Drugs / BI-1808
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04752826 | Jan 2021 → Dec 2026 expected | T-cell non-Hodgkin lymphoma, melanoma, ovarian cancer | BioInvent International AB | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2026-08-20 | BioInvent International AB | Results BioInvent Announces Publication of Preclinical Manuscript on BI-1808 and BI-1910 in Cancer Research bioinvent.com ↗ |
| 2026-08-07 | BioInvent International AB | Regulatory BioInvent Receives FDA Fast Track Designation for BI-1808 for the Treatment of Ovarian Cancer bioinvent.com ↗
FDA Fast Track Designation granted for BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of ovarian cancer. |
| 2026-06-11 | BioInvent International AB | Results BioInvent’s TNFR2 Antibody BI-1808 Delivers Meaningful Responses and Immune Activation as Single Agent and in Combination with KEYTRUDA® (pembrolizumab) in Advanced CTCL (EHA 2026) bioinvent.com ↗
BI-1808 monotherapy achieves 40% objective response rate (ORR), including a complete response ongoing at two years, and a 93 % disease control rate (DCR) |
| 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 ↗
Early clinical findings demonstrating meaningful and sustained responses, alongside evidence of immune activation, support its potential as both a monotherapy and combination treatment. |
| 2026-05-21 | BioInvent International AB | Results BioInvent Reveals Solid Data with its TNFR2 Antibody BI-1808 and KEYTRUDA® (pembrolizumab) in Advanced Ovarian Cancer at ASCO bioinvent.com ↗
Treatment was generally safe and well tolerated, with immune-related adverse events consistent with expectations for immunotherapy and effectively managed using standard clinical practice, and a low rate of treatment related discontinuations ( < 5%). |
| 2026-05-12 | BioInvent International AB | Results BioInvent’s TNFR2 Antibody BI-1808 Shows Strong Activity and Immune Activation as Single Agent and in Combination with KEYTRUDA® (pembrolizumab) in Advanced CTCL (EHA 2026) bioinvent.com ↗
The data underscore BI-1808’s potential as both a single agent and combination therapy in this difficult-to-treat cancer with limited therapeutic options. |
| 2026-04-21 | BioInvent International AB | Results BioInvent to Present Data of BI-1808 Plus KEYTRUDA® (Pembrolizumab) in Recurrent Ovarian Cancer at the 2026 ASCO Annual Meeting bioinvent.com ↗
The results indicated an overall response rate of 24% and a disease control rate (DCR) of 57%; 5 partial responses (PR), 7 patients with stable disease (SD), with several durable SD beyond 10 months and ongoing. |
| 2026-01-05 | BioInvent International AB | Results BioInvent Reports Promising Data from Ongoing Phase 2a study for BI-1808 with KEYTRUDA® (pembrolizumab) in Recurrent Ovarian Cancer bioinvent.com ↗
The interim data from the signal-seeking cohort of patients with recurrent ovarian cancer demonstrates an overall response rate (ORR) of 24%, which represents a meaningful improvement over pembrolizumab monotherapy. |
| 2025-12-07 | BioInvent International AB | Results BioInvent Presents Promising Early Phase 2a BI-1808 Monotherapy Data in CTCL at ASH 2025 bioinvent.com ↗
Overall, treatment has been well‑tolerated with encouraging monotherapy activity in patients with CTCL; n=14; (13 evaluable for efficacy) and peripheral T-cell lymphoma (PTCL; n=2). |
| 2025-11-17 | BioInvent International AB | Regulatory EMA Positive Opinion for Orphan Drug Designation to BioInvent’s BI‑1808 for the Treatment of Cutaneous T-cell Lymphoma bioinvent.com ↗
The positive opinion by the EMA underscores the potential of our anti-TNFR2 approach to address serious and underserved hematologic malignancies |
| 2025-11-03 | BioInvent International AB | Results BioInvent to Present Updated Phase 2a BI-1808 Monotherapy Data in CTCL at ASH 2025 bioinvent.com ↗
Data from this signal-seeking cohort show efficacy associated with strong immune activation with a very high disease control rate (DCR), demonstrating the continued promise of BI-1808 to deliver meaningful clinical benefit. |
| 2025-06-12 | BioInvent International AB | Results BioInvent Presents Promising Phase 2a Monotherapy Data for BI-1808 in CTCL at EHA 2025 bioinvent.com ↗
As of the cut-off date May 15, 2025, data showed a 100% disease control rate in nine evaluable patients with CTCL. |
| 2025-05-14 | BioInvent International AB | Results BioInvent Presents Additional CTCL Phase 2a Data for BI-1808 Monotherapy at EHA 2025 bioinvent.com ↗
As of the cut-off date February 20, 2025, one patient had achieved a complete response (CR), three achieved partial response (PR), and four demonstrated stable disease (SD). |
