Collaboration supports manufacture of the OPTF01 product to Drive Next-Generation Chimeric Antigen Receptor T Cell (CAR-T) Development
Indianapolis, Indiana, and Ehime, Japan, May 5, 2025 / – 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.
Genezen Media Contact
Meg Bor
Email: PR@genezen.com
Optieum Biotechnologies Media Contact
Hinako Osawa
- Optieum Biotechnologies Inc. Secures up to $39M Grant from the Japanese Agency for Medical Research and Development
- Funds will support the development of OPTF01, Optieum’s lead CAR-T program targeting glioblastoma
Ehime, Japan, March 18th, 2025 – Optieum Biotechnologies Inc. (“Optieum”), a preclinical stage company dedicated to the discovery and development of innovative CAR-T cell therapies, is pleased to announce that it has been awarded up to $39M in non-dilutive grant funding under the “Strengthening Program for Pharmaceutical Startup Ecosystem” by the Japan Agency for Medical Research and Development (AMED).
The grant will be used to support the development of OPTF01, Optieum’s lead CAR-T candidate targeting Fibroblast Activation Protein Alpha (FAPα) to an Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA) for the treatment of glioblastoma (GBM).
“We are excited to announce that, OPTF01, has been selected by AMED for funding to accelerate its preclinical and clinical development.” said Shun Nishioka, CEO of Optieum Biotechnologies. “Combined with the continued support from our investors, this AMED grant positions us to rapidly advance OPTF01 toward the next clinical development milestones, and ultimately closer to providing a new treatment option for patients.”
Optieum received approval for this funding with support from Saisei Ventures, Keio Innovation Initiative, and ANRI as certified VCs. Through this grant, Optieum will be eligible to receive AMED grant funds equal to twice the investment from these certified VCs toward the continuing development of OPTF01, the company’s first clinical candidate in its expanding pipeline of next-generation CAR-T therapies.
For more information about AMED’s Strengthening Program for Pharmaceutical Startup Ecosystem, please visit: https://www.amed.go.jp/program/list/19/02/005.html (in Japanese)
About Optieum Biotechnologies Inc.
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 www.optieumbio.com and follow us on LinkedIn.
Contact:
Optieum Biotechnologies
Email: info@optieumbio.com
Optieum Biotechnologies Inc., and GI CELL (HQ: Seongnam, Korea / CEO: Dr. Chun Pyo Hong) has entered into a Research License and Option Agreement on chimeric antigen receptor (CAR)-NK Cell Therapy.
The Research License and Option Agreement will aim to generate novel CAR-NK cells with GI CELL’s CAR-NK technology platform and Optieum’s novel scFv antibodies against hematological tumor targets.
Optieum Biotechnologies has a proprietary platform to identify functional scFv/CAR constructs that enhance therapeutic efficacy against the target of interest. Whereas, GI CELL has developed an NKPUREExpander® platform that generates superior NK cells with high efficiency, safety, as well as manufacturability.
Under the terms of the agreement, GI CELL will receive a license option. Upon exercise of the option, Optieum will receive an upfront option exercise fee and milestone payments upon the successful achievement of certain development milestones. In addition, Optieum is eligible to receive royalties on future sales of products that arise from the license.
“We are pleased to enter this collaboration with Optieum Biotechnologies as we continue unlocking the full potential of our NKPURE Expander® platform,” said Dr. Chun Pyo Hong, CEO of GI CELL. “We look forward to evaluating the scFv antibodies from Optieum Biotechnologies’ discovery platform, which have the potential to accelerate the development of our novel CAR-NK cells.”
“We have been dedicated to expanding the toolbox to enable immune cell-based therapies in cancer treatment, through our proprietary Eumbody System. Optieum Biotechnologies’ strength in discovery of functional and improved scFvs in conjunction with GI CELL’s expertise in NK cell engineering and manufacturing may lead to a generation of promising cellular immunotherapy for unmet medical needs,” said Shun Nishioka, CEO of Optieum Biotechnologies.
About GI CELL
GI CELL is a biotechnology company that drives research and development of novel immune cell-based therapies with innovative technologies. Using its proprietary Immune CellPURE Expander® platform for highly potent NK and T cell development, GI CELL has integrated its ancillary material screening and cell expansion technologies to streamline the entire cell product development process. The Company is advancing its allogenic NK cell therapies to transform the treatment paradigm for patients with hematological malignancies and solid tumors. GI CELL has multiple NK cell product candidates in IND-enabling and preclinical development.
