interesting...

"Ascend gears up for cancer immunotherapy trials

By Dylan Bushell-Embling | Posted in Cancer on 22 August, 2013

The life science sector is devoting a lot of attention to immunotherapy in cancer treatment. Citi Research Equities recently estimated that immunotherapy will become the treatment backbone for up to 60% of cancers over the next 10 years.

Melbourne-based Ascend Biopharmaceuticals is preparing to enter pivotal clinical trials for two cancer treatment candidates, a cancer vaccine and a virus, and is well placed to capitalise on this immunotherapy momentum.

Ascend CEO Clement Leong said the Australian trials will focus on breast cancer and nodular basal cell carcinoma (BCC) respectively.

Ascend Biopharmaceuticals was founded out of Australia’s Austin Research Institute - now the Burnet Institute - in 2006. Leong was a founding investor and chairman of the company, and was appointed CEO around a year ago.

ASN-004: Training the immune system

ASN-004 is a cancer vaccine which is designed to train the immune system to selectively destroy cancer cells by recognising tumour antigen MUC-1. The antigen is expressed in a wide variety of cancer types, but Ascend is initially planning to commercialise the vaccine in breast cancer.

Leong said the breast cancer focus is due to the development history of the product. The vaccine is based on work by then Austin Research Institute professor Ian McKenzie during the late ’80s and early ’90s. The work culminated in a study demonstrating encouraging results in early-stage breast cancer.

“When we saw the data we were very impressed,” Leong said. “We knew that we had to do a lot of work around moving what was an academic program into a bona fide commercial program, but there were sufficient tantalising clinical results in breast cancer that caused us to invest into the program.”

During the course of clinical development, which focused on ensuring the product is approvable by regulators, the company has discovered ways to make improvements to the original composition. “We were able to discover that there’s a way of improving the immunogenicity of the vaccine,” Leong said.

While the details are subject to change, Ascend plans to commence a phase Ib trial of ASN-004 in late 2014. The company aims to enrol 24 breast cancer patients. Leong said the company felt the need to go back to a phase Ib study because of the improvements made to the vaccine composition.

“We’re building a bridge with a new product that we believe will be acceptable to the regulators,” he said. “And that’s why we really need to [re-establish] basic safety and basic characteristics of the product.”"


- See more at: http://lifescientist.com.au/content/health-medical/article/ascend-gears-up-for-cancer-immunotherapy-trials-533111508?