• A differentiated -agonist- approach from BI-1808, the first-in-class antibody currently in phase 1 clinical development
• Phase 1/2a study of BI-1910 as single agent and in combination with pembrolizumab
• Exploratory cohorts planned in hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC)
• Five drug candidates in six clinical trials, reflecting the high efficiency of the F.I.R.S.T technology in identifying new targets and their corresponding antibodies

Lund, Sweden – June 2, 2023 – 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 it has received Investigational New Drug (IND) approval for the monoclonal antibody BI-1910, which will now become its second anti-tumor necrosis factor receptor 2 (TNFR2) program to enter clinical development.

BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent’s first-in-class anti-TNFR2 antibody which is currently in a Phase 1/2a trial. 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.

Using a surrogate monoclonal antibody to BI-1910 in experimental models, BioInvent has been able to take a deep dive into the search for pharmacodynamic biomarkers. These PD markers will be explored in patients and will likely provide guidance during clinical development.

The planned Phase 1/2a clinical study will be conducted in the US and Europe and will have an innovative, adaptive design to allow for ideal dose optimization. Exploratory cohorts are planned in hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC) and initial investigations will be as both a single agent and in combination with pembrolizumab.

“I am very excited to be moving BI-1910 into clinical trials to explore the potential of this differentiated anti-TNFR2 approach. We have built up a strong understanding of the biology of TNFR2 and this means we can move forward with two different monoclonal antibodies against this promising target. BI-1910 becomes the fifth product in clinical development, in six different trials, reflecting the productivity of the BioInvent technology platform and its potential to radically intervene on the tumor microenvironment and significantly improve treatment for cancer patients,” said Martin Welschof, CEO of BioInvent.

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 three drug candidates in four ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively and a fifth program just initiating clinical development. The Company’s validated, proprietary F.I.R.S.T™ technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.

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. Follow on Twitter: @BioInvent.

For further information, please contact:
Cecilia Hofvander, Senior Director Investor Relations
Phone: +46 (0)46 286 85 50
Email: cecilia.hofvander@bioinvent.com

BioInvent International AB (publ)
Co. Reg. No. Org nr: 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.