Kenox Pharmaceuticals announces 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

On December 14, 2021 Kenox Pharmaceuticals Inc, a privately owned pharmaceutical company focused on respiratory drug products, reported that it has submitted Type B Pre-Investigational New Drug (IND) meeting request with the U.S. Food and Drug Administration (FDA) for its lead program KNX018, a novel inhaled drug-device combination product as an adjunct sensitizer for radiation therapy in Non-Small-Cell Lung Carcinoma (NSCLC) patients in October 2021 and received a positive response supporting the planned CMC, non-clinical and clinical development strategy (Press release, Kenox Pharmaceuticals, DEC 14, 2021, View Source;a-novel-inhaled-drug-device-combination-product-as-an-adjunct-sensitizer-for-radiation-therapy-in-nsclc-patie-301443308.html [SID1234597166]).

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Kenox Pharmaceuticals Inc plans to submit an Investigative New Drug Application (IND) to FDA in 2022

Lung cancer is the leading cause of cancer deaths globally, about 1.8 million people die as a result of the disease each year. NSCLC is the most prevalent type, 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.