Enrollment completed for heart failure with reduced ejection fraction cohort of RENEU-HF, Phase 2b study of JK07; topline results expected in 1H26

Company initiated RENEU-PH, Phase 2a study of JK07 in patients with Group 2 pulmonary hypertension and heart failure

Phase 1 dose escalation data for JK06, first-in-class 5T4-targeted biparatopic antibody-drug conjugate, to be presented at ESMO 2025

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced updates on the company’s Phase 2 clinical program evaluating JK07 in heart failure with reduced ejection fraction (HFrEF), heart failure with preserved (HFpEF) and Group 2 pulmonary hypertension (PH), as well as its Phase 1 clinical study of JK06 in solid tumor indications.

“We are thrilled to have two clinical-stage programs both progressing and expanding in development. Importantly, we have now completed enrollment for the HFrEF cohort in the ongoing Phase 2 RENEU-HF study, putting us on track for a topline readout of the primary endpoint in the first half of 2026. We continue to believe that JK07, the first and only clinical-stage selective ErbB4 agonist, has the potential to be the first disease-modifying biologic for heart failure, and we very much look forward to these results. We are also pleased to announce that we have initiated the open-label Phase 2a RENEU-PH study evaluating JK07 in patients with combined pre- and post-capillary Group 2 pulmonary hypertension due to heart failure, a population with no approved treatment options and a poor prognosis. JK07’s potential to target both myocardial dysfunction and the pulmonary vasculature may provide a unique dual benefit in this population,” said Sam Murphy, Chief Executive Officer of SalubrisBio.

“We are also eagerly anticipating the European Society for Medical Oncology Congress next month, where we will present initial data from our ongoing first-in-human study evaluating JK06, our novel, first-in-class biparatopic antibody-drug conjugate (ADC) targeting 5T4, and are excited to now be moving into the expansion cohort stage of the study.”

JK07 Phase 2 (RENEU-HF) Study

RENEU-HF (NCT06369298) is a global Phase 2, randomized, double-blind, placebo-controlled, multiple-dose study designed to evaluate the efficacy and safety of JK07 in patients with HFrEF and HFpEF in 282 subjects. The study has two cohorts: cohort 1, which has completed enrollment, is comprised of patients with HFrEF; cohort 2 is currently enrolling patients with HFpEF. The primary endpoint of the study for the HFrEF cohort is change in left ventricular ejection fraction (LVEF) at 26 weeks. The HFrEF cohort enrolled 215 subjects, randomized 1:1:1 to high or low dose JK07 or placebo. Results of the primary endpoint analysis are expected in the first half of 2026.

Heart failure affects an estimated 6.7 million Americans¹ and more than 64 million people worldwide², with HFrEF and HFpEF each affecting over 3 million patients in the US alone. HF is a chronic condition in which patients experience progressively worsening symptoms and quality of life, hospitalizations and death. In HFrEF, the left ventricle loses its ability to contract normally, and the heart cannot pump with sufficient force to push enough blood into circulation. In HFpEF the heart becomes stiff and loses its ability to function properly.

JK07 Phase 2a (RENEU-PH) Study

The Phase 2a, open-label, multiple-dose study is designed to evaluate the safety, efficacy, and tolerability of JK07 in patients with combined pre- and post-capillary Group 2 pulmonary hypertension (cpcPH) due to HF. This 6-month study is expected to enroll up to 30 patients who will receive four every-4-week (QW4) doses of JK07, over the course of 13 weeks, with a 12-week follow-up period.

Chronic pulmonary hypertension (PH) due to left heart disease represents a significant complication in patients with HF. Epidemiologic studies suggest that up to 50% of patients with HFrEF or HFpEF exhibit some degree of PH, and cpcPH is associated with markedly worse outcomes, including increased hospitalizations and mortality³.

JK06 Phase 1 Study

The ongoing Phase 1, open-label, dose escalation and expansion study (EUCT2024-512421-92-00) is designed to assess the safety, pharmacokinetics, and preliminary efficacy of JK06 in a basket of solid tumors known to express the protein 5T4, with a target enrollment of up to 155 patients. Enrollment has now been completed in the dose escalation phase of the study, and initial data will be presented at the European Society for Medical Oncology (ESMO) Congress taking place on October 17-21, 2025, in Berlin, Germany. Details of the presentation are as follows:

Title: A Phase 1/2 Study of JK06, a 5T4-Targeted Antibody Drug Conjugate (ADC), in Patients with Unresectable Locally Advanced or Metastatic Cancer

Presenter: Nuria Kotecki, M.D. at Institut Jules Bordet, Anderlecht, Belgium

Abstract #: 961P

Session: Developmental Therapeutics

Date/Time: Sunday, October 19, 2025

About JK07

JK07 is a recombinant antibody fusion protein consisting of an active polypeptide fragment of the human growth factor neuregulin (NRG-1) and a fully human immunoglobulin IgG1 monoclonal antibody targeting ErbB3. NRG-1 is a clinically validated growth factor that has shown promising activity in HF, but also undesirable side effects. Research has shown that NRG-1 induces signaling through interaction with two different receptors – ErbB3 and ErbB4. The ErbB4 pathway appears to be responsible for the regenerative effects in the heart, while the ErbB3 pathway appears primarily responsible for the safety and tolerability limitations of recombinant NRG-1. By blocking ErbB3 signaling with an antibody fusion design, JK07 selectively stimulates the ErbB4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects. JK07 is in clinical development for the treatment of HFrEF, HFpEF, and cpcPH.

About JK06

JK06 is a first-in-class quadrivalent, biparatopic antibody drug conjugate (ADC) that selectively targets 5T4 with a monomethyl auristatin E (MMAE) payload. 5T4 is an oncofetal protein that is overexpressed in a wide range of tumor types, including lung and breast cancers, and is associated with more aggressive tumor progression and reduced survival. JK06 has demonstrated picomolar affinity for 5T4 and rapid internalization due to the biparatopic design. Together with stable, site-specific payload conjugation, JK06 has further demonstrated robust efficacy and a clean safety profile in non-clinical studies.

About SalubrisBio

SalubrisBio is a clinical-stage biotechnology company dedicated to discovering and developing complex biologics for cardiovascular disease and cancer. SalubrisBio was founded in August 2016 as a wholly-owned subsidiary of the China-based pharmaceutical company Shenzhen Salubris Pharmaceuticals Co. Ltd. Headquartered in the US, SalubrisBio reflects Shenzhen Salubris Pharmaceuticals’ commitment to innovation and expansion into the global market and retains the core philosophy of developing therapeutics for large patient populations with significant unmet needs.

¹Centers for Disease Control and Prevention, Heart Failure, https://www.cdc.gov/heart-disease/about/heart-failure.html, (accessed January 21, 2025).

²Groenewegen, A., Rutter, F., Mosterd, A., & Hoes, A. (2020). Epidemiology of heart failure. European Journal of Heart Failure, 22(8), 1342-1356. https://onlinelibrary.wiley.com/doi/10.1002/ejhf.1858

³Lam CSP, Voors AA, de Boer RA, Solomon SD, van Veldhuisen DJ. Heart failure with preserved ejection fraction: from mechanisms to therapies. Eur Heart J. 2018;39(30):2780-2792.

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