RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (MSCs), highly engineered media, and bioprocess development services, and Secretome Therapeutics, a clinic-stage company developing novel therapies derived from neonatal cardiac progenitor cells (nCPC), today announced completion of commercial scale production of Secretome's lead nCPC, STM-01.

In March 2025, RoosterBio initiated a development services program to establish a 50L scale cGMP compatible bioreactor-based process for production of Secretome's lead clinical asset, STM-01, currently in phase I clinical trials for the treatment of heart failure with preserved ejection fraction (HFpEF) and dilated cardiomyopathy (DCM). This 50L bioreactor process is intended to replace Secretome's previously established 2D flask-based process for STM-01, enabling greatly enhanced productivity and scalability for continued clinical manufacturing. Process development performed at RoosterBio included media comparability and process optimization studies leveraging Ambr®250 microscale bioreactors, followed by confirmation of process suitability in 3L bioreactors. Most recently, a full scale 50L bioreactor run was successfully completed, and the process is now being transferred to Secretome's contract manufacturer for immediate implementation.

A critical element of STM-01 production process is the use of RoosterBio's cGMP-grade cell expansion medium, ^prcRoosterNourish™-MSC-CC, and accompanying bioreactor feed, ^prcRoosterReplenish™-MSC-CC. This fed batch media system was specifically designed for highly productive, efficient, and scalable production of cell therapies in bioreactors, enabling simpler, more cost-effective manufacturing of highly innovative products like STM-01.

"We're thrilled to partner with the amazing team at Secretome Therapeutics, a true innovator in the field of cell and secretome therapy," stated Tim Kelly, CEO of RoosterBio. "RoosterBio has spent the last twelve years developing the products and biomanufacturing processes necessary to achieve scalable, cost-effective production of cell and exosome therapeutics. It's extremely gratifying to be part of the team making transformative therapies like STM-01 more accessible to patients suffering from heart failure."

"Historically, the scale-up of stem cell-based therapeutics has represented a hurdle towards FDA approval, making manufacturing a top area of focus for Secretome since its founding 3 years ago," said Vinny Jindal, President and CEO of Secretome. "The RoosterBio team's world-class experience scaling up production of mesenchymal stem cells enabled us to reach this major milestone, and we look forward to working with them on STM-03 and our other pipeline products."

RoosterBio and Secretome's partnership also includes development of Secretome's lead preclinical asset, STM-21, the secretome from STM-01, which is being evaluated for neurological conditions including amyotrophic lateral sclerosis (ALS) and diabetic neuropathy, and for burns and other inflammatory conditions of the skin. As with STM-01, the scope of work being performed by RoosterBio includes the establishment of a 50L bioreactor-based production process for STM-21.