BioNTech SE · NASDAQ:BNTX
BioNTech — J.P. Morgan Healthcare Conference 2020
44 slides from BioNTech's conference presentation, Jan 15, 2020
Slide 1: J.P. Morgan Healthcare Conference January 2020
J.P. Morgan Healthcare Conference January 2020 Ugur Sahin, MD CEO and Co-Founder Exhibit 99.1
Slide 2: Forward-Looking Statements
This slide presentation includes forward-looking statements Forward-Looking Statements Various statements in this slide presentation concerning the future expectations of BioNTech, its plans and prospects, including the Company’s views with respect to the potential for mRNA therapeutics, its expecta
Slide 3: Agenda
Agenda Who we are and what we do Our platforms and programs Outlook for 2020 and beyond +
Slide 4: Building a 21st century individualized immunotherapy company: Executive summary
Building a 21st century individualized immunotherapy company Executive summary Large addressable market opportunity in solid tumors More than USD 90bn solid tumor market3 addressed Commercialization or co-commercialization rights retained in key geographies World-leading collaborators 7 pharmaceutic
Slide 5: Our Vision: We aspire to individualize cancer medicine
Our Vision: We aspire to individualize cancer medicine Overview mRNA Therapeutics Engineered Cell Therapies Antibodies Small Molecule Immunomodulators Off-the-shelf drugs Interindividual variability Tailored-on-demand immunotherapies Clinical samples Sample profiling bioinformatics big data, deep da
Slide 6: We collaborate with global leaders in our industry
We collaborate with global leaders in our industry Strategic collaborations Oncology Collaborations with at least one program in the clinic 50:50 Cost and Profit share (2016) 50:50 Cost and Profit share (2015) Cost and Profit share (2015) Other Oncology, Infectious Diseases and Rare Diseases Collabo
Slide 7: Targeting Cancer Immunomodulation: our multi-platform approach
Targeting Cancer Immunomodulation mRNA Cancer Vaccines Antibody Targeting Small Molecule Immunomodulators Next Generation Immunomodulators FixVac, iNeST Targeted Antibodies RiboMabs Engineered Cell Therapies CAR-T, TCRs Bispecific Antibodies (CPI + co-stimulation) TLR agonist Engineered Cytokines In
Slide 8: A technology agnostic approach increases our addressable market
A technology agnostic approach increases our addressable market Solid tumor market segmentation Cancer segment Patient Population Challenge Our Therapeutic Strategy High mutational burden/ adjuvant stage cancers Significant portion of cancer patients Poor risk-benefit profile of checkpoint inhibitor
Slide 9: One of the broadest mRNA toolkits in the industry
One of the broadest mRNA toolkits in the industry Local Intratumoral Systemic Tissue specific Adjustable activity in vivo from minutes up to weeks Various delivery routes Liposomes / LPX LNPs Polyplexes Broad formulation spectrum Multiple mRNA formats uRNA modRNA saRNA taRNA 5’ Cap 5’ UTR ORF 3’ UTR
Slide 10: Additional late stage trial starts planned for FixVac and iNeST in 2020
Additional late stage trial starts planned for FixVac and iNeST in 2020 Our pipeline Drug Class Platform Product Candidate Indication (Targets) Preclinical Phase 1 Phase 2 Rights Collaborator Milestones Oncology mRNA FixVac (fixed combination of shared non-mutated cancer antigens) BNT111 advanced me
Slide 11: We plan to start first-in-human trials for RiboMabs & RiboCytokines in 2020
We plan to start first-in-human trials for RiboMabs & RiboCytokines in 2020 Our oncology pipeline Drug Class Platform Product Candidate Indication (Targets) Preclinical Phase 1 Phase 2 Rights Collaborator Milestones Oncology mRNA RiboMabs (mRNA-encoded antibodies) BNT141 multiple solid tumors fully-
