Pipeline

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EXPLORE OUR PRODUCT CANDIDATES

201124_BiontechPipeline_without milestones.pdf

DRUGCLASS

PLATFORM

PHASE

RIGHTS

mRNA

FixVac

BNT111

PHASE

PRE123

Indication:

Advanced Melanoma (Adjuvant and Metastatic)

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

Advanced Melanoma (Adjuvant and Metastatic)

Rights/Collaborations:

Global

BNT111 is developed for the treatment of advanced melanoma in patients with metastatic tumors and as an adjuvant treatment after tumor resection. It is designed to elicit an immune response to…

BNT111 is developed for the treatment of advanced melanoma in patients with metastatic tumors and as an adjuvant treatment after tumor resection. It is designed to elicit an immune response to four melanoma-associated antigens.

We are currently studying BNT111 in an ongoing Phase 1 clinical trial. Find out more about the Lipo-MERIT study here.

An earlier version of the BNT111 only targeting NY-ESO-1 and tyrosinase has already completed a first-in-human dose escalation study (MERIT study) evaluating the safety and tolerability of intranodal administration in patients with advanced melanoma. See more information on the clinical study here.

DRUG CLASS

mRNA Therapeutics (mRNA)

We are utilizing messenger ribonucleic acid, or mRNA, to deliver genetic information to cells, where it is used to express proteins for therapeutic effect. We are developing a portfolio of immunotherapies that utilize four different mRNA formats and three different formulations to derive five distinct platforms for the treatment of cancer. Three of these platforms are currently in human testing:

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

In addition, we are developing two platforms in which we use mRNA to express directly in the patient either (a) particular antibodies, or RiboMabs, or (b) specific cytokines, or RiboCytokines. In collaboration with Pfizer and Genevant, we are also leveraging our mRNA technology beyond oncology to treat influenza and rare diseases.

More about mRNA

PLATFORM

Fixed combination of shared cancer antigens (FixVac)

Fixed combination of shared cancer antigens

Concept: Cancer immunotherapies targeting shared antigens that we have identified to be frequently expressed across patients with a specific cancer type.
mRNA Format: Optimized mRNA providing superior immunogenicity.
mRNA Delivery Formulation: Proprietary size- and charge-based RNA-LPX targeting DCs.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT111 for metastatic melanoma.
Data Highlights: Four partial responses and eight stable diseases in 22 patients with metastatic lesions at enrollment, following BNT111 monotherapy.

More about FixVac

mRNA

FixVac

BNT112

PHASE

PRE123

Indication:

Prostate Cancer

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

Prostate Cancer

Rights/Collaborations:

Global

We are currently studying BNT112 in an open-label, multi-center, first-in-human Phase 1/2 individual dose titration study in patients with metastatic Castration Resistant Prostate Cancer (mCRPC)…

We are currently studying BNT112 in an open-label, multi-center, first-in-human Phase 1/2 individual dose titration study in patients with metastatic Castration Resistant Prostate Cancer (mCRPC) and high-risk localized prostate cancer, or LPC.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Fixed combination of shared cancer antigens (FixVac)

Fixed combination of shared cancer antigens

Concept: Cancer immunotherapies targeting shared antigens that we have identified to be frequently expressed across patients with a specific cancer type.
mRNA Format: Optimized mRNA providing superior immunogenicity.
mRNA Delivery Formulation: Proprietary size- and charge-based RNA-LPX targeting DCs.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT111 for metastatic melanoma.
Data Highlights: Four partial responses and eight stable diseases in 22 patients with metastatic lesions at enrollment, following BNT111 monotherapy.

More about FixVac

mRNA

FixVac

BNT113

PHASE

PRE123

Indication:

HPV16+ Head and Neck Cancer

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

HPV16+ Head and Neck Cancer

Rights/Collaborations:

Global

BNT113 is designed to elicit an immune response against the well-characterized HPV16-derived oncoproteins E6 and E7, which are strongly immunogenic, viral neoantigens that are found in HPV16-…

BNT113 is designed to elicit an immune response against the well-characterized HPV16-derived oncoproteins E6 and E7, which are strongly immunogenic, viral neoantigens that are found in HPV16-positive solid cancers such as head and neck squamous cell carcinoma. BNT113 is under development for the treatment of HPV-positive head and neck cancer and is currently being studied by the University of Southampton in an ongoing investigator-sponsored Phase 1/2 basket study in HPV-positive cancers, including head and neck cancer. Find out more on the study here.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Fixed combination of shared cancer antigens (FixVac)

