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2022-09-06

BioInvent completes the planned dose-escalation in Phase 1/2a trial of BI-1808 in advanced malignancies

  • BI-1808 shown to be safe and well tolerated with no serious adverse events observed
  • Given the positive safety and tolerability profile, higher doses will be explored
  • Three disease stabilizations observed during the escalation process
  • Cohort to explore potential synergistic activity in combination with Keytruda® is now enrolling patients

Lund, Sweden – September 6, 2022 – 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 the completion of the planned dose escalation part of its Phase 1/2a trial of the anti-TNFR2 drug candidate BI-1808. Given the positive safety and tolerability profile observed so far, a higher dose of BI-1808 as single agent will be tested to explore the effect of higher exposure.

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. Only grade 1 and 2 adverse events related or possibly related to BI-1808 were observed during treatment. Three disease stabilizations were observed during the escalation process.

“We are pleased that our Phase 1/2a trial of BI-1808 is progressing as planned. These interim results are a further reinforcement of the very promising data generated so far on BI-1808, with a very favorable tolerability profile and no safety concerns, and with translational data showing similar biomarker correlations in patient samples as we have previously observed in the preclinical setting. We look forward to continuing to investigate BI-1808 as part of our expanding pipeline, which now includes four products in five clinical trials,” said Martin Welschof, CEO of BioInvent.

The Phase 1/2a study is evaluating the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent and in combination with the anti-PD-1 therapy Keytruda® (pembrolizumab) in patients with ovarian cancer, non-small cell lung cancer and cutaneous T-cell lymphoma (CTCL). The study (NCT04752826) is expected to enroll a total of approximately 120 patients.

Completion of the planned dose escalation phase of BI-1808 as single agent will trigger the initiation of cohorts of BI-1808 in combination with Keytruda.

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 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

Disclaimer - BioInvent
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.

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BioInvent completes the planned dose-escalation in Phase 1/2a trial of BI-1808 in advanced malignancies

Författare MFN