Australian pharma company Bionomics has signed a deal with contract manufacturer SAFC Pharma for the scale-up of its flagship cancer drug.
Under the terms of the agreement, a batch of one and a half kilograms of the drug, BNC105, will be manufactured and used to complete pre-clinical studies as well as Phase I and II clinical trials, expected to start at the end of next year. "The GMP manufacture of BNC105 will be assisted by virtue of the fact that it has been discovered using our MultiCore synthesis technology that gives concise, efficient synthetic access to drug candidates in a manner that is applicable to scale-up and GMP manufacture," said Bernard Flynn, VP of Chemistry Bionomics. "This is a feature that is too often overlooked in drug discovery, leading to expensive delays in the subsequent development of drug candidates for clinical trials." BNC105 is a new type of drug called a vascular disruption agent (VDA) that acts to rapidly shut down the blood supply within a solid tumour, and has the effect of "starving" the tumour of the oxygen and nutrients it needs to survive. The company also claims that a key benefit of BNC105 is the selective targeting of blood vessels in cancers. Agents that target blood vessels are at risk of interfering with the blood supply to healthy tissues as well as the tumour, but pre-clinical studies have shown that BNC105 leaves the capillaries supplying healthy tissues intact. According to Bionomics, VDAs have significant clinical potential to be the next generation treatment for cancer, as they may be applied across a very wide variety of cancer types, including colon, lung and breast cancers. Breast cancer is the leading cause of cancer-related mortality among women worldwide and in 2006, more than 447,000 cases of the disease are expected to be diagnosed in the seven major pharmaceutical markets, according to a recent Datamonitor report. These figures could boost the market potential for VDAs, which, according to Bionomics, has been estimated at approximately $5bn (€3.9bn) annually. A number of other companies are showing interest in VDAs and several compounds are in development worldwide but Bionomics said that preclinical studies showed that BNC105 has the strongest selectivity on tumour blood vessels, relative to its effects on normal organs. The company also claims that its new drug is 15 times more potent than a competing VDA in clinical trials for the treatment of breast cancer, as it is safer and more effective in enhancing the efficacy of chemotherapies. "Preclinical studies have also indicated that BNC105 is able to improve the effectiveness of current drug treatments for cancer, including doxorubicin and 5-flurouracil," the company said.
Bionomics expects the manufacture to be completed in the last quarter of 2006, and is hoping to get approval for Phase I and II clinical trials at the end of next year.