September 2022: CryoCrate LLC Marched into the Immunotherapy Market by Enabling Biocompatible Cryopreservation of CAR-T and NK Cells and Won a NIH SBIR Phase II Award from NCI

CryoCrate received a new NIH NCI Phase II SBIR. The overall goal of CryoCrate LLC related to this project is to commercialize a first-in-class biocompatible cryopreservation medium product for biobanking practices associated with cellular adoptive immunotherapies for cancers. This goal is part of the company’s long-term vision to provide enabling and efficient options for biobanking urgently needed for the development and implementation of emerging biomedical technologies. Cryopreservation technologies and products currently on the market are still dependent on the use of various types of small molecular cryoprotectants, such as DMSO and glycerol, that are not tolerated by or compatible with most cell types and tissues due to their cell permeating and reactive nature. Use of these cell permeating reagents in cryopreservation of T, NK and CAR-T cells is well known to cause numerous technical and regulatory concerns, esp. in reduced expansion and migration efficiency, impaired cytotoxicity, and use of anima serum or human proteins. CryoCrate recently discovered a novel mechanism of action that is based on the use of biocompatible polysaccharides to promote nano-scale cubic ice formation in extracellular solutions and simultaneously prevent damaging intracellular ice formation without the need for cell permeating processes. The invention is based on our discovery of the unique mechanism to achieve “Hexagonal-ice Ablation on Nano-scale”, abbr. as “HAN” effect. Based on this breakthrough discovery, CryoCrate developed a novel cryopreservation medium, trademarked as OdinSol^®, which no longer requires the inclusion of a cell permeating chemical for the cryoprotection of mammalian cells. The OdinSol^® technology also allows for effective cryostorage in standard laboratory freezers at -80°C, thereby eliminating the need for expensive and hazardous liquid nitrogen facilities. The OdinSol^® protocol is free of protein and serum products. We have demonstrated the efficacy of OdinSol^® in significantly improving post-thaw viability and functionality of various tissue types (through third-party evaluations by the Precision Medicine Center of Univ. of Missouri) and T, NK and CAR-T cells. Considering the emerging adoption of those cell-based therapeutic materials in a wide range of ongoing clinical trials or recent success in cancer treatments, CryoCrate aims to secure Good Manufacturing Practice (GMP) production and FDA 510(k) clearance to provide the adoptive immunotherapy companies and researchers with efficient options for cryostorage and biobanking.