BioNTech SE · NASDAQ:BNTX
BioNTech — Corporate Update (April 2020)
15 slides from BioNTech's corporate update, Apr 22, 2020
Slide 1: Update on Clinical Development Program: BioNTech BNT162 COVID-19 Vaccine
Update on Clinical Development Program April 2020 BioNTech BNT162 COVID-19 Vaccine Exhibit 99.2
Slide 2: Forward-looking statements
BioNTech Forward-looking statements This presentation contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to co
Slide 3: Next generation immunotherapy
Next generation immunotherapy Harnessing the full potential of the immune system Industry-leading global collaborations Broad suite of novel technology platforms Immunotherapies for cancer and infectious diseases Fully integrated w/in-house GMP manufacturing
Slide 4: COVID-19 vaccine program with global consortium
COVID-19 vaccine program with global consortium “Lightspeed” program includes both vaccines and therapeutics BNT162: different mRNA-based vaccine candidates aimed at preventing COVID-19 infection Exploits highly potent Lipid-Nano-Particulate (LNP) mRNA vaccine platforms for the prevention of infecti
Slide 5: Paul-Ehrlich-Institut has approved Phase 1/2 trial for BNT162
Paul-Ehrlich-Institut (PEI) has approved Phase 1/2 trial for BNT162 First clinical trial of COVID-19 vaccine in Germany Fourth regulatory approval worldwide for vaccine candidate testing Additional trials expected in USA (Pfizer), Europe, and China (Fosun Pharma) Regulatory approval to conduct trial
Slide 6: BNT162 Program Update
BNT162 Program Update Dr. Ugur Sahin, Co-Founder and CEO
Slide 7: BNT162 COVID-19 mRNA Vaccine Program
Goal: Rapid development, clinical testing and approval of well-tolerated and safe vaccines for prevention of COVID-19 Based on our established mRNA technologies Induction of long-term memory immune response, protecting individuals from SARS-CoV-2 infections and COVID-19 illness Clinical testing of 4
Slide 8: Mechanism of action of mRNA vaccines
Mechanism of action of mRNA vaccines: Delivery of mRNA-coded genetic information as blueprint for vaccine into cells of vaccinated individual mRNA uptake into cells results in vaccine antigen synthesis mRNA stimulates immune system of vaccinated individual, generating immune response to the vaccine
Slide 9: mRNA pharmaceuticals as pandemic vaccines
Synthetic variants of naturally occuring genetic molecules Biochemically defined biopharmaceuticals High purity and free of animal product Inherent immune-activating qualities with no need for additional adjuvant Stimulates both antibody and T-cell immune response at low doses More than 400 patients
Slide 10: BNT162 target structures: SARS-CoV-2 Spike-Protein and RBD
BNT162 target structures: SARS-CoV-2 Spike-Protein and RBD BNT162 COVID-19 Vaccine Development SARS-COV-2 Spike Protein 3D Structure (Wrapp et al., 2020, Science) Spike Protein ACE2 Receptor Binding Domain (RBD) Spike-Antigen Whole Protein SARS-COV-2 (3D Model)
Slide 11: BNT162 mRNA vaccine technologies
BNT162 mRNA vaccine technologies BNT162 COVID-19 Vaccine Development Uridine mRNA (uRNA)1 Nucleoside-modified mRNA (modRNA) 2 Self-amplifying mRNA (saRNA) 3 Rationale Prime / boost Strong adjuvant effect Active at low doses Strong antibody response CD8 T-Cells > CD4 T-Cells Rationale Prime / boost M
Slide 12: Project Lightspeed: BioNTech's COVID-19 Program
Project Lightspeed: BioNTech`s COVID-19 Program BNT162 COVID-19 Vaccine Development Established R&D concept (January 16-29) Initiation of R&D activities (January 29) Advisory meetings with regulatory institution in Germany (PEI) (February 6, March 20, April 8) Development of assays for the analysis
Slide 13: BNT162b1 mRNA LNP
BNT162b1 mRNA LNP EM imaging, Tom Madden, Acuitas * Collaboration with Acuitas (Vancouver), Polymun (Austria) Nucleoside-modified mRNA against RBD subunit of SARS-CoV-2 mRNA nanoparticle-formulation* BNT162 COVID-19 Vaccine Development
Slide 14: BNT162 Phase 1/2 clinical trial in Germany
BNT162 Phase 1/2 clinical trial in Germany BNT162 COVID-19 Vaccine Development Design Testing of 4 vaccine candidates in one clinical trial Concomitant approval of every vaccine candidate Separate evaluation of each candidate Testing via i.m. injection of 1µg -100µg doses Prime / boost or prime only
Slide 15: Summary - Outlook
Rapid progress from start to approval for FIH trials demonstrated Established international collaboration consortium to address pandemic (Pfizer, Fosun) Additional trials expected, including in the USA, Europe and China Regulatory approval to begin clinical testing expected shortly in USA Four vacci