WALTHAM, Massachusetts and Tsukuba, Ibaraki, Japan, August 27, 2015
Minerva Biotechnologies and ID Pharma Co., Ltd. (formerly DNAVEC) announced today that they have signed an agreement granting Minerva worldwide rights to use and commercialize their non-integrating Sendai virus vectors, together with Minerva’s proprietary technology, for generating Induced PluripotentStem (iPS) cells. Sendai virus enables delivery of genes into a host cell without permanently altering the cell’s chromosome, which is critical for stem cell therapies. Professor Shinya Yamanaka, MD, Ph.D., won the Nobel Prize for Medicine in 2012 for his discovery that four genes can reprogram an adult’s cell to go back in time to become that person’s own stem cell. Minerva Biotechnologies discovered a naturally occurring, primitive growth factor that continues this reprogramming to an even earlier, embryonic-like point called the ‘naïve’ state.
Scientists believe that because these earlier, naïve stem cells have a clean slate, they are more easily directed to develop into functional mature cells, which could be used for transplant. Naïve stem cells have several advantages over currently available stem cells (known as ‘primed’ state). These advantages are important for the future of stem cell therapies. Naïve stem cells do not yet have DNA methylation marks that commit the cells to certain developmental decisions. Additionally, naïve stem cells have a much higher cloning efficiency than primed state cells, which is critical for the realization of stem cell based gene therapies. Importantly, only naïve stem cells can contribute to the generation of chimeric animals. A futuristic stem cell therapy, which may not be that far off, is the generation of human-non-human chimeras that would express some human tissues or even entire human organs, for transplant.
Minerva’s proprietary primitive stem cell growth factor dramatically increases the efficiency of making human iPS cells, which greatly reduces the time and the cost of making iPS cells for research or for personalized stem cell banking. A problem that currently plagues the stem cell field is that although protocols have been devised that direct stem cells to mature into specific cell types, not every iPS cell line can mature into any cell type. As a consequence, researchers have to test many stem cell clones to determine which ones can form heart cells, which ones can form liver cells, etc. This problem is called ‘clonal restriction’ and would make personalized stem cell therapy impractical. In contrast, human iPS cells generated with Minerva’s technology are not clonally restricted; each of our human iPS cell clones has been demonstrated to have the ability to mature into heart cells, liver cells or neural cells. Minerva’s naïve state human iPS cells, or mature cells generated from, can be rapidly and inexpensively generated for use in basic research, drug toxicity testing or for personalized stem cell banking.
The agreement with ID Pharma Co., Ltd. allows Minerva to generate and sell naïve state human iPS cells as well as mature cells derived from them for research, drug toxicity testing and for personalized stem cell banking. Minerva Biotechnologies is the first company to generate human naïve state iPS cells using a single, naturally occurring human stem cell growth factor. Previous attempts to grow human stem cells in the elusive naïve state, which used cocktails of biochemical inhibitors and mouse growth factors, were prone to develop abnormal karyotype. Naïve stem cells generated with Minerva’s primitive growth factor have normal and stable karyotype. The generation of iPS cells from adult skin or blood cells does not involve the use of embryos and so does not invoke ethical issues.
“The agreement with ID Pharma Co., Ltd. provides Minerva with a powerful combination of technologies that will advance the study of basic science as well as accelerate the timeline to clinical applications of regenerative medicine,” said Dr. Cynthia Bamdad, CEO Minerva Biotechnologies. “We are very excited about our relationship with ID Pharma Co., Ltd. that allows us to disseminate our technology to others.”
“We have developed cell reprogramming kit based on our SeV vector technology as CytoTune®-iPS which could generate chromosomal damage free iPS cells easily with high efficiency. Now, the kit is well accepted in the field of stem cell research.” said Mr. Toyotaka Mori, Chairman of the board of ID Pharma Co., Ltd. “With the Minerva’s technology, we hope the iPS cells using CytoTune®-iPS technology will accelerate the development of regenerative medicine for unmet medical needs. That is very exciting.”
About Minerva Biotechnologies
Minerva Biotechnologies is a pioneer in the field of stem cells and cancer stem cells. Minerva was first to discover that cancer cells hijack an otherwise normal stem cell growth mechanism, involving a growth factor receptor called MUC1* (pronounced muk 1 star). By studying human stem cells in parallel with human cancer cells, Minerva scientists figured out how cancer cells override the normal ‘shut off’ switch that stops stem cells from self-replicating indefinitely. The Company is developing a panel of anti-cancer drugs that target a cancer-specific MUC1* growth factor receptor and a testis specific cancer antigen that promotes metastasis.
As of this date, Minerva will market its naïve state stem cells and its naïve-inducing stem cell growth factor and reagents. For more information, visit www.minervabio.com
About ID Pharma Co., Ltd.
ID Pharma Co., Ltd. successfully developed an innovative vector system, which is expected to be an indispensable device for gene-and cell-therapy and gene vaccines. Sendai virus vector is one such vector. Functioning as RNA, not DNA, this vector has the benefit of not damaging the cell’s chromosome. The company has developed a system to efficiently deliver pluripotency genes involved in reprogramming adult cells to become induced pluripotent stem (iPS) cells. ID Pharma markets an iPS kit, “CytoTune-iPS,” globally. As Japan’s first viral vector for gene therapy, the Sendai virus vector also has great potential for application in cell engineering, cell therapy and regenerative medicine. For more information, visit www.DNAVEC.co.jp.