Drugs / BI-1206
BI-1206
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04219254 | Jun 2020 → Nov 2027 expected | cancer | BioInvent International AB | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03571568 | May 2018 → Sep 2027 expected | indolent B-cell non-Hodgkin lymphoma | BioInvent International AB | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02933320 | Oct 2016 → Mar 2020 | B-cell chronic lymphocytic leukemia, Waldenstrom macroglobulinemia | Cancer Research UK | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 37
| 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 ↗
BI-1206, an anti-FcγRIIB antibody with a wild-type Fc domain, was shown to enhance the activity of the approved αPD-1 antibodies nivolumab and pembrolizumab by protecting effector CD8+ T cells from macrophage-mediated depletion. |
| 2026-06-11 | BioInvent International AB | Results BioInvent’s BI-1206 Triplet Achieves 83% Response Rate in Refractory NHL with Improved Safety vs. SOC (EHA 2026) bioinvent.com ↗
Acalabrutinib (Calquence ® ) with BI-1206 + rituximab boosted efficacy without increasing toxicity |
| 2026-06-01 | BioInvent International AB | Results BioInvent to Host a KOL Event in Stockholm on June 11, 2026, to Discuss Updated BI-1206 & BI-1808 Data in Hematology bioinvent.com ↗
Presentations will include new insights into BI-1206’s ability to overcome resistance to rituximab through FcγRIIB blockade, including encouraging activity observed in the triple combination with rituximab and Calquence® (acalabrutinib) in patients with relapsed or refractory NHL. |
| 2025-12-08 | BioInvent International AB | Results BioInvent Presents Impressive Response Data from Ongoing Phase 2a Trial of Triple Combination BI-1206, Rituximab, and Calquence in r/r NHL at ASH 2025 bioinvent.com ↗
47% of patients exhibited complete responses (CR), with an overall response rate of 80% |
| 2025-11-03 | BioInvent International AB | Results BioInvent to Present Early Phase 2a Data from Ongoing Trial with Triple Combination of BI-1206, Rituximab, and Calquence in r/r NHL, at ASH 2025 bioinvent.com ↗
Abstract data (as of August 4, 2025) published in the November supplemental issue of Blood demonstrates that the triple combination regimen is safe and well-tolerated, with encouraging efficacy data. |
| 2025-06-11 | BioInvent International AB | Results BioInvent Announces Promising Phase 1 Data of BI-1206 in Combination with KEYTRUDA® (pembrolizumab) in Solid Tumors bioinvent.com ↗
The Phase 1 dose escalation has been completed, and results show encouraging early signs of clinical activity in solid tumors with one complete response, one long-lasting partial response, and 11 patients with stable disease. |
| 2025-05-14 | BioInvent International AB | Results BioInvent Announces Updated Phase 2a Triple Combination Arm Data of BI-1206, rituximab, and Calquence for the treatment of non-Hodgkin's lymphoma bioinvent.com ↗
All patients exhibited disease control at first assessment (DCR 100%), and results show an overall objective response rate of 63% with two patients achieving a complete response (CR) and three patients with partial responses (PR). |
| 2025-01-08 | BioInvent International AB | Results BioInvent announces promising initial efficacy data from triple combination arm of BI-1206, rituximab and Calquence for the treatment of non-Hodgkin's lymphoma bioinvent.com ↗
The preliminary data demonstrates that the combination treatment is well tolerated with the two enrolled patients already showing clinical responses. |
| 2024-10-31 | BioInvent International AB | Results BioInvent International AB: Interim report January–September 2024 bioinvent.com ↗
As part of our Q3 report, we are today pleased to present continued positive data from the Phase 1 part of the study with BI-1206 as a subcutaneous (SC) formulation for the treatment of NHL. |
| 2024-05-23 | BioInvent International AB | Results BioInvent Presents Promising Phase 1 Data for BI-1206 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Solid Tumors at ASCO 2024 bioinvent.com ↗
The data show promising and durable responses in patients who previously failed on anti-PD-1/L1 therapy. |
| 2024-05-14 | BioInvent International AB | Results BioInvent to Present Additional Promising Phase 1/2a Data at EHA 2024 for BI-1206 with rituximab in NHL bioinvent.com ↗
Further updates from the IV arm; a fifth CR has been observed, adding to a total of 5 CR, 1 PR and 6 SD out of 17 evaluable patients. |
| 2024-03-05 | BioInvent International AB | Results BioInvent International: CASI Pharmaceuticals Report Positive Interim Phase 1 Data For BI-1206 In The Treatment Of Relapsed/Refractory Indolent Non-Hodgkin’s Lymphoma In China bioinvent.com ↗
The Phase 1 dose-escalation study showed impressive signs of clinical efficacy, with 4 partial responses (PR) and 1 complete response (CR) out of 8 evaluable patients. |
