05 May 2020
29 Apr 2020 Trial Update BioNTech plans a phase I/II trial in COVID-19 infections (Prevention) in USA [9] Updated 05 May 2020
28 Apr 2020 Trial Update Biontech in collaboration with Pfizer plans a phase I/II trial in COVID-19 infections (Prevention) (IM, Injection) in April 2020 (NCT04368728) Updated 05 May 2020
22 Apr 2020 Regulatory Status BioNTech announces intention to submit regulatory applications for a clinical trial for COVID-2019 infections in USA [10] Updated 24 Apr 2020
22 Apr 2020 Trial Update BioNTech plans a clinical trial for COVID-2019 infections in USA [10] Updated 24 Apr 2020
20 Apr 2020 Phase Change - I/II Phase-I/II clinical trials in COVID-2019 infections (Prevention) in Germany (IM) (EudraCT2020-001038-36) Updated 05 May 2020
09 Apr 2020 Regulatory Status Pfizer and BioNTech plan to launch the vaccine for COVID-2019 infections by the end of 2020, subject to technical success of the development program and approval of regulatory authorities [12] Updated 15 Apr 2020
01 Apr 2020 Regulatory Status BioNTech receives approval from the the Paul-Ehrlich-Institut, for a phase I/II trial for COVID-2019 infections [10] Updated 24 Apr 2020
17 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (IM), prior to March 2020 [2] Updated 22 Mar 2020
17 Mar 2020 Licensing Status BioNTech and Pfizer agree to co-develop BNT 162 in China for COVID-2019 infections [2] Updated 20 Mar 2020
16 Mar 2020 Licensing Status BioNTech and Fosun Pharma agree to co-develop BNT 162 in China for COVID-2019 infections [4] Updated 20 Mar 2020
16 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in Germany (IM), prior to March 2020 [4] Updated 20 Mar 2020

References

  1. BioNTech Signs Collaboration Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza.

    Media Release
  2. Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine.

    Media Release
  3. Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development.

    Media Release
  4. BioNTech reports rapid progress on COVID-19 vaccine program to address global public health threat.

    Media Release
  5. BioNTech and Fosun Pharma form COVID-19 vaccine strategic alliance in China.

    Media Release
  6. Pfizer and BioNTech Dose First Participants in the U.S. as Part of Global COVID-19 mRNA Vaccine Development Program.

    Media Release
  7. A Phase 1/2, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study to Describe the Safety, Tolerability, Immunogenicity, and Potential Efficacy of SARS-COV-2 RNA Vaccine Candidates Against COVID-19 in Healthy Adults

    ctiprofile
  8. NYU Langone Among First Centers to Enroll Patients in US Clinical Trial for COVID-19 mRNA Vaccine.

    Media Release
  9. BioNTech and Pfizer announce completion of dosing for first cohort of Phase 1/2 trial of COVID-19 vaccine candidates in Germany.

    Media Release
  10. BioNTech and Pfizer announce regulatory approval from German authority Paul-Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine candidates.

    Media Release
  11. A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-2019 Using Different Dosing Regimens in Healthy Adults

    ctiprofile
  12. Pfizer Advances Battle Against COVID-19 on Multiple Fronts.

    Media Release
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