Pluri and Remedy Cell Hit Key Milestone, Paving Way for Human Trials of Novel Fibrosis Therapy

HAIFA, Israel – December 22, 2025 – In a significant advancement for regenerative medicine, Pluri, Inc. and Remedy Cell Ltd. today announced the successful manufacture of several clinical-grade batches of a novel therapy aimed at treating a fatal lung disease. This achievement marks a critical step toward initiating Remedy Cell’s first human clinical trial and has prompted the two companies to expand their manufacturing and development agreement.

The collaboration leverages Pluri’s advanced manufacturing capabilities to produce Remedy Cell’s innovative cell-free therapeutic, RC-0315, designed to combat Idiopathic Pulmonary Fibrosis (IPF). The successful production runs confirm the therapy can be manufactured at scale under strict regulatory standards, moving a promising potential treatment from the laboratory closer to the patients who desperately need it.

From Lab Bench to Clinical Production

The milestone is the result of an intensive collaboration that began in 2024. Under the agreement, Pluri’s Contract Development and Manufacturing Organization (CDMO) division, PluriCDMO™, worked closely with Remedy Cell’s scientific team to transfer and implement Remedy Cell’s proprietary manufacturing process into Pluri’s state-of-the-art Good Manufacturing Practice (GMP) facility.

Achieving GMP compliance is a non-trivial hurdle in drug development. It ensures that a product is consistently produced and controlled according to the highest quality standards, a prerequisite for any therapy intended for human use. The process involved extensive training and qualification for the Remedy Cell manufacturing team, followed by a series of successful engineering runs. These runs were designed to test and confirm the robustness and scalability of the manufacturing process, ensuring that the therapy could be produced reliably and in sufficient quantities for clinical trials and potential future commercialization.

The successful completion of these activities culminated in the manufacture of the first clinical-grade batches of RC-0315. This tangible progress demonstrates the synergy between Remedy Cell’s innovative science and Pluri’s industrial-scale cell expansion and manufacturing expertise.

“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.”

A New Hope for Idiopathic Pulmonary Fibrosis

The therapy at the center of this collaboration, RC-0315, targets Idiopathic Pulmonary Fibrosis, a devastating and progressive interstitial lung disease. The term "idiopathic" means its cause is unknown. The disease is characterized by the formation of scar tissue, or fibrosis, within the lungs, which makes breathing increasingly difficult.

IPF affects approximately 3 million people worldwide and is ultimately fatal. Patients diagnosed with the condition face a grim prognosis, with a median survival time of only two to five years post-diagnosis. Current therapeutic options are limited; they may slow the progression of the disease but do not halt or reverse the underlying damage. This creates a significant unmet medical need and an urgent push for innovative treatments that can offer more than just a marginal extension of life.

Remedy Cell's approach with RC-0315 has shown significant potential in preclinical studies to not only slow the disease but to repair damaged lung tissue and restore function, offering a new paradigm for treating fibrotic conditions.

The Promise of Cell-Free Therapeutics

Remedy Cell is at the forefront of developing cell-derived, cell-free therapies. Unlike traditional cell therapies that involve transplanting living cells into a patient, Remedy Cell’s Activated Remedy Cell Secretome (ARcS) platform harnesses the therapeutic payload that cells release.

The "secretome" is the collection of molecules and signals—such as proteins, growth factors, and extracellular vesicles—that cells secrete to communicate with their surroundings and orchestrate complex biological processes like tissue repair and regeneration. By isolating this secretome from activated Mesenchymal Stem Cells (MSCs), Remedy Cell has created RC-0315, a therapy that delivers the regenerative power of stem cells without the cells themselves.

This cell-free approach offers several potential advantages, including a potentially better safety profile, reduced immunogenicity, and more straightforward manufacturing, storage, and administration. The multi-target nature of the secretome allows it to address the complex biological cascades involved in fibrotic diseases, offering a pro-regenerative solution that a single-molecule drug often cannot.

A Symbiotic Biotech Collaboration

The partnership is a powerful example of the evolving biotech ecosystem, where companies with specialized expertise collaborate to accelerate innovation. For Remedy Cell, a clinical-stage biopharmaceutical company, access to Pluri’s established GMP facilities and decades of cell expansion experience has been a critical accelerator.

“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.”

For Pluri, the success of this project serves as a powerful validation of its PluriCDMO™ division, launched in January 2024. The division aims to monetize Pluri's proprietary 3D cell expansion platform and deep institutional knowledge by offering manufacturing services to other cell therapy developers. Successfully handling Remedy Cell’s complex, cell-free process positions PluriCDMO™ as a trusted partner for a growing number of companies in the regenerative medicine space.

Building on their success, the two companies are now broadening the scope of their collaboration. PluriCDMO™ will continue to provide manufacturing and process-development support as Remedy Cell advances RC-0315 through its Phase 1b clinical trial and prepares for later-stage clinical and pre-commercial programs, underscoring a shared commitment to addressing significant unmet medical needs with next-generation biologics.