Autoimmune breakthrough evades resistance issue

April 8, 2010 – 3:36 pm by Colette Pilkus

Although commercially successful, Remicade, Humira, and Enbrel have many limitations due to allergies or infections. Their high immunogenicity, their loss of effectiveness over time, and their expense (typically costing $15,000 to $20,000 per patient per year) make these monoclonal antibodies less than ideal treatments. French biotechnology company, Neovacs SA is hoping to address these challenges with an immunotherapy platform that uses the body’s own immune system to produce polyclonal antibodies to suppress disease-causing cytokine over-production. The company’s Kinoid therapy may provide a more convenient dosing regimen than traditional TNF inhibitors, with only three to four injections per year, at a potentially lower cost.

“The antibodies generated by the administration of the Kinoids are fully human in the sense that they are produced by the patient’s body, so there will be no resistance to them,� says Guy-Charles Fanneau de La Horie, CEO, Neovacs. “The treatments with the Kinoids is going to be a small dose of 200 micrograms to 300 micrograms per injection and will be three to four injections over a year, which will translate into a huge advantage in terms of cost of treatment, which may mean that the treatment could be much less expensive and much more available to much more patients.�

The company’s lead program, TNFα-K, is in a Phase I/II clinical trial in Crohn’s disease and a Phase II trial in rheumatoid arthritis patients. In Phase I/II trial for Crohn’s disease patients, Neovacs found the drug worked safely with patients’ immune systems to produce antibodies targeting the over-expressed cytokine. No cytokine suppression adverse events or other safety issues have been seen. Preliminary clinical results of this open label trial found the drug showed double the remission rate of Remicade and Humira.

The Phase II rheumatoid arthritis trial in Europe targets a subset of rheumatoid arthritis patients resistant to monoclonal antibodies. The study will be ongoing to late 2011 when Neovacs plans on launching a Phase IIb/III study. Neovacs plans to file an investigational new drug filing in 2010 with potential approval by 2014.

Neovacs is also developing an INFα Kinoid to treat lupus. The company recently initiated a Phase I/II trial in Europe. Company executives expect trial results by late 2011, with a Phase IIb trial following the results. Executives will also file for a conditional approval and or a fast track registration by 2013 or 2014.

“In rheumatoid arthritis, within two years between 40% to 60% will have failed their first TNF alpha inhibitor,� says Piers Whitehead, VP, corporate development, Neovacs. “The average age of diagnosis for rheumatoid arthritis is 40 years old, so a two-year drug doesn’t take you very far, if you’re diagnosed at [that age] because you have many more years of needing drugs to help you control your disease than just two. These antibody drugs work very well until they stop working, and so there’s a very material resistance issue that needs to be addressed.�

The market potential for these drugs may be $16 billion for the TNFα-K and between $3 billion and $5 billion for each of the other Kinoids.

Neovacs Kinoid technology is being developed to treat severe autoimmune diseases such are rheumatoid arthritis and lupus. Kinoids are active immunotherapies that, when delivered by intramuscular injection three to four times a year, stimulate the patient’s own immune system to address the underlying cause of the disease.

KLH = Keyhole Lympet Hemocyanin (Carrier protein)

Tags: Crohn’s disease, Kinoid, lupus, Neovacs, rheumatoid arthritis, TNF inhibitor