Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), and Secretome Therapeutics, a biotechnology company advancing therapies derived from neonatal cardiac progenitor cells (nCPCs), announced a partnership for cGMP manufacturing of Secretome Therapeutic’s lead asset STM-01.
Under this partnership, Cellipont Bioservices will provide technology transfer, analytical method transfer, and cGMP manufacturing for the STM-01 Master Cell Bank. STM-01, a novel nCPC product, is protected under a recently issued composition of matter patent, which also covers STM-21, Secretome’s lead secretome-based therapeutic.
About STM-01 and STM-21:
- STM-01: STM-01 is a novel cellular therapy designed to address severe cardiovascular diseases, particularly dilated cardiomyopathy (DCM) and heart failure with preserved ejection fraction (HFpEF). nCPCs release a unique set of paracrine factors that reduce inflammation, inhibit fibrosis and support tissue repair. Two multiple-ascending dose Phase 1 clinical trials studying STM-01 in patients with heart failure are expected to begin in the first quarter of 2025.
- STM-21: STM-21 is a secretome-based therapeutic comprised of the bioactive molecules secreted by nCPCs, such as cytokines and exosomes, which promote cellular repair and reduce inflammation. STM-21 is in preclinical development for conditions driven by chronic inflammation, including skin wounds and neurodegenerative disease, with additional preclinical data expected in 2025.
“This partnership with Secretome Therapeutics represents an exciting opportunity for Cellipont to support the advancement of cutting-edge cell therapies,” said Darren Head, CEO of Cellipont Bioservices. “We are very excited to collaborate with a company so dedicated to developing innovative solutions that address significant unmet medical needs and improve patient outcomes.”
“A key objective for Secretome in 2025 is to produce STM-01 drug product that is suitable for late-stage clinical testing and potential commercial use,” said Vinny Jindal, President and CEO of Secretome Therapeutics. “Cellipont’s world-class facility and deep expertise in cGMP manufacturing for cell and gene therapies make them an ideal manufacturing partner and align perfectly with our mission to deliver transformative therapies for cardiovascular diseases and beyond.”