Fixed combination of shared cancer antigens

Concept: Cancer immunotherapies targeting shared antigens that we have identified to be frequently expressed across patients with a specific cancer type.
mRNA Format: Optimized mRNA providing superior immunogenicity.
mRNA Delivery Formulation: Proprietary size- and charge-based RNA-LPX targeting DCs.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT111 for metastatic melanoma.
Data Highlights: Four partial responses and eight stable diseases in 22 patients with metastatic lesions at enrollment, following BNT111 monotherapy.

More about FixVac

mRNA

FixVac

BNT114

PHASE

PRE123

Indication:

Triple Negative Breast Cancer

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

Triple Negative Breast Cancer

Rights/Collaborations:

Global

BNT114 is designed to elicit an immune response to selected antigens that are found in breast cancers. We are evaluating BNT114 for the treatment of triple negative breast cancer in an ongoing…

BNT114 is designed to elicit an immune response to selected antigens that are found in breast cancers. We are evaluating BNT114 for the treatment of triple negative breast cancer in an ongoing three-arm clinical trial as both a monotherapy and in combination with our BNT122 individualized iNeST immunotherapy. Find out more about the ongoing study here.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Fixed combination of shared cancer antigens (FixVac)

Fixed combination of shared cancer antigens

Concept: Cancer immunotherapies targeting shared antigens that we have identified to be frequently expressed across patients with a specific cancer type.
mRNA Format: Optimized mRNA providing superior immunogenicity.
mRNA Delivery Formulation: Proprietary size- and charge-based RNA-LPX targeting DCs.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT111 for metastatic melanoma.
Data Highlights: Four partial responses and eight stable diseases in 22 patients with metastatic lesions at enrollment, following BNT111 monotherapy.

More about FixVac

mRNA

FixVac

BNT115

PHASE

PRE123

Indication:

Ovarian Cancer

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

Ovarian Cancer

Rights/Collaborations:

Global

We are currently studying BNT115 in a Phase 1 trial for the treatment of ovarian cancer.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Fixed combination of shared cancer antigens (FixVac)

Fixed combination of shared cancer antigens

Concept: Cancer immunotherapies targeting shared antigens that we have identified to be frequently expressed across patients with a specific cancer type.
mRNA Format: Optimized mRNA providing superior immunogenicity.
mRNA Delivery Formulation: Proprietary size- and charge-based RNA-LPX targeting DCs.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT111 for metastatic melanoma.
Data Highlights: Four partial responses and eight stable diseases in 22 patients with metastatic lesions at enrollment, following BNT111 monotherapy.

More about FixVac

mRNA

FixVac

BNT116

PHASE

PRE123

Indication:

NSCLC

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

NSCLC

Rights/Collaborations:

Global

We are also exploring FixVac development candidates in NSCLC.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Fixed combination of shared cancer antigens (FixVac)

Fixed combination of shared cancer antigens

Concept: Cancer immunotherapies targeting shared antigens that we have identified to be frequently expressed across patients with a specific cancer type.
mRNA Format: Optimized mRNA providing superior immunogenicity.
mRNA Delivery Formulation: Proprietary size- and charge-based RNA-LPX targeting DCs.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT111 for metastatic melanoma.
Data Highlights: Four partial responses and eight stable diseases in 22 patients with metastatic lesions at enrollment, following BNT111 monotherapy.

More about FixVac

mRNA

iNeST

BNT122

PHASE

PRE123

Indication:

Locally advanced or metastatic solid tumors

Rights/Collaborations:

Genentech

PHASE

PRE123

Indication:

Locally advanced or metastatic solid tumors

Rights/Collaborations:

Genentech

We are also studying RO7198457 (BNT122) as a monotherapy and in combination with atezolizumab in a Phase 1a/1b basket study of patients with locally advanced or metastatic solid tumors (including…

We are also studying RO7198457 (BNT122) as a monotherapy and in combination with atezolizumab in a Phase 1a/1b basket study of patients with locally advanced or metastatic solid tumors (including in melanoma, non-small cell lung cancer, bladder cancer as well as other solid tumors). Find out more about the study here.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Individualized Neoantigen Specific Immunotherapy (iNeST)

