Industry Update: Business development
Latest developments compiled from 1—30 September 2016
Latest developments in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from nonacademic institutions, 1—30 September 2016, published in Volume 12 Issue 1 of Regenerative Medicine.
Collaborations, partnerships & alliances
Co-development & commercialization agreement: Cynata & FUJIFILM
Cynata Therapeutics (Australia; http://cynata.com) announced the execution of a term sheet with FUJIFILM Corporation (Japan; www.fujifilmholdings.com) for the development and commercialization of Cynata technology, including Cynata’s lead induced pluripotent stem cell (iPSC)-derived therapeutic mesenchymal stem cell (MSC) product, CYP-001. The term sheet anticipates that, under a definitive agreement, Cynata will grant FUJIFILM an option to an exclusive, worldwide license to market and sell CYP-001 for prevention and treatment of graft-versus-host disease (GvHD), as well as an option to negotiate a license for manufacturing those products, and rights to Cynata’s proprietary Cymerusâ„¢ technology used to produce MSC precursors, mesenchymoangioblasts, from iPSCs. Under a definitive agreement, FUJIFILM will make a direct investment through the acquisition of Cynata shares to the value of US$3 million, and paying upfront and milestone payments to Cynata, together with a royalty on end product sales.
Collaboration agreement: Plasticell & CellSpring
Plasticell (UK; www.plasticell.co.uk) has announced collaboration with CellSpring (Switzerland; http://cellspring.co/index.html), a company that has developed a high throughput 3D cell culture system, the 3D Bloom®Biopolymer Platform, which enables more informed ‘stop/go’ decisions for preclinical candidates. Plasticell and CellSpring are developing tissue models using 3D Bloom Biopolymer seeded with human MSCs that are subsequently differentiated to bone, cartilage and brown/white fat tissue using CombiCult® derived differentiation media. 3D cultures of cells resemble natural tissues more closely compared with conventional 2D cultures grown on flat dishes. In particular, 3D tissues have more accurate biological responses to drug treatment and are used in the pharmaceutical industry to identify promising lead compounds in all stages of drug discovery.
License agreement: GE Healthcare & STEMCELL Technologies
GE Healthcare (UK; www.gehealthcare.com) has agreed with STEMCELL Technologies (Canada; www.stemcell.com) to provide T-cell reagents for commercial-scale cell therapy production. Under the agreement, GE Healthcare will commercialize current good manufacturing practice-grade versions of STEMCELL Technologies’ T-cell reagents for the isolation, activation and culture of T cells in clinical applications. These reagents are critical tools in the development and manufacturing of cell and gene therapies intended for administration to patients.
Partnership agreement: Fate & Memorial Sloan Kettering Cancer Center
Fate Therapeutics (CA, USA; www.fatetherapeutics.com) has entered to a partnership with Memorial Sloan Kettering Cancer Center (NY, USA; www.mskcc.org) for the development of off-the-shelf T-cell product candidates using engineered pluripotent cell lines.
Partnership agreement: L’Oreal & Poietis
L’Oréal (France; www.loreal.com) and Poietis (France; www.poietis.com) are giving themselves the means to pursue a new scientific challenge: bioprinting a hair follicle, the small organ that produces hair, using a bioprinter. The laser-assisted bioprinting technology developed by Poietis to produce biological tissue can position cells in 3D with extremely high cellular resolution (on the order of 10 microns) and cellular viability (over 95%). This unique bioprinting technology involves successively layering microdrops of bioinks using a quick scan by a laser beam. The living biological tissue created must then be matured for around 3 weeks before it can be used in tests. The combination of this exclusive technology with L’Oréal’s unique expertise in hair biology could make it possible to create a functional follicle capable of producing hair.
Launching new projects, products & servicesCellenkos
Golden Meditech Holdings (Hong Kong; www.goldenmeditech.com/eng/global/home.php) and The University of Texas at MD Anderson Cancer Center (TX, USA; www.mdanderson.org) have created Cellenkos, a start-up enterprise focused on umbilical cord blood derived T-reg cellular therapies. Cellenkos, to be based in Houston, is funded with an initial investment of US$10 million with warrants to purchase an additional US$10 million worth of shares by Golden Meditech and an independent strategic investor. Golden Meditech and the strategic investor will collectively own 51% of the voting stock of the new company following the exercise of the warrants. The investment includes options to expand the T-reg technologies of Cellenkos into key Asian markets.
Cellular Dynamics International
Cellular Dynamics International (CDI) (WI, USA; www.cellulardynamics.com), a FUJIFILM (Japan; www.fujifilmholdings.com) company, announced that effective 1 September 2016, the company operations were divided into two equally important business units: Therapeutics Business Unit and The Life Science Business Unit. CDI’s new Therapeutics Business Unit will be focused on developing and bringing to market iPSC-based therapies in the ocular, cardiac, Parkinson’s and oncology spaces, with IND applications in all these therapeutic areas expected in the 2018—2020 time period. The Life Science Business Unit will concentrate on building the research products business by propelling innovative cell products, applications and services into the fast growing iPSC marketplace.
In unrelated press release, the company announced the launch of iCell® Hepatoblasts, liver progenitor cells generated from human iPSCs. These cells show promise for liver regeneration therapy research by enabling researchers to identify molecules capable of stimulating liver progenitor cell proliferation and growth. They also provide an in vitro cellular system for studying hepatic development and regeneration and they can be engineered to develop complex liver models for use in in vitro and in vivo applications.
Furthermore, CDI has launched a new venture — Opsis Therapeutics. Opsis Therapeutics (WI, USA; http://opsistherapeutics.com) was formed on 31 July and is focused on discovering and developing novel medicines to treat patients suffering from retinal diseases. Therapeutic candidates will be developed in conjunction with the company’s haplobanking, enabling the therapeutic cells to be matched to the patient’s immune system. CDI has an ongoing contract with the National Eye Institute to manufacture clinically compatible iPSC-derived human retinal pigment epithelial cells.
MiMedx
MiMedx Group (GA, USA; www.mimedx.com) launched AmnioFillâ„¢ — the first product in the MiMedx placental collagen matrix product family. AmnioFill is a collagenous matrix derived from the placenta and comprised of placental extracellular matrix tissue. AmnioFill is a tissue allograft containing extracellular matrix proteins, growth factors, cytokines and other specialty proteins present in placental tissue. Over 226 growth factors, cytokines and chemokines, including important modulators of inflammation and factors critically important in wound healing, are contained in the AmnioFill placental tissue. MiMedx employs terminal sterilization in addition to aseptic processing techniques in its proprietary processing methodology to enhance the safety of AmnioFill and its other amniotic and placental products.
UKSCB
The UK Steering Committee has approved 38 UK embryonic stem cell lines for clinical application and the UK Stem Cell Bank (UK; www.nibsc.org/ukstemcellbank) has now executed legal agreements with the Depositors for all these cell lines. Furthermore, the Bank has already accessioned 27 of these and has completed its Due Diligence process on 20 cell lines, all of which have been confirmed as The European Union Tissue and Cells Directives Grade — in other words, compliant with the Human Tissue Act Directions and suitable for use as starting materials for clinical applications under the EU regulation. Due Diligence on a further seven cell lines is being conducted. Detailed human leukocyte antigen data has been received from Depositors for 34 of the lines and is available upon request.