Industry Update: Business development – Launching new projects, products & services

Latest developments compiled from January 01 — February 28, 2017.

Latest business developments in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from non-academic institutions from January 01 — February 28, 2017, scheduled to be published in Volume 12 Issue 4 of Regenerative Medicine.

Launching new projects, products & services

3D Cell Bioprinting Consortium

3D Cell Bioprinting Consortium (www.3dcellprinting.com) has been launched at the Society for Laboratory Automation and Screening (SLAS; IL, USA; www.slas.org) annual International Conference and Exhibition in February 2017. The consortium consists of the 3-D Matrix Group (Japan; http://puramatrix.com/wp/company/3-d-matrix-group/) , Cell Applications (CA, USA; www.cellapplications.com), AthenaESâ„¢ (MD, USA; www.athenaes.com) and Digilab (MA, USA; www.digilabglobal.com), and is headed by Executive Chairman at Digilab. Together, the consortium member companies offer a unified source for proven bioprinter and liquid handling systems, printable ECMs, primary cells, culture media, reagents and growth supplements. Their expert integration on instruments, consumables and knowledge translates into consistent solutions, customization services, technical assistance, out-sourced proof of concept and feasibility studies. The consortium successfully enacts joint development of bioprinted tissues with academic, corporate, non-profit and government laboratories.

Aivita

AIVITA Biomedical (CA, USA; www.aivitabiomedical.com) has launched PROVOQUEâ„¢ Eye Complex, a patented stem cell derived formula to address functional concerns of eye aesthetics, including thin periocular skin, dryness, fine line wrinkles and under eye hyperpigmentation. PROVOQUEâ„¢ Eye Complex is AIVITA’s second product in their anti-aging skin care line – all products are backed by blinded clinical studies confirming performance and safety.

Allele

Allele Biotechnology & Pharmaceuticals (CA, USA; www.allelebiotech.com) has announced that it has officially entered into the development of induced pluripotent stem cell (iPSC)-derived cell therapies after the development plan received strong support by the Scientific Advisory Board and was approved by the Board of Directors in December of 2016.

Antibe

Antibe Therapeutics (ON, Canada; www.antibethera.com) has announced that its subsidiary Citagenix (ON, Canada; www.citagenix.com) has launched PentOS OIâ„¢ Max for the dental biologics market. PentOS OI Max is an inductive collagen matrix that can be mixed with the clinician’s choice of patient derived concentrates (including stem cells and blood components). Osteoinductivity is demonstrated in each lot in both in vivo and in vitro assays using independent laboratories. In vitro testing demonstrated levels of bone morphogenetic protein (BMP) up to 40-times that of the control. BMP is a naturally occurring growth factor found in the human body and plays a crucial role in bone formation. In vivo testing demonstrates all five elements of bone formation are present in our PentOS OIâ„¢ grafts: chondrocytes, osteocytes, bone marrow cells, cartilage, and new bone. In vitro studies also demonstrated excellent cell viability and proliferation.

Axiogenesis

Axiogenesis (Germany; www.axiogenesis.com), a leading provider of iPSC products worldwide, announced launch of a new service, Cardio.Force. This service offers assay services for iPSC-derived cardiomyocyte functionality and toxicity assessment. Cardio.Force offers an efficient system for pharmacological and toxicological studies using human cells outside of an animal model, and is also reproducible and scalable, which gives it further cost advantages as compared to current systems available which are animal based.

BioTime

BioTime (CA, USA; www.biotimeinc.com) and its majority-owned subsidiary, Cell Cure Neurosciences (Israel; www.cellcureneurosciences.com) have dedicated a new, 800 m2, state-of-the-art, cGMP manufacturing center located in the Jerusalem Bio Park on the campus of Hadassah University Hospital in Jerusalem. The new manufacturing center, initially to be staffed by 25-30 employees, is equipped to produce a range of cell therapies for the treatment of various degenerative human diseases. In the near term, the plan is to supply OpRegen for the company’s ongoing clinical trial program for the treatment of dry age-related macular degeneration.

