Industry Update: Latest Developments in the Field of Stem Cell Research and Regenerative Medicine Compiled from Publicly Available Information and Press Releases from Nonacademic Institutions from 1 January 2013 Until 28 February 2014

Business Development

Collaborations, partnerships & alliances

Collaboration agreement: Agilent & Cell Line Genetics

Agilent Technologies (CA, USA; www.agilent.com) announced collaboration with Cell Line Genetics (WI, USA; www.clgenetics.com) to develop high-throughput, genomic characterization workflows to confirm and monitor the integrity of cell lines for translational and regenerative medicine research. The workflows will be based upon Agilent’s custom, targeted comparative genomic hybridization plus single nucleotide polymorphism microarrays and SureFISH technology. Cell Line Genetics will use FISH assays to confirm aberrations identified down to the single-cell level.

Collaboration agreement: California Stem Cell & UC Irvine

California Stem Cell (CA, USA; www.californiastemcell.com) has initiated a collaborative study with the University of California, Irvine (CA USA; http://uci.edu). The study, funded by a US$4.5 million grant from the California Institute of Regenerative Medicine (CA, USA; www.cirm.ca.gov) will investigate the potential of improving a patient’s visual function by transplanting human stem cell-derived 3D retinal tissue into their retina.

Collaboration agreement: Plasticell & JCR Pharmaceuticals

Plasticell (UK; www.plasticell.co.uk) has signed a collaboration agreement with JCR Pharmaceuticals (Japan; www.jcrpharm.co.jp/en) to discover novel custom stem cell culture media and cGMP-ready protocols for therapeutic applications using its award-winning combinatorial stem cell technology, CombiCult^®. Financial terms of the agreement were not disclosed.

Collaboration & license agreement: Biogen & Sangamo

Biogen Idec (MA, USA; www.biogenidec.com) and Sangamo BioSciences (CA, USA; www.sangamo.com) signed an exclusive worldwide collaboration and license agreement focused on the development of therapeutics for hemoglobinopathies. The agreement will enable Biogen to further enhance its expertise in nonmalignant hematology by leveraging Sangamo’s proprietary genome-editing technology platform to develop cell-based treatments targeting sickle cell disease and β-thalassemia.

Licensing agreement: Derma Sciences & BioD

Derma Sciences (NJ, USA; www.dermasciences.com) has licensed exclusive rights to two novel human placental-derived tissue products for all dermal indications in the advanced wound care and burn markets from BioD (TN, USA; www.biodlogics.com). These products will be branded as AmnioMatrix^® and launched in Q3 of 2014, expanding Derma Sciences’ portfolio of advanced wound care products. Terms of the license include an upfront cash payment, royalties on product sales and performance-based milestones to be paid in cash and Derma Sciences stock options.

Licensing agreement: HUB Foundation & StemCell Technologies

The HUB Foundation for Organoid Technology (The Netherlands; www.hub4organoids.eu) has signed a licensing agreement with StemCell Technologies (BC, Canada; www.stemcell.com) for the manufacturing and worldwide distribution of cell culture media for growing organoids. Organoids, mini-organs grown in vitro from small pieces of tissue derived from patients with cancer and other diseases, are exciting new tool for scientific research, drug discovery and validation.

Manufacturing agreement: Regeneus & Lonza

Regeneus (Australia; www.regeneus.com.au) announced that Lonza (Switzerland; www.lonza.com) will manufacture and then distribute to participating trial veterinarian clinics Regeneus’ cell therapy CryoShot^® Canine. CryoShot Canine is an off-the-shelf allogeneic cell therapy product for the treatment of musculoskeletal conditions in dogs and is currently under a preregistration trial in Australia. The cell therapy is produced from a small amount of adipose tissue derived from a donor animal. The tissue is processed and cultured to isolate and increase the regenerative cells before being cryogenically frozen and stored in liquid nitrogen. It is delivered to veterinary clinics cryogenically frozen and then thawed for injection by the treating veterinarian.

Supply agreement: CDI & Nestle

Cellular Dynamics International (WI, USA; www.cellulardynamics.com) signed a long-term supply agreement with the Nestlé Institute of Health Sciences (Switzerland; www.nestleinstitutehealthsciences.com). Terms of the agreement were not disclosed. Cellular Dynamics’ iCell^® product line includes cardiomyocytes, neurons, hepatocytes and endothelial cells, with numerous other cell types in development. The company’s MyCell^® Products are cell products manufactured from donor samples using induced pluripotent stem cell (iPSC) technology to make stem cells or differentiated cells from any individual, including those with diseases of interest.

