Kairos Pharma Ltd. (NYSE American: KAPA) reported positive interim efficacy data from its ongoing Phase 2 trial of ENV-105 in combination with apalutamide for patients with metastatic castration-resistant prostate cancer (mCRPC). 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 versus two months for those on apalutamide alone (P=0.0008). This marked difference underscores ENV-105’s potential to address drug resistance, a major challenge in prostate cancer treatment.
In response to the data, Kairos Pharma has amended the Phase 2 protocol to enroll patients earlier in disease progression. Patients who experience a PSA increase after upfront treatment with an androgen signaling inhibitor will now be randomized to receive either enzalutamide alone or enzalutamide plus ENV-105. This change aims to expand the eligible patient population, facilitate enrollment, and potentially demonstrate even greater efficacy in a less advanced setting. The company targets completion of the trial in or before the fourth quarter of 2027.
ENV-105 is an antibody targeting CD105, a protein implicated in drug resistance and immune suppression. By blocking CD105, ENV-105 seeks to reverse resistance and restore sensitivity to standard therapies across multiple cancer types. The interim results provide early clinical validation for this mechanism and could position Kairos Pharma as a leader in oncology therapeutics. For investors, the data represent a key milestone for the company’s lead candidate, potentially de-risking its development path and attracting partnership interest.
Based in Los Angeles, Kairos Pharma utilizes structural biology to overcome drug resistance and immune suppression in cancer. The company’s focus on CD105 as a therapeutic target differentiates it in a competitive landscape. With the protocol amendment, Kairos aims to generate robust data that could support a future registrational trial. The full press release is available at https://ibn.fm/EDpxx.
The announcement was distributed through BioMedWire, a specialized communications platform for the biotech and life sciences sectors. BioMedWire is part of the Dynamic Brand Portfolio at IBN, which offers wire solutions via InvestorWire, editorial syndication to 5,000+ outlets, and social media distribution. For more details on Kairos Pharma, visit Kairos Pharma (NYSE American: KAPA).
