Covington, KY, and Ehime, Japan, August 27, 2026 – CTI Clinical Trial & Consulting (CTI) and Optieum Biotechnologies (Optieum Bio) today announced a partnership to advance the clinical development of OPTF01, Optieum Bio’s investigational CART-cell therapy targeting Fibroblast Activation Protein alpha (FAPα) for patients with glioblastoma (GBM). The collaboration will support a Phase Ia / Ib clinical study evaluating OPTF01 in patients with recurrent GBM whose disease has progressed following standard therapy.
The partnership brings together Optieum Bio’s innovative cell therapy platform and CTI’s expertise in oncology, cell and gene therapy development, and complex early-phase clinical trial execution.
“Advancing novel cell therapies requires close collaboration between scientific innovators and experienced development partners,” said Tim Schroeder, CTI Founder and Executive Chairman. “We are proud to support Optieum Bio as they advance OPTF01 into the clinic and look forward to helping execute this important program for patients with glioblastoma.”
Glioblastoma is among the most aggressive forms of brain cancer and continues to represent a significant unmet medical need despite advances in surgery, radiation therapy, and systemic treatment. OPTF01 is an investigational CAR T-cell therapy designed to target fibroblast activation protein alpha (FAPα), a protein expressed by a proportion of tumor cells as well as cells forming the suppressive tumor microenvironment. The study will evaluate the safety, tolerability, and preliminary clinical activity of OPTF01 administered via intracerebroventricular (ICV) delivery through an Ommaya reservoir.
“We are excited to partner with CTI as we advance OPTF01 into clinical development”, said Shun Nishioka, Founder and CEO of Optieum Biotechnologies. “Glioblastoma remains one of the most devastating cancers with limited treatment options, and OPTF01 has the potential to fundamentally change the treatment paradigm. CTI’s deep expertise in cell and gene therapy development and execution makes them an ideal partner as we prepare for this important clinical milestone. Together, we look forward to bringing OPTF01 to patients in need.”
CTI has supported the OPTF01 program since the early stages of development, providing protocol review and strategic guidance to help prepare the program for clinical evaluation. Through the partnership, CTI will support key aspects of the Phase Ia / Ib study, drawing on its experience in CAR-T clinical operations, apheresis oversight, FACT-accredited site coordination, advanced safety monitoring, and regulatory strategy for innovative therapies.
Optieum Biotechnologies, Inc. is a biotechnology company developing next-generation CAR-T cell therapies. The Company leverages its proprietary Eumbody System, a functional CAR screening and optimization platform designed to identify constructs with balanced activation, persistence, and durability. Optieum’s lead program, OPTF01, targets fibroblast activation protein alpha (FAPα) to address both tumor cells and the tumor microenvironment in recurrent and newly diagnosed glioblastoma. The Company is advancing its pipeline toward global clinical development with a focus on rigorous science, disciplined execution, and international regulatory strategy.