Individualized Neoantigen Specific Immunotherapy

Concept: Individualized cancer immunotherapy targeting neoantigens identified on a patient by patient basis and selected for immunogenicity.
mRNA Format: Optimized mRNA providing superior immunogenicity.
mRNA Delivery Formulation: Proprietary size- and charge-based RNA-LPX targeting DCs.
Development Approach: 50:50 cost share with Genentech.
Lead Indication: RO7198457 (BNT122) as a first-line melanoma therapy in combination with pembrolizumab.
Data Highlights: In a previous Phase 1 trial of BNT121, we observed first-in-human data in 13 patients with metastatic melanoma demonstrating stable progression-free survival in nine patients for up to 41 months, and additional objective responses in three of five patients with metastatic disease at time of treatment with iNeST including one patient receiving combination therapy. We also observed a significant decrease in the cumulative recurrence rate post-treatment as compared to pre-treatment.

More about iNeST

mRNA

iNeST

BNT122

PHASE

PRE123

Indication:

1L Melanoma with CPI

Rights/Collaborations:

Genentech

PHASE

PRE123

Indication:

1L Melanoma with CPI

Rights/Collaborations:

Genentech

We and our collaborator Genentech are developing RO7198457 (BNT122) for the treatment of metastatic melanoma and other solid tumors. We are currently conducting a randomized Phase 2 trial in…

We and our collaborator Genentech are developing RO7198457 (BNT122) for the treatment of metastatic melanoma and other solid tumors. We are currently conducting a randomized Phase 2 trial in collaboration with Genentech in first-line melanoma in combination with pembrolizumab. Find out more about the study here.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Individualized Neoantigen Specific Immunotherapy (iNeST)

Individualized Neoantigen Specific Immunotherapy

Concept: Individualized cancer immunotherapy targeting neoantigens identified on a patient by patient basis and selected for immunogenicity.
mRNA Format: Optimized mRNA providing superior immunogenicity.
mRNA Delivery Formulation: Proprietary size- and charge-based RNA-LPX targeting DCs.
Development Approach: 50:50 cost share with Genentech.
Lead Indication: RO7198457 (BNT122) as a first-line melanoma therapy in combination with pembrolizumab.
Data Highlights: In a previous Phase 1 trial of BNT121, we observed first-in-human data in 13 patients with metastatic melanoma demonstrating stable progression-free survival in nine patients for up to 41 months, and additional objective responses in three of five patients with metastatic disease at time of treatment with iNeST including one patient receiving combination therapy. We also observed a significant decrease in the cumulative recurrence rate post-treatment as compared to pre-treatment.

More about iNeST

mRNA

ITIT

BNT131

PHASE

PRE123

Indication:

Solid Tumors

Rights/Collaborations:

Sanofi

PHASE

PRE123

Indication:

Solid Tumors

Rights/Collaborations:

Sanofi

Together with Sanofi we are developing SAR441000 (BNT131) as an intratumoral immunotherapy for the treatment of solid tumors. It utilizes mRNA to encode the cytokines IL-12sc, IL-15sushi, IFNα and GM-CSF. By increasing the concentration of these cytokines in the tumor microenvironment, the immune system may more easily recognize and fight cancer.

SAR441000 (BNT131) is being studied in a Phase 1 basket clinical trial as a monotherapy in patients with advanced melanoma and in combination with an anti-PD-1/PD-L1 checkpoint inhibitor in patients with advanced melanoma and certain solid tumors. Find out more about the study here.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Intratumoral Immunotherapies (ITIT)

Intratumoral Immunotherapies

Concept: Immunomodulator-encoding mRNA injected directly into the tumor in order to avoid off-target toxicities.
mRNA Format: Nucleoside-modified mRNA engineered for minimal immunogenicity in order to avoid immune detection and allow translation of the encoded cytokines to occur within the cells.
mRNA Delivery Formulation: Various formulations, delivered by intratumoral injection.
Development Approach: Co-development and co-commercialization, at our option, in collaboration with Sanofi.
Lead Candidate: SAR441000 (BNT131) for advanced solid tumors as a monotherapy and in combination with cemiplimab.

