Sunshine Biopharma Inc. has initiated negotiations with several CMOs for the GMP manufacture of 1kg of Adva-27a, the company's lead drug in development for the treatment of breast cancer that has become resistant to current anti-cancer therapies.
The supply of Adva-27a will be used to complete the upcoming animal toxicity studies and plans to file an IND to proceed with the planned Phase I trial. The company intends to make any leftover material available for compassionate-use programs.
"We are excited to be at the stage of conducting GMP manufacturing of our drug," said Dr. Steve N. Slilaty, president and chief executive officer of Sunshine Biopharma. "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 CMOs to supply us with kilogram quantities of Adva-27a to complete the data for the IND application and conduct Phase I clinical trials. The excitement is growing stronger at Sunshine Biopharma as we move towards completion of the IND-Enabling studies and the filing of our IND application."