Medigene and Bluebird Bio Expand Cancer Collaboration to $1.5 Billion

MediGene, based in Martinsfried and Munich, Germany, and bluebird bio, headquartered in Cambridge, Massachusetts, announced they are expanding a strategic research and development collaboration inked in September 2016.

Under the terms of the original deal, Medigene was responsible for creating and delivering T cell receptors (TCR) using its TCR isolation and characterization platform. After the collaborative preclinical development, bluebird handled the clinical development and commercialization of the TCR product candidates. Bluebird also received an exclusive license for the intellectual property that came out of the TCRs.

Medigene received an upfront payment of $15 million (U.S.), as well as possible preclinical, clinical, regulatory and commercial milestone payments. Together they had the potential to reach $1 billion for the four TCR products, or about $250 million for each TCR.

Under the new expansion, they have added two additional TCR candidates under the same terms, bringing the possible deal total up to $1.5 billion, in addition to royalties on sales if anything makes it to market. Bluebird is also paying Medigene $8 million upfront and additional research-and-development funding to cover the new programs.

Analysts at Baader Helvea confirmed their “buy” recommendation for Medigene, indicating the collaboration extension validated Medigene’s tech platform.

In February, Medigene announced that its first Phase I/II clinical trial of its TCR-modified T-cell therapy MDG1011 had been approved by German regulatory authorities. Its contract manufacturer had also received the necessary manufacturing license to create the study materials. This program is independent of the bluebird bio collaboration.

MDG1011 targets the tumor antigen PRAME (PReferentially expressed Antigen in MElanoma). In the trial, it will be tested in about 92 patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM).

“Attaining these approvals for MDG1011 is an important step towards the start of our clinical trial, and a further validation of our research and product development work,” said Kai Pinkernell, senior vice president clinical affairs and chief medical officer of Medigene, in a statement. “With our specific study design, we are able to evaluate our T-cell therapy simultaneously in various diseases and to generate data in three hematological indications in parallel.”

Under the new terms, Medigene is anticipating a milestone payment of $1 million based on the first project from the collaboration.

“We are delighted to broaden this outstanding collaboration for the joint research and discovery of TCR lead candidates designed for the treatment of multiple cancer indications,” said Dolores Schendel, Medigene’s chief executive officer and chief scientific officer, in a statement. “Medigene is contributing its unique TCR technology platform, which encompasses multiple innovative screening and assessment tools to identify and characterize specific, non-modified TCRs to selected target antigens in a highly competitive framework. The expansion of this alliance further validates the efficiency and quality of Medigene’s TCR platform technology.”

Medigene also updated their financials as a result of the deal, indicating that it “improves the Company’s cash burn guidance for 2018 and now anticipates a cash usage of EUR 16-19 million instead of EUR 21-25 million for the full year. Revenue, R&D expense and EBITDA guidance for 2018 will not change substantially as a result of this expansion of the agreement. Full financial guidance will be provided in Medigene’s six-months report 2018.”