Although there are key players in markets like the U.S., Australia, and the EU, Japan continues to accelerates its position as a hub for induced pluripotent stem cell (iPS cell) therapy with generous funding, acquisitions, and strategic partnerships.
FUJIFILM Cellular Dynamics licenses University of California – Irvine’s technologies for derivation of microglia
MADISON, Wis., June 6, 2018 — FUJIFILM Cellular Dynamics, Inc. (FCDI), a leading developer and manufacturer of human induced pluripotent stem cells (iPSCs) and differentiated tissue-specific iPSCs, announced today that it has entered into an exclusive patent license agreement with the University of California – Irvine (UCI) through its offices at UCI Applied Innovation to license and commercialize UCI’s technologies for derivation of microglia in the commercial research field and also a non-exclusive patent license agreement to commercialize microglia media formulation. [Read more…]
Mesoblast Partners With Cartherics to Develop ’off-the-shelf’ Cell-based Immunotherapies for Solid Cancers
Relapsed Ovarian and Gastric Cancers Initial Targets for Allogeneic CAR-T Cells
NEW YORK and MELBOURNE, Australia, May 29, 2018 — Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) today announced that it has entered into a partnership with Cartherics Pty Ltd to develop allogeneic ‘off-the-shelf’ CAR-T cells armed with multiple targeting receptors for use in solid cancers. Off the shelf CAR-T therapies have the potential to reduce costs dramatically and open up this very effective treatment to millions of cancer patients across the world. The initial targets are relapsed ovarian and gastric cancers. Mesoblast and Cartherics will jointly own the intellectual property produced using their combined technologies. [Read more…]
On 16 May, Nature News reported that “Japan’s health ministry gave doctors at Osaka University permission to take sheets of tissue derived from iPS cells and graft them onto diseased human hearts.” The team of Japanese doctors, led by cardiac surgeon Yoshiki Sawa at Osaka University, will use iPS cells to “create a sheet of 100 million heart-muscle cells.”
From preclinical studies in pigs, the team determined that thin sheets of cell grafts can improve heart function, likely through paracrine signalling. Paracrine signalling is a type of cell-to-cell communication through which cells “talk” to one another, often regulating inflammation, fibrosis (scarring), and and cellular recovery.
While the treatment will only be tested in three patients, a follow-up trial could enroll ten or more patients. Under Japan’s accelerated regulatory pathway for regenerative medicines (cell, gene and tissue products), Dr. Sawa’s iPS cell therapy could be conditionally marketed to the public if a follow-up trial demonstrated safety and an initial proof of efficacy.
Launched in late 2014, Japan’s fast-track system allows for regenerative therapies to receive conditional marketing authorization for up to 7 years, following confirmation of safety and an initial proof of efficacy in Japan in diseases that are serious and have a high unmet need. [Read more…]
Kyoto University has announced that it will start providing human embryonic stem cells (ES cells) by July 2018 to universities and companies within Japan for clinical trial applications. This is a world-first, as most countries have been hesitant to support wide-spread production and distribution of this controversial cell type.
Previously Japan limited the use of human embryonic stem cells to basic research, because the cells are produced from human embryos, making them a highly controversial cell type. In 2014, the Japanese government revised it guidelines, making possible the use human ES cells in clinical studies, as well as laboratory research. [Read more…]