Kairos Pharma (NYSE American: KAPA) has reported 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 announced that among 13 patients treated with ENV-105 to date, no Grade 3 or higher treatment-related adverse events have been observed, a result 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 the safety, tolerability, and recommended Phase 2 dose of the combination therapy. All reported side effects have been manageable through standard supportive care, according to the company.
Kairos believes ENV-105 has the potential to extend the clinical utility of osimertinib by addressing acquired resistance after disease progression. This is significant because osimertinib resistance is a major clinical challenge, and there are limited treatment options for patients who progress on this therapy. The interim safety data provides a foundation for further investigation into whether ENV-105 can help overcome this resistance.
The full press release is available at https://ibn.fm/SmdwW.
Kairos Pharma, based in Los Angeles, California, is focused on oncology therapeutics, utilizing 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 the 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.
The importance of this announcement lies in the potential for ENV-105 to address an unmet medical need in lung cancer, where acquired resistance to targeted therapies like osimertinib limits treatment duration and patient outcomes. Successful development of ENV-105 could provide a new option for patients with limited alternatives.