Launching new projects, products & services

BioLeonhard

BioLeonhardt (CA, USA; http://bioleonhardt.com) has developed a programmable implantable stem cell infusion pump and electrical stimulator combination for treating advanced heart failure. The stem cell pump is implanted in the patient’s abdomen and has a silicone septum, which allows re-loading via a microneedle syringe of stem cells, genes, growth factors and nutrient hydrogels. The pump is attached to a combination coaxial reinforced infusion catheter and electrical conduction lead, which has its tip anchored into the patient’s damaged heart tissue.

CariCord

CariCord (CO, USA; www.carocord.com) has been launched as the private family cord blood bank of the University of Colorado’s ClinImmune Labs (CO, USA; www.clinimmune.com). It will be the first and only company in the world delivering cord blood stem cell banking to private consumers in a US FDA licensed laboratory. The exclusive public–private venture delivers the highest quality cord blood processing to families choosing CariCord’s services. Cord blood banking and processing at ClinImmune Labs was previously limited to only publicly donated units.

Coriell

Coriell Institute (NJ, USA; www.coriell.org) launched a West Coast repository that will house the world’s largest collection of iPSC lines. The creation of the repository is being funded through a US$10 million grant from the California Institute for Regenerative Medicine (CA, USA; www.cirm.ca.gov), which was announced last year and recently finalized.

European Bank for induced pluripotent Stem Cells

Pharmaceutical companies, members of the European Federation of Pharmaceutical Industries and Associations, joined forces with small- and medium-sized enterprises and academia in an Innovative Medicines Initiative (www.imi.europa.eu)-supported public–private partnership project to establish the leading facility for the storage and distribution of iPSCs in Europe. The consortium of 26 partners plans to establish the ‘European Bank for induced pluripotent Stem Cells’ (www.ebisc.org).

StemGenex

StemGenex (CA, USA; www.stemgenex.com) has announced a new therapeutic approach to assist patients diagnosed with chronic obstructive pulmonary disease: nebulizing adipose stem cells down to a mist so that patients can painlessly breathe the stem cells directly into their lungs. The goal of this new technique is to encourage more stem cells to travel directly to the inflamed tissue of the lungs.

TxCell

TxCell (France; www.txcell.com) has initiated a full development program with Col-Treg for the treatment of autoimmune uveitis. Col-Treg is a personalized cell-based immunotherapy product, based on the properties of autologous collagen II-specific regulatory T lymphocytes. Col-Treg uses the natural properties of the patient’s own Type 1 Tregs, which home preferentially to the sites of injury and control inflammation by multiple pathways: secreting natural immunosuppressive molecules, initiating cell–cell contact-mediated suppression through surface molecules and killing of myeloid cells. These multiple mechanisms of action lead to inhibition of proinflammatory cell activation, proliferation and cytokine production. TxCell is developing innovative personalized cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need using its unique and proprietary ASTrIA technology platform based on the properties of autologous antigen-specific regulatory T lymphocytes. The company has completed a Phase I/IIa study of its lead product candidate, Ovasave^® in refractory Crohn’s disease patients and has reported good tolerability and positive signals of efficacy.

Achievements

Cord Blood America

Cord Blood America (NV, USA; www.cordblood-america.com) has achieved AABB accreditation for cell therapy activity associated with cord blood processing, storage and distribution.

Genea Biocells

Genea Biocells (Australia; www.genea.com.au) is now the world’s largest provider of human embryonic stem cell (hESC) lines on the US NIH Stem Cell Registry. The approval of 52 of Genea’s hESC lines provides researchers with innovative cellular tools to drive the discovery of new treatments for serious genetic or acquired diseases including orphan diseases. Among the 52 stem cell lines listed with the NIH Stem Cell Registry are 43 disease-specific hESC lines representing 24 different genetic diseases. Genea has the world’s largest private bank of pluripotent hESCs, with more that 100 individual lines representing almost 30 different genetic diseases. NIH applications for remaining Genea cell lines are in preparation.

Organovo

Organovo Holdings (CA, USA; www.organovo.com) has performed its first 3D liver tissue delivery to a laboratory outside of the company to a key opinion leader for experimentation, and marks the achievement of a milestone along the pathway to commercial launch of its 3D liver tissue product. Organovo expects to commence the commercial launch and start generating revenue through a services model prior to December 2014. 3D kidney tissues and breast cancer tissues are under development.

