Bluebird bio selects Medigene for TCR development

Martinsried-based immunoncology drug developer Medigene AG has added a service module to its business: using the company’s high throughput approach for T cell receptor (TCR) selection. Its very first customer, Boston-based gene therapy specialist bluebird bio is willing to pay up to US$1bn in milestones for bringing T cell cancer therapies with chimeric antigene receptors (CARs) developed by Medigene to the market. Bluebird bio, which currently develops CAR-T leukemia and lymphoma therapies directed against CD19, CD30, and BCMA surface antigens, paid US$15m upfront for the  generation and delivery of TCRs directed against four undisclosed targets and appropriate exclusive IP rights. Both partners will carry out preclinical testing, bluebird will be responsible for clinical development and commercialisation of the cell therapies. 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.

Medigene’s TCR platform works by mixing dendritic cells, which present a selected tumour antigen on a HLA peptide, with T cells that have not developed immune tolerance against that HLA peptide. Consequently, the T cells recognise the antigen and form a TCR pool with diverse affinities and crossreactivities from which the optimal “natural” TCR can be selected for cancer immune therapy.

Up to now, Medigene was a pure play drug development company that established a dendritic cell vaccine to fight mimimal residual disease. But last year, its CEO Dolores Schendel uncovered plans to make the company’s proprietary technology available for pharma and biotech partners.

"With its T cell immunotherapy expertise and outstanding gene delivery and genome editing capabilities, bluebird bio is an ideal partner for us to jointly discover and develop a new generation of T cell therapeutics to treat unmet oncology indications", she said. "Our first commercial agreement based on Medigene’s TCR technology is testimony to our rapid progress as an immuno-oncology company," added Dave Lemus, COO at Medigene.

Current clinical CAR-T therapies are directed against blood cancers. All approaches to target the ten-fold larger market for solid tumours have failed so far. CAR-T cell therapies, which require TCRs with high binding affinity to cancer targets, are a risky business, according to a brand new study of EP Vantages expert Daniel Plieth, as manufacturing of autologous CAR-Ts in hospital-associated facilities is prohibitively expensive, not very reproducible and slow. All competitors and drugs under development including bluebird bio’s programme are subject of the current market analysis.