Population model successfully developed to characterize BI-1910 pharmacokinetics and pharmacodynamics across a broad range of doses
Model will support dose selection for upcoming studies; Phase 2a as single agent and in combination with pembrolizumab planned to start in H2 2025
Poster to be presented at PAGE 2025 to be held in Thessaloniki, Greece, June 4 to 6, 2025
LUND, SE / ACCESS Newswire / June 4, 2025 / 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 the presentation of a poster highlighting the model-informed early clinical development of the company's anti-TNFR2 program BI-1910 at the Population Approach Group in Europe (PAGE) 2025 meeting, being held in Thessaloniki, Greece from June 4 to 6, 2025.
"We are very pleased to be showcasing our anti-TNFR2 program BI-1910 at this year's PAGE meeting, and in particular how model-based methods derived from clinical data can be used to support early clinical development and dose selections for upcoming studies," said Martin Welschof, Chief Executive Officer of BioInvent. "The indicated wide therapeutic dose range of BI-1910 could bring multiple benefits to the product in terms of clinical utility, safety and market potential. We look forward to continuing the rapid progress including initiation of both the combination and single agent parts of the Phase 2a study during the second half of this year."
BI-1910 data and progress
BI-1910 is being investigated as both a single agent and in combination with KEYTRUDA ® (pembrolizumab). The first part of the BI-1910 Phase 1/2a study was a dose escalation Phase 1 study to evaluate the safety, tolerability, and potential signs of efficacy of BI-1910 as a single agent (Part A) in patients with advanced solid tumors. In another part of the study, BI-1910 in combination (Part B) with MSD's anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab) were evaluated. Both Phase 1 parts have been successfully concluded.
In January 2025 BioInvent reported stable disease for six out of 12 evaluable patients in the single agent dose escalation Phase 1 study. The data also indicated a favorable pharmacokinetic profile and a robust target engagement, with patients in the target dose range demonstrating induction of T cell proliferation.
The Phase 2a study of BI-1910 as a single agent (Part A) in several tumor types including HCC (hepatocellular cancer) patients is planned to start in H2 2025. Furthermore, BioInvent will also initiate Phase 2a part of the study evaluating BI-1910 with pembrolizumab (Part B) in the same indications during H2 2025.
BI-1910 Poster at PAGE 2025
Title: A population modelling framework to support early clinical development of BI-1910, an agonist monoclonal antibody for tumor necrosis factor 2
Abstract Number: 11618
Session: Drug/Disease Modelling - Oncology
Date: Thursday June 5, 2025
Time: 9:50-11:45 AM CEST
The full poster will be posted to the company's website https://www.bioinvent.com/en/our-science/scientific-publications .
KEYTRUDA ® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About BI-1910
BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent's first-in-class anti-TNFR2 antibody currently in a Phase 1/2a development. Both monoclonal antibodies were chosen as potential best-in-class, from a large family of binders generated through BioInvent's proprietary F.I.R.S.T technology platform.
About BioInvent
BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities.
The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com.
For further information, please contact:
Cecilia Hofvander, VP Investor Relations
Phone: +46 (0)46 286 85 50
Email: cecilia.hofvander@bioinvent.com
BioInvent International AB (publ)
Co. Reg. No. 556537-7263
Visiting address: Ideongatan 1
Mailing address: 223 70 LUND
Phone: +46 (0)46 286 85 50
www.bioinvent.com
The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.
Attachments
BioInvent Presents at PAGE 2025 a Poster Highlighting Model-Informed Early Clinical Development of anti-TNFR2 drug candidate BI-1910
SOURCE: BioInvent International
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/bioinvent-presents-at-page-2025-a-poster-highlighting-model-informed-early-clinical-d-1035315
