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.
BioNTechGotistobart (BNT316/ONC-392)
In Development
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.
Latest update Sep 14, 2026
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Current status
Pivotal, two-stage Phase 3 PRESERVE-003 trial (691 patients total) versus docetaxel in metastatic squamous NSCLC after progression on a PD-(L)1 inhibitor. Non-pivotal stage 1 at WCLC 2026 (September 14, 2026) reported the first median overall survival: 18.5 months for gotistobart versus 10.0 months for docetaxel (HR 0.56; nominal p=0.0295) in 87 patients after 25.4 months median follow-up, after ELCC 2026 had shown a 54% reduction in risk of death with median OS not yet reached. Pivotal stage 2 is ongoing at more than 160 sites globally. The FDA granted Orphan Drug Designation in squamous NSCLC in January 2026, on top of a 2022 Fast Track designation.
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Specifications2
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In the news1
Gotistobart nearly doubles survival in squamous NSCLC
BioNTech and OncoC4 presented the first median overall-survival data from non-pivotal stage 1 of the Phase 3 PRESERVE-003 trial at WCLC on September 14: gotistobart (BNT316/ONC-392) posted 18.5 months median OS versus 10.0 months for docetaxel (HR 0.56; nominal p=0.0295). The July 17, 2026 cut-off covered 87 previously treated squamous NSCLC patients (45 gotistobart, 42 docetaxel) after a median 25.4 months of follow-up; grade 3 or higher treatment-related adverse events were 44.4 percent versus 48.8 percent. Pivotal stage 2 is ongoing at more than 160 sites.
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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
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
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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