Secretome Therapeutics Doses First Patient in Phase 1 Trial for Heart Failure Cell Therapy STM-01
According to Secretome, the first-in-human, open-label trial is the first trial to assess an allogeneic stem cell therapy product for HFpEF.
Secretome Therapeutics has dosed the first patient in a phase 1 clinical trial (NCT06560762) evaluating STM-01, an investigational allogeneic neonatal cardiac progenitor cell (nCPC)-derived cell therapy, for the treatment of heart failure with preserved ejection fraction (HFpEF).1
According to Secretome, the first-in-human, open-label trial is the first trial to assess an allogeneic stem cell therapy product for HFpEF. The study utilizes an ascending dose design, in which an intravenous infusion of either 100 million or 200 million nCPCs will be delivered to patients. The infusion process is expected to take 1 hour.
“The launch of our first clinical trial is a major milestone for the STM-01 program, and for Secretome,” Vinny Jindal, the president and chief executive officer of Secretome Therapeutics, said in a statement.1 “Having recently secured multiple patents for STM-01, launched large-scale GMP manufacturing, completed our Seed Round of financing, and now launched this phase 1 study, we are well positioned to develop STM-01 as a potentially transformative therapeutic option in this multi-billion-dollar market.”
The first patient was treated at The University of Texas, Southwestern Medical Center (UTSW). According to the clinicaltrials.gov page, the study will also take place at Northwestern Medicine in Chicago, IL.
“Despite recent advances that have improved outcomes in HFpEF, residual risk is still very high and many of these patients will continue to worsen,” principal investigator Sanjiv Shah, MD, the Stone Endowed Professor and the director of the HFpEF Program at the Northwestern University Feinberg School of Medicine, added to the statement.1 “The next step in improving outcomes for patients is better and broader control of inflammation and restoration of normal cellular immunity. In preclinical studies, STM-01 significantly reduced inflammation on both cellular and molecular levels in HFpEF, resulting in improved cardiac function and exercise tolerance.”
Earlier this month, STM-01 was granted fast track designation by the FDA for the treatment of HFpEF.2 STM-01 is intended to function by decreasing inflammation, supporting tissue repair, and inhibiting fibrosis. In addition to HFpEF, Secretome is also developing STM-01 for the treatment of dilated cardiomyopathy. The company also has another product, a secretome-based therapeutic dubbed STM-21, under development for the treatment of various inflammatory conditions, such as skin wounds and diabetes comorbidities. STM-21 remains in preclinical development.
Secretome is not the only company developing an advanced therapeutic for the treatment of HFpEF. Medera subsidiary Sardocor is assessing SRD-001, an investigational adeno-associated virus (AAV) vector-based gene therapy, for the treatment of HFpEF in the phase 1/2a MUSIC-HFpEF clinical trial (NCT06061549).3 Notably, SRD-001 received fast track designation from the FDA in February 2024. At the time, 3 patients had been dosed in the trial, which is expected to enroll 10 participants in total. SRD-001 is directly delivered to cardiac ventricular muscle cells by use of Sardocor’s proprietary intracoronary infusion system that is designed to increase the protein expression and functional activity of SERCA2a. In preclinical research conducted with Medera subsidiary Novoheart’s bioengineered HFpEF Human mini-Heart models, downregulated SERCA2a protein levels were implicated as the key factor in disease-associated calcium-handling defects.
“The enrollment of the first patients in this gene therapy trial will serve to validate the large body of work that has implicated deficiency of calcium cycling in HFpEF”, Roger Hajjar, MD, cofounder of Medera and Sardocor and the director of the Mass General Brigham Gene and Cell Therapy Institute, said in a February 2024 statement.3
