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 Oct 29, 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. On Oct. 26, 2026 a different Phase 3, DYNASTY-Breast02 in chemotherapy-naive HR-positive HER2-low metastatic breast cancer, met PFS with a statistically significant but modest improvement. The release gives no median, hazard ratio, confidence interval, or event count, says overall survival is immature, and says the companies will discuss next steps. They did not name a new trial or filing for that setting.
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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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