MedImmune is taking its new YTE technology to China. Last week, the biologics arm of AstraZeneca plc established a joint venture with WuXi AppTec to develop its anti-inflammatory drug MEDI5117 for the China market.

MEDI5117 uses MedImmune's YTE technology. Three mutations – the YTE stands for the three mutated amino acids, Tyrosine, Threonine and Glutamic acid – increase the antibody immunoglobulin (IgG) affinity for the neonatal Fc receptor (FcRn receptor).

Among other duties, the FcRn is responsible for binding IgG in cells and recycling them to the surface where they're released back into the blood. "Recycling the antibody to the surface decreases degradation," Bahija Jallal, executive vice president of R&D at MedImmune, told BioWorld Insight. The decreased lysosomal degradation leads to at least a three-fold increase in half life of the antibody.

MEDI5117, a fully human monoclonal antibody that targets IL-6, is currently being studied in autoimmune and inflammatory diseases such as rheumatoid arthritis. The drug, which is in Phase I trials in the U.S. and Europe, is currently the most advanced molecule MedImmune has in its pipeline using the YTE technology. It has others in preclinical development.

In addition to integrating the long-lasting technology into drugs that MedImmune is developing, Jallal recognizes the potential to incorporate the YTE mutations into drugs currently on the market. Biobetters could decrease dosing, an important consideration since antibody drugs have to be injected or infused. Or the extended half life might increase the efficacy of the drug using the same dosing schedule. "It's one tool we have, for sure," Jallal said.

And there's the option of out-licensing the technology for other companies to incorporate the mutations into their antibody drugs. MedImmune has already done one such deal, allowing GlaxoSmithKline plc to use the technology for a specific target. Deal terms weren't disclosed.

For its deal with WuXi, the partnership is a 50/50 joint venture, although both companies have the ability to get paid by the joint venture for their respective contributions to the venture. WuXi will earn revenue based on services provided to the joint venture, while MedImmune will receive development milestone payments.

"We're combining the expertise," Jallal said. "WuXi knows how to navigate and understand a complex pathway for approval of biologics in China."

For MedImmune to develop a drug in China that hasn't been approved elsewhere, the company needs a local manufacturer to get the drug through the regulatory process. Once MEDI5117 is approved, MedImmune has the option to acquire the full rights to commercialize the drug from the joint venture.

The company could bring the drug into China without a partner, but it would have to gain approval elsewhere and then work through the imported drug license pathway, which can add additional time. "If you go with the imported drug license, you delay getting the drugs to the patients by four to six years," Jallal said.

Like the YTE technology, Jallal sees the joint venture as having potential beyond just MEDI5117. "I like to plan for success. [The joint venture] could be a pathway to bring more drugs into China."