Genmab–BioNTech Cancer Antibody Trial Ends Early: What Investors Need to Know

Biontech Se Sponsored Adr (BNTX), Genmab (Otc) (GMAB) announced an update on their ongoing clinical study.

Genmab and BioNTech have updated a key early-stage cancer trial testing their antibody GEN1055 in solid tumors. The study, officially titled “First-In-Human, Open-Label, Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of GEN1055 as Monotherapy and as Combination Therapy in Subjects With Malignant Solid Tumors,” aims to see if GEN1055 can be given safely and whether it shows early signs of benefit in advanced cancers, either on its own or together with other cancer drugs. The trial matters because it explores a new antibody approach that could add to, or improve on, current immunotherapy options.

The main treatments in the trial are GEN1055, an antibody drug given by IV, and pembrolizumab, an established immunotherapy, also given by IV. Some patients receive GEN1055 alone, some get it with pembrolizumab, and others receive a triple mix of GEN1055, pembrolizumab, and standard IV chemotherapy. The goal is to see if layering GEN1055 onto proven cancer drugs can boost responses without causing too many side effects.

The study uses an interventional design, meaning all participants receive active treatment rather than placebo. It is a Phase 1/2, open-label trial, so there is no blinding; doctors and patients know what is being given. Doses of GEN1055 are increased in steps in a “dose escalation” phase, then the most promising dose levels move into “expansion” groups that enroll more patients. The primary aim is treatment-focused: define safe dose levels and gather early data on how well tumors respond to these regimens.

The trial was first submitted in April 2024, marking the start of formal regulatory tracking and signaling the move of GEN1055 into human testing. While detailed primary and final completion dates are not provided in the extract, the design suggests each participant could be followed for up to roughly 39 months, including screening, treatment of up to 24 months, and follow-up. The record was last updated on December 24, 2025, and the status now shows as “terminated,” indicating the study ended earlier than originally planned, which may relate to safety, efficacy, strategic, or operational reasons.

For investors, the terminated status is a clear setback for this specific asset and may temper near-term enthusiasm around the GEN1055 program for both Genmab and BioNTech. It reduces optionality in their early oncology pipeline and could shift attention toward other partnered or in-house programs, where both companies still have broad immunotherapy and antibody portfolios. In a competitive field dominated by large players in checkpoint inhibitors and next-generation antibodies, the loss of a first-in-human program can raise questions on asset selection and R&D risk, but the diversified nature of both companies’ pipelines should limit long-term damage to overall equity stories. The update is likely to create short-term headline pressure, yet sentiment will hinge on management’s explanation and the progress of other late- and mid-stage assets.

The study has been updated and is no longer ongoing, with further details available on the ClinicalTrials.gov portal.

To learn more about BNTX’s potential, visit the Biontech Se Sponsored Adr drug pipeline page.