Nohla Therapeutics has signed an exclusive supply agreement with LifeSouth Community Blood Centers headquartered in Gainesville, Florida. Under this agreement, LifeSouth’s cord blood banking program will supply Nohla Therapeutics with clinical grade cord blood units that will be used in the production process for the Company’s expanded hematopoietic stem and progenitor cell (HSC/HPC) products. [Read more…]
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Cynata Approved to Launch World’s 1st Clinical Trial with an Allogeneic iPSC-Derived Product
In a major world first, Australian stem cell company Cynata Therapeutics (ASX:CYP) announced it received advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA) that its Phase I clinical trial application has been approved.
The clinical trial has been named “An Open-Label Phase 1 Study to Investigate the Safety and Efficacy of CYP-001 for the Treatment of Adults With Steroid-Resistant Acute Graft Versus Host Disease” (NCT02923375).
It will be the world’s first clinical trial involving a therapeutic product derived from allogeneic (unrelated to the patient) induced pluripotent stem cells (iPSCs).
Highlights of Cynata Therapeutics’ Upcoming Phase 1 Clinical Trial (Protocol Number: CYP-GvHD-P1-01)
Participants for Cynata’s upcoming Phase I clinical trial must be adults who have undergone an allogeneic haematopoietic stem cell transplant (HSCT) to treat a haematological disorder and subsequently been diagnosed with steroid-resistant Grade II-IV GvHD.
The first eight participants will be enrolled in Cohort A and receive two infusions of CYP-001 at a dose of 1 million cells per kilogram of body weight (cells/kg), up to a maximum dose of 100 million cells.
There will be one week between the two CYP-001 infusions in each patient.
The next eight participants will be enrolled into Cohort B and receive two infusions of CYP 001 at a dose of 2 million cells/kg, up to a maximum dose of 200 million cells.
The primary objective of the trial is to assess safety and tolerability, while the secondary objective is to evaluate the efficacy of two infusions of CYP-001 in adults with steroid-resistant GvHD.
Efficacy will be assessed on the basis of response to treatment (as determined by change in GvHD Grade) and overall survival at 28 and 100 days after the administration of the first dose.
Participants will also be followed up for up to two years under a separate non-interventional study protocol.
Importantly, Cynata’s Cymerus™ mesenchymal stem cell (MSC) technology is a second generation process that does not rely on multiple donors or massive expansion of the end product, and therefore, is a commercially viable solution to the manufacture of consistent, robust MSC therapeutic products.
“10 Years of iPSCs” Explores Future Growth as iPSC Field Enters 2nd Decade
To celebrate the decade that has passed since the landmark discovery of induced pluripotent stem cells, Cell Press hosted “10 Years of iPSCs,” a symposium focused on iPSC research and applications. In 2006, Shinya Yamanaka and Kazutoshi Takahashi reported the Nobel Prize winning discovery of induced pluripotent stem cells (iPSCs) in Cell.
Over the past 10 years, iPS cells have become a lab workhorse — providing an unlimited supply of once-inaccessible human tissues with specific genetic mutations for research.
iPSC technology also spurred renewed interest in direct reprogramming across lineages. Progress in understanding the biology of iPSCs and reprogramming has moved in parallel with work on clinical translation to apply the insights obtained, and the first iPSC-based clinical trials are now underway within Japan and launching within the UK.
About “10 Years of iPSCs” by Cell Press
Cell Press is excited to bring together leaders in biology, medicine, and industry to give an up-to-date view of this exciting and rapidly moving area. At this meeting, you can expect to hear about the latest advances in technology development, mechanistic understanding, and therapeutic application of reprogramming for both drug development and cell-based therapy.
The goal of the meeting is to serve as a catalyst for new ideas and future growth as the iPSC and reprogramming field enters its second decade.
Key themes will include:
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- Mechanisms of reprogramming
- Disease modeling and drug discovery
- Direct reprogramming
- Technology development
- Clinical translation
There will also be a panel on ethical considerations for clinical translation of iPSC research, on Sunday, September 25, 2016, from 17:00-18:00.
Symposium speakers Shinya Yamanaka, George Daley, Christine Mummery, Lorenz Studer, and Deepak Srivastava, and Bioethicist Hank Greely will discuss the most pressing ethics issues facing the field as it moves towards the clinic. Discussion topics will range from the ethics of patient and donor consent in iPSC banking and application to medical use of genome-edited iPSC derivatives and lessons from existing approaches in gene and cell therapy.
Speakers at “10 Years of iPSCs” Symposium
The keynote speakers for the “10 Years of iPSCs” are Shinya Yamanaka (Japan/USA) and Rudolf Jaenisch (USA).
BrainXell Enters Agreement for iPSC Patent Technology with iPS Academia Japan
BrainXell and iPS Academia Japan have announced a global licensing agreement covering components of the induced pluripotent stem (iPS) cell patent portfolio owned by iPS Academia Japan. Under the terms of the non-exclusive agreement, BrainXell will be able to commercialize iPS-derived cells and offer related services to it customers. The value and terms of the agreement have not been announced.
The iPS cell patent portfolio being licensed by BrainXell has resulted from work by Professor Shinya Yamanaka at the Center for iPS Cell Research and Application (CiRA) at Kyoto University.
BrainXell is a a stem cell company based in Madison, Wisconsin, while iPS Academia Japan is based in Kyoto, Japan. BrainXell specializes in using iPSC-derived neural cells for use on a custom basis to pharmaceutical companies for research programs. iPS Academia Japan is an affiliate of Kyoto University, a major research university in Japan. Kyoto University is also a global leader in developing induced pluripotent stem cell (iPSC) technologies.
BrainXell is making brain cells by the billions. @UWMadison spinoff sells neural cells to drug researchers via @UWMadScience. pic.twitter.com/zuw6l0EMec
— CIRM (@CIRMnews) November 1, 2016
The role of iPS Acadmia Japan is to commercialize the patents and other IP created by Kyoto University and other universities and research institutions developing iPSC technologies.
According to Zhong-Wei Du, Chief Technology Officer of BrainXell, “BrainXell is now enabled through this iPS cell technology license and its Wisconsin Alumni Research Foundation (WARF) license on neural stem cell differentiation to provide a broad range of neural cells for research at numerous institutions and biopharmaceutical companies.”
To learn more, view the license announcement.
Cynata Shares Jump as Japan’s FUJIFILM Negotiates Deal to Commercialize Cymerus™ Stem Cell Technology
Cynata Therapeutics (ASX: CYP) has executed a term sheet with FUJIFILM Corporation of Japan for the development and commercialisation of certain Cynata technology, including Cynata’s lead product, CYP-001.  CYP-001 is an induced pluripotent stem cell (iPSC) derived mesenchymal stem cell (MSC) product that is anticipated to be the first allogeneic iPSC product to enter a clinical trial.
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