Medigene AG

bluebird bio and Medigene establish strategic T cell receptor (TCR) alliance in cancer immunotherapy - Seite 2

"Our first commercial agreement based on Medigene's TCR technology is testimony to our rapid progress as an immuno-oncology company," added Dave Lemus, Chief Operating Officer, Medigene. "Furthermore, the agreement provides Medigene with significant additional financial resources for both the short term and potentially the long term as we participate in the value creation of the cell therapeutics that we jointly create."

Under the terms of the agreement, Medigene will be responsible for the generation and delivery of the TCRs using its TCR isolation and characterization platform. Following the collaborative preclinical development, bluebird bio will assume sole responsibility for the clinical development and commercialization of the TCR product candidates and will receive an exclusive license for the intellectual property covering the resulting TCRs.

Medigene will receive an upfront payment of USD 15 million as well as potential preclinical, clinical, regulatory and commercial milestone payments, which together could total over USD 1 billion in the aggregate for the four potential TCR products across several indications. Additionally, Medigene will receive R&D funding for all work performed in the collaboration and is eligible for tiered royalty payments on net sales up to a double-digit percentage.

Contractual parties to the agreement are Medigene Immunotherapies GmbH, a wholly owned affiliate of Medigene AG, and bluebird bio, Inc.

Press and analysts' conference call: Medigene will hold a press and analysts conference call (in English) today at 3:00 pm CEST / 9:00 am EDT and will webcast the call live via Medigene's website, www.medigene.com.

About Medigene's TCR technology: The TCR technology aims at arming the patient's own T cells with tumor-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient's tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient's T cells outside the body (ex-vivo).

TCR therapy is developed to detect a greater number of potential tumor antigens than other T cell-based immunotherapies, such as chimeric antigen receptor T cell (CAR T) therapy. Medigene is preparing the clinical development of its first TCR candidates and is establishing a library of recombinant T cell receptors, and has established Good Manufacturing Practice (GMP)-compliant processes for their combination with patient-derived T cells. The start of a clinical Phase I TCR investigator-initiated trial (IIT) with Medigene participation is expected in 2017. Medigene plans to commence its own first clinical TCR trial in 2017 and a second trial in 2018.