Cell Therapy has granted the Japan license for its innovative cardiac regeneration medicine, Heartcel (immuno-modulatory progenitor (iMP) cells) to Daiichi Sankyo.
Daiichi Sankyo will undertake all development, regulatory and commercial activities for iMP cells in the territory of Japan, while CTL retains its worldwide rights outside of Japan as well as global manufacturing responsibilities. Under the terms of the agreement, CTL will receive a £12.5 million upfront licensing fee and additional milestone payments and royalties.
“The accelerated regulatory pathway for regenerative medicines in Japan enables faster patient access, making it a natural priority for us,” says Ajan Reginald, chief executive officer, CTL. “This allows CTL to focus on US and European phase 3 trials, and accelerating the development of our pre-clinical pipeline.”
“CTL’s in-house technology focuses on the discovery of novel tissue-specific cellular medicines,” comments Martin Evans, Nobel laureate and CTL’s chief scientific officer.
Immuno-modulatory progenitor cells are an advanced therapeutic medicinal product (ATMP) and investigational allogeneic regenerative medicine. They were injected into cardiac scar during bypass surgery in a phase 2 clinical trial of 11 severe heart failure patients at high risk of incomplete re-vascularisation (ICR). At 12 months following treatment, results demonstrated the following change from baseline: a 30% improvement in heart function (left ventricular ejection fraction), a 40% decrease in cardiac scar area and significant improvement in quality of life (characterised by a 50% increase in ‘Minnesota Living with Heart Failure’ score). At 36 months following treatment, all patients remained alive.