Stellar Biotechnologies, Inc. and Neovacs S.A. have announced their entry into a joint venture agreement to manufacture and sell conjugated therapeutic vaccines (the "Joint Venture") using Stellar's proprietary Keyhole Limpet Hemocyanin (KLH). The purpose of the Joint Venture is to produce Neovacs' Kinoid immunotherapy product candidates, including IFNa-Kinoid, as well as potentially manufacture and sell other KLH-based immunotherapy vaccine products to third party customers worldwide.
Neovacs is a leader in the development of active immunotherapies for autoimmune and inflammatory diseases. Neovacs' patented Kinoid technology combines a targeted cytokine attached to a carrier protein as the immune-stimulating molecule. Neovacs' lead product candidate is IFNa-Kinoid a conjugated vaccine based on IFNa and KLH from Stellar. IFNa-Kinoid is in a multicenter Phase IIb clinical trial in Europe, Asia and Latin America for the treatment of moderate to severe systemic lupus erythematosus (lupus).
Neovacs recently received FDA permission to extend the Phase IIb clinical trial of IFNa-Kinoid to the United States. The IFNa-Kinoid development program was recently expanded to include Dermatomyositis, an orphan indication in which IFNa plays an important role. In January 2016, Neovacs secured public financing of EUR 5 million from The General Commission for Investment operated by Bpifrance. Nevoacs plans to use these funds to establish the manufacturing facility that will produce Neovacs' immunotherapy vaccines, including IFNα-Kinoid.
Under the terms of the Joint Venture agreement, Stellar and Neovacs will form a company in France (the "Joint Venture Company") to carry out the business of the partnership including, but not limited to, operational activities, staffing, and the negotiation of agreements related to supply and services for the Joint Venture. The formation of the Joint Venture Company is expected to close on or before June 30, 2016. The Joint Venture Company will be owned initially 70% by Neovacs, with Stellar holding the remaining 30% interest.
The Joint Venture will be governed by a three-member board of directors, two of whom will be appointed by Neovacs and one appointed by Stellar. Stellar will have certain minority shareholder rights requiring, among other things, unanimity for approval of by the board and/or shareholders of certain key decisions. The Joint Venture has an initial ten-year term, renewable for successive five-year terms.
Miguel Sieler, Chief Executive Officer of Neovacs said, "This joint venture with Stellar Biotechnologies is an important alliance because it further strengthens Neovacs' industrial plan. Neovacs has secured funding to move forward on the manufacturing facility and now this joint venture provides access to scalable capacity of KLH which is a key component of our Kinoid technology. These steps will support the manufacturing infrastructure as we progress through clinical trials and to potential market launch of our KLH-Kinoid immunotherapy vaccines."
"This partnership is both a natural extension of Stellar's strong relationship with Neovacs and, we believe, a unique opportunity for Stellar. It will position Stellar to benefit from the anticipated manufacturing and sale of finished immunotherapy products and to advance the market for our KLH protein products," stated Frank Oakes, President, CEO and Chairman of Stellar Biotechnologies, Inc. "Through this joint venture, Stellar and Neovacs can work together to ensure the success of Neovacs products like IFNα-Kinoid for lupus while we lay the groundwork to offer similar support to other companies developing KLH-based immunotherapies."