Genezen and Optieum Biotechnologies Partner to Support cGMP Manufacturing of Groundbreaking CAR-T Therapy for Glioblastoma

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Collaboration supports manufacture of the OPTF01 product to Drive Next-Generation Chimeric Antigen Receptor T Cell (CAR-T) Development

INDIANAPOLIS and EHIME, Japan, May 5, 2025 /PRNewswire/ — Genezen, a leading viral vector Contract Development and Manufacturing Organization (CDMO), and Optieum Biotechnologies, Inc. (Optieum), a preclinical stage company dedicated to the discovery and development of innovative CAR-T cell therapies, today announced a partnership for cGMP manufacturing of the lentiviral vector (LVV) construct used in the production of OPTF01, a novel CAR-T therapy for glioblastoma treatment.

Derived from Optieum’s proprietary Eumbody System, OPTF01 specifically targets Fibroblast activation protein-alpha (FAPα), a protein expressed on both tumor cells and the surrounding pericytes and Cancer-associated Fibroblasts (CAFs). Hence, OPTF01 can potentially disrupt the immunosuppressive microenvironment around the tumor while simultaneously attacking the malignant cells within the tumor. Successful development of this therapeutic approach would address a critical unmet medical need for patients with refractory glioblastoma who currently face limited treatment options with poor prognoses, as well as various other solid tumor indications.

Under this collaboration, Genezen will provide the technology transfer, process development, and cGMP manufacturing of the LVV construct used in the onward production of the OPTF01 CAR-T product. “Genezen is honored to support Optieum’s best-in-class CAR-T programs with our best-in-class LVV expertise to bring these critical therapies to life,” said Steve Favaloro, Chairman and CEO of Genezen. “This collaboration with Optieum underscores our rich experience and the capabilities of both our people and state-of-the-art facilities to support customers on a global scale – now including a leading Japanese biotech.”

Shun Nishioka, CEO of Optieum added, “At Optieum, we are committed to redefining the future of CAR-T therapy through relentless innovation and scientific rigor. Partnering with Genezen’s team of experts ensures that critical materials for our groundbreaking therapies are manufactured to the highest standards, accelerating our progress toward delivering next-generation therapies for glioblastoma and other solid tumors.”

OPTF01 is derived from the Eumbody System, a proprietary platform representing a significant advancement in CAR-T cell therapy development. This platform leverages rapid and expansive functional screening to identify and optimize CAR constructs in unprecedented fashion. By dynamically harmonizing single-chain variable fragment (scFv) sequences to enhance the functional capabilities of T cells, the Eumbody System sets a new standard in CAR-T innovation.

About Genezen
Genezen is a best-in-class gene therapy CDMO with over a decade of experience and state-of-the-art viral vector manufacturing facilities. With capabilities to work across vector-modality – from concept to commercial – Genezen helps innovator companies deliver life-saving gene and cell therapies worldwide. With flexible and customer-centric programs, Genezen tailors its partnership-model approach to all sizes and stages of organizations, from academic institutions and seed-funded companies to large, multinational biopharma enterprises. For more information, please visit www.genezen.com and follow us on LinkedIn.

About Optieum Biotechnologies
Optieum Biotechnologies Inc. is a cutting-edge biotechnology company dedicated to engineering hope for patients through the development of next-generation CAR-T cell therapies. At the heart of Optieum’s innovation is its proprietary Eumbody System, a revolutionary platform that optimizes CAR constructs to unlock the full therapeutic potential of T cells by dynamically harmonizing CAR binding domains. This transformative platform has the potential to redefine CAR-T cell therapy, enabling the development of groundbreaking treatments for challenging diseases. For more information, visit http://www.optieumbio.com and follow us on LinkedIn.

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