Country: India

Pandorum, a biotechnology company working in the space of Tissue Engineering and Regenerative Medicine with RnD labs and clinical centers in India and the US. At Pandorum, we have developed a technology platform to develop exosomes with tunable cargos from clinical grade Mesenchymal Stem Cells (with existing Drug Master File at USFDA) in a scalable and consistent manner. Using specific inducers, we can optimize the properties of these exosomes, such as, anti-inflammatory, anti-fibrotic, anti-angiogenic, neurogenesis to fit the need of a specific tissue and disease indication, such as cornea, liver and beyond. Our flagship product Kuragenx – the ‘Liquid’ Cornea, combines exosomes containing specialized cargos delivered with cornea-mimetic biopolymers to promote corneal tissue regeneration. Kuragenx can be visualized as a transparent viscous liquid that is administered dropwise to the excavated wound site after the corneal surgeon removes the diseased tissue. The liquid spreads, solidifies within a few minutes under visible light and helps to grow a new cornea in less than a year. Kuragenx was developed using quantitative experimental data including in vitro and in vivo studies to ‘map’ various tissue-states in order to assess the effectiveness of the treatment. Studies in New Zealand rabbits suffering from Neurotrophic Keratitis have demonstrated restoration of healthy cornea with neuronal plexus within three months post-treatment, paving the way to treat patients suffering from unmet clinical needs. Kuragenx has been assigned by USFDA to the Office of Tissues and Advanced Therapies, and our First in Human clinical study is planned in 2024, to treat advanced keratitis- a severe indication with unmet medical needs. | Pandorum is a deep-tech biotech company, operating out of US (Pandorum International Inc.) and India (Pandorum Technologies Pvt. Ltd.), that specializes in the field of Tissue Engineering and Regenerative Medicine. At Pandorum, we have built a technology platform for Tissue (regenerative) Reprogramming using smart biomaterials and cell modulators. Flagship Product: Kuragenx- the ‘liquid cornea’, is designed to address corneal diseases characterized by inflammation, fibrosis, and neurodegeneration, leading to partial or complete visual impairment. Kuragenx promotes efficient regeneration and restoration of corneal tissue function. The cornea, being the transparent, central, outer layer of the eye, serves as the window to the world, allowing the passage of light and focusing it due to its convex shape. Traditional restoration of vision in patients with corneal blindness relies on suitable donor corneas, but with an estimated 12.7 million people awaiting corneal transplants and only 1 in 70 patients being covered, there is a significant unmet need. Further, a subset of the patients, such as suffering from advanced Neurotrophic Keratitis (NK), are at high risk of donor cornea rejection with failure in re-innervation/ host-integration. Kuragenx is composed of tissue (cornea) mimetic biopolymers combined with specialized Exosomes derived from clinical grade Mesenchymal Stem Cells – with the designation of combination product (Biologics), being regulated by the Office of Therapeutic Products, CEBR, USFDA. We have completed our pre-IND with USFDA and end-route to conduct a Phase 1/2a study with 9-18 patients suffering from NK, compounded by inflammation, epithelial and neuronal damage and fibrosis. We’re currently involved in clinical manufacturing and of IND data generation for Phase 1/2a study in 2025. The first patient dosing is planned in Chicago in 2025, with Northwestern University Medical School as our primary clinical partner. Kuragenx has been assigned to the USFDA’s Office of Therapeutic Products (OTP) under the Center for Biologics Evaluation and Research (CBER) as a combination product-biologics, emphasizing its novel approach. Pipelines beyond Cornea: Pandorum’s technology extends beyond corneal applications to address fibrosis and inflammation of vascular tissues, as well as at systemic level. Using the inherent plasticity of human multi-potent stem cells, we have developed proprietary exosome variants with signature cargo contents and properties, such as enhanced neurogenesis, anti-fibrotic and anti-inflammatory. Pandorum’s exosome based therapeutics have demonstrated safety and potency via reversal of inflammation and fibrosis in human cell based assays and in organoids/ microphysiological systems, and are currently undergoing further screening, characterization and functional validation for vascular tissue and systemic applications. The research is supported by multiple grants from the Department of Biotechnology, Government of India, and has attracted attention from the US Department of Defense (USDoD), Military Health Systems Research Symposium (MHSRS), and the Defense Research and Development Organization (DRDO), India for regenerative reprogramming of human tissues with war-time injuries. Pandorum has raised US$ 22+ million from marquee investors including 3 Billionaires, VCs, Dept. of Biotechnology and Govt. innovation funds. Owing to recently closed key milestones and achievements, we are raising a funding round for supporting the flagship Cornea pipeline (avascular tissue regeneration) and the platform technology, which goes beyond cornea, to the treatment of vascular tissue regeneration (such as, lung and liver) and for the reversal of multi-tissue inflammation and fibrosis, for combating age related diseases and the expansion of healthspan. #Assorted publications and media coverage: 1) Revolutionizing regenerative medicine with engineered biomaterials: https://www.nature.com/articles/d43747-023-00098-w 2) How India is building its 3D bioprinting industry: https://www.nature.com/articles/d44151-024-00008-8 3) Entrepreneurship World Cup global finalists – Pandorum: https://youtu.be/DLcPy2F2Rws?si=WvlVp_KK9zDCFcoX