Lund, Sweden – June 13, 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 that an abstract reporting the clinical profile of its lead drug candidate BI-1206, the novel anti-FcgRIIB antibody, has been accepted at the International Conference of Malignant Lymphoma (ICML) Annual Meeting 2023. The conference is taking place in Lugano, Switzerland, June 13-17, 2023. 

In the ongoing Phase 1/2a study of BI-1206 in combination with rituximab for the treatment of non-Hodgkin’s lymphoma (NHL), the dose escalation phase of intravenously (IV) administered BI-1206 has been completed and the recommended IV Phase 2 dose (RP2D) has been identified.

A subcutaneous (SC) formulation is being developed in parallel to the IV and the first results will be available during H1 2023. The SC formulation should allow a great deal of flexibility in dosing and regimen to assure the best development of BI-1206.

All patients in the ongoing study of BI-1206 have previously been treated with one or multiple rituximab containing treatments and classified as refractory or relapsed. In the IV dose escalation cohort, responses have been observed across the dose range of 30-100 mg, including 4 complete responders (CR), 3 partial responders (PR) and 4 cases of stable disease (SD) out of 15 evaluable patients. Among the CR population, responses have been long-lasting, three of them lasting years after end of treatment, while the 4th is still on treatment. As of June 12th, 2023, the median duration of complete response was 2.5 years, with three patients still ongoing. No maximum tolerated dose has been defined, and Phase 2a dose expansion cohort is currently enrolling patients.

The details of the abstract are as follows: 
 
Abstract title: Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab in Subjects with Indolent B-Cell Lymphoma
Authors: M. Jerkeman , P. Abrisqueta Costa , H. E. Hagberg , J. M. Sancho Cia , M. Bastos-Oreiro, D. Stevens , J. B Cohen , R. Cordoba Mascunano, E. Domingo Domenech, I. Fernández Román, S. Novelli Canales, M. Borggren , B. Frendeus, I. Karlsson, L. Mårtensson, S. Patel, I. Teige, J. E. Wallin, A. Mc Allister
Publication Nr. OT16 
 

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 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)
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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.