Kairos Pharma announces interim efficacy analysis of ENV105

Kairos Pharma (KAPA) announced efficacy data from its ongoing Phase 2 clinical trial of ENV105 in patients with metastatic castration-resistant prostate cancer. Kairos Pharma is hosting a virtual KOL event to provide perspectives on this data at 5 p.m. ET / 2 p.m. PT. All patients enrolled in the trial had already failed at least one other hormone therapy modality. This predetermined interim analysis covers the same 10 patients from the safety-arm of the trial, with all patients having failed at least one androgen receptor inhibitor hormone therapy prior to acceptance. Two of the ten patients withdrew from the trial for unrelated events. Of the eight remaining patients, the median progression-free survival was more than 13 months, with five of the eight patients continuing treatment without progression. Seven of nine patients demonstrated a decrease of their prostate-specific antigen from baseline. The interim efficacy analysis of the trial demonstrated that ENV105, a CD105 antagonist, in combination with standard of care hormone therapy apalutamide demonstrated a progression-free survival of 13 months. Notably, the trial is powered to show a 45% improvement in the PFS. This translates to an increase in PFS from 3.7 to 6.7 months. This mark was far exceeded by the ENV105/ Apalutamide combination. The four-month timeframe is significant as 2nd or 3rd line standard of care hormone therapy has a 3.7-month median efficacy, as reported by the CARD trial. The same study also showed the use of chemotherapy provided eight months’ PFS, by imaging, accompanied with greater toxicity. The randomized Phase 2 trial aims to enroll 100 patients in total and is presently accruing patients at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Center. The study is designed to evaluate the safety, tolerability, and early signs of efficacy of ENV105, a CD105 antagonist, in men whose disease has progressed following standard hormone-based therapies. The interim safety analysis of the same trial, announced in July of this year, demonstrated that ENV105 was well tolerated when combined with standard of care hormone therapy, apalutamide, from the first 10 enrolled patients. Thus far, there have been no dose-limiting toxicities or unexpected adverse events reported to date. In addition, the treatment-related side effects were manageable with standard supportive care. Notably, no Grade 3 or Grade 4 toxicities were observed.