Kairos Pharma Ltd. (NYSE American: KAPA) has announced positive interim efficacy data from its ongoing Phase 2 trial evaluating ENV-105 in combination with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). The analysis revealed a statistically significant difference in progression-free survival (PFS), with a median PFS of 17.7 months for patients receiving ENV-105 plus apalutamide compared with two months for those receiving apalutamide alone (P=0.0008). This marked improvement suggests that ENV-105, an antibody targeting CD105, may reverse drug resistance and restore the effectiveness of standard therapies in prostate cancer.
The magnitude of the benefit—nearly nine times longer PFS—is clinically meaningful and could reshape treatment paradigms for mCRPC, a condition where patients often develop resistance to androgen signaling inhibitors. The data supports the company's structural biology approach to overcoming resistance and immune suppression. For investors, this interim result de-risks the ENV-105 program and highlights its potential across multiple cancer types. The full press release can be accessed at https://ibn.fm/EDpxx.
In response to the data, Kairos Pharma has modified the Phase 2 protocol to enroll patients earlier in disease progression. Patients who experience a PSA increase following upfront treatment with an androgen signaling inhibitor will now be randomized to receive either enzalutamide alone or enzalutamide in combination with ENV-105. This change is intended to expand the eligible patient population and facilitate enrollment, with completion of the Phase 2 trial targeted in or before the fourth quarter of 2027. By moving ENV-105 into earlier lines of therapy, the company aims to demonstrate even greater clinical benefit and potentially accelerate regulatory pathways.
Kairos Pharma, based in Los Angeles, California, is at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Its lead candidate, ENV-105, targets CD105—a protein identified as a key driver of resistance and disease relapse in response to standard therapy. ENV-105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. The latest news and updates relating to KAPA are available in the company's newsroom at https://ibn.fm/KAPA.
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