April 10, 2019
Sound Biologics Announces FDA Allowance of its IND Application for PSB205, an Anti-PD-1/CTLA-4 MabPair, in Relapsed and Refractory Solid Tumors
SEATTLE, April 10, 2019 /PRNewswire/ — Qilu Puget Sound Biotherapeutic Corp. (Sound Biologics), an emerging biotechnology company dedicated to developing next generation antibody combination therapies, today announced that U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application and issued authorization to commence a Phase I First-in-Human Clinical Trial of PSB205 for the treatment of patients with relapsed/refractory solid tumors. PSB205 is an immuno-oncology biotherapeutic that represents the first of a new class of therapeutic modality.
PSB205 is a novel bifunctional product that contains a mixture of unique anti-PD-1 and anti-CTLA4 monoclonal antibodies produced by a single cell line via the company’s proprietary MabPair technology. MabPair products offer many advantages over bispecific antibodies. The relative ratio of the two antibodies in the MabPair can be well-controlled and each antibody is individually engineered for optimal target coverage, effector function, pharmacokinetics and exposure. PSB205 represents a potentially best-in-class immuno-oncology product that promises to exhibit robust combination activity while being significantly more tolerable to patients than currently approved anti-PD-1/anti-CTLA-4 combinations.
“We’re pleased to take this critical step toward providing cancer patients with a better therapeutic option for blockade of two key immunotherapy pathways,” said Wei Yan, Chief Executive Officer of Sound Biologics. “PSB205 represents the first product to contain two antibodies expressed from one cell line. We’re excited to be the first to explore this innovative approach to biologic combinations and look forward to reviewing the initial clinical data in late 2019.”
About Sound Biologics
Qilu Puget Sound Biotherapeutic Corp. (Sound Biologics) is a privately held biotech company specializing in discovery and development of novel oncology biotherapeutics. The company’s MabPair technology is a powerful new platform enabling production of two distinct monoclonal antibodies from a single cell line. Products derived via the MabPair platform will offer compelling advantages compared to bispecific antibody products or conventional antibody combinations including full flexibility in choice of different Fc backbones for antibody effector function, streamlined regulatory and clinical development paths, and single-entity pricing power. Sound Biologics is actively sourcing discovery and clinical collaborations while continuing to build a robust internal pipeline.
Contact: Sound Biologics
Wei Yan, Ph.D.
Chief Executive Officer
Jelle Kijlstra, MD, MBA
Chief Medical Officer