Four years ago, Takeda Pharmaceutical Company and The Center for iPS Cell Research and Application (CiRA) at Kyoto University established a 10-year joint research program. Today, the organizations made an announcement.
Four years ago, Takeda Pharmaceutical Company and The Center for iPS Cell Research and Application (CiRA) at Kyoto University established a 10-year joint research program. Today, the two organizations announced that Kyoto University was transferring the first novel induced pluripotent stem (iPS) cell-derived chimeric antigen receptor (CAR-T) therapy to Takeda.
Under the terms of the deal, Takeda has global rights to develop and commercialize the iCART product and CiRA will receive various milestone payments. They will continue to collaborate as the iCART program moves toward the clinic in 2021.
CAR-T therapy is an immunotherapy that takes a patient’s T-cells, which are then genetically modified in the laboratory to focus more intensely on the patient’s specific cancer cells and are then reinfused into the patient. The first-generation autologous CAR-T products are very individualized, which is both slow and expensive.
The CiPS/Takeda product, which was developed by CiRA’s Shin Kaneko, uses a clonal master iPS cell bank to create an off-the-shelf CAR-T therapy that can then be modified to adapt to the individual patient. One of the hopes is that this can be both less expensive and less time-consuming, as it is very scalable.
“The iCART program demonstrated the value of our T-CiRA collaboration—applying iPSC technology to develop new approaches to drug discovery and creating a bridge to transfer promising programs to Takeda to accelerate them toward clinical development and therapeutic use,” stated Shinya Yamanaka, director of CiRA and T-CiRA.
T-CiRA was founded in 2015 and run by Yamanaka, who won the Nobel Prize in 2012 for his iPSC research. Takeda provided 20 billion yen in collaborative funding and jointly ran multiple projects led by invited researchers from CiRA and other institutions. T-CiRA’s research focus is broader than CAR-T and immuno-oncology, evaluating iPS cells in heart failure, diabetes, neuro-psychiatric diseases, and muscle diseases at Takeda’s Shonan Health Innovation Park.
“Today, we celebrate with Dr. Yamanaka, Dr. Kaneko, and our CiRA colleagues as the first T-CiRA cell therapy program is transferred to Takeda for clinical development,” stated Andy Plump, Takeda’s president of Research and Development. “The iCART program demonstrates our commitment to bringing transformational, next-generation CAR-T therapies to patients by applying our translational cell therapy engine. Of Takeda’s 12 CAR-T programs in development, iCART is one of five with planned first-in-human studies by 2021.”
Today, Takeda also launched its Enzyme Replacement Therapy portfolio for Lysosomal Storage Disorders (LSD) in India. As part of this launch, Takeda will market in India Idursulfase for Hunter Syndrome, Velaglucerase Alpha for Gaucher Disease and Agalsidase Alfa for Fabry Disease.
“At Takeda, we are committed to patient care by developing innovative new medicines and making existing medicines more readily available,” stated Vineet Singhal, Country Head, Takeda India. “Takeda is working towards shortening the time to diagnosis for rare diseases, with the aim to help healthcare practitioners support patients along the entire journey to enable them to better manage their care. Takeda in India has also been the pioneer in the management of hemophilia which has transformed the lives of thousands of patients.”
