According to Kenox Pharmaceuticals, the company “received a positive response supporting the planned CMC, non-clinical and clinical development strategy” following a pre-IND meeting with FDA regarding the company’s KNX018 inhaled sensitizer for use with radiation therapy for the treatment of non-small cell lung cancer (NSCLC). The company said that it now plans to submit an IND in 2022.
Kenox President and CEO Sitaram Velaga commented, “We are extremely pleased and appreciate FDA for thoughtful feedback, which provides a path forward for KNX018; a first-of its kind adjuvant therapy in NSCLC patients. We will continue to work with the agency to ensure all CMC and clinical requirements are fulfilled for a successful filing and approval of NDA. I’m grateful and tremendously proud of my team for the hard work, dedication, and creativity in advancing this program.”
The Kenox web site does not name other drugs in its pipeline but says, “We repurpose approved drugs to inhalation route using innovative formulations, devices/drug delivery systems, and thereby enhance therapeutic efficacy and/or decrease adverse effects. Diversified portfolio of 505(b)(2) products are in different phases of development. Our target indications include Asthma/COPD, Insomnia, Lung cancer/adjuvant therapy, Depression, Chorea, Nicotine replacement therapy, and Pulmonary arterial hypertension.”
Read the Kenox Pharmaceuticals press release.