Slide 12: We now have antibodies in clinical testing
We now have 3 antibodies in clinical testing Our oncology pipeline Drug Class Platform Product Candidate Indication (Targets) Preclinical Phase 1 Phase 2 Rights Collaborator Milestones Oncology Engineered Cell Therapies CAR-T Cells BNT211 multiple solid tumors (CLDN6) fully-owned phase 1/2 start 1H
Slide 13: 2019 Highlights
2019 Highlights Year in review Pipeline Initiated clinical trials for 6 Investigational Medicinal Products (IMPs) across various cancer indications Started first randomized Phase 2 trial for iNeST Dosed more than 440 patients across all BNTX programs1 as of end 2019 Corporate Raised $225m in Series
Slide 14: Agenda
Agenda Who we are and what we do Our key platforms and programs mRNA vaccines – FixVac and iNeST Antibodies CARVac platform – CLDN6 CAR-T RiboCytokines Outlook for 2020 and beyond
Slide 15: Our mRNA vaccine platforms: FixVac and iNeST
Our mRNA vaccine platforms: FixVac and iNeST mRNA drug class | vaccine platforms Off-the-shelf mRNA immunotherapy Targeting a fixed combination of shared antigens Non-mutated antigens shared among patients with a specific cancer type Applicable for almost all types of tumor antigens FixVac iNeST Fix
Slide 16: Our RNA-LPX vaccine approach
. 2.1% 10.1% 10.3% Our RNA-LPX vaccine approach mRNA drug class | vaccine platforms Strong vaccine-induced ex vivo CD8+ T cell responses1 across different cancer types FixVac iNeST HPV16-E7 Head Neck Cancer BNT113, HARE40 trial Mutant Neoantigen TNBC BNT114, TNBC MERIT trial MAGE-A3 Melanoma BNT111,
Slide 17: FixVac: BNT111 interim clinical activity data
FixVac: BNT111 interim clinical activity data (dose range 14µg -100µg) 1CPI = Checkpoint Inhibitor, 2based on 18F-FDG-PET/CT analysis mRNA drug class | FixVac platform | BNT111 (FixVac advanced melanoma) Summary Advanced melanoma patients (Stage IIIB,C, Stage IV) Out of 74 patients with follow-up im
Slide 18: BNT112: FixVac Prostate Cancer
BNT112: FixVac Prostate Cancer mRNA drug class | FixVac platform | BNT112 (FixVac prostate cancer) Ph1/2: first patient enrolled in December 2019 Multipronged vaccine: Targeted antigens of BNT112 are 5 prostate cancer specific antigens (PAP, PSA and 3 undisclosed antigens) RNA-LPX vaccine format val
Slide 19: FixVac: an expanding pipeline of clinical stage programs
FixVac: an expanding pipeline of clinical stage programs Product candidate mRNA drug class | FixVac platform FixVac Pipeline Advanced melanoma HPV positive head & neck cancer (IIT) Triple negative breast cancer Prostate cancer BNT111 BNT113 BNT114 BNT112 BNT115 Preclinical Phase 1 Phase 2 Ph. 3 star
Slide 20: Conclusions from iNeST clinical trials
Conclusions from iNeST clinical trials mRNA drug class | iNeST platform | clinical trials Clinical efficacy evaluation in randomized phase 2 trials initiated Long-term follow-up of completed trial with BNT121 (Intra-nodal administration, RNA): Long-term relapse free disease activity with BNT121 iNeS
Slide 21: Update for BNT121 (as of October 2019)
Update for BNT121 (as of October 2019) mRNA drug class | iNeST platform | clinical trials Metastatic relapse analyses 9 of 13 patients without documented PFS Events Melanoma Stage IIIb, IIIc, and IV, 13 patients, intranodal delivery against 10 neoantigens Stable progression free survival in adjuvant
Slide 22: A technology agnostic approach increases our addressable market
