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.
BioNTechBNT113 (tenumomeran/raplemomeran)
In Development
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.
Latest update Oct 14, 2026
01
Current status
BioNTech announced FDA Fast Track on 21 January 2026 for HPV16-positive, PD-L1-expressing head and neck cancer. On 13 October 2026 the company reported that the Phase 3 part missed its progression-free-survival dual primary; numerical PFS was not disclosed. Overall survival continues and can still make the trial positive. ClinicalTrials.gov lists the study as active, not recruiting, with 358 participants and primary completion in August 2028.
02
Upcoming milestones2
Announced next steps from BioNTech that mention BNT113 (tenumomeran/raplemomeran).
2026-2027
Additional 2026-2027 late-stage cancer readouts
Deliver further pivotal data across the now-14-trial pivotal pipeline: gotistobart's pivotal Phase 3 PRESERVE-003 stage 2 in squamous NSCLC (after non-pivotal stage 1 at WCLC 2026 posted 18.5 vs 10.0 months median OS versus docetaxel, plus January 2026 FDA Orphan Drug Designation), the BNT113 mRNA vaccine in HPV16-positive head and neck cancer, and early pivotal progress for the newly Phase 3 elfetabart drozuntecan (BNT324) in prostate cancer, dosed since May 2026. Management guided to three late-stage readouts across immunomodulator, ADC and mRNA cancer-immunotherapy programs before year-end 2026; the WCLC 2026 gotistobart OS update is one of those visibility points, while registrational stage 2 remains the confirmation test.
2026
AHEAD-MERIT overall-survival readout for BNT113
TargetOS dual primary continues after the Oct 13, 2026 PFS miss; ClinicalTrials.gov lists primary completion August 2028
03
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
Trastuzumab pamirtecan (BNT323/DB-1303)
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.
- 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.
04
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