SHANGHAI – Aslan Pharmaceuticals Pte Ltd. signed an agreement for global rights with CSL Ltd. to develop an anti-IL13 receptor monoclonal antibody, CSL334, for severe to moderate asthma.

Aslan, of Taipei and Singapore, will fund and develop the drug to become known as Aslan004 through to clinical proof of concept in a development program to be conducted in Asia.

Deal terms were undisclosed, but CSL, of Melbourne, will be entitled to a share of returns generated by Aslan from partnering the project at a later stage.

"The licensing deal, allows us to develop and ultimately sublicense the global commercial rights downstream," Carl Firth, Asla's CEO, told BioWorld Asia.

The project shows Aslan's appetite to go ever earlier in its hunt for the right opportunity with the right partner. The project may be preclinical but according to Firth it is ready to go into "GLP tox" and fits well into their strategy.

Aslan has a unique business model, licensing global rights for innovative assets to be developed by leveraging Asian clinical resources. (See BioWorld Asia, Feb. 19, 2014, and Oct. 18, 2013).

It expects to partner at phase III, after conducting phase I and phase II trials in countries like Korea, Taiwan, Singapore and Australia where approval can be timely and the investigators are experienced. Not forgetting the elephant in the room, China comes in at a later stage.

"When we are phase IIb or even beyond, I think that is a perfect time to make sure we start to involve China," said Firth. "To make sure we have the right data, the right experience, to ensure China can ultimately offer an approval there."

Asthma is a worldwide issue but is particularly acute in Asia where air pollution is rife. Globally, asthma is a $13 billion a year market, Firth said, and many patients are using a combination of inhaled products such as Advair (fluticasone/salmeterol) from Glaxosmithkline plc or Symbicort (formoterol and budesonide) from Astrazeneca plc. There is one biologic product, Xolair (omalizumab), a $1.4 billion product.

The challenge is to provide solutions for sufferers of moderate to severe asthma, said Firth where the condition can be fatal and very costly to treat.

"The ones that are not controlled live in fear of their next exacerbation," said Firth, "whether it is a chest infection or something else, it may mean being taken to hospital and in some cases this can be a life threatening event. And though it is a small number of asthmatics that are not controlled, it is this small number that represents 50 percent of the total cost of treating asthma."

While asthma affects 3 percent to 9 percent of the world's population, in China there is a particular unmet need with some 15,000 fatalities a year related to asthma.

Aslan is aware many large companies are going after a better solution to asthma, but is counting on their nimble, innovative approach to get them ahead faster. This is in part how they convinced CSL to work with them, said Firth.

Compared to Aslan, CSL is a much larger player with offices in Australia, Germany, Switzerland and the U.S., employing some 11,000 people.

"Aslan's focus on efficiently designing and executing innovative clinical strategies, combined with its teams experience in asthma drug development, make it the ideal partner for moving this therapy forward," said Andrew Nash, CSL's senior vice president, research.

It was important for Aslan to seek out a drug that would provide more than a marginal benefit to existing therapies but rather "have a significant impact on how patients are treated" and that his how the company regards Aslan004.

The drug is a fully human monoclonal antibody (MAb) against interleukin-13 receptor α1 that has been shown to block binding and signal transduction of both IL4 and IL13.

"The antibody itself is in a very exciting area of inflammatory biology," said Firth, "in particular the antibody blocks a path to the IL-13 receptor, this is a receptor involved in the information cascade responsible for a number of different diseases including asthma."

Taking on the challenge of its first preclinical drug and a MAb seem to be alleviated by Aslan's confidence in its partner. "They [CSL] worked in this area for a long time and put together an incredibly fantastic package of data," said Firth. "It certainly helps to know you are working with one of the world's strongest companies in a particular space. That gave us a lot of reassurance."

Aslan has three other assets in its pipeline, a pan-HER inhibitor licensed from Array Biopharma Inc., of Boulder, Colo., in phase IIb; a cMET inhibitor from Bristol-Myers Squibb Co., of Princeton, N.J., in phase I; and a DHODH inhibitor licensed from Almirall S.A., of Barcelona, in phase I for rheumatoid arthritis.