Pandorum Partners with AGC Biologics to Support Clinical Manufacturing of Exosome-Based Kuragenx, a Treatment of Ulcerative Corneal Blindness

Today, we 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&GT 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, we hold 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 our 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.