Cellenkos has submitted a clinical development proposal to the Biomedical Advanced Research and Development Authority (BARDA) to start a Phase 1/2 clinical trial with CK0802 for treatment of COVID-19 mediated acute respiratory distress syndrome (CoV-ARDS). Cellenkos will leverage its clinical experience with CK0802 for other inflammatory disorders, including amyotrophic lateral sclerosis and fast-track development of CK0802 to treat respiratory complications caused by COVID-19 infection.

The company owns and operates an independent ISO-7 cleanroom manufacturing facility in Houston since 2017. The site is engaged in manufacturing of clinical cell therapy products, ensure control of over process development, manufacturing & quality control. This facility is staffed with qualified/trained and experienced personnel and is well-equipped to support product supply for the clinical trials. Cellenkos already holds two FDA-INDs in effect for inflammatory bone marrow failure and for Guillain-Barré Syndrome (GBS). Cellenkos' manufactured cell therapy has already demonstrated safety in human clinical trial (NCT03773393) and show early efficacy signal as a single agent.

"I think there is good reason to believe that an uncontrolled cytokine storm may be responsible for the acuity of the respiratory distress in some of the patients infected with COVID-19. Their body's mechanism of controlling the dysregulated inflammatory process caused by COVID-19 becomes overwhelmed partially due to the dysfunction of their regulatory T cells (T-reg cells), responsible for halting the inflammation. Therefore, adoptive therapy with healthy, T-reg cells that carry the homing signals for the lungs may be particularly effective since these cells are focused on resolving inflammation in the lung tissue and do not spill into other areas of the body," said Dr. Siddhartha Mukherjee, Pulitzer Prize winner for his book, "The Emperor of All Maladies," and Scientific Advisor for Cellenkos. "Rather than indiscriminate therapy with an anti-immune drug, such as an inhibitor of a cytokine, like IL-6, the T-reg cells can potentially and specifically calm inflammation exactly where it is most active -- without causing a more general "global" immunosuppression which would be harmful for a virally infected patient. This is a hypothesis that needs to be tested and I look forward to these urgently needed studies."

"The highly pathogenic COVID-19 is associated with rapid virus replication and a massive inflammatory cell infiltration that results in acute lung injury leading to the fatal complication of acute respiratory distress syndrome (ARDS). No specific treatment exists except for supportive care including mechanical ventilation where mortality rates exceed 50%. Novel therapeutic options are urgently needed. CK0802 can mechanistically restrict inflammation-induced lung damage via multiple mechanisms leading to tissue-repair and regeneration and offers potential for life-saving transformative therapy," said Tara Sadeghi, VP, Clinical Operations, Cellenkos Inc. "We are committed to fast-track development of CK0802 as a potential treatment for respiratory complications caused by COVID-19. The proposed collaboration with BARDA will support a clinical development program and provide clinical data on efficacy and safety of CK0802. We are confident of quickly starting the clinical development of CK0802 for respiratory complications caused by COVID-19."

Cellenkos' TREG platform aims to develop T-regulatory (TREG) cell therapy for various underserved inflammatory diseases and autoimmune disorders. The technology can be tailored to induce varying degrees of immune responses against antigens of choice, potentially providing potent prophylactic vaccines for the prevention of infectious diseases, such as rabies, as well as immunotherapies for the treatment of cancer. The technology can also be adapted to avoid such immune activation for purposes of molecular therapies, thereby providing potential new therapeutic modalities for patients suffering from rare diseases.

CK0802, is a novel allogenic cell therapy, consisting of TREG cells derived from clinical-grade umbilical cord blood units (CB-TREG), developed from Cellenkos' proprietary manufacturing platform that overcomes immune dysfunction by resolving chronic inflammation.  CK0802 is cryopreserved and readily available without any requirement for HLA matching. One manufacturing process can result in multiple doses that can be shipped to the patient's bedside for intravenous infusion. CK0802 express homing marker for lung tissue responsible for its transport to CoV-ARDS sites of inflammation. CK0802 interrupts CoV-ARDS cytokine storm.

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