Emulate

Emulate (MA, USA; https://emulatebio.com) has expanded its Organs-on-Chips technology to model viral infection in a human-relevant system, opening new opportunities for studying infectious diseases and better predicting human responses to new medicines [1]. The new application uses the Intestine-Chip to demonstrate how a human pathogenic virus enters polarized cells in the intestine, replicates to drive the infectious disease process, and is released into the intestinal lumen. This is not possible using conventional human cell cultures. By demonstrating the release and function of a virus in a human-relevant system, Emulate’s Organs-on-Chips technology offers the potential to evaluate efficacy and safety of new medicines prior to human trials. The technology could also be applied in the future to study viruses ranging from seasonal flu, to diseases of global health concern like Ebola and Zika.

Fosun Pharma Kite

Kite Pharma (CA, USA; www.kitepharma.com) and Shanghai Fosun Pharmaceutical (China; www.fosunpharma.com) have announced a joint venture, Fosun Pharma Kite Biotechnology, to develop, manufacture and commercialize axicabtagene ciloleucel in China with the option to include additional products. Axicabtagene ciloleucel (KTE-C19), Kite’s lead product candidate, is an investigational chimeric antigen receptor (CAR) T-cell therapy under development for the treatment of B-cell lymphomas and leukemias. The joint venture will be registered in Shanghai and owned equally between Kite Pharma and Fosun Pharma. Under the terms of the agreement, Fosun Pharma will provide US$ 20 million in funding to support clinical development and manufacturing activities and Kite will provide certain technical transfer services to the joint venture. Each party will share in any profits from the joint venture with Kite Pharma receiving 40% and Fosun Pharma receiving 60%. Kite will also receive an upfront fee of $40 million from the joint venture, funded by Fosun Pharma, regulatory and commercial milestones totaling US$ 35 million and mid-single digit sales royalties for axicabtagene ciloleucel (KTE-C19).

JangoBio

JangoBio (WI, USA; www.jango-bio.com), a University of Wisconsin spinout has announced the launch of a stem cell-based solution for restoring the flow of hormones in aging patients. This “next generation” hormone replacement therapy could help prevent diseases such as Alzheimer’s and diabetes and other aging-related problems. The treatment will involve introducing manufactured reproductive gland cells into a patient to restore hormonal balance. The company has received US$ 365,000 in grant funding from the National Institute of Health, and is on track to raise an additional US$ 250,000 equity funding from private investors.

Minerva

Minerva Biotechnologies (MA, USA; www.minervabio.com) has launched the AlphaSTEMâ„¢ Culture System. The system uses a newly discovered growth factor that is only expressed in the naïve cells of the inner cell mass during the earliest days of embryogenesis. AlphaSTEMâ„¢ Culture System is a simple, natural method for inducing the naïve state in human stem cells without the use of biochemical inhibitors. Naïve stem cells do not yet have DNA methylation marks that have already committed the cells to certain developmental decisions. Directed differentiation efficiency and functionality are increased with ‘clean slate’ AlphaSTEMâ„¢ naïve cells. Stem cells cultured in AlphaSTEMâ„¢ maintain normal karyotype for 70 passages. Stem cell expansion is faster and scalable, and can be completely automated since it eliminates unwanted spontaneous differentiation. Further, iPSC generation in AlphaSTEMâ„¢ Culture System is orders of magnitude more efficient than FGF-based reprogramming.

NuGene

NuGene International (CA, USA; www.nugene.com) has launched newly reformulated REVELLUSâ„¢ Hair Fortifying Serum, which is designed to help improve the overall vitality of the scalp and promote the appearance of fuller, thicker, and more voluminous hair.

REVELLUSâ„¢ is formulated with Human Cancer Secretome Database (HSCD) Proteins, which are obtained through NuGene’s patent pending adipose derived stem cell culture process, and a powerful blend of antioxidants, natural extracts, and peptides. The improved formulation helps to revitalize the scalp and nourish the follicles for a more volumizing and youthful look by effectively addressing the nutrient needs of the hair.

