• Starting dose predicted to provide drug exposure at levels already shown to have elicited responses
• Subcutaneous formulation is significantly more convenient administration for patients

Lund, Sweden – December 19, 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 inclusion of the first patient in a Phase 1 trial with a subcutaneous formulation of its lead drug candidate, the novel anti-FcyRIIB antibody BI-1206.

The starting dose of 150 mg is predicted to provide drug exposure at levels at which responses have already been observed. The adaptive study design implemented will allow for efficient escalation to higher doses. BI-1206 is currently being studied in two Phase 1/2 trials, in combination with rituximab in non-Hodgkin’s lymphoma (NHL) and in combination with pembrolizumab in solid tumors.

“The start of this trial with a subcutaneous formulation is an important milestone in the development of BI-1206, which has the potential to significantly improve treatment for lymphoma and solid tumor patients. The subcutaneous formulation was developed and brought to the clinic by BioInvent in record time and its ease of administration, compared with intravenous, will provide significant convenience and flexibility to both patients and healthcare personnel. The team are now working hard on implementing subcutaneous administration also in our Phase 1/2 trial in solid tumors, and we anticipate treating the first patient in this study in H1 2023,” said Martin Welschof, CEO of BioInvent.

About BI-1206
BI-1206 is currently being studied in two Phase 1/2 trials, in combination with rituximab in non-Hodgkin’s lymphoma (NHL) and in combination with pembrolizumab in solid tumors. Latest data from the Phase 1/2 trial with BI-1206 in combination with rituximab in NHL show there are three ongoing complete responses, two beyond two years after end of treatment, and four partial responses, one of which is ongoing. As anti-CD20 based therapy will remain central for the treatment of NHL, BI-1206 has the potential to be uniquely positioned within NHL. 
 
The ongoing clinical trial with BI-1206 in solid tumors is progressing through the dose-escalation part of the trial and the two patients reported last December still show clear clinical improvement. The subcutaneous arm of the study in solid tumors is on track to be initiated in H1 2023. 

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)
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.