AdAlta’s AD-214 Granted Patent Protection in China

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The China National Intellectual Property Administration has granted AdAlta a patent covering AD-214, the biotech company’s experimental therapy for idiopathic pulmonary fibrosis (IPF).

The patent — number CN 107427574 B — entitled “CXCR4 binding molecules,” will expire in early January 2036.

“China is now the second largest (and fastest growing) pharmaceutical market in the world (after the US), representing 11% of the global prescription drug market,” Tim Oldham, PhD, CEO of AdAlta, said in a press release.

“IPF is included in the Chinese Rare Diseases List, including it as part of China’s plan to increase availability of drugs for rare diseases,” Oldham added. “Patent protection for AD-214 in this important market is anticipated to further increase the already significant interest from potential China partners.”

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Potential IPF Treatment AD-214 Works in Inhaled Form, AdAlta Says

China is the fifth country to grant patent protection to AD-214. The therapy has received two patents in Australia — AdAlta is based in Victoria, in that country — two in the U.S., and one each in Japan and Singapore. AdAlta is currently pursuing claims to receive patent protection in other large markets, including India and the European Union.

AD-214 contains two fused i-bodies — modified antibodies that are built on the scaffold of human proteins and whose shape mimics that of shark antibodies — that target a receptor protein called CXCR4. This protein is expressed in cells called fibrocytes, which, as their name suggests, are potent drivers of fibrosis, or tissue scarring. IPF is characterized by progressive fibrosis in the lungs.

By binding to CXCR4, AD-214 is designed to reduce fibrosis-driving fibrocyte activity, ultimately lessening scarring in IPF and other conditions characterized by excessive fibrosis.

The therapy has shown promising anti-fibrotic activity in preclinical animal studies, according to AdAlta. The company has also completed Phase 1 clinical studies for AD-214.

AdAlta announced late last year that it had successfully developed a formulation of AD-214 that can be made into an aerosol for inhalation, allowing for more efficient delivery to the lungs in IPF.

The newly issued patent in China protects the i-body sequence that is used in AD-214, as well as sequences that are similar, and pharmaceutical compositions and derivatives containing those i-body sequences. The patent also covers the use of these sequences in therapies or diagnostic tools for IPF.