Celyad ($CYAD) has struck a JPY 31 billion ($306 million) deal with Ono Pharmaceutical for the rights to its allogeneic NKR-2 T-cell immunotherapy in Japan, Korea and Taiwan. The deal gives Celyad an upfront cash boost and a source of ongoing income at a time when it is trying to recover from the late-phase failure of its heart failure cell therapy.
Mont-Saint-Guibert, Belgium-based Celyad has pocketed $12 million of the deal fee upfront, with the rest set to follow if the NKR-2 T-cell immunotherapy hits certain clinical and commercial milestones. In return, Ono is gaining the right to develop the drug in its home country of Japan and the neighboring nations of Korea and Taiwan. Celyad will continue developing the asset for the U.S. and European markets, and is open to collaborating with Ono on global registration and combination trials. Ono has regional rights to Bristol-Myers Squibb's ($BMY) Opdivo.
Such studies are still a fairly distant prospect. Celyad is currently trialling an autologous version of the immunotherapy--to which Ono has an exclusive option--in patients with acute myeloid leukemia or multiple myeloma in a Phase I/IIa study. Last month, the trial dosed the first patient in the fourth dose level cohort. At that time, Celyad had given the drug to nine patients without detecting adverse events, an outcome that had encouraged it to move up through the planned dose ranges.
The safety of the drug has taken on particular significance following the deaths in Juno Therapeutics’ ($JUNO) clinical trial. Juno linked the deaths to the use of the chemotherapy fludarabine to wipe out diseased B cells prior to the administration of its therapy. Celyad CEO Christian Homsy used a call with investors to discuss the Ono deal as an opportunity to differentiate his company’s approach from that pursued by Juno.
“In contrast to traditional CAR-T therapeutic approaches, and based on strong preclinical evidence, Celyad’s current NKR-2 program does not, and I repeat, it does not, employ patient lymphodepletion preconditioning, thereby avoiding any toxicity associated with chemotherapy and allowing the immune system to remain intact,” Homsy said. Data from the Phase I/II dose-escalation study are due around the end of the year.
While safety is the primary focus of the trial, Celyad has also designed it to look for signs of efficacy. The ability of the drug to deliver such data is becoming more and more important to Celyad. On one level, the deal with Ono means Celyad is set to benefit financially as the program advances. Equally, with the prospects of Celyad’s lead candidate C-Cure being thrown into doubt by its failure to meet the primary endpoint in a Phase III trial, the cancer asset is taking on greater significance.
Celyad bought its way into oncology in 2015 through the acquisition of OnCyte. The deal gave Celyad access to technology it thinks can improve on traditional CAR-T therapies, specifically because it supports the recognition of multiple tumor antigens. The lead candidate to emerge from the platform is a T cell engineered to express NKG2D, a natural killer cell receptor. Celyad expects that the drug will induce cell killing when NKG2D binds to ligands commonly overexpressed in cancer.
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