Kenox Pharmaceuticals announces the successful completion of a pre-IND meeting with the US FDA for its lead program KNX018 - a novel inhaled drug-device combination product as an adjunct sensitizer for radiation therapy in NSCLC patients.
NSCLC is the most prevalent type of lung cancer, accounting for approximately 85% of all lung cancers. Depending on the stage, radiation therapy in combination with chemotherapy and PD-1 is often the treatment of choice. KNX018 is being developed to act as a sensitizer to facilitate the combination therapy to obtain more favorable therapeutic outcomes.
"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" said Dr. Sitaram Velaga, CEO and President of Kenox Pharmaceuticals.Back To Top
Novel Inhaled Drug-Device an Adjunct Sensitizer for RT in NSCLC Patients . Appl Rad Oncol.