Kairos Pharma Ltd. (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, 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, with all reported side effects manageable through standard supportive care. According to Kairos, 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 development is significant because acquired resistance to osimertinib represents a major clinical challenge in the treatment of EGFR-mutated NSCLC. If ENV-105 can successfully reverse this resistance, it could provide a new therapeutic option for patients who have limited alternatives after progressing on osimertinib. The favorable safety profile observed so far is an encouraging sign for the combination's potential tolerability in a broader patient population.
Kairos Pharma is focused on oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. The company's lead candidate, ENV-105, is an antibody that targets CD105, a key driver of resistance and disease relapse in response to standard therapy. ENV-105 aims to reverse drug resistance and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV-105 is also 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 United States Food and Drug Administration or any other comparable foreign regulator. The full press release can be accessed at https://ibn.fm/SmdwW. For more information about Kairos Pharma, visit their newsroom at https://ibn.fm/KAPA.
