Kairos Pharma, Ltd. a privately-held clinical-stage biotechnology company focused on cancer drug resistance and immunotherapy, announced today that its activated T cell therapy, KROS 201, has received FDA approval to move forward with a Phase 1 clinical trial in patients with recurrent glioblastoma. Kairos Pharma is funding the phase I trial, which will occur at Cedars Sinai Medical Center in Los Angeles.
John Yu, M.D., Kairos CEO, commented, "This IND acceptance is the second substantial clinical milestone within the past month as Kairos accelerates toward its clinical goals for 2022. This first-in-man Phase 1 clinical trial will activate T cells against the cancer stem cells at the root of glioblastoma."
"This achievement pushes the envelope of immune therapies designed to target T cells against devastating cancers."
Neil Bhowmick, Ph.D., Kairos Chief Scientific Officer
KROS 201 activated T cells (ATCs) are killer T cells created in cell culture by activating a patient's white blood cells with cytokines or T cell activating signals and priming dendritic cells with antigens specific to glioblastoma cancer stem cells. Patients with recurrent glioblastoma are given the strongly activated T cells intravenously. As a result, cancer stem cells, which are the source of cancer, are killed by these cells.
In February, the FDA granted an IND for a Phase 2 trial of ENV105 with apalutamide, in addition to the planned Phase 1 trial of activated T cell treatment for KROS 201. In 2022, an ENV105 Phase 1 trial with Tagrisso (AstraZeneca) for lung cancer is expected.
Kairos Pharma also published a notice of allowance of their patent Compositions and Methods for Treating Fibrosis by the United States Patent and Trademark Office, which coincides with the advancement of its clinical milestones. The method of treating fibrosis and certain types of cancer, the composition of matter, and the administration of therapy utilizing KROS-401, a cyclic peptide inhibitor of the IL-4 and IL-13 cytokine receptor complex, are all covered by this patent. This drug has been proven to treat fibrosis and cancer by reversing the M1 to M2 immunosuppressive macrophage shift in cancer and fibrosis.
CEO of Kairos Pharma, Dr. John Yu, stated, "This milestone further supports the already substantial and diversified intellectual property portfolio of Kairos and enables the unfettered clinical development of this novel and transformative therapeutic."
Dr. Ramachandran Murali, Kairos VP of Research and Development and inventor of the KROS 401 molecule, commented, "KROS-401, in addition to fibrosis and cancer, opens a new avenue in therapeutic development for neurological disorders such as Alzheimer's disease."