Source: isak55/Shutterstock
Source: isak55/Shutterstock

Medigene has agreed to expand its nearly two-year-old, up-to-$1 billion-plus cancer immunotherapy collaboration with bluebird bio, saying today that the expansion could generate up to $509 million-plus more for Medigene, nearly all of that tied to developing two more T-cell receptor–modified T-cell (TCR-T) cancer immunotherapies.

The companies have agreed to expand from four to six the number of target antigen/major histocompatibility complex (MHC) restriction combinations for the discovery of specific TCR lead candidates by Medigene. The two new targets are undisclosed, as are the four initial targets.

In return, Celgene has agreed to pay Medigene a one-time payment of $8 million, up to $250 million in milestone payments for each of the two new TCR programs, and tiered royalty payments on net sales up to a double-digit percentage if the TCR programs are successfully developed and marketed through several indications and markets.

Additionally, Medigene said, it anticipates receiving from Celgene $1 million more in association with the first collaboration project under the agreement, as well as an increase in R&D funding.

The collaboration—valued at more than $1 billion when it was launched in September 2016 —is designed to combine Medigene’s TCR isolation and characterization platform with bluebird bio’s lentiviral vector, genome-editing, synthetic biology, and manufacturing capabilities.

Medigene’s TCR platform is designed to modify a patient's own T cells with tumor-specific TCRs, creating cells that can detect and efficiently kill tumor cells—and overcome tumor-induced immunosuppression—by activating the patient's T cells ex vivo, genetically modifying them with tumor-specific TCRs and then multiplying them.

Reducing “Cash Burn”

Medigene has agreed to oversee the discovery of TCRs for each target antigen selected by bluebird bio using its TCR technology platform.

Following the collaborative nonclinical development, bluebird bio agrees to assume sole responsibility for preclinical and clinical development and commercialization of the TCR-T product candidates—in return for receiving an exclusive license for the intellectual property covering the selected TCRs.

As a result of the expansion of its collaboration with Celgene, Medigene has issued revised “cash burn” guidance to investors that reduces its cash usage forecast to between €16 million and €19 million ($19.2 million and $22.8 million), down from the company’s initial projected range of €21 million to €25 million ($25.2 million to about $30 million).

Revenue, R&D expense, and EBITDA guidance for 2018 will not change “substantially” as a result of this expansion of the agreement, Medigene said—adding that it will provide full financial guidance in its upcoming report of financial results for the first six months of this year, set to be released on August 7.

Separately from bluebird bio, Medigene is applying its TCR platform to develop a proprietary pipeline of recombinant TCRs. In March, Medigene launched a company-sponsored Phase I/II trial with its proprietary TCR-T therapy MDG1011 in high-risk myeloid and lymphoid neoplasms (NCT03503968).

MDG1011 consists of patient-derived autologous T cells, persistently transduced with a preferentially expressed antigen in melanoma (PRAME)-specific human leukocyte antigen (HLA)-A*02:01-restricted TCR.

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