Apitope has raised €12 million ($13 million) to advance its lead candidates into the clinic. The Merck Serono-partnered autoimmune specialist will funnel the cash into the advance of in-house peptides for the treatment of Factor VIII intolerance in hemophilia A patients and Graves' disease.
|Sir Chris Evans|
Preclinical work on the programs began last year and Apitope is planning to move both drugs into Phase I within the next four months. Sir Chris Evans' Wales Life Sciences Fund has come on board to bankroll the programs, leading a Series B round that also attracted cash from existing investors Vesalius Biocapital, LRM, PMV and Wyvern. The investors were attracted by the potential of Apitope's plan to treat autoimmune diseases, which is based around the idea of manipulating interleukin 10 (IL-10) secreting regulatory T cells to address the source of the aberrant pathology.
"We're trying to switch off antibodies," Apitope CEO Keith Martin told FierceBiotech. "The way we do that is to prevent the T cells from driving that response through B cells. This is a very, very specific approach so we only affect the part of the immune system that's gone wrong." The Merck Serono-partnered multiple sclerosis program is validating the specificity of the approach. "We have a very good side effect profile. We haven't seen any treatment-related SAEs to date, nor have we seen very many adverse events. [It] has the potential to be very clean."
Apitope now wants to find out if its therapeutic concept works in Factor VIII intolerance and Graves' disease. ATX-F8-117, the Factor VIII intolerance treatment, was the first of Apitope's in-house drugs to enter preclinical development. The drug is designed to stop the immune systems of people with hemophilia A from rejecting Factor VIII treatments, something that happens to a significant minority of patients. Regulators on both sides of the Atlantic have awarded the drug orphan status. "It's a very serious problem for hemophilia A patients," Martin said.
The Graves' disease program entered preclinical shortly after ATX-F8-117 and is receiving funding from the European Commission's Framework Programme 7. Having closed the Series B round, Apitope has enough cash to complete first-in-man studies of both drugs, something Martin expects to happen early in 2017. The trials will primarily look at safety, but Apitope is including secondary endpoints to look for signs of efficacy. "Both of these indications … have good hard clinical endpoints that you can use quite effectively to get early signs of efficacy in your clinical trials," Martin said.
Apitope has worked on its projects from locations in Bristol, United Kingdom and Diepenbeek, Belgium. Now, with Wales Life Sciences Fund coming on board as an investor, Apitope is to move its U.K. headquarters to Wales. The exact location is yet to be decided but Apitope is looking for a site between Bristol and Cardiff, cities that sit either side of the England-Wales border. Apitope is to retain a lab operation in Bristol, the city in which the firm began life as a university spinout in 2002. Current CSO and University of Bristol researcher Professor David Wraith founded the company.
Prior to the fundraising round, Apitope was best known for striking a €154 million multiple sclerosis deal Merck Serono in 2009. Apitope advanced the lead candidate in the collaboration as far as Phase II before handing over to Merck Serono for further trials. Merck Serono wrapped up enrollment in a Phase IIa trial of the drug, ATX-MS-1467, in people with relapsing MS in August and is set to post data next year.
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