Theraclone Sciences just got the results a few weeks ago from the clinical trial of its first antibody drug candidate, and today it’s moving ahead with program No. 2.
The Seattle-based biotech company said today it has started the first clinical trial of an antibody it calls TCN-202, which is designed to fight human cytomegalovirus (CMV) infections. The study will enroll about 80 healthy volunteers who will be randomly assigned to get different doses of the new drug, or a placebo. The aim of the study will be to assess the drug’s side effect profile at different doses, how well it is absorbed and distributed through the body, and whether it provokes an undesired immune response against the product itself. Theraclone said it expects to see results by the first half of 2013.
This antibody drug candidate is the second one Theraclone has discovered internally, and put through all the required tests to enter clinical trials. The first product has been designed to have broad capability to neutralize a wide variety of flu strains. While flu is a pretty obvious health concern, especially among elderly people with weakened immune systems, CMV isn’t a household name. Theraclone said today it is going after CMV partly because it can cause hearing loss and other neurological disorders in children when it strikes pregnant women. The infection can also be life-threatening when it hits people with weakened immune systems, such as people undergoing organ transplants, or those with HIV.
“Broadly protective antibodies are important, as viruses like CMV are prone to mutations and, therefore, drug resistance,” Theraclone CEO Cliff Stocks said in a statement. The new drug candidate, he said, is aimed at what the company believes is a “universal target within CMV variations.”
While the CMV drug moves through this initial study, the flu antibody is on track to move into a more rigorous mid-stage clinical trial later this year that will give Theraclone the first data that could demonstrate the drug works. The company pulled in $10.6 million in venture financing last September to help move its R&D programs forward.
