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
Ehime, Japan, March 4th, 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 the United States Patent and Trademark Office (USPTO) has granted and registered patent number US 12,241,061 B for its core platform technology, the Eumbody System. This achievement strengthens Optieum’s intellectual property foundation as the company progresses from discovery-stage research towards clinical development.
“The granting of this patent in the U.S. is a pivotal milestone for Optieum and underscores the uniqueness and strength of the Eumbody System,” said Shun Nishioka, CEO of Optieum Biotechnologies. “This technology has the potential to redefine how CAR-T therapies are developed, paving the way for more effective treatments for patients in need, the first of which we are now moving forward towards an Investigational New Drug (IND) filing in the U.S. for the treatment of glioblastoma (GBM).”
Based on international patent application (WO2020/162452) and following on from previously granted patents in Japan (Patent No. 6821230, etc.) and Australia (AU 2020218446 B2), the United States is now the third jurisdiction to grant protection for this innovative platform.
Optieum remains committed to advancing the field of CAR-T cell therapy through continuous innovation and rigorous scientific research. The company’s Eumbody System serves as the foundation for its growing pipeline of next-generation CAR-T candidates, aimed at addressing some of the most challenging unmet medical needs.
For more information about Optieum and the Eumbody System, please visit www.optieumbio.com.
About The Eumbody System
The Eumbody System represents a breakthrough in CAR-T cell therapy development. This proprietary 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 through empirical evaluation, the Eumbody System significantly enhances the functional capabilities of T cells, setting a new standard in CAR-T innovation.
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
Ehime, Japan, January 22, 2025 – Optieum Biotechnologies Inc. (“Optieum”), a biotechnology company focused on discovering and developing innovative CAR-T cell therapies, today announced the appointment of Dr. Dan MacLeod to the role of Chief Scientific Officer (CSO) and Dr. Stewart Craig to the role of Chief Technology Officer (CTO), further strengthening our executive leadership team.
“We are thrilled to welcome Dan and Stewart to Optieum’s executive leadership team. Their combined deep expertise in cell and gene therapy product research, development and delivery will be instrumental in advancing our products into clinical trials,” said Shun Nishioka, Optieum’s President and Chief Executive Officer.
Dr. MacLeod is an experienced biotechnology leader and innovator in the cell therapy space with 20 years of experience in immunology, oncology, cancer immunotherapy, gene-editing and virology. Throughout his career, Dan has successfully led numerous teams in translating platform technologies into clinical candidate cell therapies, including four CAR-T therapies that advanced from early-stage research through IND-enabling studies and into Phase 1/2 clinical trials. Prior to joining the Optieum team, Dan was Senior Vice President of Discovery at ImmunoScape, where he led R&D for autologous TCR-T cell therapies. He also held roles of increasing responsibility during his time at Precision BioSciences, leading the discovery and development of gene-edited, allogeneic CAR-T cell therapies. Earlier in his career, Dan held roles at GlaxoSmithKline and the International AIDS Vaccine Initiative (IAVI).
Dr. Craig is an accomplished biotechnology professional with extensive experience in development, technical operations, quality systems and regulatory affairs for complex biologicals including over 30 years of experience in cell and gene therapy product manufacturing. He has held executive level positions designing, implementing and operating the CMC and GMP manufacturing infrastructure for various pioneering cell and gene therapy companies, including Orchard Therapeutics, Sangamo Therapeutics, Erytech Pharma and Xcyte Therapies. During his career, he has successfully led the development, manufacturing and clinical delivery of recombinant proteins, monoclonal antibodies, gene therapies and cell therapies, including activated T cells and gene-modified T cells.
“With its groundbreaking Eumbody System, Optieum is set to unlock the full therapeutic potential of CAR-T therapies. I’m thrilled to join this mission to bring transformative treatments to patients facing the most challenging diseases,” said Dr. MacLeod, CSO of Optieum Biotechnologies.
“I am honored to join Optieum and be a part of transitioning this innovative CAR-T platform into clinical trials,” said Dr. Craig, CTO of Optieum Biotechnologies.
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
Ehime, Japan, January 14, 2025 – Optieum Biotechnologies Inc. (“Optieum”), a biotechnology company focused on discovering and developing innovative CAR-T cell therapies, today announced the successful completion of its ¥1.33 billion Series A financing round. The financing was led by Saisei Ventures (“Saisei”), with participation from new investors Keio Innovation Initiatives (“KII”), ZEON Corporation and Kobe University Capital. Existing investors ANRI, UntroD Capital Japan and Iyogin Capital also participated in the round.
Proceeds from the Series A financing will advance 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).
“FAPα is a cell surface protein expressed by cancer-associated fibroblasts (CAFs), which are a critical component of the micro environment that supports the growth of many solid tumors, in part by shielding cancer cells from immune surveillance” said Shun Nishioka, CEO of Optieum. “Hence, directly targeting CAFs provides a potential opportunity for us to expand the therapeutic use of OPTF01 to other solid tumor targets beyond GBM.
The funds will also support onward development of the company’s proprietary Eumbody System, a discovery platform that leverages empirical methodologies to identify optimized CAR binding constructs for immune therapies and expand the company’s therapeutic pipeline.
Concurrent with this financing, Optieum has appointed three new board members; Jonathan Yeh, managing partner at Saisei, Yuto Torii, principal at KII, and Yusuke Miyazaki, principal at ANRI.
“Recent promising studies have breathed renewed enthusiasm into the CAR-T modality and the pursuit for optimized and clinically validated CAR binders will only increase as the next wave of increasingly complex allogeneic approaches come to fruition,” said Jonathan Yeh, managing partner at Saisei Ventures. “At Saisei, our mission is to empower companies with strong Japanese foundations and unlock their potential through the integration with global expertise. We are excited to collaborate with Optieum, whose rigorous scientific approach and advanced platform for identifying novel CAR binders hold great promise for improving safety and efficacy in the field. Through this partnership, we further demonstrate our commitment to fostering the growth of Japan’s biotech ecosystem by nurturing domestic talent and complementing it with global perspectives.”
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.
About Saisei Ventures
Saisei Ventures is a life science venture capital firm dedicated to building next-generation companies in the healthcare sector. We create ventures that start from bold ideas and empower dynamic entrepreneurs by providing technical, operational, and financial guidance. Our approach combines Western expertise and Japanese innovations to build globally competitive companies that will have the greatest impact on patient lives. With operations in Japan and the United States, Saisei aims to enhance the value of its portfolio by leveraging its unique networks and the institutional advantages of both countries. For more information, visit https://www.saiseiventures.com/.
Contact:
Optieum Biotechnologies
Email: info@optieumbio.com
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