BioInvent Enrolls First Patient in Phase I/IIa Trial of BI-1206 in Combination With KEYTRUDA® for the Treatment of Patients With Solid Tumors

LUND, Sweden, June 23, 2020 /PRNewswire/ -- BioInvent International AB ("BioInvent") (OMXS: 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 enrollment of the first patient in a Phase I/IIa clinical trial of BI-1206 in combination with anti-PD-1 therapy KEYTRUDA^®(pembrolizumab) for patients with solid tumors.

The objective of this trial is to explore the safety and tolerability profile of the combination of BI-1206 with KEYTRUDA, to characterize the pharmacokinetic/pharmacodynamic (PK/PD) profile and to determine the recommended dose of BI-1206 when combined with KEYTRUDA. It will be conducted in several sites across the US and Europe and will assess potential signs of antitumoral activity, as well as exploring the expression of potential immunological markers that might be associated, and eventually predict clinical responses.

The Phase I/IIa trial is divided into part A, a dose escalation of BI-1206 in combination with the standard dose of KEYTRUDA, and part B, which will explore the activity of the combination treatment in patients with advanced lung cancer, melanoma and other types of malignancies. Patients will be refractory to or have progressed on previous treatments with anti-PD1/PDL1 targeting agents.

BI-1206 is a first-in-class monoclonal antibody that exquisitely targets FcgRIIb, the only inhibitory Fcg receptor, "the brakes" of the innate immune system. It is currently also being investigated in patients with non-Hodgkin lymphoma (NHL).

Martin Welschof, CEO of BioInvent, said, "We are very excited to be starting this trial in collaboration with MSD. Based on a strong scientific rationale the trial will explore a potentially important mechanism of resistance to anti-PD1/PDL1 targeting agents. We believe BI-1206's potential ability to increase and enhance the response rates to anti-PD1 targeting agents such as KEYTRUDA may be a powerful approach for the future treatment of a broad range of solid and liquid tumors."

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (NYSE: MRK), with whom BioInvent has a clinical trial collaboration and supply agreement for this study.

About BioInvent

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. Two preclinical programs in solid tumors are expected to enter clinical trials by the end of 2020. The Company's validated, proprietary F.I.R.S.T™ technology platform simultaneously 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 or for additional licensing and partnering.

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.

For further information, please contact:

Martin Welschof
CEO  
+46 (0)46 286 85 50                                     
martin.welschof@bioinvent.com  

Hans Herklots
LifeSci Advisors
+41 79 598 71 49
hherklots@lifesciadvisors.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.

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