A company heading towards filing its IND with the FDA that likely will be hitting the radar of investors is Sunshine Biopharma (SBFM). The company is developing Topoisomerase 2 inhibitor Adva-27a, a novel derivative of the non-alkaloid toxin lignin podophyllotoxin, which has been shown in preclinical research to be a potent tumor suppressor in a several cancer lines (breast, lung, uterine and pancreatic), notably tumors that are resistant to today's approved drugs. It does so by being unaffected by P-Glycoprotein, the enzyme responsible for making cancer cells resistant to chemotherapy drugs. Lab research has shown the small molecule drug to have a strong pharmacokinetic profile and no toxicity at high concentrations.
Nothing describes the potential for Adva-27a like the commonly used drug Etoposide, also a derivative of Podophyllotoxin, that is approved for use in a bevy of cancers including, but not limited to, leukemia, lymphoma, testicular, lung, brain, prostate, bladder, colon, ovarian and liver. The critical difference is that Adva-27a is a novel chemical entity with more desirable biological properties while demonstrating the ability to destroy drug-resistant tumors, positioning it potentially as a front-line, or final-line, defense.
While Adva-27a certainly appears to have the potential to spiderweb into a great many cancer types, Sunshine Biopharma is initially targeting drug-resistant breast cancer, and for good reason. Etoposide is not effective against this aggressive form of cancer that kills about 458,000 people worldwide annually with a new diagnoses rate of 1.38 million each year.
Two well-known enzyme biomarkers, Top-2 (Topoisomerase 2) and HER-2 (Human Epidermal Growth Factor Receptor 2), are associated with aggressive forms of breast cancer. Swiss drug maker Roche Holding AG (RHHBY), the biggest manufacturer of cancer drugs in the world, generates about $6 billion annual from sales of Herceptin(R) for HER-2 positive breast cancer patients. While certainly a formidable sales total, it's amassed through only treating the 20-percent of breast cancer patients that are HER-2 positive, leaving and incredible void and large opportunity for a potent drug targeting Top-2 positive patients.
Sunshine Biopharma falls under the umbrella a parent company Advanomics Corporation. Advanomics received two research grants in Augusts totaling $1.45 million for the development of Adva-27a. Additionally, Advanomics recently bought privately-held Garmen Laboratories, a profitable Good Manufacturing Practices lab with 45 employees working in a 50,000-square-foot headquarters in Montreal, Canada (Sunshine Biopharma is also based in Montreal). The acquisition cuts through the red tape, shaves expenses and eliminates waiting in queue at other laboratories for the manufacturing of Adva-27a for clinical trials. Advanomics generating revenue, receiving grants and essentially doing all the heavy lifting regarding manufacturing certainly bodes very well for Sunshine Biopharma going forward.
Sunshine Biopharma has not issued guidance on when they will be filing the IND to proceed to the clinic, but it has been disclosed that the trials will be hosted by McGill University's Jewish General Hospital in Montreal. Extrapolating from press releases, it seems probable that the lab research is nearing completion and the regulatory filing would be coming in the first quarter of 2014, which could portend some significant movement in share value if the general pattern of a biotech cycle is followed. With a market capitalization of only $11.3 million, Sunshine Biopharma also has substantial upside potential.
News 
Market Data 
Discover 
