Lund, Sweden – 4 September, 2018 – BioInvent International AB (OMXS: BINV) started dosing of the first patient today in a dose escalation, consecutive-cohort, open-label phase I/IIa study of BI-1206 after recently obtaining approval from the Swedish Medical Product Agency and the U.S. Food and Drug Administration to initiate patient inclusion. The study will recruit approximately 30 patients across sites in the EU and the U.S. The trial will evaluate BioInvent’s proprietary antibody BI-1206 in combination with rituximab in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma. The targeted sub-indications are mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma. The study will explore BI-1206’s safety and tolerability, and seek to determine a recommended phase ll dose when given in combination with rituximab.

Andres McAllister, Chief Medical Officer of BioInvent, said: “With its unique ability to recover and enhance the activity and efficacy of rituximab – a major component of the current standard treatment of NHL and clinically one of the best validated antibodies in cancer therapy, BI-1206 has the potential to become a mainstay in the cancer drug arsenal, and substantially improve outcomes.”

About BI-1206 in combination with rituximab
BI-1206 is a monoclonal antibody that recognizes with high affinity and selectivity FcγRIIB (CD32B), the only inhibitory member of the FcγR family. CD32B is highly overexpressed by a number of NHL tumors, and overexpression has been shown to be associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma or follicular lymphoma. By blocking FcγRIIB, BI-1206 is expected to recover and enhance the activity of rituximab or other anti-CD20 monoclonal antibodies. The combination of the two drugs could provide a new and important option for patients suffering from NHL.

About BioInvent
BioInvent International AB (OMXS: BINV) is focused on the discovery and development of novel and first-in-class immuno-regulatory antibodies to treat cancer. The Company’s clinical programs are BI-1206, currently in a Phase I/II for non-Hodgkin’s lymphoma and chronic lymphatic leukaemia, and TB-403, in cooperation with Oncurious, currently in Phase I/II for medulloblastoma. BioInvent has a promising pre-clinical portfolio based on novel immuno-modulatory antibodies that target regulatory T cells, and tumour-associated myeloid cells. The Company has a strategic research collaboration with Pfizer Inc., and also works with leading academic institutions, such as the University of Southampton, Cancer Research UK, and Penn Medicine. BioInvent has partnerships with Bayer Pharma, Daiichi Sankyo, and Mitsubishi Tanabe Pharma and generates revenues from the manufacturing for third parties of antibodies for research through to late-stage clinical trials. More information is available at www.bioinvent.se

For further information, please contact:

BioInvent International AB (publ)
Co. reg. No. 556537-7263
Visiting address: Sölvegatan 41
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.

This information is information that BioInvent International AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 9.45 a.m. CET, on 4 September, 2018.