First Patient Dosed in Phase 2 Trial of ENV105 with Apalutamide to Improve Therapy Sensitivity for Castrate-Resistant Prostate Cancer

2024-01-31

临床2期

LOS ANGELES, Jan. 30, 2024. Kairos Pharma, Ltd., a clinical stage biopharmaceutical company developing cancer therapeutics designed to reverse cancer drug resistance and immune suppression, announces the dosing of its first patient in its Phase 2 trial testing a combination therapy for its lead therapeutic candidate ENV105 in combination with apalutamide for the treatment of castrate resistant prostate cancer (CRPC).

Kairos Pharma CEO John Yu stated, “Many cancer therapeutics run up against the problem of resistance as the cancer circumvents their mechanism of action, thereby making the therapeutic ineffective, or sometimes less effective over time. Whether it be in prostate cancer or lung cancer, Kairos’s ENV105 is designed to reverse this resistance. This randomized multi-institutional Phase 2 trial will compare the efficacy of the combination of ENV105 and apalutamide with apalutamide alone in treating castrate-resistant prostate cancer.”

Prostate cancer patients that develop resistance to androgen signaling inhibitors are often given chemotherapy with androgen signaling inhibition combination. While effective initially, the side effects from such a combination can be intolerable. Based on previous open-label clinical studies demonstrating the conversion of 44% of CRPC patients to castrate sensitivity with ENV105, the primary objective of this randomized trial is to evaluate the efficacy of the novel combination therapy. The multi-site trial aims to enroll 100 patients who have already developed resistance to androgen receptor signaling inhibitors.

Dr. Neil Bhowmick, Chief Scientific Officer at Kairos Pharma, added, “Studying the second indication for ENV105, next to lung cancer, this Phase 2 trial is the product of extensive work to best understand its mechanism of action and develop essential clinical experience in prostate cancer patients.”

About Kairos Pharma

Based in Los Angeles, California, Kairos Pharma, Ltd. is a clinical-stage biopharmaceutical company focused on developing a diversified pipeline of cutting-edge oncology therapeutics that reverse the inhibitory effects of cancer on the immune system. The Company is advancing its portfolio of innovative drug candidates designed to reverse resistance and immune suppression from cancer.

CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding clinical research surrounding ENV105. You can identify forward-looking statements as those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. The reader is cautioned not to rely on these forward-looking statements. If underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kairos Pharma. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance. In evaluating these forward-looking statements, you should consider various factors, including: our success in completing the newly initiated clinical trials, commence new trials, and obtain regulatory approval following the conclusion of such trials; challenges and uncertainties inherent in product research and development; and the uncertainty regarding our future commercial success. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking statements discussed in this press release and other statements made from time to time by us or our representatives may not occur and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. We are not obligated to publicly update or revise any forward-looking statement, and Kairos Pharma is not required to update any forward-looking statement as a result of new information or future events or developments.

Posted: January 2024

FDA Approves Erleada (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) - September 17, 2019

FDA Approves Erleada (apalutamide) for Non-Metastatic Castration-Resistant Prostate Cancer - February 14, 2018

Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer - October 11, 2017

Erleada (apalutamide) FDA Approval History

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