Drugs / BI-1607
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06784648 | Dec 2024 → Sep 2026 overdue | cutaneous melanoma, metastatic melanoma, uveal melanoma | BioInvent International AB | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05555251 | Jul 2022 → Feb 2024 | HER2 positive breast carcinoma, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | BioInvent International AB | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-07-28 | BioInvent International AB | Results BioInvent Publication in JECCR: Tailored FcγR Blockade with BI-1206 and BI-1607 Enhances Cancer Antibody Therapies and Overcomes Resistance in Preclinical Models bioinvent.com ↗
In the same study, structurally distinct anti-FcγRIIB antibody variants, BI-1607 and its murine surrogate, engineered with an Fc-silenced Fc domain, were shown to enhance αCTLA-4 antibodies, including ipilimumab, through selective FcγRIIB blockade. |
| 2025-11-18 | BioInvent International AB | Results BioInvent Announces Publication of Preclinical and Early Phase 1 Data for BI-1607 in HER2-Positive Advanced Solid Tumors bioinvent.com ↗
Most (78%) patients experienced disease control (stable disease), including heavily pretreated individuals with HER2-positive breast and gastric cancers |
| 2023-12-05 | BioInvent International AB | Results BioInvent presents positive first clinical data on anti-FcyRIIB antibody BI-1607 bioinvent.com ↗
Treatment was well tolerated and no serious adverse events related to BI-1607 were observed. |
| 2022-12-08 | BioInvent International AB | Results BioInvent Outlines Strong Progress in Clinical and Preclinical Pipeline at R&D Day 2022 bioinvent.com ↗
Latest data from the Phase 1/2 trial with BI-1206 in combination with rituximab in NHL show there are three ongoing complete responses, two beyond two years after end of treatment, and four partial responses, one of which is ongoing. |
| 2022-11-18 | BioInvent International AB | Regulatory BioInvent receives FDA IND approval for anti-FcyRIIB antibody BI-1607 bioinvent.com ↗
today announces the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its FcyRIIB-blocking antibody BI-1607. |
| 2022-03-08 | BioInvent International AB | Results BioInvent’s BI-1607 to extend reach of anti-FcyRIIB approach to breast cancer bioinvent.com ↗
The AACR22 data show that a BI-1607 surrogate antibody enhances the therapeutic efficacy of anti-HER2 antibodies in a syngeneic in vivo tumor model system. |
| 2021-12-08 | BioInvent International AB | Regulatory BioInvent has submitted a CTA for a Phase 1/2a trial of BI-1607, a novel anti-FcyRIIB antibody for the treatment of patients with solid tumors bioinvent.com ↗
today announces it has submitted a Clinical Trial Application (CTA) for the novel, fully human FcyRIIB-blocking antibody, BI-1607. |
| 2021-03-11 | BioInvent International AB | Results BioInvent presents proof-of-concept data on anti-FcyRIIB antibody BI-1607 at AACR Annual Meeting 2021 bioinvent.com ↗
The data on BI-1607 are very exciting and provide proof-of-concept of its ability to enhance anti-cancer immunity, illustrated by its ability to boost activity and overcome resistance to CTLA-4-based therapy, |
All press releases naming this drug 12 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BI-1607 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06784648 ↗ |
| Action | Inhibit | “BI-1607 is a human mAb that specifically blocks FcγRIIB” PMID 41071338 ↗ Dec 2025 |
| Modality | Monoclonal antibody | “BI-1607 is a human mAb” PMID 41071338 ↗ Dec 2025 |
| Route | Intravenous | “administered at different doses in Phase I by intravenous infusions every 3 weeks.” NCT05555251 ↗ |