For more information, please visit https://www.gi-cell.com/en/.
About Optieum Biotechnologies
Optieum Biotechnologies is a biotechnology company with a platform engine to elicit functional and improved scFvs for CAR-T cell and CAR-NK therapies with superior anti-tumor toxicity and persistence. Optieum Biotechnologies’ scFv generation platform, Eumbody System, enables to acquire the scFv from the CAR-T cell’s functionality perspective rather than conventional binding affinity approach. The company is advancing multiple CAR-T cell product candidates targeting hematological malignancies and solid tumors which demonstrate significantly improved anti-tumor toxicity, proliferation capacity and mitigated antigen depletion.
For more information, please visit https://optieumbio.com/
We are pleased to announce that Optieum Biotechnologies Inc. (“Optieum”) has entered into a research collaboration agreement with the National Cancer Center Japan(“NCC”) to initiate multiple projects to discover and develop innovative CAR-T cell therapy assets targeting solid tumors.
Optieum has a platform technology to elicit functional and improved scFvs that can lead to superior antitumor reactivity of CAR-T cells. NCC, Exploratory Oncology Research and Clinical Trial Center (NCC-EPOC) has expertise in clinical research and development of cancer immunotherapy, and is capable of accelerating translational research by integrating its clinical resources into this collaboration.
With the completion of signing, Optieum and Division of Cancer Immunotherapy (Chief, Dr. Tetsuya Nakatsura) of NCC-EPOC, will begin joint research to develop CAR-T cell therapies for patients with solid tumors.
We are pleased to announce that Optieum Biotechnologies Inc. has been awarded “NEDO STS” grant from New Energy and Industrial Technology Development Organization (NEDO).
This grant was submitted with the support of ANRI, a venture capital. With this funding, we will continue to expand our platform technology and accelerate the development of in-house CAR-T cell programs.
We are committed to go beyond the limits of immuno-oncology drug development and deliver the most appropriate treatment for the cancer patients in needs.
We are pleased to announce that Optieum Biotechnologies Inc. has raised JPY 290 million ($ 2.6 million) in seed round funding. The round was led by ANRI and the participation of Real Tech Fund, Iyogin Capital and an angel investor.
Optieum Biotechnologies Inc. is a biotechnology company committed to develop innovative scFv antibody-based therapies for the treatment of cancer patients. Our proprietary platform technology, Eumbody System, enables us to develop and detect scFv-based product candidates that specifically bind, modulate, and ultimately enhance the immune-cell function for oncology targets.
With this funding, we will continue to expand the platform technology and accelerate the collaboration with pharmaceutical companies as well as the development of in-house CAR-T cell programs.
We are committed to go beyond the limits of immuno-oncology drug development and deliver the most appropriate treatment for the cancer patients in needs.
We are pleased to announce that Optieum Biotechnologies Inc. has entered into a research collaboration with Daiichi Sankyo Company, Limited. (Tokyo: 4568). Optieum Biotechnologies intends to use its Eumbody System technology to identify a new functional single chain fragment variables (scFvs) that can be utilized for CAR-T cell against the target of interest selected by Daiichi Sankyo.
Eumbody System is a single-chain antibody generation system yielding CAR-T cells with superior antitumor function developed by Dr. Toshiki Ochi, co-founder of Optieum Biotechnologies, which exclusive license is granted to Optieum Biotechnologies.
Under the terms of the agreement, Optieum Biotechnologies will receive an undisclosed upfront payment, and is eligible for payments associated with the achievement of certain development milestones.
We are pleased to announce that co-founder of Optieum Biotechnologies, Dr. Toshiki Ochi’s, paper on “A single-chain antibody generation system yielding CAR-T cells with superior antitumor function” has been published in the Communications Biology and is now accessible online.
Article: “A single-chain antibody generation system yielding CAR-T cells with superior antitumor function”
Authors: Toshiki Ochi, Masaki Maruta, Kazushi Tanimoto, Fumitake Kondo, Toshihiro Yamamoto, Mie Kurata, Hiroshi Fujiwara, Junya Masumoto, Katsuto Takenaka, Masaki Yasukawa