On March 28, 2023 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported it received $35 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd (Press release, Salubris Biotherapeutics, MAR 28, 2023, View Source [SID1234629613]). 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.
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"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."
"We’re thrilled about the progress we made in 2022, particularly completing enrollment in the Phase 1b study of JK07 in HFrEF. The study achieved its objective of characterizing the safety and activity of the molecule and defining the therapeutic window. We’re excited to now turn our focus towards initiating a Phase 2 study this year," said Sam Murphy, Chief Executive Officer of SalubrisBio. "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."
JK07 Advancing into Phase 2
Patient dosing has been completed in the Phase 1b clinical trial assessing the safety, tolerability, pharmacokinetics and exploratory efficacy of JK07 in HFrEF. This study demonstrated robust changes in biomarkers and exploratory efficacy parameters at dose levels that were safe and well tolerated. Topline results are planned to be presented at an upcoming medical meeting. The first Phase 2 study is expected to begin in 2H of 2023. A second Phase 1b study in HFpEF is actively enrolling, with interim results expected in the second half of 2023.
For more information on the JK07 clinical trial, please visit View Source and View Source
JK08 Phase 1/2 Study Progress
The fourth cohort in the ongoing Phase 1/2 study of JK08 as a monotherapy treatment for solid tumors is now recruiting. Through the first three cohorts, preliminary data indicate favorable safety and encouraging, dose-dependent pharmacodynamic activity. SalubrisBio expects to report preliminary findings later this year at a medical meeting.
For more information on the JK08 clinical trial, please visit View Source
About JK07
JK07 is a recombinant fusion protein consisting 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. Research has shown that NRG-1 induces signaling through interaction with two different receptors – HER3/ErbB3 and HER4/ErbB4. The HER4/ErbB4 pathway appears to be responsible for the regenerative effects in the heart, while the HER3/ErbB3 pathway appears primarily responsible for safety and tolerability limitations of recombinant NRG-1. By blocking HER3/ErbB3 signaling with an antibody fusion design, JK07 selectively stimulates the HER4/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.
About JK08
JK08 is a recombinant fusion protein consisting of a CTLA-4-specific antibody and a C-terminal IL-15/sushi domain. JK08 was designed based on clinical studies from both individual molecules, which together portend synergistic effects in an antibody fusion construct. The CTLA-4-specific antibody ipilimumab validated CTLA-4 as a target for cancer therapy, but response rates are limited. Analysis of clinical samples demonstrated that NK cell activity signatures and ADCC biomarkers correlate with ipilimumab responses. Recombinant IL-15 has demonstrated potent stimulation of NK cell expansion and activation in clinical studies. JK08 channels the potent immune stimulation of IL-15 through the CTLA-4 antibody domain towards T-regulatory cell depletion and reversing immunosuppression which may contribute to cancer progression.