Salubris Biotherapeutics has topped up its bank balance to the tune of $32 million. The U.S.-based offshoot turned to its parent company Shenzhen Salubris Pharmaceuticals for the funding, giving it the financial firepower to study a bispecific antibody in cardiovascular disease.
The funding positions SalubrisBio to advance a pipeline that is headed up by JK07, an antibody-based NRG-1 fusion protein in phase 1 development as a treatment for heart failure with reduced ejection fraction. There is a long history of interest in NRG-1, reflecting its role in heart disease, but projects such as clinical-phase explorations of recombinant forms of the protein are yet to deliver a drug.
SalubrisBio has identified the side effect profile of earlier candidates as a problem, leading it to try to widen the therapeutic window and improve outcomes by blocking one of the two signaling pathways used by NRG-1. By blocking HER3 signaling with an antibody fusion design, SalubrisBio aims to selectively stimulate the alternative HER4 pathway and thereby improve on earlier approaches to NRG-1.
The financing tees SalubrisBio up to put that idea to the test. Two phase 1b clinical trials are planned for this year as SalubrisBio works to build on early signs of efficacy in the five patients enrolled in the first cohort of its existing study.
SalubrisBio saw absolute improvements in ejection fraction of up to 18% over baseline—a more than 50% relative improvement—in the first cohort in its placebo-controlled, single-ascending dose study. Enrollment in the second dose cohort is now underway.
“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,” Wilson Tang, M.D., lead investigator and a research director at the Cleveland Clinic, said in a statement.
SalubrisBio wants to expand its pipeline and is already eyeing additional funding to support development of antibody fusion proteins and other complex biologics. The planned programs will leverage the discovery and development SalubrisBio has established since setting up shop in 2016.