| 2024-03-05 | CASI pharmaceuticals, Inc. | Results CASI Pharmaceuticals Report Positive Interim Phase 1 Data For BI-1206 In The Treatment Of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma In China issuerdirect.com ↗
The Phase 1 dose-escalation study showed impressive signs of clinical efficacy, with 4 partial responses (PR) and 1 complete response (CR) out of 8 evaluable patients. |
| 2023-06-13 | BioInvent International AB | Results BioInvent Announces Abstract Presentation of BI-1206 at the 17th International Conference of Malignant Lymphoma 2023 bioinvent.com ↗
In the IV dose escalation cohort, responses have been observed across the dose range of 30-100 mg, including 4 complete responders (CR), 3 partial responders (PR) and 4 cases of stable disease (SD) out of 15 evaluable patients. |
| 2023-06-07 | BioInvent International AB | Results BioInvent announces additional efficacy data from intravenous part of Phase 1/2 trial with BI-1206 in solid tumors bioinvent.com ↗
One additional patient has developed a partial response (PR) and one patient has remained on stable disease for over 80 weeks |
| 2023-04-26 | BioInvent International AB | Results BioInvent International AB: Interim report January-March 2023 bioinvent.com ↗
We now have a fourth complete response in the ongoing Phase 1/2 trial with BI-1206 in combination with rituximab in non-Hodgkin’s lymphoma. |
| 2023-04-20 | BioInvent International AB | Results BioInvent announces a fourth complete response in Phase 1/2 trial with BI-1206 in non-Hodgkin’s lymphoma bioinvent.com ↗
For the IV arm of the study in total, clinical responses (complete and partial responses) have been observed in 7 out of 15 evaluable patients and in addition, 4 patients have shown stable disease. |
| 2022-12-08 | BioInvent International AB | Regulatory BioInvent Outlines Strong Progress in Clinical and Preclinical Pipeline at R&D Day 2022 bioinvent.com ↗
The U.S. Food and Drug Administration (FDA) has approved BioInvent’s Investigational New Drug (IND) application for its FcyRIIB-blocking antibody BI-1607. |
| 2022-01-20 | CASI pharmaceuticals, Inc. | Regulatory CASI PHARMACEUTICALS PARTNER, BIOINVENT, ANNOUNCES BI -1206 GRANTED ORPHAN DRUG DESIGNATION BY THE U.S. FDA FOR THE TREATMENT OF PATIENTS WITH FOLLICULAR LYMPHOMA issuerdirect.com ↗
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announced today, that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its partner BioInvent International AB, for BI-1206, an investigational anti-FcyRllB antibody, for the treatment of follicular lymphoma (FL), the most common form of slow-growing Non-Hodgkin lymphoma (NHL). |
| 2022-01-19 | BioInvent International AB | Regulatory BioInvent: The FDA grants Orphan Drug Designation to BI-1206 for the treatment of follicular lymphoma bioinvent.com ↗
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 announces that its anti-FcyRllB antibody BI-1206 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of follicular lymphoma (FL), the most common form of slow-growing Non-Hodgkin lymphoma. |
| 2021-12-17 | BioInvent International AB | Results BioInvent announces positive early data from ongoing solid cancer trial of BI-1206 in combination with pembrolizumab bioinvent.com ↗
Early observations are that BI-1206 may stem and reverse metastatic disease progression in patients who have previously progressed on PD-1/PDL-1 therapies and other prior treatments. |
| 2021-12-11 | BioInvent International AB | Results BioInvent’s latest NHL data at ASH show increased and sustained responses to BI-1206 in relapsed patients bioinvent.com ↗
When considered alone, the response rate for Follicular lymphoma is particularly impressive: of nine evaluable patients, three developed a CR, three developed a PR and one patient had SD at the cut-off date, giving a 67% ORR and 78% DCR. |
| 2021-12-10 | BioInvent International AB | Regulatory BioInvent and CASI Pharmaceuticals announce CTA approval for clinical studies of BI-1206 in NHL in China bioinvent.com ↗ |
| 2021-12-10 | CASI pharmaceuticals, Inc. | Regulatory CASI PHARMACEUTICALS AND BIOINVENT ANNOUNCE CTA APPROVAL FOR CLINICAL STUDY OF BI-1206 IN NHL IN CHINA issuerdirect.com ↗ |
| 2021-12-10 | CASI pharmaceuticals, Inc. | Regulatory BioInvent and CASI Pharmaceuticals Announce CTA Approval for Clinical Studies of BI-1206 in NHL in China issuerdirect.com ↗
BioInvent and CASI Pharmaceuticals Announce CTA Approval for Clinical Studies of BI-1206 in NHL in China |
| 2021-11-05 | CASI pharmaceuticals, Inc. | Results CASI Pharmaceuticals Partner, BioInvent, To Present Further Positive Clinical Data On BI-1206 At ASH 2021 issuerdirect.com ↗
BI-1206, in combination with rituximab, demonstrated an objective response rate (ORR) of 50%, with three complete responses and three partial responses seen in twelve patients evaluated for therapeutic benefit. |
