Articles from Salubris Biotherapeutics, Inc.

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.

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced positive interim data from the Phase 2 trial of JK07 (RENEU-HF) in patients with heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF). The objective of this pre-specified interim analysis was to assess the safety of multiple doses of JK07 at the 0.045 mg/kg dose prior to opening of the 0.09 mg/kg dose treatment arms. 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.

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced it has received approval from the European Medicines Agency (EMA) to initiate a Phase 1 clinical trial of JK06 in a basket of solid tumors known to express 5T4.

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced a new capital infusion of $35 million to fund continued research and development of clinical and pre-clinical programs. SalubrisBio also provided progress updates for JK07, the first investigational antibody fusion protein for heart failure, JK08, the first investigational IL15-CTLA4 antibody fusion for solid tumors and JK06, a first-in-class biparatopic antibody-drug conjugate (ADC) targeting a known tumor antigen.

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced that positive initial data from the first-in-human study evaluating JK08 in adults with solid tumors were presented in a poster session during the European Society of Medical Oncology Annual Congress 2023.

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced positive updated results from the completed Phase 1b study of JK07 in patients with HFrEF. The data were presented in a late breaking oral session during the Heart Failure Society of America Annual Scientific Meeting 2023. JK07 is the first investigational antibody fusion protein and first selective ErbB4 agonist to enter clinical development for heart failure. Heart failure is a leading cause of morbidity and mortality globally, with estimates of more than 6 million patients affected by HFrEF and HFpEF in the US.

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced positive updated results from the ongoing Phase 1b study of JK07 in heart failure with reduced ejection fraction (HFrEF). The data were presented in a late breaking oral session during the annual congress of the European Society of Cardiology’s Heart Failure Association. JK07 is the first investigational antibody fusion protein and first selective ErbB4 agonist to enter clinical development for heart failure. Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans1.

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today 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.

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced positive interim data from the ongoing Phase 1b study of JK07 in heart failure with reduced ejection fraction (HFrEF). The interim data includes eleven NYHA II/III subjects across three single-ascending dose cohorts. Single doses were administered intravenously and changes from baseline values of left ventricular EF were measured for each patient. Following completion of enrollment in the first two cohorts, administration of JK07 led to dose-dependent improvements in EF, with an average improvement of 30% observed at day (D) 90 in Cohort 2. The unblinded sentinel subject in Cohort 3 has shown a 70% improvement from baseline at D30.

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today reported new data from Cohort 2 of the ongoing Phase 1 study evaluating JK07, the Company’s lead drug candidate, for the treatment of heart failure with reduced ejection fraction (HFrEF). The Company also announced the submission of the first clinical trial application (CTA) in Europe for its lead oncology program, JK08, and the appointment of Arian Pano, M.D., as Chief Medical Officer.