• Phase 1 data from 18 patients treated with BI-1607 in combination with trastuzumab presented at San Antonio Breast Cancer Symposium
• BI-1607 well tolerated with no serious adverse events, at doses of 75-900mg
• Stable disease have been observed in 6/11 evaluable patients who had previously progressed after trastuzumab containing lines of treatment

Lund, Sweden – December 5, 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 presents the first clinical data from a Phase 1/2a trial of its second FcyRIIB-blocking antibody BI-1607. BioInvent pipeline currently includes five drug candidates progressing through six clinical trials.

The Phase 1 data, presented in a poster at the San Antonio Breast Cancer Symposium, covered 18 patients treated at doses ranging from 75 mg up to 900 mg flat dose. Treatment was well tolerated and no serious adverse events related to BI-1607 were observed. The best clinical response reported in the poster was stable disease (SD) in 4/11 evaluable patients, with disease control lasting up to 7 cycles (21 weeks). To date two additional SDs have been observed, adding to 6/11 evaluable patients.

“These first clinical data on our novel anti-FcyRIIB antibody BI-1607 are very encouraging, showing it is well tolerated with a good safety profile. We also see promising early signs of efficacy, indicating that BI-1607 may enhance the activity of trastuzumab. This can very likely be extrapolated to many other tumor-targeting monoclonal antibodies.” said Dr. Martin Welschof, CEO of BioInvent. “The good progress of BI-1607 reinforces the productivity of BioInvent’s technology platform, with four drug candidates progressing through five clinical trials. We are excited about the potential of our immuno-modulatory antibodies to improve the outcome of cancer treatments. We are now looking forward to further expanding our pipeline with a fifth drug candidate.”

Pharmacokinetic and pharmacodynamic data allowed identification of a wide dose range, where complete target engagement throughout a 3-week dose interval can be achieved, and this will provide the basis for further investigation in a Phase 2a trial, which planned to start 2024.

BI-1607 is developed to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. The reported trial is a first-in-human, open-label, multicenter, dose-escalation, consecutive-cohort study of BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors.

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

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, 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 the social media platform X: @BioInvent.

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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