Salubris Biotherapeutics Secures $35 Million to Advance Lead Programs into Phase II Clinical Testing, Including JK07 for Heart Failure with Reduced Ejection Fraction

By Alex Keown
March 28, 2023

Salubris Biotherapeutics secured a $35 million infusion of cash from its parent company that is expected to support advancement of its two lead programs into Phase II clinical testing.

Gaithersburg-based Salubris, a division of China-based Shenzhen Salubris Pharmaceuticals Co., Ltd. is currently assessing JK07 in a Phase Ib program in patients with Heart Failure with Reduced Ejection Fraction (HFrEF). In September 2022, the company announced positive interim data from the ongoing Phase 1b study of JK07 that showed the medication led to dose-dependent improvements in EF, with an average improvement of 30% observed after 90 days in one of the trial cohorts. At the time, an unblinded sentinel subject in a different cohort showed a 70% improvement from baseline after 30 days, the company reported. Topline results are expected in the first half of this year. The study demonstrated robust changes in biomarkers and exploratory efficacy parameters at dose levels that were safe and well tolerated.

JK07 is a recombinant fusion protein that consists of a fully human immunoglobulin IgG1 monoclonal antibody and an active polypeptide fragment of the human growth factor neuregulin [NRG-1]. NRG-1 is a clinically validated growth factor that has shown promising activity in HFrEF, but also undesirable side effects. Heart failure with reduced ejection fraction occurs when the muscle of the left ventricle does not pump as well as it should. The ejection fraction of the blood is considerably less than the body needs. The prognosis of these patients is typically poor, with about half dying within five years.

Current treatment for this indication is with the use of drugs such as ivabradine, a hyperpolarization-activated cyclic nucleotide-gated channel blocker designed to slow the heart rate so blood is pumped more efficiently. Other prescribed drugs include intravenous phosphodiesterase-3 inhibitors, beta adrenergic receptor agonists and intravenous calcium-sensitizing agents.

Sam Murphy, chief executive officer of Salubris, told BioBuzz the company is excited about the potential of JK07 in this indication. He said there are five approved drug classes for this type of heart failure. Despite the number of available drugs, patients still experience a high mortality rate. JK07 could be the first disease modifying therapeutic that significantly improves patient outcomes for the millions of people with this form of heart failure, Murphy said.

JK07 simultaneously blocks HER3/ErbB3 signaling, while selectively stimulating the HER4/ErbB4 pathway. He said the experimental drug has the potential to significantly widen the therapeutic window of NRG-1. Murphy noted the company will engage with the FDA to discuss plans for the Phase II trial that could begin in the second half of this year.

In addition to HFrEF, Murphy said JK07 has potential as a therapeutic for trial in heart failure with preserved ejection fraction (HFpEF), a condition where the heart pumps normally but the left ventricle does not fill with enough blood for the body. A Phase Ib trial is enrolling and topline results are anticipated later this year.

The company’s second clinical asset is JK08, a potential monotherapy for solid tumors being evaluated in a Phase I/II study. Murphy said the oncology asset is a combination of a CTLA-4-specific antibody and a C-terminal IL-15/sushi domain. JK08 is designed to channel the potent immune stimulation of IL-15 through the CTLA-4 antibody domain towards T-regulatory cell depletion, he said. Salubris is currently enrolling patients in a Phase I/II study. So far, the drug candidate is demonstrating favorable pharmacodynamic activity across the cohorts, Murphy said.

In addition to advancing JK07 and JK08, the $35 million financing will also support advancement of a neurological asset. Murphy said the funds is expected to carry the 22-person company through 2024. In 2022, the company received $32 million from its Chinese parent company. Salubris will continue to receive financing from that company until external investors are required, Murphy said.