A technology agnostic approach increases our addressable market Solid tumor market Cancer segment Patient Population Challenge Our Therapeutic Strategy High mutational burden/ adjuvant stage cancers Significant portion of cancer patients Poor risk-benefit profile of checkpoint inhibitors mRNA Neoant
Slide 23: Individualized Neoantigen Specific Immunotherapy (iNeST)
Individualized Neoantigen Specific Immunotherapy (iNeST) mRNA drug class | iNeST platform | clinical trials Overview Targeting multiple neoantigens Intended to be a universal approach applicable for the majority of cancers 50:50 profit/loss share with Genentech Turnaround time reduced from three mon
Slide 24: Digitization and automation for neo-antigen vaccine manufacturing
Digitization and automation for neo-antigen vaccine manufacturing Paperless documentation Semiautomatic manufacturing 2 mRNA GMP production facilities: Idar-Oberstein (GMP since 2011) and Mainz (GMP since 2018) Construction and GMP licensure of new Mainz facility for iNeST expected in 2022/2023 Part
Slide 25: Agenda
Agenda Who we are and what we do Our platforms and programs mRNA vaccines – FixVac and iNeST Antibodies CARVac platform – CLDN6 CAR-T RiboCytokines Outlook for 2020 and beyond
Slide 26: Next-Gen checkpoint immunomodulators: BNT311 and BNT312
BNT311 (GEN1046) BNT312 (GEN1042) Next-Gen checkpoint immunomodulators PD-L1 4-1BB K409R F405L Fc-silencing mutations matched CH3 mutations L234F L235E D265A CD-40 4-1BB K409R F405L Fc-silencing mutations matched CH3 mutations L234F L235E D265A Two bispecific antibodies partnered with Genmab Potenti
Slide 27: BNT311 mode of action
Characteristics Bi-specific antibody combining constitutive CPI blockade and conditional co-stimulatory activity Enhanced proliferation of antigen specific activated T cells in the presence of PD-L1-positive cells Constitutive PD-L1 blockade & Conditional 4-1BB agonism 1 2 Increased tumor infiltrati
Slide 28: A technology agnostic approach increases our addressable market
A technology agnostic approach increases our addressable market Solid tumor market Cancer segment Patient Population Challenge Our Therapeutic Strategy High mutational burden/ adjuvant stage cancers Significant portion of cancer patients Poor risk-benefit profile of checkpoint inhibitors mRNA Neoant
Slide 29: BNT321 (MVT-5873)
BNT321 (MVT-5873) BNT321: Cancer antibody targeting Cancer Associated Carbohydrate sLea sLea Phase 1 resumed in 2H 2019 Pancreatic ductal adenocarcinoma Colon carcinoma Lung adenocarcinoma Urinary bladder, mucinous adenocarcinoma Colon metastatic to ovary Breast carcinoma, lymph node sLea expression
Slide 30: First-in-human Ph1 trial also supports theranostic potential
First-in-human Ph1 trial also supports theranostic potential Lohrmann et al., Clin Cancer Res, 2019 in press PET/CT imaging study with MVT-2163 (PET conjugated Ab version; 89Zr-DFO-HuMab-5B1) Robust accumulation in tumors lesions; tumor uptake increasing over time. Validates the target and the antib
Slide 31: Agenda
Agenda Who we are and what we do Our platforms and programs mRNA vaccines – FixVac and iNeST Antibodies CARVac platform – CLDN6 CAR-T RiboCytokines Outlook for 2020 and beyond
Slide 32: BNT211: Next generation CAR-T targeting CLDN6 with CARVac primer
Complete eradication of advanced tumors demonstrated in an ovarian carcinoma xenograft model BNT211: Next generation CAR-T targeting CLDN6 with CARVac “primer” Engineered Cell Therapies | CAR-T therapies | BNT211 CAR-T cell therapy + RNA Vaccine to amplify CAR-T cell in vivo CLDN6 is not present in
Slide 33: BNT211: Next generation CAR-T targeting CLDN6 with CARVac primer
