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Canbridge, Azaya Ink Deal to Develop ATI-1123 for NSCLC

 

By Shannon Ellis
Staff Writer

Tuesday, September 24, 2013

SHANGHAI – Beijing newcomer Canbridge Life Sciences Ltd. has partnered with emerging nanotech specialist Azaya Therapeutics Inc., of San Antonio, to develop non-small-cell lung cancer (NSCLC) treatment ATI-1123 in China and North Asia.

ATI-1123 is a liposomal formulation of docetaxel that has successfully completed U.S. FDA-approved Phase I trials for multiple solid tumor cancers. Lung cancer is the most prevalent solid tumor cancer in China.

The in-licensing deal for ATI-1123 marks Canbridge’s unofficial launch. Small in size, the 10-person team comes with a strong pedigree. Founder and CEO James Xue was the founding general manager of Genzyme China and is an early returnee who came back to China with an MBA and PhD from the U.S. Crystal Xu heads up clinical development and is the former director of medical and regulatory affairs at Genzyme.

“We are focusing on diseases that most affect the quality of life of Chinese and East Asians and on patients that are also the most underserved,” Xue noted. “Over time, we will build a robust pipeline of drugs and devices in late-stage clinical development that originated at other biopharmaceutical companies outside our region and develop and launch them for China, Taiwan and South Korea. We will not be doing any discovery research. We are focusing on development.”

Licensing a treatment for lung cancer promises to be a good start in a country where smoking and air pollution are rampant. China is the largest producer and consumer of cigarettes in the world. Lung cancer has been found to be two to three times more prevalent in heavily polluted cities.

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“In China, over two-thirds of the newly diagnosed lung cancer patients are not eligible for surgery,” Xue said. “Their only options are chemotherapy and radiation. We are racing against time to develop and deliver a more effective treatment to Chinese and Asian lung cancer patients. We see ATI-1123 as a promising potential new treatment in this underserved Asian market.”

ATI-1123 passed Phase I trials in the U.S. with 88 percent of 29 patients using the drug to stabilize the disease.

Under terms of the agreement with Azaya, Canbridge will finance the development and commercialization of ATI-1123 for China, South Korea and Taiwan and will make undisclosed royalty and milestone payments. Phase II trials are planned by Azaya in the U.S. for the use of the drug in NSCLC, gastric cancer, pancreatic cancer and soft-tissue sarcoma.

“Our commercialization strategy for ATI-1123 is to seek approval in the U.S. and the European Union, primarily. However, the Canbridge opportunity was presented, and we felt it was too good to pass up,” said Mike Dwyer, president and CEO of Azaya Therapeutics. “The people who comprise the Canbridge team were responsible for Chinese regulatory approval of several leading Genzyme products. We know them personally and know they only take on drugs they believe will suit their market.”

Azaya’s proprietary technology “improved” docetaxel with a liposomal formulation that, according to Azaya’s licensing proposal, “provides longer exposure to the drug at the site of the tumor while reducing systemic toxicities.” The most common treatment for breast and prostate cancer is docetaxel (Taxotere, Sanofi-Aventis), but the drug can be highly toxic with serious side effects.

Xue said that the nanotechnology developed by Azaya is what makes the drug promising.

ATI-1123 encapsulates the highly toxic cancer agent in a liposomal coating with a diameter of 90 nm, which is smaller than a blood cell.

“Liposome encapsulation works because cancer tumors have leaky vasculature and nano-sized particles can be absorbed and retained,” said Xue. “In turn, the active ingredient is released more slowly and at a higher concentration, resulting potentially in higher levels of efficacy with a much lower side-effect profile.”

Azaya is private biotech firm set up in 2003. The company uses a targeted nanotechnology platform called Protein Stabilized Liposomes to deal with problems created by water insoluble active pharmaceutical ingredients. Also in Azaya’s pipeline is ATI-0918 (generic Doxil/Caelyx), which has been approved as an investigational new drug and is undergoing bioequivalency tests in ovarian cancer.