Lonza To Manufacture Sunshine Biopharma's Anti-Cancer Compound
By Cyndi Root
Sunshine Biopharma and Lonza have struck a manufacturing deal. Lonza has agreed to manufacture Sunshine’s lead anti-cancer drug, Adva-27a. Sunshine announced the partnership in a press release, stating that Lonza's expertise and experience was an ideal fit.
Dr. Steve N. Slilaty, said, "We are delighted to have a global leader like Lonza as our manufacturing partner. We have made significant recent strides in terms of research results showing the effectiveness of our lead compound against cancer cells, as well as in our manufacturing and recent fund raising efforts."
Lonza and Sunshine Biopharma Agreement
Lonza works in small molecules and API manufacturing, from small quantities for process validation and clinical trials to large-scale manufacturing for commercialization. It has the capabilities to support emerging companies like Sunshine shepherd their products to market. To manufacture Adva-27a, the companies have agreed to a two-step manufacturing process, which will begin at Lonza’s Nansha, China facility and end in Visp, Switzerland, Lonza’s headquarters. The two companies did not disclose the financial terms of the transaction.
Adva-27a
Adva-27a is a Topoisomerase II inhibitor. The small molecule has shown efficacy against multiple types of cancer, including breast cancer, lung cancer, and pancreatic cancer. The United States Trademark and Patent Office (USTPO) issued U.S. patent number 8,236,935 for Adva-27a in 2012. Sunshine is currently planning Phase 1 trials for pancreatic cancer and multi-drug resistant breast cancer.
In November 2014, Sunshine announced that a review of the Ebola Virus Disease (EVD) revealed that EVD progression is similar to the Influenza A virus, which was successfully treated with Etoposide. Sunshine believes that since Adva-27a is a Topoisomerase II inhibitor like Etoposide, Adva-27a may be effective in treating Ebola. Dr. Slilaty, CEO of Sunshine Biopharma, said, “We are heartened by the possibility that our Adva-27a can potentially be used to treat Ebola in the event there is a need.”
Sunshine indicated in September 2014 that it was looking for a contract research organization (CRO) to compile and manage a master drug file for Adva-27a. Engaging a CRO to keep the file would help Sunshine in acquiring and organizing all the information that regulatory agencies require as part of the approval process. In the file, information such as preclinical data, GMP manufacturing process, large animal studies, and human trials helps the company and the FDA proceed to Phase 1 trials.