More about Intratumoral Immunotherapies

mRNA

rMAB

BNT141

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Global

BNT141 is our RiboMab product candidate for the treatment of solid tumors currently in preclinical development. BNT141 is designed to encode secreted IgG antibodies that target multiple epithelial…

BNT141 is our RiboMab product candidate for the treatment of solid tumors currently in preclinical development. BNT141 is designed to encode secreted IgG antibodies that target multiple epithelial solid tumors, including gastric and pancreatic cancers.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

RiboMabs (rMAB)

RiboMabs

Concept: Antibodies encoded by mRNA and produced in the patient as an alternative to recombinant antibodies.
mRNA Format: Nucleoside-modified mRNA engineered for minimal immunogenicity in order to avoid immune detection and allow translation of the encoded antibodies to occur within the cells.
mRNA Delivery Formulation: Various liver-targeting LNP formulations, delivered intravenously, to ensure systemic availability and prolonged production of the antibody in vivo.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT141 in multiple solid tumors.

More about RiboMabs

mRNA

rMAB

BNT142

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Global

BNT142 is designed to encode a secreted bispecific antibody that targets CD3 and CLDN6. It is currently in preclinical development for the treatment of solid tumors.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

RiboMabs (rMAB)

RiboMabs

Concept: Antibodies encoded by mRNA and produced in the patient as an alternative to recombinant antibodies.
mRNA Format: Nucleoside-modified mRNA engineered for minimal immunogenicity in order to avoid immune detection and allow translation of the encoded antibodies to occur within the cells.
mRNA Delivery Formulation: Various liver-targeting LNP formulations, delivered intravenously, to ensure systemic availability and prolonged production of the antibody in vivo.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT141 in multiple solid tumors.

More about RiboMabs

mRNA

rCK

BNT151

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Global

BNT151 encodes a modified version of the human interleukin-2, or IL-2, cytokine. It is in preclinical development for the treatment of solid tumors. BNT151 is designed to stimulate T cells without…

BNT151 encodes a modified version of the human interleukin-2, or IL-2, cytokine. It is in preclinical development for the treatment of solid tumors. BNT151 is designed to stimulate T cells without triggering immunosuppression in the tumor microenvironment.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

RiboCytokines (rCK)

RiboCytokines

Concept: Cytokines encoded by mRNA and produced in the patient as an alternative to recombinant cytokines.
mRNA Format: Nucleoside-modified mRNA engineered for minimal immunogenicity in order to avoid immune detection and allow translation of the encoded cytokines to occur within the cells.
mRNA Delivery Formulation: Various liver-targeting LNP formulations, delivered intravenously, to ensure systemic availability and prolonged production of the cytokine in vivo.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT151 in multiple advanced malignancies.

More about RiboCytokines

mRNA

rCK

BNT152, BNT153

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Global

BNT152 and BNT153 are RiboCytokines designed to encode IL-7 and IL-2 for the treatment of solid tumors. The program is currently in preclinical development.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

RiboCytokines (rCK)

RiboCytokines

Concept: Cytokines encoded by mRNA and produced in the patient as an alternative to recombinant cytokines.
mRNA Format: Nucleoside-modified mRNA engineered for minimal immunogenicity in order to avoid immune detection and allow translation of the encoded cytokines to occur within the cells.
mRNA Delivery Formulation: Various liver-targeting LNP formulations, delivered intravenously, to ensure systemic availability and prolonged production of the cytokine in vivo.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT151 in multiple advanced malignancies.

More about RiboCytokines

mRNA

INF

BNT161

PHASE

PRE123

Indication:

Influenza

Rights/Collaborations:

Pfizer

PHASE

PRE123

Indication:

Influenza

Rights/Collaborations:

Pfizer

We are collaborating with Pfizer to develop an influenza vaccine based on our mRNA drug classes. Our product candidate BNT161 will encode influenza virus antigens selected by the WHO in advance of…

We are collaborating with Pfizer to develop an influenza vaccine based on our mRNA drug classes. Our product candidate BNT161 will encode influenza virus antigens selected by the WHO in advance of the flu season.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Infectious Disease Immunotherapies (INF)

Infectious Disease Immunotherapies

Concept: mRNA-based vaccines targeting infectious disease pathogens.
mRNA Format: Self-amplifying mRNA providing high immunogenicity with smaller amounts of mRNA.
mRNA Delivery Formulation: Lipid nanoparticles (LNPs).
Development Approach: Collaboration with Pfizer and exclusive option arrangement with Penn.
Lead Candidate: Influenza vaccine.

