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. 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 to two months for those receiving apalutamide alone (P=0.0008). This result is important because it suggests that adding ENV-105 to standard therapy may substantially delay disease progression in a patient population with limited treatment options.
In response to these 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. The company said the 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. This strategic shift could accelerate the development of ENV-105 and potentially bring a new treatment option to patients sooner.
ENV-105 is an antibody that targets CD105, a protein identified as a key driver of resistance and disease relapse in response to standard therapy. By targeting CD105, ENV-105 aims to reverse drug resistance and restore the effectiveness of standard therapies across multiple cancer types. The interim data not only validate this mechanism but also highlight the potential of ENV-105 to address a critical unmet need in prostate cancer, where resistance to androgen receptor signaling inhibitors remains a major challenge.
For investors, the statistically significant PFS benefit is a key value driver. It de-risks the program and increases the likelihood of successful later-stage trials. The protocol amendment to enroll patients earlier may also lead to faster data readouts and a more competitive positioning in the prostate cancer treatment landscape. Kairos Pharma (NYSE American: KAPA) is at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. The company’s lead candidate, ENV-105, is central to its strategy. The latest news and updates relating to KAPA are available in the company’s newsroom at https://ibn.fm/KAPA. To view the full press release, visit https://ibn.fm/EDpxx.
About BioMedWire: BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries. For more information, please visit www.BioMedWire.com. Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/Disclaimer.
