– LeadClinical Candidate, JK07, Demonstrates Favorable Safety and Further Promising Activityin Cohort 2 of Phase 1b Heart Failure with Reduced Ejection Fraction Study; Enrollmentin Cohort 3 Now Ongoing –
– Clinical Trial Application Submitted in Europe forLead Oncology Program JK08, the first CTLA-4/IL-15 Antibody Fusion Protein, forthe Treatment of Solid Tumors –
– Industry Executive Arian Pano, M.D., Appointed ChiefMedical Officer –
Gaithersburg,MD – May 23, 2022 – Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stagebiotechnology company dedicated to discovering anddeveloping novel complex biologic therapeutics, today reportednew data from Cohort 2 of the ongoing Phase 1 study evalsuating JK07, theCompany’s lead drug candidate, for the treatment of heart failure with reducedejection fraction (HFrEF). The Company also announced the submission of thefirst clinical trial application (CTA) in Europe for its lead oncology program,JK08, and the appointment of Arian Pano, M.D., as Chief Medical Officer.
“Our study of JK07 in heart failurewith reduced ejection fraction continues to demonstrate favorable safety and promisingsignals of clinical activity, and we look forward to gaining further insightsas we enter Cohort 3,” said Sam Murphy, Chief Executive Officer of SalubrisBio.“In addition, we’re thrilled to announce that the first CTA has been filed inEurope for JK08, to evalsuate this novel CTLA-4/IL-15 antibody fusion protein inthe treatment of solid tumors. We have made considerable progress this year acrossour pipeline and remain laser-focused on advancing these important programs tobring differentiated complex biologics to patients with unmet needs,” concludedMurphy.
New Cohort 2 Data for JK07 ShowsFavorable Safety and Further Promising Activity in Patients with HFrEF
In this ongoing randomized,double-blind, placebo-controlled, dose-escalation Phase 1b study evalsuatingJK07, patients treated in Cohort 2 (n=5) demonstrated a favorable safetyprofile and encouraging signals of clinical activity. In addition,dose-dependent increases in biomarker surrogates of target engagement have beenobserved across the two completed cohorts. Enrollment in Cohort 3, of fiveplanned cohorts, has commenced in this Phase 1b study and SalubrisBio plans toreport additional data from this study at future medical meetings.
CTA for JK08 Submitted in Europe
The first CTA has been filed in Europe seekingapproval to initiate a Phase 1/2 study evalsuating JK08 monotherapy for thetreatment of advanced solid tumors. JK08 augments the T-regulatory celltargeting of a CTLA-4-specific antibody with an IL-15/sushi domain fusionpeptide, which locally induces NK cell activation and antibody-dependentcellular cytotoxicity (ADCC), two biological hallmarks predictive of responseto CTLA-4 targeted therapy. The study will assess thesafety, pharmacokinetics, and anti-tumor activity of JK08 at multiple doselevels and will include multiple expansion cohorts following selection of theoptimal biologic dose. Upon obtaining regulatory approvals, theCompany plans to initiate recruitment during the third quarter of 2022.
Appointment of Arian Pano, MD asChief Medical Officer
Dr. Pano comes to SalubrisBio fromKiniksa Pharmaceuticals, where he served as SVP of Clinical Development,overseeing all functional groups, including medical, research, clinicaloperations, regulatory, safety, biometrics, and medical writing. Previously heserved as SVP of Clinical Development for Galapagos NV, and concurrently servedas the US country head and Global Head of Safety. Dr. Pano has an extensivebackground in research and development with a focus on cardiovascular,metabolic rare diseases, inflammation and fibrosis. He earned his MD degreefrom the University of Tirana, Albania, completing fellowships in invasivecardiology and pediatrics. In addition, he holds an MPH in HealthcareManagement from Harvard’s School of Public Health.
“Since clinical data is the currencyof our industry, and as we are now generating meaningful clinical results, thetime was right to expand and strengthen the leadership team by bringing on Ari tobuild our clinical organization, chaperone our drugs through mid- and late-stagedevelopment, and ensure our data management and pharmacovigilance functionssupport future planned regulatory filings,” added Murphy.
About JK07
JK07 is a recombinant fusion protein consisting of a fully humanimmunoglobulin IgG1 monoclonal antibody and an active polypeptide fragment ofthe human growth factor neuregulin [NRG-1]. NRG-1 is a clinically validatedgrowth factor that has shown promising activity in HFrEF and undesirable sideeffects. Research has shown that NRG-1 induces signaling through interactionwith two different receptors – HER3 and HER4. The HER4 pathway appears to beresponsible for the regenerative effects in the heart, while the HER3 pathwayappears primarily responsible for safety and tolerability limitations of recombinantNRG-1. By blocking HER3 signaling with an antibody fusion design, JK07selectively stimulates the HER4 pathway with a favorable pharmacokineticprofile, which has the potential to significantly widen the therapeutic windowof NRG-1 and yield better clinical effects.
About JK08
JK08 is a recombinant fusion protein consisting of a CTLA-4-specificantibody and an IL-15 fusion domain. The JK08 design builds upon a breadth of clinicalstudies with CTLA-4 antibodies and recombinant IL-15 molecules, which together portendsynergistic effects in an antibody fusion construct. The CTLA-4-specificantibody ipilimumab validated CTLA-4 as a target for cancer therapy, butresponse rates are limited. Analysis of clinical samples demonstrated that NKcell activity signatures and ADCC biomarkers correlate with ipilimumabresponses. Recombinant IL-15 has exhibited potent stimulation of NK cellexpansion and enhancement of ADCC in pre-clinical and clinical studies. Throughthe incorporation of a CTLA-4 antibody and IL-15 into a single molecule, JK08 can channel the potent immune stimulation of IL-15 through the CTLA-4antibody domain towards depletion of T-regulatory cells and targeted reversalof immunosuppression which may contribute to cancer progression.
About SalubrisBio
SalubrisBiois a clinical-stage biotechnology company dedicated to discovering anddeveloping complex biologics for cardiovascular, oncology, andneurodegenerative diseases. SalubrisBio was founded in August 2016 as awholly-owned subsidiary of the China-based pharmaceutical company Shenzhen SalubrisPharmaceuticals Co. Ltd. Headquartered in theUS, SalubrisBio reflects Shenzhen Salubris Pharmaceuticals’ commitment toinnovation and expansion into the global market and retains the core philosophyof developing therapeutics for large patient populations with significant unmetneeds.
For further information, pleasecontact:
Argot Partners
212.600.1902 | SalubrisBio@argotpartners.com
