NEW YORK – Allarity Therapeutics said on Friday that due to pandemic-related manufacturing delays, it is now expecting to file the new drug application for its investigational kidney cancer drug dovitinib with US regulators next year.
Denmark-headquartered Allarity, which until recently was known as Oncology Venture, had a pre-NDA meeting with the US Food and Drug Administration earlier this year and based on the agency's feedback had projected an NDA filing for dovitinib in late or in the second half of 2020.
Dovitinb is a pan-tyrosine kinase inhibitor that previously failed while under Novartis. Allarity wants to advance the drug as a third-line treatment option for patients with renal cell carcinoma who are predicted to benefit based on its drug response predictor (DRP) platform. The DRP platform uses an AI-driven algorithm to identify best responders to the drug.
Based on FDA's feedback, Allarity had planned to show dovitinib's non-inferiority to sorafenib (Bayer's Nexavar) within the study supporting its NDA. According to the company, a third-party contractor has experienced delays in manufacturing the "registrational batch" of the drug due to the COVID-19 pandemic, which is a mandatory component of the application. However, the company said it is still on track to file its premarket approval application for the DRP platform this year with the FDA.
"Although we are disappointed with the unanticipated contract manufacturing delay for our priority dovitinib program, and the resulting setback of our planned first NDA filing for this promising cancer therapeutic, we recognize the delays are a result of the ongoing coronavirus pandemic that is affecting many facets of our industry," Allarity CEO Steve Carchedi said in a statement. "We remain fully committed to advancing the near-term filing of our first dovitinib NDA towards hopeful US approval and to bringing this beneficial cancer therapeutic to RCC patients."