More about Infectious Disease Immunotherapies

mRNA

INF 2

BNT162

PHASE

PRE123

Indication:

COVID-19

Rights/Collaborations:

Fosun Pharma (China), BioNTech and Pfizer (Global, except of China)

PHASE

PRE123

Indication:

COVID-19

Rights/Collaborations:

Fosun Pharma (China), BioNTech and Pfizer (Global, except of China)

BNT162 is BioNTech’s mRNA vaccine program aimed at preventing COVID-19 infection. It is the first product candidate from Project Lightspeed and leverages BioNTech’s proprietary mRNA platforms for infectious diseases, its fully-owned GMP manufacturing infrastructure for mRNA vaccine production, and its global clinical development capabilities, drawing on BioNTech’s broad network of global collaborators.

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Infectious Disease Immunotherapies (INF 2)

Infectious Disease Immunotherapies

Concept: mRNA-based vaccine targeting infectious disease pathogens.
mRNA Formats: uridine-containing mRNA (uRNA), nucleoside modified mRNA (modRNA), and self-amplifying mRNA (saRNA) providing high immunogenicity.
mRNA Delivery Formulation: Lipid nanoparticles (LNPs).
Development Approach: Global development program, in collaboration with Fosun Pharma.
Lead Candidate: COVID-19 Vaccine.

More about Infectious Disease Immunotherapies

mRNA

BNT171

PHASE

PRE123

Indication:

Not disclosed

Rights/Collaborations:

Genevant

PHASE

PRE123

Indication:

Not disclosed

Rights/Collaborations:

Genevant

Target not selected

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Rare Disease PRT (RD)

Rare Disease PRT

Concept: Therapeutic proteins encoded by mRNA and produced in the patient as an alternative to recombinant protein replacement.
mRNA Format: Nucleoside-modified mRNA, deimmunized to avoid immune activation in order to allow for translation of the therapeutic protein in the cells.
mRNA Delivery Formulation: Liver-targeting LNPs.
Development Approach: 50:50 cost and profit share with Genevant.

More about Rare Disease PRT

ECT

CAR T

BNT211

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Global

BNT211 is our CAR T cell therapy for the treatment of CLDN6-positive solid tumors. BNT211 targets CLDN6 and will initially be evaluated in combination with a FixVac that encodes CLDN6.

…

BNT211 is our CAR T cell therapy for the treatment of CLDN6-positive solid tumors. BNT211 targets CLDN6 and will initially be evaluated in combination with a FixVac that encodes CLDN6.

CLDN6 is a highly specific oncofetal cell surface antigen that is found in multiple cancers, including ovarian, testicular and lung cancers, but not in normal cells. We have observed compelling preclinical data, demonstrating potent anti-tumoral efficacy, including eradication of advanced tumors in an ovarian carcinoma xenograft model.

DRUG CLASS

Engineered Cell Therapies (ECT)

We are developing a range of novel cell therapies in which the patient’s T cells are modified to target cancer-specific antigens. These include two platforms for the treatment of solid tumors: chimeric antigen receptor, or CAR, T cells and T cell receptor, or TCR, programs. We are also combining our mRNA FixVac platform with our first CAR T product candidates to enhance the persistence of CAR-T cells in vivo.

More about Engineered Cell Therapies

PLATFORM

CAR T Cell Platform (CAR T)

CAR T Cell Platform

Concept: Second-generation CAR T therapy designed to overcome the shortcomings of CAR T therapy in solid tumors.
Mechanism: T cells with CARs engineered to target cancer-specific antigens, including novel antigens selected from our proprietary antigen library and administered with a FixVac immune booster to enhance CAR-T cell expansion and persistence.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT211 for multiple solid tumors.

