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TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Press Release

MabSpace Biosciences Submits Investigational New Drug Application for its Second Generation PD-L1 Antibody With pH-Dependent Antigen Binding Property

25 Oct, 2017

SUZHOU, China--(BUSINESS WIRE)--MabSpace Biosciences Co., Ltd., today announced it has filed an IND application to CFDA on September 12th, 2017 for MSB2311, a second-generation PD-L1 antibody with pH-dependent antigen binding property. The program was supported by China’s 13th Five-Year Plan National Key R&D Program Initiatives and thus is eligible for accelerated review. MabSpace plans to file a US IND in December 2017 and start an FIH trial in the US and subsequently in China in the first half of 2018.

“We are pleased to have advanced this second-generation PD-L1 antibody program toward human clinical studies,” said Dr. Xueming Qian, Founder and CEO of MabSpace. The unique pH-dependent antigen binding property allows active antibody penetration and recycling in tumors, and leads to a much longer tumor residence time and has displayed excellent anti-tumor activities in multiple tumor models. MSB2311 thus has the potential to be the best-in-class PD-L1 antibody with significantly improved efficacy and tolerability than the FDA-approved first-generation of PD-L1 antibodies and an ideal backbone for combination therapy.

MSB2311 is the first pH-dependent PD-L1 antibody in the world. The preclinical data of MSB2311 were selected for presentation early this year at ASCO-SITC. MSB2311 was discovered using MabSpace’s unique immune tolerance breaking technology and translational science platform, which is designed to generate and identify candidate antibodies binding to distinct epitopes on the therapeutic target. MabSpace owns the global right for the molecule.

MSB2311 is the first program from MabSpace’s pipeline to enter clinics. MabSpace has built an immune-oncology focused pipeline designed to work in combination with MSB2311, including six antibody molecules targeting immune-modulatory functions of regulatory T cells, myeloid derived suppressive cells, dendritic cells and stromal cells.