Salubris Biotherapeutics Announces $35 Million Financing to Advance Development Activities and Provides Pipeline Updates
March 28 2023 - 5:00AM
Business Wire
– JK07 Advancing into Phase 2 Clinical Trial in
Heart Failure with Reduced Ejection Fraction (HFrEF); Topline Phase
1b Results Expected in 1H 2023 –
–Fourth Cohort Enrolling in Phase 1/2 Study
Evaluating JK08 Monotherapy in Advanced Solid Tumors; Favorable
Pharmacodynamic Activities Observed Across Cohorts –
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.
“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
https://clinicaltrials.gov/ct2/show/NCT04210375 and
https://www.clinicaltrials.gov/ct2/show/NCT05322616.
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
https://clinicaltrials.gov/ct2/show/NCT05620134.
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.
About SalubrisBio
SalubrisBio is a clinical-stage biotechnology company dedicated
to discovering and developing complex biologics for cardiovascular,
oncology, and neurodegenerative diseases. 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.
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For further information, please contact: Argot Partners
212.600.1902|SalubrisBio@argotpartners.com