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TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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Press Release

MabSpace Biosciences Announces FDA Approval of IND for MSB2311, a Second Generation PD-L1 Antibody With pH Dependent Antigen Binding and Recycling Property

22 Feb, 2018

SUZHOU, China--(BUSINESS WIRE)--MabSpace Biosciences announces on February 16th, 2018 FDA cleared Investigational New Drug (IND) for MSB2311, a humanized programmed death protein-ligand 1 (PD-L1) antibody for the treatment of patients with locally advanced/metastatic solid tumors. MabSpace plans to start a first-in-human, open label, multiple center, dose escalation and dose expansion study of MSB2311 in patients with locally advanced or metastatic solid tumors.

PD-L1 is a key checkpoint protein employed by tumor cells to escape host immune surveillance. Multiple antibodies inhibiting PD-L1 have been approved by FDA for the treatment of various solid tumors. MSB2311 is differentiated by its distinct binding epitope and unique pH dependent PD-L1 binding and recycling property. MSB2311 is a human IgG1 with no FcR binding ability and thus has no ADCC-inducing activity. MSB2311 has shown to be safe in non-human primate and efficacious in multiple mouse tumor models, and has exhibited robust CMC profile.

MabSpace is a global biotechnology company focused on discovering and developing innovative antibody therapeutics using its proprietary immune tolerance breaking technology. MabSpace has built a pipeline focused on immuno-oncology with MSB2311 as its first molecule entering into clinic. With a panel of pipeline antibody molecules targeting various pathways regulating tumor immune cycle, MSB2311 will also serve as a key backbone agent for combination approach.

"The approval of MSB2311 IND by FDA marks an important milestone for MabSpace. Although there are several antibodies with pH dependent recycling property in late stage development, MSB2311 is the only PD-L1 antibody with this property globally. We are excited about this molecule in providing a differentiated and potentially more efficacious therapeutic agent for cancer patients around the world," said Xueming Qian, Ph.D, Founder, Chairman and CEO of MabSpace.