Clinical Trials

apceth

apceth (Germany; www.apceth.com) announced that the first clinical trial worldwide with genetically modified mesenchymal stromal cells (MSCs) for patients suffering from advanced adenocarcinoma of the GI tract has commenced. This innovative next-generation MSC therapy is based on cells harvested from the patient’s own bone marrow, which are processed, genetically modified and re-infused into the patient. The cells specifically target the tumor, or its metastases, where the cytotoxic gene product is selectively activated, increasing local efficacy with reduced systemic toxicity. This unique principle is also applicable to other cancer types. apceth intends to advance this treatment to an off-the-shelf product where cells obtained for healthy donors will be used to treat multiple patients.

BrainStorm

BrainStorm Cell Therapeutics (Israel; www.brainstorm-cell.com) has published a case report on an individual patient diagnosed with both myasthenia gravis and amyotrophic lateral sclerosis (ALS) who showed significant improvements in both cognitive and motor function following initial and repeat treatments with the NurOwn™ [1]. NurOwn is a proprietary, first-of-its-kind technology that induces autologous bone marrow-derived MSCs to secrete neurotropic factors (NTF). The NurOwn treatment approach is to transplant these ‘MSC-NTF’ cells back into the patient at or near the site of damage, in the spine and/or muscles. Brainstorm is currently conducting a Phase IIa ALS clinical trial with NurOwn at the Hadassah University Medical Center in Jerusalem. The company also plans to begin a Phase II clinical trial in the USA in early 2014, pending FDA approval. NurOwn was granted Orphan Drug designation by the FDA and the European Commission. Further information about the clinical trials is available at www.clinicaltrials.gov (ID: NCT02017912, NCT01777646 and NCT01051882).

In an unrelated press release, the company announced that it has signed a definitive agreement with the Mayo Clinic (MN, USA; www.mayoclinic.org) to conduct its Phase II clinical trial of NurOwn in ALS, pending FDA approval. Mayo’s Human Cell Therapy Laboratory will manufacture the NurOwn cells for their clinical trial participants. The other two sites slated for the multicenter trial are the University of Massachusetts Memorial Hospital and Massachusetts General Hospital (MA, USA).

Capricor

Capricor Therapeutics (CA, USA; www.capricor.com) was set to begin a Phase II study of its new stem cell therapy with approximately US$20 million in support from the California Institute for Regenerative Medicine (CA, USA; www.cirm.ca.gov), when Johnson & Johnson (NJ, USA; www.jnj.com) stepped up with an additional US$12.5 million. Capricor shares shot up 22% on the news. Capricor is testing off-the-shelf allogeneic stem cells in two patient populations – one group 30–90 days after a heart attack and another, sicker group 30 days–1 year after a heart attack, and they are hoping to see the kind of reduction in scar tissue that enthused researchers in the Phase I trial. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01458405).

Mesoblast

Mesoblast (Australia; www.mesoblast.com) announced positive 12-month outcome results from the 100-patient Phase II clinical trial of its proprietary allogeneic, or ‘off-the-shelf’, mesenchymal precursor cells (MPCs) in patients with chronic moderate-to-severe discogenic low back pain. The results showed that a single injection of MPCs into degenerating intervertebral discs reduced low back pain and improved function for at least 12 months. When compared with controls, MPC-treated patients used less opioids for pain relief, had greater radiographically defined disc stability, and underwent less additional surgical and nonsurgical treatment interventions. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01290367).

Mologen

Mologen (Germany; www.mologen.com) has presented final results from the Phase I/II clinical study with MGN1601 (ASET trial). The trial evaluated safety and tolerability of MGN1601 in 19 heavily pretreated patients with advanced renal cancer, which had no other treatment options. The monotherapy with tumor cell-based cancer vaccine MGN1601 was well tolerated and safe. Furthermore, treatment with MGN1601 resulted in promising median overall survival data in a subgroup of patients. MGN1601 is based on genetically modified, allogeneic tumor cells and the active principle is induction of a cross-reaction of the patients’ immune system against their own cancer cells after the immune system has learned what cancer cells typically look like via its response to the genetically modified foreign cancer cells. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01265368).

