Cellares, ProTgen to Automate Manufacturing of Novel Progenitor T-Cell Therapy

Cellares and ProTgen now have a partnership automating manufacturing and quality control of ProT-096, ProTgen’s personalized progenitor T-cell therapy. The therapy is meant for patients with refractory leukemia, and other hematologic malignancies, who have exhausted standard treatment options.

How Cellares and ProTgen Will Coexist

Cellares, an integrated development and manufacturing organization (IDMO), will provide regulatory support to ProTgen for an Investigational New Drug application draft. ProTgen describes itself as a biotechnology company pioneering targeted Notch activators to reactivate the thymus, reconstituting the adaptive immune system.

As a personalized progenitor T-cell therapy, the intent of ProT-096 is to restore long-term immune protection. This is important because patients with refractory hematologic malignancies may have severely compromised immune systems following intensive treatments and therapies.

ProTgen CEO Carter Cliff said for these patients, the therapy and this new partnership can be game changers.

“ProT-096 represents a new approach to immune reconstitution, with the potential to address a significant unmet need,” Cliff said.

Why T-Cell Therapy is the Way Forward

That said, to be effective, a therapy such as ProT-096 requires precision manufacturing at scale. Automation ensures this by helping achieve necessary reproducibility, process consistency and cost efficiency to support clinical development—and eventually, commercialization.

In this partnership, Cellares plans to leverage its two fully automated platforms. Cell Shuttle handles end-to-end cell therapy manufacturing, and Cell Q is used for automated in-process and release quality control. Together, these meet demands of both clinical- and commercial-scale production, and maintain rigorous good manufacturing practice (GMP) manufacturing quality standards.

“Hematologic malignancies have waited too long for cell therapy to deliver on its promise,” said Cellares Co-Founder/CEO Fabian Gerlinghaus. “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. 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.”