Stellar Biotech and Neovacs Form JV

Stellar Biotechnologies and Neovacs S.A. have entered a joint venture agreement to manufacture and sell conjugated therapeutic vaccines using Stellar’s 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 involved in the development of active immunotherapies for autoimmune and inflammatory diseases. Neovacs’ Kinoid technology combines a targeted cytokine attached to a carrier protein as the immune-stimulating molecule. The companies 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 U.S. 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 €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 its immunotherapy vaccines, including IFNα-Kinoid.

Stellar and Neovacs will form a company in France 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 new company will be owned initially 70% by Neovacs, with Stellar holding the remaining 30% interest. It will be governed by a three-member board of directors, two of whom will be appointed by Neovacs and one appointed by Stellar.

“This joint venture with Stellar Biotechnologies is an important alliance because it further strengthens Neovacs’ industrial plan,” said Miguel Sieler, chief executive officer, Neovacs. “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,” said Frank Oakes, president, chief executive officer and chairman, Stellar Biotechnologies. “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.”