TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Transcenta, biologics, antibody

TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Press Release

MabSpace Biosciences Doses First Patient in China Phase 1 Trial for MSB2311 and Submitted IND for MSB0254 to NMPA

05 Sep, 2018

SUZHOU, China--(BUSINESS WIRE)--MabSpace Biosciences announced that on August 24th, 2018, MSB2311 was successfully administered to the first Chinese cancer patient at Beijing Cancer Hospital in its China Phase 1 trial. 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.

The current dose-escalation study is designed to extend the ongoing phase 1 trial in US and establish safety, tolerability, and pharmacokinetic profiles as well as explore preliminary efficacy in Chinese cancer patients. More detailed information about this China Phase 1 trial of MSB2311 can be found at the China Clinical Trials Registry (CTR20180925). The US Phase 1 study has been on-going since April 2018, and the available preliminary data have shown excellent safety, tolerability, and pharmacokinetic profiles. Both China and US phase 1b studies are planned to further explore efficacy in tumor-type specific or biomarker-enriched expansion cohorts.

“Our mission at MabSpace is to provide cancer patients with superior and affordable antibody-based therapeutics. The successful completion of dosing of MSB2311 into the first Chinese cancer patient is an important milestone for us,” said Xueming Qian, Ph.D., Founder, Chairman and CEO, MabSpace Biosciences. “We will advance this program into registration trial next year. In addition, we will also initiate combination trials early next year with MSB2311 as the backbone.”

MSB2311 is the first product candidate derived from MabSapce’ pipeline generated using its immune tolerance breaking technology platform. MabSpace has 12 ongoing programs in its R&D pipeline. On August 28th, 2018, Mabspace submitted another IND application to NMPA for MSB0254, the second product candidate from the platform. “We will continue to move at least one more innovative biologics asset in our pipeline per year into clinical stage to meet patients’ needs,” added Xueming Qian.

MSB0254 is a novel humanized VEGFR2 antibody which antagonizes both VEGF-A and VEGF-C mediated tumor-associated angiogenesis, an important pathway utilized by tumor cells for growth and metastasis. A VEGFR2 blocking antibody in the same class has been approved in US for the treatment of 2nd line gastric cancer, NSCLC, and CRC and recently shown to have benefits in a subset of 2nd line HCC patients. MSB0254 will be developed for these cancer types and may also serve as an important combination therapy with PD-1/PD-L1 inhibitors such as MSB2311.