More about the CAR T Cell Platform

ECT

CAR T

BNT212

PHASE

PRE123

Indication:

Pancreatic, Other Cancers

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

Pancreatic, Other Cancers

Rights/Collaborations:

Global

BNT212 is under development for the treatment of CLDN18.2-positive solid tumors and will initially be evaluated in combination with a FixVac that encodes CLDN18.2. BNT212 targets Claudin 18.2, or…

BNT212 is under development for the treatment of CLDN18.2-positive solid tumors and will initially be evaluated in combination with a FixVac that encodes CLDN18.2. BNT212 targets Claudin 18.2, or CLDN18.2. CLDN18.2 is a highly specific target which is only expressed in cancer and in differentiated epithelial cells of the gastric mucosa, but it is absent from the gastric stem cell zone. CLDN18.2 is expressed in numerous epithelial solid tumors, including gastric, pancreatic, esophageal, ovarian and lung tumors.

DRUG CLASS

Engineered Cell Therapies (ECT)

More about Engineered Cell Therapies

PLATFORM

CAR T Cell Platform (CAR T)

CAR T Cell Platform

Concept: Second-generation CAR T therapy designed to overcome the shortcomings of CAR T therapy in solid tumors.
Mechanism: T cells with CARs engineered to target cancer-specific antigens, including novel antigens selected from our proprietary antigen library and administered with a FixVac immune booster to enhance CAR-T cell expansion and persistence.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT211 for multiple solid tumors.

More about the CAR T Cell Platform

NGIM

BNT311

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Genmab

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Genmab

GEN1046 (BNT311) is a bispecific antibody designed to target PD-L1 and 4-1BB to block the inhibitory PD-1/PD-L1 axis and simultaneously activate essential co-stimulatory activity via 4-1BB.

…

GEN1046 (BNT311) is a bispecific antibody designed to target PD-L1 and 4-1BB to block the inhibitory PD-1/PD-L1 axis and simultaneously activate essential co-stimulatory activity via 4-1BB.

PD-L1 is a validated target that is expressed on tumor cells. 4-1BB is a trans-membrane receptor belonging to the TNF super-family and is expressed predominantly on activated T cells.

In collaboration with Genmab, we are conducting a Phase 1/2, open-label, single arm safety basket trial of GEN1046 (BNT311). Find out more about the study here. We have announced the dosing of the first patient in June 2019. See the press release here.

DRUG CLASS

Antibodies (AB)

We are developing, in collaboration with Genmab, next-generation bispecific antibodies that are designed to target immune checkpoints that modulate the patient’s immune response to cancer. We are also exploring additional targeted cancer antibody approaches utilizing our in-house and recently acquired antibody capabilities.

More about Antibodies

PLATFORM

Next-Gen Checkpoint Immunomodulators (NGIM)

Next-Gen Checkpoint Immunomodulators

Concept: Bispecific antibodies for dual immunomodulation, initially targeting 4-1BB, an immune checkpoint that is expressed on T cells and NK cells and can enhance immune cell proliferation and activation, in combination with simultaneous checkpoint inhibition.
Mechanism: Conditional activation of 4-1BB checkpoint only upon simultaneous binding of PD-L1 or CD40 (in the case of our initial candidates), potentially avoiding toxicities seen in prior attempts at 4-1BB agonism by localizing 4-1BB activation to the tumor environment.
Development Approach: 50:50 cost and profit share with Genmab, combining our and Genmab’s immunostimulatory antibodies and extensive immunology expertise with Genmab’s DuoBody bispecific antibody platform.
Lead Candidate: GEN1046 (BNT311), our PD-L1x4-1BB product candidate for multiple solid tumors.

More about Next-Gen Checkpoint Immunomodulators

NGIM

BNT312

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Genmab

PHASE

PRE123

Indication:

Multiple Solid Tumors

Rights/Collaborations:

Genmab

GEN1042 (BNT312) is a bispecific antibody designed to activate an anti-tumor immune response through conditional CD40-mediated stimulation of antigen presenting cells crosslinked with conditional…

GEN1042 (BNT312) is a bispecific antibody designed to activate an anti-tumor immune response through conditional CD40-mediated stimulation of antigen presenting cells crosslinked with conditional stimulation of 4-1BB-positive T cells. The cell surface molecule CD40 is a member of the tumor necrosis factor receptor superfamily and is broadly expressed by a wide range of tumor cells. The candidate has completed preclinical development and entered clinical development in 2019. Find out more about the study here.

