Collaboration Leverages the OPTF01 product to Drive Next-Generation CAR-T Development

The Woodlands, Texas and Ehime, Japan, May 8, 2025/ Cision / – Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), and Optieum Biotechnologies (Optieum), a preclinical stage company dedicated to the discovery and development of innovative Chimeric Antigen Receptor (CAR) T cell therapies, today announced a partnership for cGMP manufacturing of OPTF01, Optieum’s novel CAR-T therapy for glioblastoma treatment, a product derived from their 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, Cellipont Bioservices will provide the technology transfer, process development, and cGMP manufacturing of Optieum’s novel OPTF01 CAR-T product. “Glioblastoma remains one of the most aggressive and difficult-to-treat cancers, demanding urgent innovation beyond traditional approaches,” said Darren Head, CEO of Cellipont Bioservices. “Our collaboration with Optieum presents an exciting opportunity to leverage advanced CAR-T technologies and bring meaningful solutions to patients in need. We are honored to be part of this critical mission.”

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 Cellipont’s team of experts ensures that 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 Cellipont 

Cellipont Bioservices is a premier Contract Development and Manufacturing Organization (CDMO) specializing in the advancement of cell therapies. With a team of industry-leading experts, Cellipont is at the forefront of cell therapy development and manufacturing, offering comprehensive solutions from process development, analytical services, to large-scale commercial manufacturing. Our purpose-built facility, combined with our cutting-edge technology and commitment to quality enable us to support our clients in delivering life-changing cell therapies to patients worldwide. Cellipont Bioservices is dedicated to excellence in all aspects of our operations, ensuring that we not only meet but exceed the expectations of our clients and the communities we serve. To learn more, visit www.cellipont.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.

Cellipont Media Contact

Edwin Beale

CCO

ebeale@cellipont.com

Optieum Biotechnologies Media Contact

Hinako Osawa

info@optieumbio.com

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

info@optieumbio.com

  • 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

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 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