BioInvent Announces Publication of Preclinical and Early Phase 1 Data for BI-1607 in HER2-Positive Advanced Solid Tumors

LUND, SE / ACCESS Newswire / November 18, 2025 / BioInvent International (STO:BINV):

• Most (78%) patients experienced disease control (stable disease), including heavily pretreated individuals with HER2-positive breast and gastric cancers

• A favorable clinical safety profile and early signs of efficacy further support the potential of FcγRIIB-blocking monoclonal antibodies in multiple solid tumors

• BioInvent remains focused on BI-1206, its lead FcγRIIB‑blocking antibody, and BI-1808, its anti-TNFR2 antibody,and the BI‑1607 program is currently paused

BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced that preclinical data and early clinical results from its first‑in-human study of BI‑1607, a novel FcγRIIB-blocking monoclonal antibody, have been published in the peer-reviewed journal Clinical Cancer Research, a journal of the American Association for Cancer Research.

The publication, entitled "A First-in-Class Monoclonal Antibody (BI-1607) Targeting FcRIIB: Preclinical Data and First-in-Human Studies in Patients with HER2-Positive Advanced Solid Tumors," highlights the preclinical rationale and early clinical findings from the Phase 1 dose-escalation study (NCT05555251). While the BI-1607 program is currently on pause as BioInvent prioritizes its more advanced clinical-stage programs BI‑1206 and BI-1808, the Company remains encouraged by the scientific and clinical insights generated from this study.[1]

"The publication of our BI-1607 study in Clinical Cancer Research underscores the potential of FcγRIIB blockade as a novel strategy to enhance the efficacy of tumor-targeting antibodies," said Martin Welschof, Chief Executive Officer of BioInvent. "While we have paused this program to focus on our lead clinical candidates, the data further validate tailored FcyR-blockade to enhance antibody immunotherapy. Our lead FcγRIIB blocking antibody, BI-1206, is developed to enhance efficacy and overcome rituximab resistance in NHL, as well as to enhance anti-PD-1 in solid cancers."