Kairos Pharma Ltd. (NYSE American: KAPA) has announced 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 reported no Grade 3 or higher treatment-related adverse events among the 13 patients treated with ENV-105 to date, supporting 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. According to the company, all reported side effects have been manageable through standard supportive care.
Kairos 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. This is a significant area of unmet medical need, as many patients eventually develop resistance to osimertinib, limiting its effectiveness.
The full press release is available at https://ibn.fm/SmdwW.
Kairos Pharma, based in Los Angeles, California, is focused on oncology therapeutics, using structural biology to overcome drug resistance and immune suppression in cancer. ENV-105 is also being evaluated in a Phase 2 clinical trial for castrate-resistant prostate cancer. As of the date of this press release, ENV-105 has not been approved as safe or effective by the U.S. Food and Drug Administration or any other comparable foreign regulator.
The importance of this announcement lies in the potential of ENV-105 to restore sensitivity to osimertinib, which could significantly improve outcomes for patients with EGFR-mutated NSCLC who have limited options after developing resistance. If further studies confirm efficacy, this combination therapy could become a new standard of care, addressing a critical gap in lung cancer treatment.
For more information, visit the company's newsroom at https://ibn.fm/KAPA.
