Ono Pharmaceutical has agreed to develop and commercialize Celyad’s allogeneic NKR-2 T-cell cancer immunotherapy in Japan, South Korea, and Taiwan under a collaboration that could generate up to $299.5 million for Celyad.

Celyad said today it grated an exclusive license to Ono that will expand the global footprint of its NKR-2 T-cell immunotherapy—designed to target a wide range of solid and hematological tumors—and potentially enable its development for other diseases.

NKR-2 is the lead candidate developed through Celyad’s Natural Killer Receptor (NKR)-based T-Cell platform, designed to target a wide range of solid and hematological tumors. NKR-2 is a T-cell engineered to express the human NK receptor NKG2D, an activating receptor designed to trigger cell killing through the binding of NKG2D to any of eight ligands known to be overexpressed on more than 80% of tumors.

Unlike traditional chimeric antigen receptor (CAR) T-cell therapy, which targets only one tumor antigen, NK cell receptors enable a single receptor to recognize multiple tumor antigens.

NKR-2 is now the subject of a Phase I trial in acute myeloid leukemia and multiple myeloma patients. The trial is designed to assess the safety and feasibility of NKR-2, with secondary endpoints including clinical activity.

Celyad says preclinical results indicate that NKR-2 has multiple mechanisms of action and goes beyond direct killing by signifying that its encoded T cells attack the tumor cells, inhibit the mechanisms that enable tumors to evade the immune system, activate and recruit antitumor immune cells, and disrupt the blood supply to the tumor. The preclinical research was originally conducted at Dartmouth College by Charles L. Sentman, Ph.D., and has been published extensively in peer-reviewed publications.

Under their licensing agreement, Celyad will continue developing its NKR-2 T-cell immunotherapy in the U.S. and the E.U., while both companies agreed to explore collaborating to run global registration trials and combination trials.

Celyad also granted to Ono an exclusive option to license the development and commercialization of its autologous NKR-2 T-cell product in Japan, South Korea, and Taiwan.

In return, Ono agreed to pay Celyad $12.5 million upfront, and could receive up to $299 million in payments tied to achieving development and commercial milestones. Ono also agreed to pay Celyad double-digit royalties based on net sales of NKR-2 T-cell immunotherapy in the three Asian countries covered by the deal.

“This license agreement is a great opportunity for Celyad to expand the scope of its immuno-oncology clinical programs and bring this breakthrough science to numerous patients around the world,” Celyad CEO Christian Homsy, M.D., M.B.A., said in a statement.

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