Salubris Biotherapeutics (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, announced a new funding round of $35 million to fund continued R&D of clinical and pre-clinical programs. The company 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 targeting a known tumor antigen).
JK07 Phase 2 Study Design
RENEU-HF (Clinical trial) is a Phase 2, randomized, double-blind, placebo-controlled, multiple-dose trial created to evaluate the efficacy and safety of JK07 in patients with heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). This study is expected to enroll 282 subjects randomly assigned (1:1:1) to receive multiple doses of JK07 low dose, JK07 high dose, or placebo. The co-primary endpoints for HFrEF are improvement in ejection fraction along with safety and tolerability, and the primary endpoint for HFpEF is safety and tolerability.
HFrEF and HFpEF affect about 6.2 million Americans and over 64 million people worldwide. And heart failure is a chronic condition in which patients experience progressively worsening symptoms, lower quality of life, hospitalizations, and death.
JK08 Phase 1b/2 Study Progress
The ongoing Phase 1b/2, open-label, dose-escalation and cohort expansion study (NCT05620134) is designed to evaluate the safety and preliminary anti-tumor activity of JK08 in patients with unresectable locally, advanced or metastatic cancer. Over 50 subjects have received JK08 monotherapy in the ongoing dose escalation cohorts, and the first patient has now been dosed in the cohort expansion phase, which will further define the safety and initial efficacy of JK08 in combination with targeted agents, including pembrolizumab. SalubrisBio plans to report additional data from this study in the second half of 2024.
JK06 CTA Filing
JK06 is positioned to be the first biparatopic ADC targeting a known tumor antigen for which no approved therapies currently exist. Due to limited expression and internalization, this antigen is ideally suited for the biparatopic design intended to overcome both limitations, and JK06 has demonstrated low picomolar affinity and robust target internalization. It has shown a highly favorable risk: a non-clinical benefit profile, which will now be evaluated in a dose-escalation study, including a basket of solid tumors.
KEY QUOTES:
“We are pleased with the clinical progress across our pipeline of novel, complex biologic therapeutics, positioning us for multiple inflection points over the coming year and into 2025. Enrollment of the first patient in our Phase 2 clinical trial of JK07 is an important milestone in our heart failure program. Promising 6-month, Phase 1b data reported last year suggests that JK07 has the potential to improve heart function and long-term outcomes. We look forward to building on these promising findings and potentially delivering a new treatment option that can restore quality of life for heart failure patients.”
“We are encouraged by the early data observed in the ongoing dose escalation portion of the JK08 Phase 1b/2 study and look forward to exploring the clinical benefit of combining JK08 with pembrolizumab in solid tumors.”
- Sam Murphy, Chief Executive Officer of SalubrisBio
