Kairos Pharma, Ltd. (“Kairos”), a privately held clinical stage biotechnology company focused on drug resistance and immunotherapy for cancer, today announced that it has received FDA approval to proceed with a Phase 2 clinical trial of ENV105 with apalutamide for the treatment of metastatic castration-resistant prostate cancer.
| LOS ANGELES, Feb. 15, 2022 /PRNewswire/ -- Kairos Pharma, Ltd. (“Kairos”), a privately held clinical stage biotechnology company focused on drug resistance and immunotherapy for cancer, today announced that it has received FDA approval to proceed with a Phase 2 clinical trial of ENV105 with apalutamide for the treatment of metastatic castration-resistant prostate cancer. The phase II trial is sponsored by Enviro Therapeutics, a wholly-owned subsidiary of Kairos Pharma.
Kairos CEO John Yu, M.D. commented, “This IND acceptance establishes the first of many substantial clinical milestones that Kairos is working toward in 2022. We will roll out our Phase 2 clinical trial with the goal of verifying the benefit of our transformative technologies to reverse the normal course of drug resistance in patients with prostate cancer, lung cancer, and breast cancer.” ENV105 has been demonstrated to complement standard of care androgen targeted therapy with non-steroidal anti-androgens such as XTANDI® (enzalutamide) and Zytiga® (abiraterone acetate) in limiting therapeutic resistance to these drugs in a previous Phase II trial. These encouraging results is the premise for this randomized, multi-center phase II trial enrolling 100 patients. Prostate cancer patients failing to respond to androgen targeted therapy interventions will be randomized to receive the combination of ENV105 and a third-generation androgen receptor antagonist, apalutamide or apalutamide alone. Interruption of the BMP/CD105 signaling between cancer cells and surrounding non-cancer cells with ENV105 sensitizes prostate tumors to androgen targeted therapy through a novel mechanism of action. Three academic medical centers will participate in the randomized trial including Cedars Sinai Medical Center, University of Utah, and City of Hope. Kairos Chief Scientific Officer Neil Bhowmick, Ph.D. added, “This achievement represents the next major step in testing the degree of potential clinical benefit of ENV105 for patients with androgen resistant prostate cancer.” In addition to the upcoming Phase 2 trial of ENV105 with apalutamide, a Phase 1 trial of ENV105 with Tagrisso (AstraZeneca) for lung cancer is planned to start in 2022, and a Phase 1 trial of activated T cell therapy for KROS 201 in patients with glioblastoma will enter Phase 1 clinical trials in 2022. 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.
SOURCE Kairos Pharma |
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