| 2025-04-29 | BioInvent International AB | Regulatory BioInvent Receives FDA Fast Track Designation for BI-1808 for the Treatment of Cutaneous T-cell Lymphoma bioinvent.com ↗ |
| 2025-03-20 | BioInvent International AB | Regulatory BioInvent Receives FDA Orphan Drug Designation for BI-1808 for the Treatment of T-cell 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 the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for BI-1808, a first-in-class anti-TNFR2 antibody for the treatment of T-cell Lymphoma (TCL). |
| 2025-01-08 | BioInvent International AB | Results BioInvent announces promising data for BI-1910 as single agent from Phase 1 study in solid tumors bioinvent.com ↗
Today’s announcement on BI-1910, together with data on BI-1808 showing deepening responses in CTCL patients, further validates this target as a novel immune checkpoint |
| 2024-09-09 | BioInvent International AB | Results BioInvent Announces Additional Positive Efficacy Data with Single Agent BI-1808 from the Phase 2a anti-TNFR2 program bioinvent.com ↗
Three out of four evaluable patients achieved a partial response (PR) in the CTCL cohort of patients who had progressed after standard therapy. |
| 2024-05-23 | BioInvent International AB | Results BioInvent Presents Promising Clinical Efficacy and Safety for anti-TNFR2 agent BI-1808 at ASCO 2024 bioinvent.com ↗
Initial efficacy and safety data from the ongoing Phase 1/2a study show: One complete response (CR), one partial response (PR) that is still improving, and nine patients with stable disease (SD) in single agent arm of BI-1808 |
| 2023-11-03 | BioInvent International AB | Results BioInvent presents positive data at SITC from clinical Phase 1/2a trial of BI-1808 as single agent bioinvent.com ↗
BI-1808 administered as single agent induced a robust partial response (PR) in a patient with a gastrointestinal tumor (GIST) who had received 12 previous lines of treatment. |
| 2023-06-21 | BioInvent International AB | Results BioInvent reports strong interim safety data and early signs of efficacy in Phase 1/2a trial with anti-TNFR2 antibody BI-1808 in advanced malignancies bioinvent.com ↗
The BI-1808 infusions were well tolerated and no dose limiting toxicity or serious adverse events related to BI-1808 were observed, at any dose level. |
| 2022-09-06 | BioInvent International AB | Results BioInvent completes the planned dose-escalation in Phase 1/2a trial of BI-1808 in advanced malignancies bioinvent.com ↗
In the ongoing study, BI-1808 was shown to be safe and well tolerated with no serious adverse events or dose-limiting toxicity observed during dose-escalation. |
| 2022-03-08 | BioInvent International AB | Results BioInvent AACR data boost prospects for BI-1808 bioinvent.com ↗
Like in the preclinical studies, correlations between dose, RO and soluble TNFR2 have clearly been observed in patients in the ongoing Phase 1/2a clinical trial. |
| 2021-04-07 | BioInvent International AB | Regulatory BioInvent receives IND approval for Phase I/IIa trial of anti-TNFR2 antibody BI-1808 bioinvent.com ↗
BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) for the Phase I/IIa clinical study of the immuno-modulatory anti-TNFR2 antibody BI-1808. |
| 2020-11-09 | BioInvent International AB | Results BioInvent presents new preclinical data on BI-1808, a first-in-class anti-TNFR2 antibody at the SITC 35[th] Anniversary Annual Meeting bioinvent.com ↗
The data showed that BI-1808 had an expected pharmacokinetic (PK) profile and was well tolerated in doses up to 200 mg/kg. |
| 2020-10-26 | BioInvent International AB | Regulatory CTA approval of BioInvent's BI-1808, a first-in-class anti-TNFR2 antibody, sets stage for Phase I/IIa trial bioinvent.com ↗ |
| 2020-06-30 | BioInvent International AB | Regulatory BioInvent submits a CTA for a Phase I/IIa trial of BI-1808, a first-in-class anti-TNFR2 antibody for the treatment of patients with solid tumors and CTCL bioinvent.com ↗ |
| 2020-06-22 | BioInvent International AB | Results BioInvent presents proof-of-concept data for two TNFR2-targeting antibodies bioinvent.com ↗
Both antibodies showed significant antitumor activity in several immunocompetent models |
| 2020-05-15 | BioInvent International AB | Results BioInvent expands anti-TNFR2 program by selecting second monoclonal antibody for further development bioinvent.com ↗
Targeting TNFR2 demonstrates compelling therapeutic effects in syngeneic solid cancer models spanning "hot" and "cold" tumors. |
All press releases naming this drug 39 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BI-1808 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04752826 ↗ |
| Modality | Monoclonal antibody | “BI-1808, a Monoclonal Antibody to TNFR 2” NCT04752826 ↗ |
| Route | Intravenous | “flat-dose IV infusion” NCT04752826 ↗ |