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companiesCompany
BioNTech
From COVID vaccine to a broad oncology pipeline: personalised vaccines, ADCs from China, and a PD-L1×VEGF bispecific sold to BMS for $11B.
Overview
BioNTech, based in Mainz and listed as BNTX, moved from its COVID vaccine into a broad oncology pipeline of personalised vaccines, antibody-drug conjugates licensed from China, and a PD-L1 by VEGF bispecific sold to Bristol Myers Squibb for 11 billion dollars. Its programmes include autogene cevumeran with Genentech, trastuzumab pamirtecan, or BNT323, from DualityBio, pumitamig, or BNT327, with BMS, BNT113 against HPV16 and the Claudin 6 CAR-T BNT211. OnCo links it to pancreatic ductal adenocarcinoma through Rojas 2023, in which a personalised mRNA vaccine trained T cells against each patient's cancer, to Claudin 6 as a target, to CureVac and to the University Cancer Center Mainz. Cold tumours and the immunosuppressive microenvironment are the bottleneck its vaccines address. Autogene cevumeran has its own page.
Headquarters
Mainz, DE
Scorecard
All companies#148of 1244 companies, score 40
- phase 3 +12
- phase 1/2 +1
- targets +8
- modalities +6
- registry trials +13
0 approved, 4 in phase 3, 1 earlier, 4 targets, 40 registry studies. Formula on the scorecards page.
Deals
Deal map| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2025-06-02 | BioNTech to Bristol Myers Squibb BNT327 (pumitamig), PD-L1 x VEGF bispecific antibody | Co-development | $1.5bn (plus $2.0bn in non-contingent payments through 2028) | up to $11.1bn | source |
| 2024-11-13 | Biotheus to BioNTech Biotheus, developer of the PD-L1 x VEGF bispecific PM8002 (BNT327, pumitamig) | Acquisition | $800m | up to $950m | source |
| 2023-10 | MediLink Therapeutics to BioNTech YL202 (BNT326), HER3 ADC on the TMALIN linker platform | Licence | $70m | more than $1.0bn | source |
| 2023-04-03 | Duality Biotherapeutics to BioNTech DB-1303 (HER2 ADC, later BNT323) and DB-1311 (B7-H3 ADC, BNT324) | Licence | $170m | more than $1.5bn | source |
Type
Biotech · BNTX
Stage
Public
Website
Phase 2Personalised mRNA neoantigen vaccine
Autogene cevumeran is BioNTech and Genentech's personalised mRNA vaccine encoding each patient's own tumour neoantigens. In a small phase 1 in resected pancreatic cancer, half of patients mounted T-cell responses and stayed free of recurrence far longer; phase 2 IMCODE003 tests whether that holds.
Phase 3bispecific antibody
PM8002 is an experimental bispecific antibody from Biotheus in phase 3 trials for small-cell lung cancer, triple-negative breast cancer and neuroendocrine tumours, aimed at PD-L1 and VEGF / VEGFR.
Phase 3ADC
BNT324 is an experimental antibody-drug conjugate from BioNTech SE in phase 3 trials for prostate cancer and non-small-cell lung cancer, aimed at B7-H3.
Phase 3mRNA vaccine (per the sponsor's pipeline page; form not stated in the registry record)
BNT113 is an experimental investigational agent whose form is not stated in the registry from BioNTech SE in phase 3 trials for head and neck squamous cell carcinoma, with its target not yet stated publicly.
