SUZHOU, China--(BUSINESS WIRE)--MabSpace Biosciences announced today that the first subject has been dosed in a Phase 1 clinical study of MSB2311, for the treatment of advanced solid tumors. MSB2311 is a 2nd Generation PD-L1 antibody with a unique pH-dependent antigen binding property that enables intra-tumor recycling and potentiates tumor penetration. It is the first clinical asset generated by MabSpace’s proprietary Immune Tolerance Breaking Technology (IMTB) platform.
Yuntao Wan, vice president and head of clinical development operations at MabSpace, said, “With seamless execution we moved quickly from IND clearance by FDA to first patient dosed in less than 2 months, by Dr. Papadopoulos and his team at the START clinic of San Antonio, Texas. We’d also like to thank Dr. Adjei from Mayo Clinic, for his expert input into the trial design from the very beginning. He will lead a group of prominent Mayo investigators to join the study soon. Of course, we couldn’t have achieved such a speedy and quality start without the strong support from our CRO partners Syneos Healthcare and Q2 Solutions.”
This study, MSB2311-CSP-001, is a first-in-human, open-label, Phase 1 dose-escalation study of MSB2311, a humanized anti-PD-L1 monoclonal antibody in patients with advanced solid tumors. More information can be found at www.clinicaltrials.gov (NCT03463473). A separate China Phase 1 study with several disease expansion cohorts to evaluate preliminary efficacy is at the final stage of regulatory review, and is expected to be initiated soon upon CFDA approval.
“We are excited to start the testing of MSB2311 in cancer patients and can’t wait to see how well the superior pre-clinical efficacy of MSB2311 will translate in clinical setting,” said Xueming Qian, Founder and CEO, MabSpace Biosciences.
About MabSpace Biosciences
MabSpace Biosciences Co., Ltd. is a global biotechnology company specialized in discovering and developing innovative antibody therapeutics using its proprietary immune tolerance breaking technology platform. MabSpace has built up a pipeline in immune-oncology, ophthalmology as well as nephrology. The immune-oncology (IO) pipeline is spearheaded by MSB2311, and includes molecules targeting various pathways regulating tumor immune cycle as well as multiple targeted antibodies. MabSpace is headquartered in Hong Kong, with a fully-integrated antibody discovery and development facility in Biobay, Suzhou Industrial Park, China.