On June 23, 2020 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, reported 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 (Press release, BioInvent, JUN 23, 2020, View Source [SID1234561407]).
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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.