Theraclone Enters Clinical World, With Flu Antibody That Might Be Handy in Pandemic

Theraclone Sciences has made a lot of news lately with its antibody discovery prowess, but now it’s getting to the point where the rubber hits the road in biotech—clinical trials.

The Seattle-based biotech company, founded in 2005, is announcing today that it has started its first clinical trial. This study will look at an experimental antibody, TCN-032, designed to fight various strains of the flu. The trial will enroll 40 healthy volunteers in the U.S. who will get randomly assigned to the drug or a placebo, the company says. Theraclone will be looking to see if the drug is safe at a variety of doses, and it expects to see results in the first half of 2012, says Eleanor Ramos, the company’s new chief medical officer. The antibody is one that emerged from a collaboration with Japan-based Zenyaku Kogyo that was formed two years ago.

Theraclone doesn’t yet know, and won’t learn from this study alone, exactly how a new anti-flu antibody might be used in the real world. Since it’s delivered intravenously, the antibody could be reserved as another line of treatment for serious cases of flu in hospitalized patients. Or it might be used as a protective agent for first-responders at risk of getting infected during a flu pandemic, Ramos says. What Theraclone’s scientists know so far is that this engineered antibody has shown potent ability to attack vulnerable regions on a variety of flu strains in animals. That versatility in a pinch, if proven out in humans, might make it an attractive agent for government stockpiling in case a pandemic arises of a new mutant flu strain that can resist current treatments like Roche’s oseltamivir phosphate (Tamiflu) or GlaxoSmithKline’s zanamivir (Relenza).

Theraclone has one more experimental antibody, for what’s known as cytomegalovirus (CMV) infections, teed up to enter the clinic next year, Ramos says.

It’s all been part of a very busy period at Theraclone. The company pulled in $10.6 million in additional venture capital last week. A few weeks before that, Theraclone and its collaborators had a publication in Nature that described the discovery of 17 new broadly neutralizing antibodies against the HIV virus. And it got some national recognition when it was named one of the Fierce15 emerging biotech companies by FierceBiotech, an industry publication.

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