Phase 3Antibody-drug conjugate (anti-HER2 antibody, topoisomerase I inhibitor payload)
Trastuzumab pamirtecan is DualityBio and BioNTech's HER2 antibody-drug conjugate, in phase 3 trials in breast cancers with high and with modest HER2 expression and in HER2-expressing endometrial cancer.
translationalNature 2025277 citations
RNA neoantigen vaccines prime long-lived CD8+ T cells in pancreatic cancer
The strongest human evidence that a cancer vaccine can make durable T cells in a tumour with few mutations; the randomised phase 2 IMCODE003 (260 patients, primary completion listed for January 2031) is the test of whether that translates into fewer relapses.
translationalNature 20231,139 citations
Rojas 2023: a personalised mRNA vaccine trained T cells against each patient's pancreatic cancer, and those who responded stayed cancer-free longer
Pancreatic cancer was thought to be immunologically inert because of its low mutation burden; this study showed that with the right vaccine platform its few neoantigens can still be targeted. It is the strongest human evidence so far that personalised cancer vaccines can generate durable, tumour-specific immunity, and it justifies the randomised trials now running in pancreatic cancer and melanoma. Benefit is not yet proven, because responders may simply have had more immunogenic tumours.
Similar pages
- CompanyDuality Biotherapeutics
Shares A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer, A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors, DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors, First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors.
- CompanyModerna
Shares Self-amplifying and circular RNA therapeutics, Vaccines aimed only at mutations shared by every tumour cell, Personalised cancer vaccines at commodity cost through fully automated manufacturing, Personalised vaccines given only when the blood test turns positive.
- PersonVinod P. Balachandran
Shares Autogene cevumeran phase 1 in resected pancreatic cancer (Memorial Sloan Kettering), RNA neoantigen vaccines prime long-lived CD8+ T cells in pancreatic cancer, Rojas 2023: a personalised mRNA vaccine trained T cells against each patient's pancreatic cancer, and those who responded stayed cancer-free longer, Autogene cevumeran.
- PersonUğur Şahin
Shares University Cancer Center Mainz (UCT Mainz) / Universitätsmedizin Mainz, RNA neoantigen vaccines prime long-lived CD8+ T cells in pancreatic cancer, Rojas 2023: a personalised mRNA vaccine trained T cells against each patient's pancreatic cancer, and those who responded stayed cancer-free longer, Autogene cevumeran.
- TermNeoantigen
Shares Vaccines aimed only at mutations shared by every tumour cell, Personalised cancer vaccines at commodity cost through fully automated manufacturing, University Cancer Center Mainz (UCT Mainz) / Universitätsmedizin Mainz, Personalised vaccines given only when the blood test turns positive.
- TreatmentIntismeran autogene
Shares Personalised cancer vaccines at commodity cost through fully automated manufacturing, Personalised vaccines given only when the blood test turns positive, mRNA and lipid nanoparticle manufacturing, Rojas 2023: a personalised mRNA vaccine trained T cells against each patient's pancreatic cancer, and those who responded stayed cancer-free longer.
- TrialAMPLIFY-7P
Shares A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC, Autogene cevumeran phase 1 in resected pancreatic cancer (Memorial Sloan Kettering), Resectable pancreatic ductal adenocarcinoma, Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question.
cancers
fronts
technologies
targets
drugs
Phase 2Personalised mRNA neoantigen vaccine
Phase 3mRNA vaccine (per the sponsor's pipeline page; form not stated in the registry record)
Phase 3ADC
Phase 3bispecific antibody
Phase 3Antibody-drug conjugate (anti-HER2 antibody, topoisomerase I inhibitor payload)
companies
institutions
trials
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine CancerA Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast CancerA Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung CancerA Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT3A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant TumorsA Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have NA Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent GlioblastomaA Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid TumorsA Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid TumorsA Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid TumorsA Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal CancerA Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate CancerA Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLCA Study of PM8002 in Combination With Chemotherapy in Patients With NENA Study of PM8002 in Combination With Chemotherapy in Patients With SCLCA Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBCA Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDACA Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)Autogene cevumeran phase 1 in resected pancreatic cancer (Memorial Sloan Kettering)DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid TumorsEarly-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid TumorsFirst-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid TumorsPM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal CancerPM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung CancerPM8002 in the Treatment of Patients With Advanced Solid TumorsPM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBCROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast CancerSafety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung CancerSafety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid TumorsSafety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With ChemotherapySafety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With CheSafety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung CancerSafety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy