Pluri Expands Manufacturing Partnership with Remedy Cell, Achieves Clinical-Grade Production for Fibrotic Disease Therapy
核心洞察
Pluri and Remedy Cell have successfully completed clinical-grade manufacturing of RC-0315, a first-in-class activated MSC (搜索)-derived secretome therapy for idiopathic pulmonary fibrosis (搜索).
The collaboration achieved full implementation of Remedy Cell's proprietary manufacturing process into Pluri's GMP facility, with batches intended for Phase 1b clinical trials.
Idiopathic pulmonary fibrosis (搜索) affects approximately 3 million people worldwide with a median survival of only 2-5 years post-diagnosis, representing a significant unmet medical need.
Pluri Inc. (搜索) and Remedy Cell Ltd. (搜索) have successfully achieved clinical-grade manufacturing of a novel secretome-based therapy for idiopathic pulmonary fibrosis (搜索) (IPF), marking a significant milestone in the development of cell-free therapeutics for fibrotic diseases (搜索). The collaboration has produced several clinical-grade batches of Remedy Cell's lead candidate RC-0315, intended for use in the company's initial Phase 1b clinical trial.
Manufacturing Milestone Achieved
Under the expanded manufacturing agreement, Remedy Cell's personnel and Pluri's Contract Development and Manufacturing Organization (PluriCDMO (搜索)™) division have successfully completed the full implementation of Remedy Cell's proprietary manufacturing process into Pluri's state-of-the-art Good Manufacturing Practice (GMP) facility. The collaboration included GMP training and qualification for the Remedy Cell manufacturing team, execution of engineering runs to confirm process robustness and scalability, and the manufacture of clinical-grade batches.
"Working with Pluri has been highly productive," said Ayelet Dilion-Mashiah, Chief Executive Officer of Remedy Cell. "Pluri's expertise and professionalism have been invaluable in helping us reach this critical milestone. Completing our clinical-grade manufacturing and preparing for our first clinical trial is a defining achievement for Remedy Cell."
Addressing Significant Unmet Medical Need
RC-0315 represents a first-in-class activated MSC (搜索)-derived secretome therapy targeting idiopathic pulmonary fibrosis (搜索), a fatal and highly complex progressive interstitial lung disease. IPF affects approximately 3 million people worldwide, with a median survival of only 2-5 years post-diagnosis. The therapy utilizes Remedy Cell's proprietary Activated Remedy Cell Secretome (ARcS) platform, which delivers multi-target, pro-regenerative solutions for complex fibrotic conditions.
Definitive preclinical studies have demonstrated RC-0315's potential to repair lung tissue and restore function. Despite the considerable impact of fibrotic diseases (搜索), current therapeutic options remain limited in both efficacy and scope, creating an urgent need for innovative approaches.
Expanded Collaboration Scope
Building on this manufacturing success, Pluri and Remedy Cell are broadening the scope of their collaboration. PluriCDMO (搜索)™ will continue to provide additional manufacturing and process-development support as Remedy Cell advances its clinical and pre-commercial programs.
"We are proud to continue strengthening our agreement with Remedy Cell, working together to achieve every project milestone — from technology implementation and engineering runs to the successful manufacture of clinical-grade batches for their first human trial," said Yaky Yanay, Chief Executive Officer and President of Pluri. "Remedy Cell's scientific approach is highly innovative, and it has been a privilege to contribute to their progress."
Platform Technology Validation
The completion of these manufacturing activities demonstrates PluriCDMO (搜索)™'s capability to serve complex cell-derived and cell-free processes with consistent, scalable, and regulatory-compliant manufacturing solutions. This achievement reflects the strong synergy between Remedy Cell's innovative therapeutic platform and Pluri's advanced manufacturing facilities.
The success further positions PluriCDMO (搜索)™ as a trusted partner for companies developing complex, cell-derived therapies. Pluri launched its CDMO division in January 2024, leveraging its proprietary knowledge, cutting-edge technology, and cell therapy production facility. Clients gain access to Pluri's state-of-the-art GMP facilities and patented bioreactor system, which enables cell expansion at mass scale via a fully controlled, automated, and validated process.