Sino Harbour

Sino Harbour Holdings Group (Hong Kong; www.sinoharbour.com.hk) has established a new subsidiary, Guangxi Gangrun Biotechnology following the signing of a technology cooperation framework agreement between Jiangxi Sino Harbour Technology Limited (the company’s wholly-owned subsidiary), The Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region (China; www.gxfybj.com) and Zhejiang Gene Stem Cell Biotech (China; N/A) to tap into the emerging stem cell industry in Southern China. Zhejiang GSCB will bring in expertise in commercialization of stem cell technology. The principle activities of Guangxi Gangrun will include the storage of biological resources, genetic testing technology services, production and sale of cell products, development, transfer and consultation services of cell and genetic products.

Stemedix

Stemedix (FL, USA; www.stemedix.com) has announced that they are now combining their stem cell therapy treatments with hyperbaric oxygen therapy (HBOT). Research has shown that HBOT treatments in conjunction with stem cell therapy increases the synthesis of nitric oxide, which stimulates and mobilizes fibroblasts, capillaries, osteoblasts and stem cells to promote regeneration [2, 3].

StemoniX

StemoniX (MN, USA; www.stemonix.com) has released new data showing superiority of their microHeart® microplates over industry standard cultureware as a control. With microHeart, cardiomyocytes were seen to passively align into physiologically relevant structures that closely emulate correct cardiac muscle fiber organization. MicroHeart will offer a physiologically relevant model to provide for economically scalable incorporation into a drug screening workflow.

ThermoFisher

Thermo Fisher Scientific (CA, USA; www.thermofisher.com) has launched a new pluripotent stem cell Gibcoâ„¢ StemFlexâ„¢ Medium. The medium achieves up to a two-fold faster stem cell recovery following gene editing; it achieves as much as a five-fold improvement in clonal expansion following single cell passaging in the absence of ROCK inhibitor; consistently maintains pluripotency with weekend-free feeding schedules; and it also can be used for multiple matrices and passing reagents.

TissueGene

At the 35th Annual JP Morgan Healthcare conference in San Francisco, TissueGene (MD, USA; www.tissuegene.com) has introduced Invossaâ„¢, the world’s first cell and gene therapy for degenerative arthritis. Invossa are allogeneic human chondrocytes expressing Transforming Growth Factor (TGF)-β1, mixed with fibrin-glue for osteoarthritis of the knee that has completed Phase II clinical trials in the USA (www.clinicaltrials.gov ID: NCT01825811, NCT00599248, NCT02341378, NCT02072070). Invossa is designed to treat osteoarthritis of the knee through a single intra-articular injection. Clinical trials completed in Korea and on-going trials in the US have demonstrated pain relief, increased mobility, and improvements in joint structure — offering substantial convenience and therapeutic benefits for osteoarthritis patients, while delaying their need for surgery. Recently, TissueGene’s licensee, Kolon Life Sciences (Korea; www.kolonls.co.kr/eng/), filed license application for Invossa with the Korea Ministry of Food and Drug Safety (www.mfds.go.kr/eng). TissueGene has also reached an agreement with the US FDA regarding a Special Protocol Assessment for a Phase 3 clinical trial for Invossa as the first disease-modifying osteoarthritis drug.

References

[1] Villenave R, Wales SQ, Hamkins-Indik T et al. Human gut-on-a-chip supports polarized infection of coxsackie B1 virus in vitro. PLoS One. 12(2), e0169412 (2017).

[2] Zhou HX, Liu ZG, Liu XJ, Chen QX. Umbilical cord-derived mesenchymal stem cell transplantation combined with hyperbaric oxygen treatment for repair of traumatic brain injury. Neural Regen. Res. 11, 107-113 (2016).

[3] Thom SR, Bhopale VM, Velazquez OC, Goldstein LJ, Thom LH, Buerk DG. Stem cell mobilization by hyperbaric oxygen. Am. J. Physiol. Heart Circ. Physiol. 290(4), H1378-86 (2006).