SOUTH SAN FRANCISCO, Calif. & TORONTO – May 11, 2026 – For patients with aggressive blood cancers who have exhausted all standard treatments, the promise of cell therapy has long represented a beacon of hope. Yet, this promise has been tempered by a harsh reality: the immense complexity and cost of manufacturing these personalized “living drugs” have created a critical bottleneck, leaving the vast majority of eligible patients waiting. A new partnership announced today aims to shatter that bottleneck, pairing a novel immune-restoring therapy with a factory-of-the-future approach to its production.
Cellares, a company pioneering an automated, integrated model for cell therapy production, is joining forces with ProTgen, a biotech developing a new class of medicines to rebuild compromised immune systems. The collaboration will focus on automating the manufacturing of ProT-096, ProTgen’s personalized progenitor T cell therapy for patients with refractory leukemia and other hematologic malignancies. By replacing manual lab work with a closed, automated system, the partners intend to accelerate the therapy’s journey to the clinic and ultimately make it scalable and accessible.
Rebuilding the Body’s Defenses
Patients with refractory hematologic malignancies often find themselves in a perilous situation. The intensive chemotherapy and radiation required to fight their cancer can decimate their immune systems, leaving them vulnerable to life-threatening infections and disease relapse. Their body’s primary defense-building organ, the thymus, can become impaired, unable to generate a diverse army of T cells needed for long-term protection.
This is the critical unmet need ProTgen aims to address with ProT-096. The therapy is designed to restore immune competence by using the patient’s own cells to create progenitor T cells—early-stage cells that can mature in the body to reconstitute a functional and diverse immune repertoire. The scientific engine behind this approach is ProTgen’s proprietary platform, which uses targeted activators to harness the Notch signaling pathway. This fundamental biological pathway is critical for T-cell development in the thymus. By precisely activating it, ProTgen believes it can effectively reactivate the body’s own T-cell production factory.
“ProT-096 represents a new approach to immune reconstitution, with the potential to address a significant unmet need for patients whose immune systems have been severely compromised by hematologic malignancy and prior treatment,” said Carter Cliff, Chief Executive Officer of ProTgen, in a statement. The personalized nature of the therapy, however, presents a significant manufacturing challenge that manual methods struggle to overcome consistently and cost-effectively.
The Manufacturing Choke Point
The revolutionary potential of cell therapies like CAR-T has been proven in the clinic, but their impact has been limited by a pre-industrial manufacturing paradigm. Industry data reveals a stark access gap: fewer than 5% of patients worldwide who could benefit from approved cell therapies have received them. The process is notoriously labor-intensive, with a single patient’s dose requiring over 50 manual steps, high-cost cleanroom facilities, and highly specialized personnel. This complexity not only drives up costs but also introduces variability and a high risk of batch failure, which can be devastating when a patient has no other options.
This is precisely the problem Cellares was founded to solve. The company has established itself as the industry’s first Integrated Development and Manufacturing Organization (IDMO), a model that goes beyond traditional contract manufacturing by offering a fully integrated, automated solution from development through commercial scale.
“Hematologic malignancies have waited too long for cell therapy to deliver on its promise, and manufacturing complexity has been one of the reasons,” stated Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. “Early-stage developers should not have to choose between advancing their science and securing the manufacturing foundation they need to scale.”
An Assembly Line for Living Drugs
At the heart of the Cellares solution are its Cell Shuttle and Cell Q platforms. The Cell Shuttle is a self-contained, fully automated system—often described as a “factory in a box”—that can handle the entire end-to-end manufacturing process for up to 16 different patient batches simultaneously. This approach dramatically reduces the need for manual labor and vast cleanroom space, slashing process failure rates and increasing throughput by a factor of ten compared to manual methods. The Cell Q provides integrated, automated quality control, ensuring consistency and adherence to GMP standards.
This technological leap was recently validated by the U.S. Food and Drug Administration (FDA), which granted Cellares’ Cell Shuttle the coveted Advanced Manufacturing Technology (AMT) designation. This designation acknowledges the platform’s potential to improve product quality and efficiency, and it provides a streamlined regulatory pathway for partners like ProTgen. Companies using the Cell Shuttle for their IND applications can benefit from an expedited review process, potentially shaving precious time off the journey to clinical trials and eventual approval.
For ProTgen, this partnership provides more than just a manufacturing line. Cellares will also lend its regulatory expertise to help draft the Investigational New Drug (IND) application for ProT-096, a crucial step in gaining FDA permission to begin human trials. This integrated support system is central to the IDMO model, designed to help innovative but smaller biotech firms navigate the complex and capital-intensive path to commercialization.
This collaboration also marks an expansion of Cellares’ capabilities, adding personalized progenitor T cells to a portfolio that already includes CAR T therapies and hematopoietic stem cells. The ability of the Cell Shuttle platform to adapt to different cell therapy modalities demonstrates its flexibility and reinforces its potential as a standardized global infrastructure for the next generation of medicine. By industrializing the production of these complex treatments, this partnership may represent a pivotal step toward making the hope of cell therapy a reality for countless patients.