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 no Grade 3 or higher treatment-related adverse events were observed among the 13 patients treated with ENV-105 to date, supporting the 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. 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.
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 an antibody that targets CD105, a key driver of resistance and disease relapse in response to standard therapy. It aims to reverse drug resistance and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV-105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and this Phase 1 trial for NSCLC, addressing significant unmet medical needs. 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.
These interim results are important because acquired resistance to osimertinib is a major clinical challenge in EGFR-mutated NSCLC. If ENV-105 can successfully restore sensitivity, it could significantly extend the duration of benefit from osimertinib, improving outcomes for patients with limited options. The safety profile observed so far is encouraging and supports further investigation into the efficacy of this combination. The ongoing trial will provide more data on the recommended Phase 2 dose and early signs of efficacy.
For more information about Kairos Pharma, visit their newsroom at https://ibn.fm/KAPA. BioMedWire, a specialized communications platform, covers developments in the biotechnology and life sciences sectors. This content is for informational purposes only and does not constitute investment advice.
