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Kairos Pharma reports news as a clinical-stage biopharmaceutical company developing cancer therapeutics designed to address drug resistance and immune suppression. Its updates center on ENV-105, also described as carotuximab, a CD105-targeting antibody program studied in prostate cancer and non-small cell lung cancer, along with broader oncology pipeline and structural-biology themes.
Company news also covers scientific conference presentations, clinical-data disclosures, annual meeting and shareholder matters, award recognition, and annual filing updates. Kairos has stated that ENV-105 has not been approved as safe or effective by the FDA or comparable foreign regulators.
Kairos Pharma (NYSE American: KAPA) presented interim Phase 2 efficacy data for ENV-105 (carotuximab) in metastatic castration-resistant prostate cancer at the ESMO meeting on October 20, 2025. The interim analysis reported a clinical benefit in 86% of treated patients when ENV-105 was combined with apalutamide, with all responders progression-free at least 4 months and half remaining progression-free beyond 1 year. Seven of nine evaluable patients showed PSA reductions from baseline. Imaging-reported median progression-free survival with the combination was 13.7 months. The randomized Phase 2 is actively accruing up to 100 patients across three U.S. cancer centers; results are interim and the trial is ongoing.
Kairos Pharma (NYSE American: KAPA) will present interim Phase 2 safety and clinical-activity data for ENV105 (carotuximab) combined with apalutamide in advanced, castration-resistant prostate cancer at the ESMO Congress, Oct 17–21, 2025 in Berlin.
The randomized trial is enrolling 100 men at Cedars-Sinai, City of Hope, and Huntsman Cancer Institute; patients receive apalutamide with or without ENV105. Kairos describes the interim analysis as showing encouraging safety and early efficacy. Study identifier: NCT05534646. The company framed results as preliminary and cautioned that forward-looking statements are subject to risks and uncertainties.
Kairos Pharma (NYSE American: KAPA) has announced positive interim efficacy data from its Phase 2 clinical trial of ENV105 (carotuximab) in metastatic castration-resistant prostate cancer (mCRPC) patients. The trial demonstrated a remarkable median progression-free survival of 13 months when ENV105 was combined with apalutamide.
Key findings include: 7 out of 9 patients showed decreased PSA levels, and 5 out of 8 evaluable patients continue treatment without progression. The results significantly exceeded the trial's target of 45% PFS improvement from 3.7 to 6.7 months. The study, which aims to enroll 100 patients total, follows July's positive safety analysis showing no Grade 3 or 4 toxicities.
The company is conducting the trial at multiple prestigious centers and will host a KOL event featuring leading experts to discuss these promising results.Kairos Pharma (NYSE American: KAPA) has announced a virtual KOL event scheduled for September 18th, 2025 to discuss interim efficacy results of its Phase 2 trial for ENV105 in advanced prostate cancer treatment. The event will feature distinguished experts including the company's CSO and leading oncologists from prestigious institutions.
The announcement follows positive interim safety results from July 2025, where ENV105, a first-in-class CD105 antagonist, demonstrated good tolerability when combined with apalutamide. The trial showed no dose-limiting toxicities, unexpected adverse events, or Grade 3/4 toxicities in the first 10 patients.
ENV105 aims to address the growing challenge of castration-resistant prostate cancer, affecting one million men annually in the US who develop resistance to current hormone therapies.
Kairos Pharma (NYSE American: KAPA) has announced its participation in the upcoming World Lung Cancer Conference, where initial Phase 1 data for ENV105 in non-small cell lung cancer will be presented. The presentation, led by Principal Investigator Dr. Karen Reckamp, will focus on the combination therapy of ENV105 with osimertinib for treating EFGR-mutated non-small cell lung cancer.
The open-label trial aims to evaluate the safety and tolerability of this combination therapy. The conference will take place from September 6-9, 2025, at the Fira de Barcelona Gran Via in Barcelona, Spain.
Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company specializing in cancer therapeutics, has announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference.
CEO and Chairman Dr. John Yu will deliver a corporate overview presentation, which will be available on-demand starting at 7:00 AM Eastern Time on September 5, 2025. The conference will take place at the Lotte New York Palace Hotel from September 8-10, 2025.
Investors can access the presentation webcast through the company's investor relations website, with a replay available for 90 days. One-on-one meetings with Dr. Yu can be scheduled through the conference registration system.
Kairos Pharma (NYSE:KAPA) CEO Dr. John Yu appeared on CEO.CA's 'Inside the Boardroom' to discuss significant clinical developments. The company reported promising safety data from their prostate cancer trial, demonstrating zero grade 3 or 4 toxicities, a notable improvement compared to standard treatments which show over 50% toxicity rates.
The interview highlighted upcoming efficacy data expected in September and potential expansion plans into lung cancer and other tumor types. The discussion was featured on CEO.CA, a leading investor social network platform for junior resource and venture stocks.
Kairos Pharma (NYSE American:KAPA), a clinical-stage biopharmaceutical company specializing in cancer therapeutics, has announced its participation in the upcoming H.C. Wainwright 27th Annual Global Investment Conference. The event will take place from September 8-10, 2025, at the Lotte New York Palace Hotel in New York City.
The company's CEO and Chairman, Dr. John Yu, will be available for one-on-one meetings throughout the conference. The presentation will be accessible virtually through the company's website at kairospharma.com.
Kairos Pharma (NYSE American:KAPA) has reported positive safety results from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in metastatic castration-resistant prostate cancer (mCRPC) patients. The interim analysis from the first ten patients showed the drug was well-tolerated when combined with apalutamide, with no dose-limiting toxicities or unexpected adverse events.
The randomized Phase 2 trial aims to enroll 100 patients across three medical centers, evaluating ENV-105's safety and early efficacy in men whose disease has progressed despite hormone-based therapies. Interim efficacy data is expected in September 2025, and the company plans to discuss potential Phase 3 study design with regulators.