Active
Comirnaty
The mRNA COVID-19 vaccine (BNT162b2 / tozinameran) co-developed and commercialized with Pfizer - the first mRNA vaccine authorized for human use and the product that validated the platform at global scale.
BioNTechTrastuzumab pamirtecan (BNT323/DB-1303)
In Development
A HER2-targeted antibody-drug conjugate (third-generation topoisomerase-1 inhibitor payload) co-developed with China's DualityBio - BioNTech's lead candidate for its first-ever cancer-drug regulatory submission, being tested in HER2-expressing endometrial cancer and HER2-positive breast cancer.
Latest update Aug 22, 2026
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Current status
Phase 2 data (cutoff October 17, 2025) showed a 47.9% objective response rate in HER2-expressing advanced/recurrent endometrial cancer (exceeding 70% in IHC 3+ patients), with 8.0-month median progression-free survival and 15.0-month median overall survival; additional ESMO Gynaecological Cancers Congress 2026 data (June 2026) confirmed durable activity and a manageable safety profile, and the registrational endometrial-cancer cohort is now fully recruited. A separate pivotal Phase 3 trial (DB-1303-O-3001) in HER2-positive metastatic/unresectable breast cancer met its primary endpoint of progression-free survival versus trastuzumab emtansine (T-DM1); on that data, partner DualityBio's China BLA for the breast-cancer indication was accepted for review by the NMPA on April 9, 2026 - the first regulatory filing acceptance anywhere for the asset. The endometrial-cancer indication has not yet been filed anywhere; BioNTech and DualityBio are still determining the optimal US regulatory path across both indications, with a US BLA filing still planned for 2026.
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Specifications3
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More from BioNTech6
- In Development
BNT327 (pumitamig)
BioNTech's flagship oncology asset: a next-generation bispecific antibody targeting both PD-L1 and VEGF-A, gained via the Biotheus acquisition and positioned as a potential immuno-oncology backbone across many solid tumors. Co-developed with Bristol Myers Squibb.
- In Development
Autogene cevumeran (BNT122)
An individualized neoantigen-specific mRNA cancer vaccine, custom-manufactured for each patient's tumor mutations and co-developed with Genentech (Roche) to train the immune system against residual disease after surgery.
- In Development
Elfetabart drozuntecan (BNT324/DB-1311)
A next-generation, topoisomerase-1-inhibitor-based antibody-drug conjugate targeting the immune-checkpoint protein B7-H3, co-developed with China's DualityBio - BioNTech's third late-stage oncology asset alongside BNT327 and trastuzumab pamirtecan, with clinical experience across more than ten tumor types.
- In Development
Gotistobart (BNT316/ONC-392)
A next-generation, pH-sensitive anti-CTLA-4 antibody designed to deplete regulatory T cells within tumors while sparing normal tissue, co-developed with OncoC4 since a March 2023 strategic collaboration ($200M upfront to OncoC4, costs and profits split on PD-(L)1 combination studies, BioNTech holding exclusive worldwide commercialization rights). It is BioNTech's fourth late-stage oncology asset alongside BNT327, trastuzumab pamirtecan, and elfetabart drozuntecan.
- In Development
BNT113 (tenumomeran/raplemomeran)
Investigational mRNA cancer immunotherapy encoding the HPV16 E6 and E7 proteins, also called tenu-ra. It is designed to induce HPV16-specific immune responses alongside checkpoint-inhibitor treatment. The lead study is AHEAD-MERIT (NCT04534205), a Phase 2/3 trial of BNT113 plus pembrolizumab versus pembrolizumab alone in first-line unresectable recurrent or metastatic HPV16-positive, PD-L1-expressing head and neck cancer.
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