• Strong interim safety data on BI-1808 as single agent reported in June 2023
• Next data readout, from Phase 1 combination part of trial, to come in H1 2024

Lund, Sweden – September 22, 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 recruitment of the first patient in the single agent Phase 2a part of its Phase 1/2a trial of its first-in-class anti-TNFR2 antibody BI-1808 in advanced malignancies.

In June 2023, BioInvent reported strong interim safety data on BI-1808 as a single agent, from the dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study. The trial is investigating the use of BI-1808 as a single agent and in combination with pembrolizumab in subjects with advanced malignancies, whose disease has progressed after standard therapy.

Stable disease as best response was observed in six subjects during the single agent dose escalation part. The efficacy of BI-1808 as single agent will now be further explored in the Phase 2a part of the trial in a larger sample of patients. In addition to the originally planned expansion cohorts in lung cancer, ovarian cancer and cutaneous T cell lymphoma (CTCL), BioInvent plans to enlarge the scope of the signal seeking cohorts to include new cohorts in melanoma and other forms of T cell lymphomas. This is driven by the exciting data observed so far.

“We are very pleased to initiate this Phase 2a part of our clinical trial of BI-1808. The reported early clinical data are highly encouraging, and we are excited to further investigate the safety and efficacy profile of our antibody in a larger number of patients, and different clinical settings. We are also looking forward to the next data readout from the Phase 1 part of the trial, on BI-1808 in combination with pembrolizumab, in H1 2024,” 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 four drug candidates in five ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively. 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 drug 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. Follow on social media platform X: @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

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