Kairos Pharma Ltd. (NYSE American: KAPA) has announced favorable interim safety data from its ongoing Phase 1 clinical trial evaluating ENV-105 (carotuximab) in combination with osimertinib (Tagrisso) for patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) who have developed resistance to osimertinib. The company reported that among 13 patients treated, there were no Grade 3 or higher treatment-related adverse events, indicating a manageable safety profile that supports continued advancement of the program toward an early efficacy readout.
ENV-105 is designed to inhibit CD105, a protein associated with acquired drug resistance, with the goal of restoring sensitivity to osimertinib, the current standard of care for EGFR-mutated NSCLC. The Phase 1 study is evaluating safety, tolerability, and the recommended Phase 2 dose of the combination therapy. All reported side effects have been manageable through standard supportive care, according to the company.
Kairos Pharma believes ENV-105 has the potential to extend the clinical utility of osimertinib by addressing acquired resistance after disease progression. This is a significant unmet medical need, as patients often develop resistance to osimertinib within a year of treatment. The positive interim safety data allow the trial to proceed to efficacy assessment, which could provide a new therapeutic option for these patients.
The full press release is available at https://ibn.fm/SmdwW. More information about Kairos Pharma and its pipeline can be found at the company's newsroom at https://ibn.fm/KAPA.
