JK07 / Shenzhen Salubris - LARVOL DELTA

The Novel ErbB4 Agonist JK07 Modulates Gene Expression in Key Cardiac Cells. Insights from Single-Nuclei Transcriptomics in a Murine Heart Failure Model (AHA 2025) - "JK07 promotes cardiac repair by driving cell-type-specific transcriptional programs that support metabolic adaptation in cardiomyocytes, modulate ErbB4-high fibroblast functions, and enhance endothelial regeneration. These findings highlight the therapeutic potential of JK07 as a disease-modifying agent in HF."

Preclinical • Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Immunology • EGF • ERBB3 • ERBB4 • HTRA3 • IGFBP7 • NRG1 • TGFB1

RENEU-PH: Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Salubris Biotherapeutics Inc

New P2 trial • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Single Ascending-Dose Study of Selective ErbB4 Agonist JK07 in Heart Failure With Reduced Ejection Fraction. (PubMed, JACC Basic Transl Sci) - P1 | "These findings support continued clinical investigation of JK07 in heart failure. (Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction; NCT04210375)."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • ERBB4 • NRG1

Salubris Biotherapeutics Announces Positive Interim Data from the Phase 2 Trial of JK07 in Heart Failure (Businesswire) - P2 | N=282 | RENEU-HF (NCT06369298) | Sponsor: Salubris Biotherapeutics Inc | "These interim results from the first 68 subjects randomized demonstrated a safe and tolerable profile at 0.045 mg/kg, clear and consistent target engagement with repeat administration, and positive preliminary signs of efficacy. Following the evaluation of the interim results, and in agreement with the Data Safety Monitoring Committee, the high dose of 0.09 mg/kg has opened for enrollment. JK07 is the first selective ErbB4 agonist to enter clinical development for heart failure...Preliminary efficacy data show trends towards improvement at this early stage of the study. Primary endpoint analysis is planned to be presented in 2026."

Enrollment open • P2 data • Heart Failure

ERBB4 activation prevents microvascular dysfunction in a large animal model of hypertensive heart disease (ESC 2024) - "Conclusions ERBB4 activation by JK07 is capable to prevent CMD in a DOCA hypertensive pig model. Functional rather than structural alterations may explain the protective effects of JK07 on microvascular resistance."

Preclinical • Cardiovascular • Congestive Heart Failure • Heart Failure • ERBB4 • NRG1

RENEU-HF: Study of JK07 in Patients With Chronic Heart Failure (clinicaltrials.gov) - P2 | N=282 | Recruiting | Sponsor: Salubris Biotherapeutics Inc

New P2 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

Final Analysis Of Safety And Exploratory Echo Data In A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study To Evaluate JK07 In Subjects With Heart Failure With Reduced Ejection Fraction (HFSA 2023) - "Single dose administration of 0.03 and 0.09 mg/kg JK07 was safe and well tolerated. Changes in LVEF and target engagement data suggest that JK07 selectively activates ErbB4 in patients with HFrEF. Data support further investigation of JK07 in a multiple dose Phase 2 study in HF."

Clinical • Late-breaking abstract • P1 data • Cardiovascular • Congestive Heart Failure • Gastrointestinal Disorder • Heart Failure • Hepatology • ERBB3 • NRG1

ERBB4 stimulation mitigates atrial fibrillation and remodeling in a porcine DOCA model (ESC 2023) - "ERBB4 stimulation prevents atrial fibrotic remodeling and AF inducibility in a porcine DOCA model. The effect of JK07 is unrelated to effects on blood pressure, but probably related to reduced atrial fibrogenesis."

Preclinical • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • ERBB4

Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Salubris Biotherapeutics Inc | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Congestive Heart Failure • Heart Failure

Single-Ascending Dose Study of JK07 in Subjects With HFpEF (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Salubris Biotherapeutics Inc | N=56 ➔ 0 | Trial completion date: Jul 2024 ➔ May 2023 | Recruiting ➔ Withdrawn | Trial primary completion date: Apr 2024 ➔ May 2023

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB

Salubris Biotherapeutics Announces $35 Million Financing to Advance Development Activities and Provides Pipeline Updates (Businesswire) - "Salubris Biotherapeutics, Inc...announced it received $35 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd. The investment will be used to advance and accelerate lead candidate JK07, including the planned initiation of the first Phase 2 study in HFrEF, the continuation of the ongoing Phase 1b clinical trial in heart failure with preserved ejection fraction (HFpEF), and the launch of the Company’s first neurology clinical trial with JK07. The financing will also support the ongoing Phase 1/2 trial of JK08 in solid tumors and advance JK06, a pre-clinical biparatopic antibody-drug conjugate, into an initial Phase 1/2 study."

Financing • New P1/2 trial • Trial status • Breast Cancer • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Heart Failure • Melanoma • Oncology • Solid Tumor

Salubris Biotherapeutics Announces $35 Million Financing to Advance Development Activities and Provides Pipeline Updates (Businesswire) - "We look forward to multiple additional milestones across our pipeline in the year ahead, including interim data readouts from JK07 in HFpEF and JK08 in solid tumors, and initiation of an initial clinical trial evaluating JK07 in neurodegenerative disease."

New trial • P1 data • P1/2 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Heart Failure • Melanoma • Oncology • Solid Tumor

Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Salubris Biotherapeutics Inc | Recruiting ➔ Active, not recruiting | N=63 ➔ 14 | Trial completion date: Dec 2023 ➔ Sep 2023 | Trial primary completion date: Sep 2023 ➔ Jun 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) (clinicaltrials.gov) - P1 | N=63 | Recruiting | Sponsor: Salubris Biotherapeutics Inc | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Single-Ascending Dose Study of JK07 in Subjects With HFpEF (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Salubris Biotherapeutics Inc | Trial completion date: Sep 2023 ➔ Jul 2024 | Trial primary completion date: Mar 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB

Single-Ascending Dose Study of JK07 in Subjects With HFpEF (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Salubris Biotherapeutics Inc | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2022 ➔ Oct 2022

Enrollment open • Trial initiation date • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB

Single-Ascending Dose Study of JK07 in Subjects With HFpEF (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Salubris Biotherapeutics Inc

New P1 trial • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB