Sunshine Biopharma has started discussions with contract manufacturing organizations (CMOs) for the production of its multidrug-resistant breast cancer drug, Adva-27a.
The company is looking for 1kg of Adva-27a for the forthcoming IND-Enabling animal toxicity studies and Phase I clinical trials.
Once the animal toxicity studies are completed, an investigational new drug application seeking approval to conduct Phase I trial will be submitted to the FDA.
Sunshine Biopharma president and chief executive officer Dr Steve Slilaty said the company is at the stage of conducting GMP manufacturing of its drug.
“The filing of our process patent to protect Adva-27a manufacturing in January this year allowed us to quickly move forward and securely share information with CMO’s to supply us with kilogram quantities of Adva-27a to complete the data for the IND application and conduct Phase I clinical trials,” Slilaty added.
“We have systematically collected years’ worth of data demonstrating the potential of Adva-27a and feel that we are well positioned to deliver on our commitment to build shareholder value with our novel breast cancer compound.”