BNT211: Next generation CAR-T targeting CLDN6 with CARVac “primer” Engineered Cell Therapies | CAR-T therapies | BNT211 RNA-lipoplex vaccine enhances expansion & persistence of CAR T Applicability shown for CLDN6, CLD18.2, CD19 CAR-T cells 1Reinhard et al, Science 2020: An RNA vaccine drives expansi
Slide 34: A technology agnostic approach increases our addressable market
A technology agnostic approach increases our addressable market Solid tumor market Cancer segment Patient Population Challenge Our Therapeutic Strategy High mutational burden/ adjuvant stage cancers Significant portion of cancer patients Poor risk-benefit profile of checkpoint inhibitors mRNA Neoant
Slide 35: Further development of engineered T cell therapies
Further development of engineered T cell therapies Engineered Cell Therapy Manufacturing Key Plans Start first-in-human trial for CLDN6 CAR-T in solid tumors Second CAR-T in pipeline for solid tumors: CLDN18.2 CAR-T Develop CARVac with other CAR-T therapies Plan to announce first TCRs for TCR engine
Slide 36: Agenda
Agenda Who we are and what we do Our platforms and programs mRNA vaccines – FixVac and iNeST Antibodies CARVac platform – CLDN6 CAR-T RiboCytokines Outlook for 2020 and beyond
Slide 37: A technology agnostic approach increases our addressable market
A technology agnostic approach increases our addressable market Solid tumor market Cancer segment Patient Population Challenge Our Therapeutic Strategy High mutational burden/ adjuvant stage cancers Significant portion of cancer patients Poor risk-benefit profile of checkpoint inhibitors mRNA Neoant
Slide 38: RiboCytokines: a novel therapeutic platform
RiboCytokines: a novel therapeutic platform k Preclinical Product Candidate Optimized IL-2 Phase 1 Phase 2 IL-7, IL-2 BNT151 BNT152 Pharmacokinetic Profile RiboCytokine Recombinant cytokine Expected to enter the clinic in 2H 2020 k Preclinical Product Candidate Optimized IL-2 Phase 1 Phase 2 IL-7, I
Slide 39: RiboCytokines boost clinical activity of vaccination and PD-L1 blockade
RiboCytokines boost clinical activity of vaccination and PD-L1 blockade RiboCytokines CT26 tumor model, vaccine antigen: gp70 CT26 tumor model, tumor size: 60mm2 CR: complete response, vaccine antigen:gp70 Vaccine + aPD-L1 + Effect of tumor size on treatment success of vaccination + aPD-L1 RiboCytok
Slide 40: Multiple angles for therapeutic synergy across platforms
Multiple angles for therapeutic synergy across platforms Our multi-platform approach BNT211: First-of-kind CLDN-6 CAR-T approach utilizing CAR-T Amplifying RNA Vaccine (CARVac). Significant amplification of CAR-T cells in preclinical studies (published in SCIENCE, 2020) mRNA Cancer Vaccines Engineer
Slide 41: Agenda
Agenda Who we are and what we do Our platforms and programs Outlook for 2020 and beyond +
Slide 42: We expect a significant news flow in the upcoming next months
We expect a significant news flow in the upcoming next 18 months Expected news flow Platform Candidate Indication (Target) 1H-2020 2H-2020 20213 20223 FixVac BNT111 Advanced Melanoma BNT112 Prostate Cancer BNT113 HPV16+ H&N Cancer BNT114 Triple Negative Breast Cancer iNeST RO7198457 (BNT122) 1L Mela
Slide 43: Building a 21st Century Immunotherapy Company: 2020 Outlook
Building a 21st Century Immunotherapy Company Our goals 2020 Outlook 5 trial updates (incl. publishing BNT111 FixVac Melanoma Phase 1/2 data in peer reviewed journal) Initiate Phase 3 registrational trial for BNT111 FixVac Melanoma Initiate 2 additional iNeST trials in adjuvant stage cancers Initiat
Slide 44: BioNTech SE contact details
© Copyright BioNTech SE 2019. All Rights Reserved. Jan 15, 2020 An der Goldgrube 12 55131 Mainz Germany T: +49 6131 9084-0 F: +49 6131 9084-390 M: info@biontech.de