Pandorum Partners With AGC Biologics To Support Clinical Manufacturing Of Exosome-Based Kuragenx, A Treatment Of Ulcerative Corneal Blindness

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a partnership with Pandorum to produce their flagship product Kuragenx—the 'liquid cornea'—a combination biologic. Kuragenx has demonstrated promising results in the preclinical stage, enabling restoration of functional corneas affected by advanced neurotrophic keratitis (NK) - an ulcerative form of corneal blindness and was awarded Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).

As a First-in-Class advanced therapy, Kuragenx completed the Pre-IND meeting with the Office of Therapeutic Products, Center for Biologics Evaluation and Research, FDA, and is on track for IND submission in 2025. Under the current agreement, AGC Biologics will support the stage-wise scale-up of Pandorum's proprietary modular bioprocess and manufacturing of pharmaceutical-grade exosomes derived from clinical grade mesenchymal stem cells, with defined batch release criteria in order to meet the necessary regulatory requirements.

Tuhin Bhowmick, co-founder and CEO of Pandorum commented: "Developing a First-in-Class biologic is a daunting task, which requires best-in-class manufacturing capabilities with stringent quality controls to ensure scalable production with defined potency and consistency. Besides being a global leader in Biologics/ Cell and Gene Therapy manufacturing, what made us entrust AGC Biologics as our preferred partner is the human factor, the people of AGC- their dedication to understand our requirements with the expertise and willingness to address our needs. We look forward to working closely with AGC to deliver this potentially transformative therapy to address significant unmet needs.”

“We are delighted to work with Pandorum, a true innovator in the field of ocular diseases,” said Giuliana Vallanti, Head of Development and Global Head of C> R&D at AGC Biologics. “This partnership reinforces our leadership position in developing and manufacturing exosomes, a technology where AGC Biologics was a pioneer, made significant investments and targets to be a leading supplier.”

AGC Biologics' Milan facility has 30 years of experience in the cell and gene therapy field, specializing in complex and advanced cell therapy projects. Recognized as one of the world's most accomplished CDMO production sites, it holds unique commercial manufacturing authorizations from both the FDA and the European Medicines Agency (EMA) for viral vectors and cell therapies. The Milan Center of Excellence further leverages its extensive expertise in viral vector manufacturing to develop advanced capabilities in exosome production, supporting customers in this rapidly growing and innovative field.

The Milan team has guided five viral vectors and four cell therapy products from development to commercialization and produced hundreds of batches for clinical and commercial use, demonstrating unparalleled late-stage and commercial manufacturing expertise.

To learn more about AGC Biologics’ global cell therapy services visit www.agcbio.com/capabilities/cell-therapy, go to www.agcbio.com/capabilities/viral-vector and learn more about the CDMO’s viral vector offerings.

About Pandorum

Pandorum Technologies Private Limited (India) and its US subsidiary, Pandorum International Inc., together addressed as Pandorum, are developing advanced therapies in the field of Tissue Engineering and Regenerative Medicine. At Pandorum, we are dedicated to developing and disseminating advanced therapies with scale and consistency to promote regeneration of human tissues—to treat the degenerative changes caused by disease and aging affecting millions across the globe. Pandorum’s proprietary technology platform uses clinical grade multipotent human stem cells to produce exosome-based nanotherapeutics in a scalable, consistent manner with the ability to tune its molecular cargos for functional regeneration of various human tissues. Pandorum's product pipeline is supported by a well differentiated portfolio of multiple patents covering its proprietary platform technology, precise scalable production process and potent therapeutic assets to promote functional regeneration of various human tissues including cornea, skin, neuronal tissue, liver, and lung.

Pandorum has secured multimillion US$ funding from marquee investors and VCs and has been supported by multiple grants from the Dept. of Biotechnology, Govt. of India. In addition, the company’s work has invited interest from the United States Department of Defense (USDoD), Military Health Systems Research Symposium (MHSRS), and the Defense Research and Development Organization of India (DRDO, India), due to the potential applications in treating various war-time injuries. Pandorum's goal is to make regenerative treatments a mainstream reality, accessible to millions of patients across the globe. To learn more, visit www.pandorum.com.

About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. AGC Biologics is a part of AGC Inc.’s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.