Pluristem

Pluristem Therapeutics (Israel; www.pluristem.com) announced top-line results from its Phase I/II clinical trial testing the safety and efficacy of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury. The trial indicated PLX-PAD cells were safe and statistical significance was reached (p = 0.0067) for the primary efficacy end point of the study, the change in maximal voluntary isometric contraction force of the gluteal muscle at 6 months after total hip replacement. This Phase I/II trial was a randomized, placebo-controlled, double-blinded study conducted at the Orthopedic Clinic of the Charité University Medical School under the auspices of the Paul-Ehrlich-Institute, Germany’s health authority. The injured muscle studied was the gluteus medius muscle in the buttock. Total hip replacement surgery via the standard transgluteal approach necessitates injury of the gluteus medius muscle and postoperative healing is crucial for joint stability and function. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01525667).

StemCells

StemCells (CA, USA; www.stemcells.com) announced that a team at the University of Calgary successfully transplanted its first subject in the company’s Phase I/II clinical trial in chronic spinal cord injury, with the company’s proprietary HuCNS-SC^® human neural stem cells. The ninth subject to enroll in the trial, which was initiated in Switzerland, is the first spinal cord injury patient to have undergone transplantation with HuCNS-SC in North America. This expansion from a single-site, single-country study to a multisite, multicountry program accelerates the current trial, which should complete enrollment of the remaining three patients this quarter, and pave the way for a controlled Phase II efficacy study that StemCells plans to initiate mid-year to further investigate its HuCNS-SC product candidate as a treatment for spinal cord injury. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01321333).

Thermogenesis & TotipotentRX

ThermoGenesis (CA, USA; www.termogenesis.com) and TotipotentRX (CA, USA; www.totipotentrx.com) recently merged into Cesca Therapeutics (Clinical Excellence in Stem Cell Applications; CA, USA; www.cescatherapeutics.com), announced their co-sponsored Phase Ib clinical trial safety and efficacy results treating no-option patients suffering from critical limb ischemia with Totipotent’s CLIRST (Critical Limb Ischemia Rapid Stem cell Therapy) treatment. The trial achieved both its primary safety and secondary efficacy end points at 12 months, achieving statistical significance in five key areas including, major amputation free survival rates (82.4%), both resting and walking pain reduction, improved walking distance, open wound healing and vasculogenesis in the treated leg. Furthermore, there were no serious adverse events determined related to the therapy. The open-label single-center study enrolled 17 patients and was completed at Fortis Escorts Heart Institute in New Delhi (www.fortisescorts.in/Home.aspx). CLIRST is a proprietary bed-side technology platform and method, which uses the patients own bone marrow stem cells to promote tissue repair through activation of natural stem cell repair pathways, promotion of new blood vessel formation and prevention of ongoing cell death. The integrated combination device-biological product called SURGWERKS™-CLI, contains optimized stem cell harvesting, selection, and delivery disposables in a single kit, and the procedure can be completed on a patient in less than 60 min in the operating room with mild sedation as an alternative to major limb amputation. The SURGWERKS-CLI product delivered a mean cell dose of bone marrow concentrate enriched progenitor cells of 8.04 × 10⁸ ± 3.65 cells in a 20-ml final product, which was injected intramuscularly in the lower afflicted leg. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01472289).

Regulations, Approvals & Acquisitions

Green light

Admedus

Admedus (Australia; www.admedus.com/au) has received key FDA clearance to sell CardioCel^® in the USA. CardioCel had received the CE mark allowing European sales in August 2013 and made its first sale there in November. CardioCel is a regenerative tissue product engineered by the group’s ADAPT^® tissue-engineering process to be a durable, pure collagen scaffold used to repair heart deformities including repairing and reconstructing heart valves. An ongoing Phase II extension study has confirmed no signs of calcification, a major issue with other existing tissue products, in 19 patients monitored over a 3–5-year period postsurgery.

BioLineRx

BioLineRx (Israel, www.biolinerx.com) has received notice from the FDA confirming an Orphan Drug Designation of BL-8040 as a treatment for stem cell mobilization, in addition to the Orphan Drug Designation previously granted to BL-8040 as a treatment for acute myeloid leukemia. BL-8040 is a short peptide, which functions as a high-affinity antagonist for CXCR4, which is directly involved in tumor progression, angiogenesis, metastasis and cell survival. The Orphan Drug Designation was granted for use of BL-8040, in combination with granulocyte colony-stimulating factor, to mobilize human stem cells from the bone marrow to the peripheral blood for collection for autologous or allogeneic transplantation.

