Lund, Sweden – 9 May 2018 – BioInvent International AB (OMXS: BINV) announced today that it has received authorization to proceed from the Swedish Medical Product Agency for a new clinical trial that will study the activity of its proprietary monoclonal antibody BI-1206.  The new clinical study is a Phase l/lla, dose escalation, consecutive-cohort, open-label study of BI-1206 in combination with rituximab in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). The trial is now open for recruitment and is estimated to recruit approximately 30 patients. The targeted sub-indications are mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma. The clinical evaluation of BI-1206 is ongoing in a parallel Phase I/IIa study in the UK, which is performed by Cancer Research UK.

“The decision to expand the clinical development program was taken based on pre-clinical data demonstrating that BI-1206 has the capacity to strongly enhance the activity of rituximab, a major component of the current standard treatment of NHL. By directly testing the combination of BI-1206 and rituximab, the new trial will speed-up the development of this promising drug candidate”, says Andres McAllister, CMO at BioInvent. “The results from this trial are expected to add value to the program and support discussions with potential partners in preparation for future clinical development and commercialization”, says Björn Frendéus, acting CEO at BioInvent. 


Notes to editors:

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 programmes 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 an exciting pre-clinical portfolio based on novel immuno-modulatory antibodies that target regulatory T cells (T-regs) and tumour-associated myeloid cells. The Company has a strategic research collaboration with Pfizer Inc. and BioInvent also works with leading academic institutions including the University of Southampton, Cancer Research UK, and Penn Medicine. BioInvent generates revenues from global partnerships, including Bayer Pharma, Daiichi Sankyo, and Mitsubishi Tanabe Pharma and from its manufacturing facility for the production of antibodies for research through to late- stage clinical trials. More information is available at www.bioinvent.se

For further information, please contact:
Björn Frendéus                                                     
Acting CEO and CSO                                           
+46 (0) 46 286 25 45                                             
+46 (0) 708 11 25 45
[email protected]

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 5.15 p.m. CET, on 9 May, 2018.