Adva-27a is a small molecule compound that inhibits a key enzyme involved in DNA replication – topoisomerase II – thereby preventing cell division.
The drug candidate has shown efficacy against a range of preclinical cancer models, including those for treatment resistant breast cancers and pancreatic tumours.
Sunshine hired Lonza to make Adva-27a last November in a deal that would see the Swiss contractor conduct initial production at a plant in Nansha, China before transferring it to its high containment cytotoxic facility in Visp for final processing steps.
Production of a sample batch of the drug is now complete according to the Canadian drugmaker whose CFO, Camille Sebaaly, told us the firm will conduct cytotoxicity assessments and tests to confirm biological activity.
Assuming the sample batch passes these tests, Lonza will ship a larger batch of the drug to a research centre at McGill University’s Jewish Hospital in Montreal where Phase I trials are taking place.
Sunshine is planning a Phase I clinical trial of Adva-27a for pancreatic cancer in parallel to the Phase I clinical trial of Adva-27a for multidrug resistant breast cancer at the Montreal clinical facility.
Sebaaly also confirmed that Lonza will be producing commercial supplies of Adva-27a if the drug goes on to be approved.
Initial production of Adva-27a was conducted by Canadian contract manufacturing organisation (CMO) Garmen Laboratories, which was acquired by Sunshine’s parent company Advanomics Corporation in August 2013.
A month later Sunshine announced that it was in talks several contractors with the aim being to task one of them with “initiating, compiling and managing a regulatory master drug file for Adva-27a.”