Kairos Pharma, Ltd., a privately held clinical stage biotechnology company focused on drug resistance and immunotherapy for cancer, announced that its activated T cell therapy, KROS 201, has received FDA approval to proceed with a Phase 1 clinical trial in patients with recurrent glioblastoma, a type of brain cancer.
- Phase 1 clinical trial of KROS 201 to begin in 2022 at Cedars Sinai Medical Center
- New patent covers the method of treating fibrosis and certain forms of cancer, the composition of matter, and administering a therapy using KROS-401
LOS ANGELES, March 14, 2022 /PRNewswire/ -- Kairos Pharma, Ltd. (“Kairos”), a privately held clinical stage biotechnology company focused on drug resistance and immunotherapy for cancer, today announced that its activated T cell therapy, KROS 201, has received FDA approval to proceed with a Phase 1 clinical trial in patients with recurrent glioblastoma, a type of brain cancer. The phase I trial is sponsored by Kairos Pharma and will be conducted at Cedars Sinai Medical Center in Los Angeles.
Kairos CEO John Yu, M.D. 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.”
Kairos Chief Scientific Officer Neil Bhowmick, Ph.D. added, “This achievement pushes the envelope of immune therapies designed to target T cells against devastating cancers.”
KROS 201 activated T cells (ATCs) are killer T cells that are developed in a cell culture by activating a a patient’s white blood cells with cytokines or T cell activating signals and by priming dendritic cells loaded with glioblastoma cancer stem cell specific antigens. The potent activated T cells are infused intravenously into patients with recurrent glioblastoma. These cells have been shown to kill cancer stem cells, the root cause of cancer.
In addition to the upcoming Phase 1 trial of activated T cell therapy for KROS 201, a Phase 2 trial of ENV105 with apalutamide was recently granted an IND by the FDA in February. A Phase 1 trial of ENV105 with Tagrisso (AstraZeneca) for lung cancer is planned to start in 2022.
Along with this advancement of its clinical milestones, Kairos Pharma announced a notice of allowance of the United States Patent and Trademark Office of their patent Compositions and Methods for Treating Fibrosis. This patent covers the method of treating fibrosis and certain forms of cancer, the composition of matter, and administering a therapy using KROS-401, a cyclic peptide inhibitor of the IL-4 and IL-13 cytokine receptor complex. This therapeutic has been shown to treat both fibrosis and cancer by reversing the M1 to M2 immunosuppressive macrophage transition in both cancers and fibrosis.
Dr. John Yu, CEO of Kairos Pharma 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.”
Kairos VP of Research and Development Dr. Ramachandran Murali, 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.”
About Kairos Pharma
Kairos Pharma is a clinical-stage biopharmaceutical company focused on developing a diversified pipeline of cutting-edge therapeutics for cancer patients that reverse the inhibitory effects of cancer on the immune system. The Company’s unique portfolio of seven drug candidates is anchored by a new class of novel drugs that reverse drug resistance and immune resistance to cancer. The Company has made unparalleled strides through its transformative technology, strong IP, and world-class team working to make a significant impact on the most pervasive problems in cancer treatment. kairospharma.com.
Forward-Looking Statements
This press release may contain “forward-looking statements” regarding Kairos Pharma’s current expectations and projections about future events. “Forward-looking statements” (statements as to matters other than historical facts) as defined in the Private Securities Litigation Reform Act of 1995 can be identified by terminology such as: “will,” “potential”, “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “projects,” “estimates,” “anticipates,” “believes,” or similar language. These statements are based upon current beliefs and expectations and are subject to many risks and uncertainties which are difficult to foresee and predict. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. The information in this presentation is provided only as of the date of this presentation and Kairos Pharma, Ltd. takes no obligation to update any forward-looking statements contained in this presentation based on new information of future events and/or results. These forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause the Company’s actual results, performance or achievements to be materially different than any future results, performance or achievements expressed or implied by the forward-looking statements. Actual results may differ materially from those indicated by these forward- looking statements as a result of various important factors, including the Company’s ability to discover and develop its novel product candidates and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates; actions of the Company’s collaborators regarding continued product development and product commercialization; actions of regulatory authorities, which may affect the initiation, timing and progress of clinical trials or the ability of the Company to obtain marketing authorization for its product candidates; the Company’s ability to obtain, maintain and protect its intellectual property; the Company’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; competition from others using technology similar to the Company’s and others developing products for similar uses; the Company’s ability to manage operating expenses; the Company’s ability to obtain additional funding to support its business activities and establish and maintain its existing and future collaborations and new business initiatives; the Company’s dependence on collaborators and other third parties for development, manufacture, marketing, sales and distribution of products; the outcome of litigation; and unexpected expenditures. Any forward-looking statements represent the Company’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements.
View original content to download multimedia:https://www.prnewswire.com/news-releases/kairos-pharma-receives-fda-approval-of-investigational-new-drug-ind-application-for-its-phase-1-clinical-trial-of-kros-201-for-the-treatment-of-glioblastoma-announces-new-patent-for-kros-401-301502125.html
SOURCE Kairos Pharma, Ltd.