DRUG CLASS

Antibodies (AB)

More about Antibodies

PLATFORM

Next-Gen Checkpoint Immunomodulators (NGIM)

Next-Gen Checkpoint Immunomodulators

Concept: Bispecific antibodies for dual immunomodulation, initially targeting 4-1BB, an immune checkpoint that is expressed on T cells and NK cells and can enhance immune cell proliferation and activation, in combination with simultaneous checkpoint inhibition.
Mechanism: Conditional activation of 4-1BB checkpoint only upon simultaneous binding of PD-L1 or CD40 (in the case of our initial candidates), potentially avoiding toxicities seen in prior attempts at 4-1BB agonism by localizing 4-1BB activation to the tumor environment.
Development Approach: 50:50 cost and profit share with Genmab, combining our and Genmab’s immunostimulatory antibodies and extensive immunology expertise with Genmab’s DuoBody bispecific antibody platform.
Lead Candidate: GEN1046 (BNT311), our PD-L1x4-1BB product candidate for multiple solid tumors.

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tCaAb

BNT321

PHASE

PRE123

Indication:

Pancreatic Cancer

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

Pancreatic Cancer

Rights/Collaborations:

Global

MVT-5873 (BNT321) is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), an epitope on CA19-9 that is expressed in pancreatic and other gastrointestinal cancers that plays a…

MVT-5873 (BNT321) is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), an epitope on CA19-9 that is expressed in pancreatic and other gastrointestinal cancers that plays a role in tumor adhesion and metastasis formation, and is a marker of an aggressive cancer phenotype.

MVT-5873 (BNT321) is being investigated in an open-label, multi-center, non-randomized dose escalation Phase 1/2 study evaluating the safety and recommended Phase 2 dose of MVT-5873 (BNT321) both as a monotherapy and in combination with a standard of care chemotherapy. Find out more about the study here.

DRUG CLASS

Antibodies (AB)

More about Antibodies

PLATFORM

Targeted Cancer Antibodies (tCaAb)

Targeted Cancer Antibodies

Our multiple antibody discovery engines significantly expand our targeting repertoire and enable us to directly, rapidly and efficiently produce new mAb candidates. With the acquisition of MAB Discovery GmbH’s antibody generation unit in 2019, we integrated a unique and proprietary rabbit-based antibody discovery platform that can generate and develop high quality, functional mAbs targeting traditional proteins and receptors as well as a wide variety of more challenging targets. HuMab, our human antibody discovery engine acquired from MabVax Therapeutics in 2019, led to the clinical development of our fully human IgG1 monoclonal antibody product candidate targeting Sialyl Lewisa (sLea), a carbohydrate moiety that is present in over 90% of pancreatic and a large percentage of gastrointestinal cancers.

SMIM

TLR

BNT411

PHASE

PRE123

Indication:

Solid Tumors

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

Solid Tumors

Rights/Collaborations:

Global

BNT411 is a TLR7 agonist that is designed to activate both the adaptive and innate immune system through the TLR7 pathway. This activity and the release of cytokines and chemokines are designed to…

BNT411 is a TLR7 agonist that is designed to activate both the adaptive and innate immune system through the TLR7 pathway. This activity and the release of cytokines and chemokines are designed to result in the potent stimulation of antigen specific CD8+ T cells, B cells and innate immune cells such as NK cells and macrophages.

We are currently evaluating BNT411 in a Phase 1/2a, first-in-human, dose-escalation trial as a monotherapy in patients with solid tumors and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC).

DRUG CLASS

Small Molecule Immunomodulators (SMIM)

We use small molecules to augment the activity of other drug classes by inducing specific and discrete patterns of immunomodulation. We are developing a small molecule toll-like receptor 7, or TLR7, immunomodulator for the treatment of solid tumors.

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PLATFORM

Toll-Like Receptor Binding (TLR)

Toll-Like Receptor Binding

Concept: Small molecule therapies, with a specific focus on TLRs, that can be used synergistically with other cancer therapeutics, including other product candidates in our portfolio.
Development Approach: Worldwide rights; wholly owned.
Lead Candidate: BNT411, our TLR7 agonist product candidate intended for combination therapies.

