Cryoport, Inc. , a global leader in temperature-controlled supply chain solutions for the life sciences industry, announced that Cellenkos®, Inc., a privately held, clinical-stage biotechnology company, has selected Cryoport to provide a staged, on-demand, logistics solution for COVID-19 therapy shipments for patients in need.
Working in concert, Cryoport Systems, CRYOPDP and CRYOGENE will provide the highest possible available level of tracking and proactive management for the therapies, including continuous monitoring of each step from scheduling, collection, confirming courier pickups/deliveries, and monitoring transport. Under the terms of the agreement, Cryoport Systems delivers its Cryoport Express® Shippers to Cellenkos’ manufacturing facility in Houston, Texas, on a weekly basis. When a patient is identified, the team at Cellenkos places their therapy inside the shipper and notifies Cryoport Systems. The Cryoport Express® Shipper is collected and delivered to the patient the same day or the next day for longer journeys. During the entire process, Cellenkos® has full visibility and oversight through the cloud based Cryoportal® Logistics Management Platform which provides near real-time tracking and monitoring of the shipment and the SmartPak II® Condition Monitoring System, supported by the Cryoport Systems’ 24/7 customer support team. Furthermore, CRYOPDP provides some of the logistics support and CRYOGENE provides biostorage services for Cellenkos at its nearby state-of-the-art facility.
“Having three of our Cryoport companies provide flexible logistics support for the various stages of Cellenkos’ COVID-19 therapy shipments demonstrates our ongoing commitment to helping clients find the best possible solutions for patients who need to be treated quickly and is a clear demonstration of the value of our integrated supply chain platform,” said Jerrell Shelton, CEO, Cryoport. “We look forward to working closely with Cellenkos to support the company with our full range of temperature-controlled solutions to help patients suffering from COVID-19 recover and return to their daily lives.”
“Cryoport’s best-in-class solutions enable Cellenkos to rapidly respond to patients’ urgent needs, without needing advanced notice and providing full visibility while treatments are in transit,” added Tara Sadeghi, Vice President, Clinical Operations, Cellenkos®. “Temperature-controlled logistics solutions are vital for our therapy’s success, and with the flexibility provided by Cryoport Systems, CRYOGENE and CRYOPDP, we are able to have consistent, reliable support at each stage of our therapy’s journey to the patient. During the pandemic, Cryoport’s seamless and dependable delivery logistics allowed for Cellenkos to treat critically sick, intubated patients suffering from COVID-19 ARDS with a narrow therapeutic window in multi-center clinical study (Phase 1 Double-Blinded, Randomized, Placebo Controlled Safety and Early Efficacy Trial of Cryopreserved Cord Blood Derived T-Regulatory Cell Infusions (CK0802) In The Treatment Of COVID-19 Induced Acute Respiratory Distress Syndrome (“ARDS”) NCT04468971).
“Our confidence in Cryoport’s outstanding ability to solve for a major point of failure in the cell therapeutics is exemplified by our alliance with them to be our logistics partner for the multi-center, randomized placebo control trial of CK0802 for treatment of COVID-19 ARDS: RESOLVE Trial (Regulatory T cell infusion for lung injury due to COVID-19, NCT04468971) as well as for our future planned studies.”
About Cryoport, Inc.
Cryoport, Inc. is redefining temperature-controlled supply chain support for the life sciences industry by continually broadening its platform of solutions and services, serving the Biopharma, Animal Health, and Reproductive Medicine markets. Through its family of companies, Cryoport Systems, MVE Biological Solutions, CRYOPDP and CRYOGENE, Cryoport provides strategic solutions that support the growing needs of these markets.
Cryoport’s mission is to support life and health on earth through its advanced technologies, global supply chain network and dedicated scientists, technicians and supporting teams of professionals. Cryoport serves clients in life sciences research, clinical trials, and product commercialization. We support the creation of life, the sustaining of life and life-saving advanced cell and gene therapies in over 100 countries around the world.
About Cellenkos®, Inc.
Cellenkos® is a clinical-stage biotechnology company focused on development and commercialization of Allogeneic, Tissue-Targeted, Immune T-Regulatory Cell Therapies to Treat Autoimmune Diseases and Inflammatory Disorders. Being derived from umbilical cord blood (CB), Cellenkos’ T-Regulatory cells (Tregs) are naïve, bonafide suppressor cells that resolve inflammation through multiple direct and indirect interactions. Cellenkos utilizes its’ proprietary CRANETM platform technology to isolate, activate, enrich and expand the tissue directed CB Treg cells that leverage cellular intelligence to seek, localize, proliferate and resolve tissue inflammation. Cellenkos’ in-house cGMP facility allows for large scale manufacturing where multiple doses can be generated from single cord blood unit. These off-the-shelf allogeneic cell products are cryopreserved and are available on-demand for infusion at the point-of-care.
Currently, Cellenkos® has completed enrollment for: i) Phase I trial of CK0801 in patients with Bone Marrow Failure Syndrome (NCT03773393), and ii) Phase 1 Double-Blinded, Randomized, Placebo Controlled Safety and Early Efficacy Trial of CK0802 in the Treatment of COVID-19 Induced ARDS (NCT04468971). Cellenkos® is in process for IND submission for i) Phase 1b, open-label study of add on therapy with CK0804 in participants with myelofibrosis, with suboptimal response to ruxolitinib, and ii) Phase I trial of CK0803 for the treatment of Amyotrophic Lateral Sclerosis.