California Stem Cell

California Stem Cell (CA, USA; www.californiastemcell.com) announced that the FDA has approved the company’s application to begin a Phase II clinical trial exploring the potential of a patient-specific cancer immunotherapy in women with stage III or IV ovarian, fallopian tube or primary peritoneal cancer. The company’s patient-specific approach to treating metastatic melanoma, recently approved to begin a Phase III trial, provided sufficient safety data to proceed directly to a Phase II study in ovarian cancer. The treatment is based on findings in recent years that the rapid proliferation and subsequent spreading of cancer throughout a patient’s body may be fueled by a small number of cancer stem cells. Through proprietary processes developed at California Stem Cell, researchers isolate and expand these cancer stem cells to clinically useful numbers, combine them with autologous dendritic cells, and reintroduce them irradiated into the patient with the intention of training and bolstering the patient’s immune system to target the cells that have ability to form new tumors. Further information about these clinical trials are available at www.clinicaltrials.gov (ID: NCT02033616 and NCT01875653).

Cardio3 BioSciences

Cardio3 BioSciences (Belgium; www.c3bs.com) announced that the FDA has authorized the company’s Investigational New Drug application for clinical testing of the company’s proprietary regenerative medicine product C3BS-CQR-1 (C-Cure^®) as a treatment targeting heart failure. CHART-2, the company’s second Phase III clinical trial, is intended to assess in the USA, the efficacy of C3BS-CQR-1 as a treatment for heart failure of ischemic origin. CHART-2 is designed as a prospective, multicenter, randomized, sham-controlled, patient- and evaluator-blinded study comparing treatment with C3BS-CQR-1 to a sham treatment. The trial is aimed to recruit a minimum of 240 patients with chronic advanced symptomatic heart failure. The primary end point of the trial is the 6-min walk test postprocedure, a commonly used index of cardiovascular performance. Phase II data showed C3BS-CQR-1 statistically significant improvement of 77 m in 6-min walk distance for the treated patients compared with the control group (p < 0.01), which represented a 20% improvement for treated patients versus the control group [2–4]. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01768702).

Cell Medica

Cell Medica (UK; www.cellmedica.co.uk) announced that the EMA’s Committee for Orphan Medicinal Products has issued a positive opinion on an application for orphan designation of a novel T-cell immunotherapy under development by the company. The cell therapy, Cytovir ADV, targets the treatment of adenovirus infections in patients following allogeneic bone marrow hematopoietic stem cell transplant and is comprised of adenovirus-specific T cells derived from allogeneic donor leukocytes, expanded ex vivo. Adenovirus infections are a frequent cause of complications and death in patients, particularly children, who have received bone marrow transplants. No antiviral drugs are currently approved for adenovirus infections post-transplant. Cell Medica is developing a related product, Cytovir CMV, for cytomegalovirus infections in the same patient group.

Cytori

Cytori Therapeutics (CA, USA; www.cytori.com) has received Investigational Device Exemption approval from the FDA to begin a prospective clinical trial to evaluate the safety and feasibility of Cytori Cell Therapy as a potential treatment for hamstring injuries. The trial, referred to as RECOVER, will begin as a ten-patient, open-label study in 2014. Following a 90-day assessment of the first ten patients with grade II tears of the hamstring muscle, Cytori is approved by the FDA to expand RECOVER to a multidose, multicenter, double-blind, placebo-controlled trial. Cytori Cell Therapy is derived from the Company’s Celution^® System, which enables access to a patient’s own adipose-derived regenerative cells at the point of care. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT02045888).

Miltenyi

Miltenyi Biotec (Germany; www.miltenyibiotec.com) announced that the FDA has approved the company’s CliniMACS CD34 Reagent System as a Humanitarian Use Device for the prevention of graft-versus-host disease in patients with acute myeloid leukemia in first complete remission undergoing allogeneic stem cell transplantation from a matched related donor. The FDA-approved device efficiently removes donor T cells from the graft prior to transplantation by enriching CD34 blood stem cells, which go on to repopulate the patient’s immune and blood building systems.

Pluristem

Pluristem Therapeutics (Israel; www.pluristem.com), has received approval from the Paul-Ehrlich-Institute, Germany’s health authority, to supply cells from its advanced, fully automated, and proprietary 3D cell expansion manufacturing platform implemented at its new state-of-the-art GMP facility. Pluristem’s new manufacturing facility located in MATAM industrial park near Haifa, is equipped with 500 m² of clean rooms and has the capability to efficiently produce over 150,000 doses of PLX cells annually. This marks the first regulatory approval of Pluristem’s new facility where the company has implemented its large-scale 3D bioreactor expansion of placental-derived mesenchymal-like adherent stromal cells. The company is also in the process of getting approvals from other regulatory authorities, including the FDA.

