Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, announced it received $32 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd. The investment, which was completed in the fourth quarter of 2021, will be used to advance the current pipeline, including continuation of an ongoing Phase 1b clinical trial and initiation of two additional Phase 1b clinical trials in 2022, and to further expand the pipeline through R&D.
“SalubrisBio is poised for a transformational year and I’m excited about the remarkable opportunities that lie ahead for us,” said Sam Murphy, Chief Executive Officer of SalubrisBio. “We are focused on advancing our programs and securing additional funding to progress the development of our portfolio of antibody fusion proteins and other complex biologics.”
Since its inception, SalubrisBio has built a drug discovery and development platform to address significant unmet medical needs in cardiovascular diseases, cancer and neurodegenerative diseases. The company has multiple assets in clinical/preclinical development and additional programs at the discovery stage. SalubrisBio’s lead asset, JK07, is an antibody-based NRG-1 fusion protein currently in Phase 1 trials to assess safety and tolerability and to explore activity in subjects with heart failure with reduced ejection fraction [HFrEF]. JK07 is the first bi-specific antibody globally to enter a clinical trial in a cardiovascular indication.
Results from Cohort 1 (n=5) of the ongoing randomized, double-blind, placebo-controlled, dose-escalation study demonstrate a favorable safety profile and promising signals of clinical benefit with JK07 over placebo, with observed maximum improvement in ejection fraction of up to 18% absolute over baseline (>50% relative improvement). Enrollment of Cohort 2 is ongoing and SalubrisBio plans to report additional data from this HFrEF trial at future medical meetings. In addition, the FDA has agreed on the initiation of a Phase 1 study of JK07 in heart failure with preserved ejection fraction [HFpEF], preparations for which are now underway.
“Heart failure patients experience a high burden of symptoms, and mortality remains high despite approved therapies,” said Dr. Wilson Tang, lead investigator and Research Director for the Section of Heart Failure and Cardiac Transplant Medicine at Cleveland Clinic. “The Cohort 1 data are positive and support the biological rationale for JK07. We are encouraged by JK07’s potential to address unmet needs in heart failure with reduced ejection fraction and look forward to better understanding its full potential in heart failure with preserved ejection fraction as well.”