Kairos Pharma Reports Positive, Statistically Significant Interim Efficacy Data from Phase 2 Trial of ENV-105 in Metastatic Prostate Cancer

The modified protocol will test ENV-105 with enzalutamide in patients earlier in disease progression.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

LOS ANGELES--(BUSINESS WIRE)-- Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company addressing drug resistance in cancer, today announced positive interim efficacy data from its ongoing Phase 2 clinical trial evaluating ENV-105 (carotuximab) in combination with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). The interim analysis demonstrated a statistically significant difference in progression-free survival (PFS) between all patients in the trial treated with ENV-105 plus apalutamide and those treated with apalutamide alone. Median PFS was 17.7 months with the combination compared with 2 months with apalutamide alone (P=0.0008).

With the interim efficacy signal, Kairos Pharma has modified the Phase 2 protocol to enroll patients earlier in the course of disease progression. Rather than treating patients after one or two anti-androgen agents, the modified protocol will enroll patients who experience a PSA increase following upfront treatment with an androgen signaling inhibitor. Patients will be randomized to enzalutamide alone or enzalutamide in combination with ENV-105. The protocol modification is intended to expand the eligible patient population and facilitate enrollment, with Kairos Pharma targeting completion of the Phase 2 trial in or before the fourth quarter of 2027.

"These interim results provide an important clinical signal for ENV-105 and support our strategy of targeting the mechanisms underlying drug resistance," said Kairos Pharma Chief Executive Officer Dr. John Yu. "The protocol modification will allow more patients to be eligible for the potential benefits of ENV-105 treatment while evaluating the therapy earlier in disease progression."

The findings further support Kairos Pharma's strategy of targeting mechanisms associated with cancer drug resistance. ENV-105 targets CD105, a protein identified as a key driver of resistance and disease relapse in response to standard therapy, providing the rationale for evaluating ENV-105 in combination with standard cancer therapies. The Phase 2 trial is designed to evaluate ENV-105, a first-in-class CD105 antibody, in men with metastatic prostate cancer resistant to standard hormone therapy, in combination with standard of care, apalutamide. Patients have been enrolled at Cedars-Sinai Medical Center, City of Hope and Huntsman Cancer Institute at the University of Utah.

About Kairos Pharma Ltd.

Based in Los Angeles, California, Kairos Pharma Ltd. (NYSE American: KAPA) is at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Kairos Pharma's lead candidate, ENV-105 (carotuximab), is an antibody targeting CD105 — a protein identified as a key driver of resistance and disease relapse in response to standard cancer therapy. ENV-105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. For more information, visit kairospharma.com.

Cautionary Statement Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by terminology such as "may," "should," "expects," "anticipates," "contemplates," "estimates," "believes," "plans," "projected," "predicts," "potential," or "hopes," or the negative of these or similar terms. Actual results could vary materially from expectations and projections of Kairos Pharma if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties materialize. Risk factors include but are not limited to: success and/or completion of Phase 2 clinical trials (for prostate cancer) and Phase 1 clinical trials (for lung cancer); challenges inherent in product research and development; uncertainty regarding future regulatory approval and commercial success; and other factors described in Kairos Pharma's SEC filings, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Kairos Pharma is not obligated to update any forward-looking statement except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261006533651/en/

Investor Contact:
CORE IR | investors@kairospharma.com

Source: Kairos Pharma, Ltd

Key Terms

progression-free survival medical

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

mcrpc medical

mCRPC stands for metastatic castration‑resistant prostate cancer, a form of prostate cancer that has spread beyond the prostate and keeps progressing despite treatments that lower male hormones. It matters to investors because this stage is harder to treat, drives demand for new therapies, and often involves large, expensive clinical trials and regulatory decisions that can strongly influence a drug maker’s future revenue and stock value—think of it as a stubborn problem that creates both medical need and commercial opportunity.

psa medical

Prostate-specific antigen (PSA) is a protein produced by prostate tissue and measured in blood to help detect and monitor prostate conditions, including prostate cancer and benign enlargement. For investors, changes in PSA levels reported in clinical studies or regulatory filings can signal how well a drug or diagnostic test is working, similar to how a gauge on a dashboard indicates the health of a machine and can affect a company’s valuation and regulatory outlook.

cd105 medical

A protein found on the surface of certain cells, especially those that line and form blood vessels, known as endoglin. It acts as a marker of new or active blood-vessel growth and is used in research, diagnostic tests, and as a potential drug target in areas like cancer and cardiovascular disease. Investors track CD105 because clinical trial results, diagnostic adoption, or regulatory actions involving it can influence the value of companies developing related tests or therapies.