Translational Biosciences

Translational Biosciences (Panama; www.translationalbiosciences.com), a subsidiary of Medistem Panama has received the county’s first clinical trial approval for the treatment of rheumatoid arthritis with human umbilical cord-derived MSCs from the Comité Nacional de Bioética de la Investigación Institutional Review Board. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01985464).

Red light

WARF & Advanced Cell Technologies

The Wisconsin Alumni Research Foundation (WARF; WI, USA; www.warf.org) sued Advanced Cell Technologies (ACT; MA, USA; www.advancedcell.com) for breach of contract. WARF, which handles patents and licensing for the University of Wisconsin, holds a number of key embryonic stem cell-related patents, and ACT struck a licensing deal with the foundation in 2007. The case has been sealed. Later in January, ACT announced that its CEO is stepping down. The news came a month after ACT, which had US$5.5 million in cash on-hand as of 30 September 2013, announced that it would pay US$4 million to settle a Securities and Exchange Commission charge alleging that the company had illegally sold billions of shares of stock. On the other hand, the company is about to announce the completion of their Phase I trial, in which there were no safety issues and all patients experienced some observable progress.

Acquisitions

GE Healthcare & Thermo Fisher Scientific

GE Healthcare (UK; www.gehealthcare.com) and Thermo Fisher Scientific (MA, USA; www.thermofisher.com) have entered into an agreement for GE Healthcare to acquire Thermo Fisher’s HyClone™ cell culture media and sera, and gene modulation and magnetic beads businesses for approximately US$1.06 billion. The acquisition will allow GE to expand its offering of technologies for the discovery and manufacturing of innovative new medicines, vaccines and diagnostics in its growing Life Sciences business.

Organogenesis & Shire

Organogenesis (MA, USA; www.organogenesis.com) has purchased the Dermagraft assets from Shire (Ireland; www.shire.com). Dermagraft is human fibroblast-derived dermal substitute approved for the treatment of nonhealing diabetic foot ulcers in the USA and Canada. Shire acquired Dermagraft in 2011 through US$750 million acquisition of California-based Advanced BioHealing [5]. Shire will receive no upfront payment from Organogenesis, but is entitled to receive up to US$300 million cash in total milestone payments should Organogenesis meet certain annual net sales targets between now and 2018. The US Generally Accepted Accounting Practice (GAAP) operating loss from Dermagraft operations in the 9 months ended 30 September 2013 amounted to US$324 million including the impairment of goodwill (US$192 million recorded in Q1 2013). On a non-GAAP basis for the same period, the operating loss for Dermagraft operations was US$81 million. Shire will record a loss on disposal and associated impairment charges of approximately $650 million in Q4 of 2013, which will be excluded from non-GAAP earnings.

Capital Market & Finances

Bellicum

Bellicum Pharmaceuticals (TX, USA; www.bellicum.com) has completed a second and final closing of its Series B financing, securing an additional US$14.7 million and bringing the total raised in the round to US$34.4 million. The funding will be used to expand clinical development of Bellicum’s lead cellular immunotherapy product candidates.

Coriell

Coriell Institute (NJ, USA; www.coriell.org) was awarded a US$7.7 million contract extension for its National Institute for Neurological Disorders and Stroke repository. The institution began housing the repository in 2002 and to date, the collection encompasses biospecimens collected from more than 44,000 genetically unique individuals. The US$7.7 million award will be distributed to three primary areas of the repository:

•	Whole blood collection for genetic studies;
•	Patient-derived fibroblasts and stem cells carrying well-defined mutations or genetic variants;
•	Coriell’s ‘rapidly expanding’ biomarkers discovery collection.

In unrelated news, Coriell Life Sciences, a for-profit spin-off venture of the Coriell Institute, claimed IBM’s prestigious global “Global Entrepreneur of the Year” award for 2014. Selected from an original group of 1200 companies worldwide, the award distinguishes Coriell Life Sciences as the world’s top IBM-partner startup organization. A cutting-edge enterprise invested in the exploding field of personalized medicine, it has developed a proprietary system for securely storing sequenced genetic data, constructed an interpretation service designed to more accurately determine drug efficacy, and facilitated a seamless exchange between healthcare providers, patients and physicians.

Financial & competing interests disclosure

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert t-estimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.