Allarity Therapeutics and Lonza, a CDMO, agreed to develop and manufacture dovitinib, Allarity’s renal cell carcinoma candidate therapy. The agreement aims to begin manufacturing of dovitinib in 2022 to meet Allarity’s projected needs for bringing dovitinib to market following anticipated regulatory approvals.
Dovitinib represents Allarity’s most advanced clinical asset, with possible use in other indications, such as liver cancer, breast cancer and various solid tumors. This pan-tyrosine kinase inhibitor targets fibroblast growth factor receptor, vascular endothelial growth factor receptor, and other receptor tyrosine kinases.
“Entering this agreement with Lonza is an important step in our long-term preparations to take dovitinib towards commercialization,” said Steve Carchedi, CEO, Allarity. “[Our company] now has a robust agreement covering the production and ongoing supply of dovitinib that we will need in the years to come.”
Under the terms of the agreement, Lonza will leverage its capabilities for commercial manufacturing of small-molecules and oral solid dosage forms to provide Allarity with cGMP compliant drug product supply and regulatory support towards commercialization. Allarity will leverage Lonza’s global network, technical capabilities, and integrated solution covering both drug substance and drug product.
The drug substance manufacturing and particle size reduction by micronization will be performed at Lonza’s facility in Visp, Switzerland. The drug product manufacturing will take place at Lonza’s Tampa, FL facility.