Curated News
By: NewsRamp Editorial Staff
October 06, 2026

Kairos Pharma's ENV-105 Combo Triples PFS in Prostate Cancer Trial

TLDR

  • Kairos Pharma's ENV-105 plus apalutamide achieved 17.7-month median PFS versus two months for apalutamide alone, gaining a significant edge.
  • The Phase 2 trial showed a statistically significant PFS difference with ENV-105 plus apalutamide, and the protocol now enrolls earlier patients.
  • Kairos Pharma's ENV-105 combination therapy offers hope for improved outcomes in metastatic castration-resistant prostate cancer, potentially extending lives.
  • ENV-105 targets CD105 to reverse drug resistance, and its combination with apalutamide yielded a 17.7-month median PFS in prostate cancer.

Impact - Why it Matters

This news matters because it signals a potential breakthrough in treating metastatic castration-resistant prostate cancer, a condition where patients often face limited options and rapid disease progression. The statistically significant PFS benefit—17.7 months versus 2 months—suggests that ENV-105 could meaningfully extend lives and delay the need for more toxic therapies. If validated in later trials, this combination could become a new standard of care, offering hope to thousands of men worldwide. For investors, it highlights Kairos Pharma's innovative approach and could positively impact its stock as the company advances toward pivotal data.

Summary

Kairos Pharma (NYSE American: KAPA) has announced promising interim efficacy data from its ongoing Phase 2 clinical trial of ENV-105 in combination with apalutamide for patients with metastatic castration-resistant prostate cancer. The analysis revealed a statistically significant improvement in progression-free survival (PFS), with a median PFS of 17.7 months for patients receiving the combination therapy versus just two months for those on apalutamide alone (P=0.0008). This dramatic difference underscores the potential of ENV-105 to address a critical unmet need in prostate cancer treatment.

In response to these positive findings, Kairos Pharma has modified the Phase 2 protocol to enroll patients earlier in the disease course. Specifically, patients who experience a PSA increase after upfront androgen signaling inhibitor therapy will now be randomized to receive either enzalutamide alone or enzalutamide plus ENV-105. This amendment aims to broaden the eligible patient population and accelerate enrollment, with trial completion now targeted for the fourth quarter of 2027 or sooner. The company believes this strategic shift will more effectively demonstrate the benefit of adding ENV-105 to standard therapies.

Kairos Pharma, based in Los Angeles, is a clinical-stage oncology company leveraging structural biology to overcome drug resistance and immune suppression in cancer. Its lead candidate, ENV-105, is an antibody targeting CD105, a protein implicated in resistance and relapse following standard treatments. By inhibiting CD105, ENV-105 seeks to restore the effectiveness of existing therapies across multiple cancer types. For the full press release, visit https://ibn.fm/EDpxx. The latest updates on KAPA are available in the company’s newsroom at https://ibn.fm/KAPA. This news was distributed by BioMedWire, a specialized communications platform under the Dynamic Brand Portfolio @ IBN.

Source Statement

This curated news summary relied on content distributed by InvestorBrandNetwork (IBN). Read the original source here, Kairos Pharma's ENV-105 Combo Triples PFS in Prostate Cancer Trial

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