Pluri & Remedy Cell Propel Novel Lung Disease Therapy to Human Trials

HAIFA, Israel & CAMBRIDGE, UK – December 22, 2025 – In a significant step forward for regenerative medicine, biotechnology firm Pluri Inc. and biopharmaceutical innovator Remedy Cell Ltd. have expanded a pivotal manufacturing partnership. The collaboration has successfully produced clinical-grade batches of RC-0315, a novel cell-free therapy targeting Idiopathic Pulmonary Fibrosis (IPF), a devastating and fatal lung disease. This achievement paves the way for Remedy Cell to initiate its first-in-human Phase 1b clinical trial, moving a promising new treatment from the laboratory bench closer to the patients who desperately need it.

The expanded agreement, building on a foundation set in early 2024, highlights a critical trend in the life sciences industry: the symbiotic relationship between agile biotech innovators and specialized Contract Development and Manufacturing Organizations (CDMOs). Pluri's advanced manufacturing capabilities are proving instrumental in translating Remedy Cell's cutting-edge science into a tangible therapeutic product ready for regulatory scrutiny and patient testing.

A New Frontier in Fibrosis Treatment

Idiopathic Pulmonary Fibrosis is a relentless disease characterized by the progressive scarring of lung tissue, which leads to irreversible decline in respiratory function. For the thousands diagnosed each year, the prognosis is grim, with a median survival of just three to five years. Current approved treatments, such as pirfenidone and nintedanib, can slow the disease's progression but do not halt or reverse the damage and are often accompanied by significant side effects.

Remedy Cell aims to fundamentally change this paradigm with RC-0315. Unlike traditional cell therapies that involve transplanting live cells into a patient, RC-0315 is a cell-free secretome. It is a complex cocktail of therapeutic proteins, growth factors, and exosomes harvested from specially activated mesenchymal stem cells. This approach harnesses the powerful regenerative signals that stem cells use to communicate and direct healing, but without the complexities and potential risks of administering the cells themselves.

Preclinical data for RC-0315 is compelling. In lab studies using human fibrotic lung tissue from IPF patients, the therapy demonstrated a remarkable ability to promote the degradation of scar-like collagen fibers, achieving a 50% reduction in their width. In animal models, it was shown to stimulate the activity of endothelial cells crucial for blood vessel repair, suppress harmful cytotoxic T cells, and enrich pro-regenerative macrophages. This multi-pronged mechanism suggests RC-0315 has the potential not just to slow fibrosis, but to actively repair damaged lung tissue and restore function—a true holy grail in IPF treatment.

The Engine of Innovation: Advanced Manufacturing Takes Center Stage

The journey from a promising molecule to a clinical-grade therapeutic is fraught with complexity, and manufacturing is often the biggest hurdle. This is where PluriCDMO, Pluri's manufacturing division, has become an indispensable partner for Remedy Cell. Producing a consistent, pure, and scalable supply of a complex biologic like a secretome is a monumental task that demands specialized technology and expertise.

At the core of Pluri's offering is its proprietary PluriMatrix™ 3D cell expansion platform. This bioreactor-based system allows for the mass production of high-quality cells in a controlled, automated, and highly efficient manner. The technology's design ensures batch-to-batch consistency, a non-negotiable requirement for regulatory approval and commercial viability. With over two decades of experience, Pluri's in-house Good Manufacturing Practice (GMP) facility has been approved by major global regulators, providing a solid foundation for producing therapies intended for human use.

The term "clinical-grade" signifies adherence to these stringent GMP standards, which govern every aspect of production—from the sourcing of raw materials and the establishment of master cell banks to the final sterile filtration and packaging of the drug product. For this project, PluriCDMO successfully integrated Remedy Cell’s complex and proprietary manufacturing process into its own GMP systems, conducted engineering runs to validate the process's robustness, and provided GMP training for Remedy Cell's team, culminating in the successful output of multiple batches of RC-0315.

Navigating the Path to Patients

With a stable supply of clinical-grade RC-0315 now secured, Remedy Cell is focused on its upcoming Phase 1b clinical trial. The study is designed primarily to assess the safety and tolerability of the therapy in a small cohort of IPF patients. However, it also includes key exploratory objectives to look for early signals of efficacy. Remedy Cell has strategically partnered with Qureight Ltd., a specialist imaging firm, to employ sophisticated deep-learning AI platforms. This will allow for precise analysis of high-resolution CT scans, enabling researchers to monitor subtle changes in localized areas of the lung and objectively measure the drug's impact on disease pathology.

This trial represents the first of many hurdles in the long regulatory journey for an Advanced Therapy Medicinal Product (ATMP). Global regulators, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established rigorous frameworks for these complex products. The successful GMP manufacturing campaign is a critical first step, demonstrating the control and consistency required to even begin human trials. Remedy Cell plans to submit its application to the Israel Ministry of Health in 2024 to initiate the Phase I/IIa study, marking a formal transition into a clinical-stage company.

Strategic Implications and Market Signals

For Remedy Cell, the expanded partnership is a transformative event, providing a clear and tangible path to clinical validation for its lead asset. For Pluri, it serves as a powerful endorsement of its PluriCDMO business model and its underlying technology platform. Each successful partnership with an innovator like Remedy Cell strengthens Pluri's position as a go-to manufacturing partner in the burgeoning cell and gene therapy space.

Interestingly, the market's immediate reaction to the December 22 announcement was a modest 2.94% dip in Pluri's (PLUR) stock price. However, a deeper look reveals a more complex financial picture. With a price-to-sales ratio near a 10-year low and high insider ownership of over 63%, there are signs of strong internal confidence and potential undervaluation. This collaboration is a long-term strategic play, and its true value will likely be realized as Remedy Cell's clinical program progresses.

The partnership also points to the broader ambitions of both companies. Remedy Cell's ARcS platform is designed to be adaptable, with the potential to generate therapies for a range of other fibrotic conditions beyond the lungs. Meanwhile, Pluri continues to leverage its core cell-expansion technology across a diverse portfolio, from regenerative medicine and CDMO services to sustainable food-tech ventures in cultivated meat and coffee. This collaboration is a key component of Pluri’s broader strategy to embed its technology as a fundamental engine for the next generation of cell-based industries.