| 2021-11-04 | BioInvent International AB | Results BioInvent to show further positive BI-1206 clinical data in December at ASH 2021 bioinvent.com ↗
BI-1206 in combination with rituximab demonstrated an objective response rate (ORR) of 50%, with three complete responses and three partial responses seen in twelve patients evaluated for therapeutic benefit. |
| 2021-01-28 | BioInvent International AB | Results BioInvent Phase I/IIa data suggest BI-1206 restores activity of rituximab in relapsed non-Hodgkin's lymphoma patients bioinvent.com ↗
Of the 9 patients who completed the induction cycle, 6 patients have shown either complete or partial responses several of which are still ongoing. |
| 2021-01-28 | CASI pharmaceuticals, Inc. | Results CASI Pharmaceuticals Partner, BioInvent, Presents Phase I/IIA Data That Suggests BI-1206 Restores Activity Of Rituximab In Relapsed Non-Hodgkin's Lymphoma Patients issuerdirect.com ↗
Responses in 6 out of 9 patients evaluated provide exciting evidence that BI-1206 has the potential to restore activity of rituximab in non-Hodgkin's lymphoma patients who have relapsed after treatment with rituximab |
| 2020-11-04 | BioInvent International AB | Results BioInvent presents promising new clinical and preclinical data on anti-FcγRllB antibody, BI-1206, at the ASH Annual Meeting bioinvent.com ↗
Furthermore, complete (CR) and partial (PR) clinical responses, as assessed by reduction of tumor size, were observed, in particular in the 70 mg cohort, where 3 of 5 patients have shown clinical responses. |
| 2020-04-14 | BioInvent International AB | Results BioInvent reports promising progress in Phase I/lla trial of lead program BI-1206 in combination with rituximab bioinvent.com ↗
In the Phase I part of the trial, three separate responses have been observed across different subtypes of NHL at doses of BI-1206 below what is believed to be optimal. |
| 2019-11-08 | BioInvent International AB | Results BioInvent to present BI-1206 preclinical data in mantle cell lymphoma at ASH 2019 bioinvent.com ↗
Single agent BI-1206 had potent anti-MCL activity in the FcγRIIb-expressing MCL PDX model to overcome ibrutinib-venetoclax dual resistance. |
| 2019-06-12 | BioInvent International AB | Results BioInvent publishes first clinical data from BI-1206 Phase l/lla trials bioinvent.com ↗
Receptor occupancy is dose proportionate and anticipated to yield high levels of receptor blockade at clinically relevant doses of BI-1206. |
| 2019-01-30 | BioInvent International AB | Regulatory BioInvent receives FDA orphan designation for BI-1206 for mantle cell lymphoma bioinvent.com ↗
BioInvent International AB (OMXS: BINV) announces today that the U.S. Food and Drug Administration (FDA) has granted the Company orphan designation for its proprietary antibody BI-1206 for the treatment of mantle cell lymphoma (MCL). |
| 2018-07-12 | BioInvent International AB | Regulatory FDA approval allows BioInvent to open up U.S. sites in the new Phase I/IIa study of BI-1206 bioinvent.com ↗
BioInvent International AB (OMXS: BINV) announced today that the U.S. Food and Drug Administration (FDA) has accepted BioInvent’s Investigational New Drug (IND) Application for its new clinical study that will explore the activity of its proprietary monoclonal antibody BI-1206 in combination with rituximab. |
| 2018-05-09 | BioInvent International AB | Regulatory BioInvent ready to start a Phase I/IIa study of BI-1206 in combination with rituximab in patients with non-Hodgkin lymphoma bioinvent.com ↗
BioInvent International AB (OMXS: BINV) announced today that it has received authorization to proceed from the Swedish Medical Product Agency for a new clinical trial that will study the activity of its proprietary monoclonal antibody BI-1206. |
| 2015-04-14 | BioInvent International AB | Results Cancer Cell publishes data highlighting the potential of BioInvent's BI-1206 to help overcome antibody drug resistance in cancer therapy bioinvent.com ↗
However, the researchers showed that a new antibody developed by BioInvent, called BI-1206, can effectively prevent this drug destruction process and enhance cancer killing by binding to a molecule called FcgRIIB. |
All press releases naming this drug 66 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BI1206 | “BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB)” NCT04219254 ↗ |
| Known as | 6G11 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594465 ↗ |
| Known as | Anti-hfcgammariib mab bi-1206 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594465 ↗ |
| Action | Deplete | “is thought to act by recruiting host immune cells toward the tumour leading to cancer cell death” NCT02933320 ↗ |
| Modality | Monoclonal antibody | “BI-1206, is an anti-CD32b monoclonal antibody” NCT02933320 ↗ |
| Route | Intravenous | “BI-1206 given by IV infusion” NCT02933320 ↗ |