ProT-096 designed to address critical gaps in immune recovery for patients with refractory hematologic malignancies through a manufacturing process driven by targeted Notch activation
Collaboration will apply Cellares’ fully automated Cell ShuttleⓇ and Cell Q™ platforms to ProT-096 while providing regulatory support toward IND submission
SOUTH SAN FRANCISCO, Calif. & TORONTO--(BUSINESS WIRE)--Cellares, the first Integrated Development and Manufacturing Organization (IDMO), and ProTgen, a biotechnology company pioneering targeted Notch activators to reactivate the thymus and reconstitute the adaptive immune system, today announced a partnership to automate manufacturing and quality control of ProT-096, ProTgen's personalized progenitor T cell therapy for patients with refractory leukemia and other hematologic malignancies who have exhausted standard treatment options. As part of this collaboration, Cellares will also provide regulatory support to ProTgen in the drafting of an Investigational New Drug application.
Patients with refractory hematologic malignancies often face a severely compromised immune system following the intensive therapies required to treat their disease. ProT-096 is a personalized progenitor T cell therapy designed to restore long-term immune protection and, therefore, requires precision manufacturing at scale. Achieving the reproducibility, process consistency, and cost efficiency required to support clinical development and eventual commercial scale demands a manufacturing approach that goes beyond what manual methods can deliver.
“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. “Cellares’ fully automated, GMP-ready manufacturing platform is designed to support the efficient development of cell therapy treatments for patients with significant unmet medical need. This partnership allows us to pair our targeted Notch activator platform with an automated, scalable manufacturing foundation designed to support the path toward IND submission and, ultimately, clinical development.”
"Hematologic malignancies have waited too long for cell therapy to deliver on its promise, and manufacturing complexity has been one of the reasons. Early-stage developers should not have to choose between advancing their science and securing the manufacturing foundation they need to scale," said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. "ProT-096 represents exactly the kind of innovative program for which we founded Cellares. By automating the manufacturing process and providing regulatory expertise toward IND submission, we can help ProTgen move faster and with greater confidence toward the clinic."
The Cell Shuttle's fully automated, end-to-end manufacturing workflow reduces manual touchpoints, minimizes variability, and enables standardized execution across runs, equipment, and facilities. Combined with the Cell Q, the integrated Cellares solution is designed to meet the demands of clinical- and commercial-scale production while maintaining the rigorous quality standards required for GMP manufacturing. The partnership also marks a continued expansion of Cellares' platform capabilities across cell therapy modalities, adding personalized progenitor T cells to a growing portfolio that includes CAR T cell therapies and HSC programs.
About Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO), providing global cell therapy development and manufacturing services through an Industry 4.0 approach to the mass manufacture of the living drugs of the 21st century. The company enables drug sponsors to develop, scale, and commercialize cell therapies with the capacity, reliability, and economics required to meet total patient demand.
Cellares' fully automated platforms — Cell ShuttleⓇ for end-to-end cell therapy manufacturing and Cell Q™ for automated in-process and release quality control — are deployed across its network of IDMO Smart Factories worldwide. These technologies deliver industry-leading manufacturing economics, higher process success rates, and the ability to produce up to 10× more cell therapy batches than conventional CDMOs with comparable footprint and headcount, resulting in the lowest cost of manufacturing in the industry. The Cell ShuttleⓇ is the first cell therapy manufacturing platform to receive the FDA's Advanced Manufacturing Technology (AMT) designation, and has demonstrated a 100% automation success rate across more than a dozen automated processes.
Cellares has achieved key clinical validation milestones, including FDA clearance of IND Amendments enabling active clinical manufacturing on the Cell ShuttleⓇ platform, and the successful dosing of first patients in partner clinical trials — marking the platform's transition from development-stage technology to clinically validated manufacturing infrastructure. These milestones span multiple therapeutic areas and cell therapy modalities, including both oncology and autoimmune indications.
Headquartered in South San Francisco, California, Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan. Through its global manufacturing network, Cellares is purpose-built to support both clinical and commercial programs and to expand access to life-saving cell therapies worldwide. For more information, visit www.cellares.com and follow Cellares on LinkedIn.
About ProTgen
ProTgen is developing a new class of transformative medicines to restore immune competence by unlocking the therapeutic potential of the Notch signaling pathway. Traditionally considered undruggable, ProTgen has overcome this barrier with its proprietary targeted Notch activator platform—a versatile technology capable of programming cell fate both in vivo and ex vivo. The company’s initial focus is to reactivate the thymus and rebuild a diverse, functional immune repertoire for patients with compromised or aging immune systems. Backed by top-tier investors and a world-class team of experts, ProTgen is advancing a pipeline leveraging targeted Notch activators with the potential to provide foundational new modalities across oncology, regenerative medicine, and age-related immune decline. For more information, visit www.protgen.bio and follow ProTgen on LinkedIn.
Contacts
Cellares Contacts
Business Development: bd@cellares.com
Investors: ir@cellares.com
Media: pr@cellares.com
ProTgen Contacts
Business Development: bd@protgen.bio
Investors: ir@protgen.bio
Media: pr@protgen.bio