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ECT

TCR

To be selected

PHASE

PRE123

Indication:

All Tumors

Rights/Collaborations:

Global

PHASE

PRE123

Indication:

All Tumors

Rights/Collaborations:

Global

Target not selected

DRUG CLASS

Engineered Cell Therapies (ECT)

More about Engineered Cell Therapies

PLATFORM

T Cell Receptor Cell Platform (TCR)

T Cell Receptor Cell Platform

We are developing T cell receptor therapies for the treatment of cancer, including in collaboration with Eli Lilly. Under our collaboration, Eli Lilly has an exclusive option to pursue clinical development of certain potential TCR product candidates. We and Eli Lilly have concluded the research phase of the collaboration and Eli Lilly is evaluating whether to exercise its option.

More about the T Cell Receptor Cell Platform

mRNA

INF

To be selected

PHASE

PRE123

Indication:

Up to 10 Indications

Rights/Collaborations:

Penn

PHASE

PRE123

Indication:

Up to 10 Indications

Rights/Collaborations:

Penn

Target not selected

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

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PLATFORM

Infectious Disease Immunotherapies (INF)

Infectious Disease Immunotherapies

Concept: mRNA-based vaccines targeting infectious disease pathogens.
mRNA Format: Self-amplifying mRNA providing high immunogenicity with smaller amounts of mRNA.
mRNA Delivery Formulation: Lipid nanoparticles (LNPs).
Development Approach: Collaboration with Pfizer and exclusive option arrangement with Penn.
Lead Candidate: Influenza vaccine.

More about Infectious Disease Immunotherapies

mRNA

INF

To be selected

PHASE

PRE123

Indication:

HIV

Rights/Collaborations:

Bill and Melinda Gates Foundation

PHASE

PRE123

Indication:

HIV

Rights/Collaborations:

Bill and Melinda Gates Foundation

Target not selected

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Infectious Disease Immunotherapies (INF)

Infectious Disease Immunotherapies

Concept: mRNA-based vaccines targeting infectious disease pathogens.
mRNA Format: Self-amplifying mRNA providing high immunogenicity with smaller amounts of mRNA.
mRNA Delivery Formulation: Lipid nanoparticles (LNPs).
Development Approach: Collaboration with Pfizer and exclusive option arrangement with Penn.
Lead Candidate: Influenza vaccine.

More about Infectious Disease Immunotherapies

mRNA

INF

To be selected

PHASE

PRE123

Indication:

Tuberculosis

Rights/Collaborations:

Bill and Melinda Gates Foundation

PHASE

PRE123

Indication:

Tuberculosis

Rights/Collaborations:

Bill and Melinda Gates Foundation

Target not selected

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Infectious Disease Immunotherapies (INF)

Infectious Disease Immunotherapies

Concept: mRNA-based vaccines targeting infectious disease pathogens.
mRNA Format: Self-amplifying mRNA providing high immunogenicity with smaller amounts of mRNA.
mRNA Delivery Formulation: Lipid nanoparticles (LNPs).
Development Approach: Collaboration with Pfizer and exclusive option arrangement with Penn.
Lead Candidate: Influenza vaccine.

More about Infectious Disease Immunotherapies

mRNA

To be selected

PHASE

PRE123

Indication:

4 More Rare Disease Indications

Rights/Collaborations:

Genevant

PHASE

PRE123

Indication:

4 More Rare Disease Indications

Rights/Collaborations:

Genevant

To be selected

DRUG CLASS

mRNA Therapeutics (mRNA)

our off-the-shelf shared antigen immunotherapy, or FixVac
our individualized neoantigen specific immunotherapy, or iNeST, in collaboration with Genentech
our intratumoral immunotherapy, in collaboration with Sanofi.

More about mRNA

PLATFORM

Rare Disease PRT (RD)

Rare Disease PRT

Concept: Therapeutic proteins encoded by mRNA and produced in the patient as an alternative to recombinant protein replacement.
mRNA Format: Nucleoside-modified mRNA, deimmunized to avoid immune activation in order to allow for translation of the therapeutic protein in the cells.
mRNA Delivery Formulation: Liver-targeting LNPs.
Development Approach: 50:50 cost and profit share with Genevant.

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ECT

TCR

Undisclosed

PHASE

PRE123

Indication:

Solid Tumors

Rights/Collaborations:

Eli Lilly

PHASE

PRE123