Hope springs eternal for Benitec’s IP

MELBOURNE, Australia—Although RNAi therapeutic-based biotech Benitec Ltd. closed its U.S. operation a couple years ago, relocating back to Australia in 2006, CEO Sue MacLeman says she expects that "at some stage Benitec will look to move back to a major market either itself or through merged entity." Its continuing therapeutic work with Duarte, Calif.-based hospital and research center City of Hope is a sign, she notes, of Benitec's commitment to continuing to work with the "best collaborators in the space" globally and not just remain focused on Australia.

The most recent news out of Benitec's remaining activity in the United States is the announcement toward the end of April that the company has secured further intellectual property rights that underpin its HIV/AIDS lymphoma therapeutic currently under going clinical trials at City of Hope. The therapeutic uses RNAi technology covered by Benitec's patent portfolio and the option with City of Hope covers five U.S. patents and patent applications.

City of Hope has granted Benitec an option to obtain an exclusive, worldwide royalty-bearing license to a suite of patent rights held by City of Hope, with which Benitec has been collaborating since 2004.

The news of this opportunity follows on the heels of a U.S. Supreme Court decision in favor of Benitec several days earlier regarding litigation between Benitec and Nucleonics that has been ongoing since 2004—a decision that prompted MacLeman to note in a news release that "we can now fully focus our attention, efforts, and resources toward rebuilding Benitec and developing RNAi therapeutics."

"The business is going well…and PricewaterhouseCoopers is announcing that we are again one of the top 10 performing companies in the sector," she told DDN when asked about the possibility of a move back to the United States. "Benitec plays on a global stage and clearly if based in a major market would have better access to more skilled product development and commercialization staff and access to other sophisticated investors and capital markets."

She notes that with RNAi global revenues forecast to reach $146.4 million in U.S. dollars by 2010 and the United States dominating the total RNAi market, Benitec's newly acquired option to patent rights has the potential to generate considerable investment returns. But, at the same time, the work with City of Hope is relatively early stage, being a Phase I human trial.

"So it is unlikely that we would be looking to out-license this in the short term," MacLeman says. "Our preference is to wait until with have proof of concept in humans (probably Phase IIb)."

This study at city of Hope is Benitec's first human trial and uses a triple therapy delivered using a lentiviral vector for the treatment of HIV—rHIV7-shl-TAR-CCR5RZ—a vector that suppresses HIV by expressing three therapeutic nucleic acids that are directed against key steps in HIV replication. DDN