A small-molecule, pan-tyrosine kinase inhibitor, dovitinib targets metastatic renal cell carcinoma and is Allarity’s most advanced clinical asset currently. The company also sees potential in other indications, such as liver cancer, breast cancer and various solid tumors.

“Entering this agreement with Lonza is an important step in our long-term preparations to take dovitinib towards commercialization. Allarity now has a robust agreement covering the production and ongoing supply of dovitinib that we will need in the years to come,” said the company’s CEO, Steve Carchedi.

Lonza will perform drug substance manufacturing and particle size reduction by micronization at its site in Visp, Switzerland, while manufacturing of the drug product will take place in Tampa, Florida, USA.

As Oncology Ventures, Allarity bought dovitinib from Novartis in April 2018. Then in September 2020, Oncology decided to change its name to Allarity, restructuring its board at the same time.

Earlier this month, the Danish pharma presented data at the European Society for Medical Oncology conference demonstrating that patients with renal cell carcinoma selected with a dovitinib drug response predictor (DRP) diagnostic tool had a median survival rate of 15 months compared with 11.2 months for those treated with Bayer’s Nexavar (sorafenib).

During the final quarter of 2021, Allarity plans to file a new drug application for dovitinib with the US Food and Drug Administration. It has previously filed a pre-market approval application for the dovitinib DRP.

The DRP is used to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. Allarity said by screening patients before treatment, the response rate can be increased significantly. Its DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.

For Lonza, the deal with Allarity comes at a time of rapid expansion. Last week, the company announced a further investment in drug product manufacturing facilities in Switzerland. Another aseptic flexible filling line is being added at its site in Stein to support liquid and lyophilized vial filling and processing, cartridges and pre-filled syringes. Completion is expected in 2023, and more than 70 new jobs will be created.

The investment also includes an expansion of drug product services for parenteral dosage forms in Basel, Switzerland, with the new facilities due to be operational in 2024.

Last month, the CDMO said it would add a new fill-finish line at its site in Guangzhou, China, which will be ready in 2022. Another project in China, announced in June, involves spending 20 million Swiss francs to expand an API development and manufacturing facility in Nansha.

In May, Lonza revealed plans to invest roughly 850 million Swiss francs to build two mammalian facilities at Visp and Portsmouth, New Hampshire, USA, with start-up planned for 2024 and 2023, respectively.

Author: Elaine Burridge, Freelance Journalist