Krystal Biotech announced that inhaled KB707 gene therapy for the treatment of metastasized tumors in the lung that are not successfully treated with standard therapy has been granted Fast Track designation by the FDA. The FDA had previously granted Fast Track designation to intra-tumoral KB707 for the treatment of melanoma.
In July 2023, Krystal announced that it intended to develop KB707, which delivers genes encoding interleukin-12 and interleukin-2, as an inhaled therapy for the treatment of lung tumors. According to the company, a Phase 1 study of KB707 is expected to start evaluating the inhaled formulation by mid-2024.
Krystal Biotech President, Research & Development, Suma Krishnan commented, “The FDA’s decision to grant inhaled KB707 Fast Track designation is a reflection of both the urgent unmet need that exists for patients with lung metastases and the robust preclinical data we have generated to date in stringent syngeneic mouse models of checkpoint inhibitor refractory metastatic disease. We look forward to the first patient being dosed with inhaled KB707 later this year.”
Read the Krystal Biotech press release.
