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.
BioNTechBNT327 (pumitamig)
In Development
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.
Latest update Sep 15, 2026
01
Current status
Seven pivotal trials in the ROSETTA program under way (five initiated in H1 2026 alone) across small-cell and non-small-cell lung cancer, triple-negative breast, gastric and colorectal cancers. More than 1,000 patients treated to date; ASCO 2026 data marked the third global dataset consistently showing efficacy across PD-L1 expression levels, with registrational first-line lung-cancer readouts still expected in 2026. At WCLC 2026 (September 12), first pumitamig plus elfetabart drozuntecan combo data showed a 70.4% ORR and 93.0% DCR in 71 evaluable SCLC patients.
02
Specifications2
03
Upcoming milestones2
Announced next steps from BioNTech that mention BNT327 (pumitamig).
2026-2027
BNT327 first-line lung-cancer Phase 3 readouts
Report registrational Phase 3 data for BNT327 (pumitamig) in first-line lung cancer - the key catalyst for its central immuno-oncology bet with Bristol Myers Squibb. The pivotal ROSETTA program (7 trials, 5 initiated in H1 2026) spans ROSETTA Lung-01 (1L extensive-stage small-cell lung cancer), ROSETTA Lung-02 (1L non-small-cell lung cancer), ROSETTA Lung-201 (unresectable stage III NSCLC vs durvalumab) and ROSETTA Lung-202 (1L PD-L1>=50% NSCLC vs pembrolizumab). As of the August 2026 Q2 update, ASCO 2026 data marked a third consistent global dataset showing efficacy across PD-L1 levels, but the registrational Phase 3 portions remain recruiting with no pivotal readout yet. BioNTech now runs 16 lung-cancer trials companywide (5 pivotal Phase 3 plus 2 novel-novel combination studies). WCLC 2026 (Seoul, September 12-15) delivered first pumitamig plus elfetabart drozuntecan combo data (70.4% ORR in SCLC) and the first median OS for gotistobart in PRESERVE-003 stage 1.
2030
Become a multi-product oncology company by 2030
Scale BNT327 across its seven-plus pivotal indications and broaden the now-14-trial pivotal pipeline (spanning trastuzumab pamirtecan, elfetabart drozuntecan and gotistobart) while deploying the ~€16.6B cash reserve and cutting COVID-era manufacturing costs, targeting multiple approved cancer products by the end of the decade. Markets rewarded the pivot on August 19, 2026, when the stock jumped ~23% as investors refocused on the oncology pipeline. WCLC 2026 combo and gotistobart data are the latest visibility points; no oncology product is approved yet.
04
More from BioNTech6
- 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.
- 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.
05
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