Kairos Pharma Ltd. (NYSE American: KAPA) reported favorable interim safety results 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 announced that among 13 patients treated with ENV-105 to date, no Grade 3 or higher treatment-related adverse events have been observed, a finding 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 Phase 1 study is evaluating the safety, tolerability and recommended Phase 2 dose of the combination therapy, with all reported side effects manageable through standard supportive care. The company believes ENV-105 has the potential to extend the clinical utility of osimertinib, the current standard of care for EGFR-mutated NSCLC, by addressing acquired resistance after disease progression.
"We are encouraged by the safety profile observed in this interim analysis, which supports the continued development of ENV-105 as a potential treatment for patients who have progressed on osimertinib," said a company spokesperson. The full press release is available at https://ibn.fm/SmdwW.
The implications of these findings are significant for the treatment landscape of EGFR-mutated NSCLC. Osimertinib is a highly effective first-line therapy, but acquired resistance remains a major clinical challenge, with limited options for patients who progress. If ENV-105 can successfully reverse or delay resistance, it could provide a new therapeutic strategy and improve outcomes for this patient population. The favorable safety data also de-risk further development, allowing the company to move toward dose optimization and efficacy assessments in the next stages of the trial.
Kairos Pharma is also evaluating ENV-105 in a Phase 2 clinical trial for castrate-resistant prostate cancer, targeting the same CD105 mechanism. The company’s approach focuses on structural biology to overcome drug resistance and immune suppression in cancer. As of the date of this press release, ENV-105 has not been approved as safe or effective by the United States Food and Drug Administration or any other comparable foreign regulator.
For more information about Kairos Pharma, visit their newsroom at https://ibn.fm/KAPA.
