Novadip Biosciences SA, a spinout from the University of Louvain and the Saint-Luc University Hospital, has raised €28 million in a Series A financing round to develop a therapy for bone defects that is based on adipose-derived mesenchymal stem cells.
The Netherlands-based cell therapy company Kiadis Pharma BV is planning an initial public offering (IPO) of its shares on the Euronext stock exchanges in Amsterdam and Brussels to finance the clinical development of a cell therapy that helps reconstitute the immune system after a bone marrow transplant.
Juno Therapeutics Inc, which has technology for genetically engineering T cells, has teamed up with Fate Therapeutics Inc to find out whether there is a role for small molecules in improving the profile of engineered T cells as therapies. The four-year collaboration takes T cell immunotherapy one step further by potentially introducing new modulators into the mix of technologies that are now being investigated globally for a wide range of cancers. The collaboration was announced on 6 May.
One of Japan’s biggest industrial concerns, Fujifilm Holdings Corp, has expanded further into regenerative medicine with the acquisition of Cellular Dynamics International Inc, a developer of induced pluripotent stem cells (iPS). CDI was founded by the stem-cell pioneer James Thomson.
UniQure NV has secured a gene therapy agreement with Bristol-Myers Squibb Company in cardiovascular disease, its first major commercial deal since winning regulatory approval in 2012 for Glybera, a gene therapy for lipoprotein lipase deficiency.
The cohort of companies developing products for treating cancer with genetically engineered T-cells has increased with the announcement that Merck Serono and Intrexon Corp will collaborate to generate new drug candidates using the technology.
Research by Douglas Melton of Harvard University and colleagues showing that insulin-producing pancreatic beta cells can be created in a laboratory has reached the stage of commercialisation with the launch of a new company aimed at bringing a cell therapy for diabetes into human trials.
The annual Bio-Europe Spring meeting typically brings together business development directors from small and medium-sized European companies to discuss licensing or partnering deals with their counterparts at large pharma, or with venture capitalists. In the past, the companies by and large have been developers of small molecule or antibody drugs. This year the meeting, which took place on 9 to 11 March, featured several companies with regenerative medicine technologies, including one that is just a year old.
The buzz at the Phacilitate Cell & Gene Therapy Forum in Washington DC on 26 to 28 January was that gene therapy will become a mainstream activity in the global pharmaceutical industry over the next five years, driven in part by the new gene-modified cell therapies and genome editing.
Canada-based EnGene Inc, which has developed a gene-based technology to treat autoimmune diseases, has raised $11.5 million in a Series B investment round. The funds will be used to advance the lead product which is intended to treat ulcerative colitis.
NightstaRx Ltd, a one-year old gene therapy company, has received £5 million in new venture finance to expedite the development of a treatment for choroideremia, an inherited cause of progressive blindness. This brings total funding for the company to £17 million.
Autolus Ltd, an oncology spin-out from University College (UCL) London, has raised £30 million in a Series A financing from Syncona LLP in order to develop a new generation of engineered T cell therapies. The funding, which is significant for a start-up, reflects the expectations of the founders that the new T cell technology will revolutionise the treatment of cancer. Besides Syncona, the other founder is UCL Business Plc, the technology transfer arm of UCL.
Cardio3 BioSciences SA has acquired a portfolio of immuno-oncology assets in the US thereby expanding its therapeutic focus to cancer in addition to cardiovascular medicine. The Belgium-based company specialises in regenerative medicine.
The European Medicines Agency’s main scientific committee is recommending approval of a stem cell therapy to treat limbal stem cell deficiency. It is the first positive opinion for a stem cell therapy and the fifth for an advanced therapy medicinal product (ATMP).
The Court of Justice of the European Union has issued a decision in a patent case brought by a US corporation which gives a fresh interpretation to restrictions laid down in 2011 on the patentability of human embryos for industrial or commercial purposes.
Pfizer Inc is prepared to commit up to $280 million to an experimental gene therapy for haemophilia which is under development by Spark Therapeutics in the US, while at the same time reinforcing its gene therapy research capacity in the UK.
Novartis and the University of Pennsylvania have issued a clinical update of their cell therapy for paediatric patients with acute lymphoblastic leukaemia (ALL) showing that 36 out of 39 patients, or 92% of trial participants, experienced a complete remission of their disease.
A medical device which is intended to treat congenital malformations of the heart using a regenerative medicine approach has been backed by a syndicate of leading European investors in a €27 million Series B financing round.
France-based TxCell SA has enrolled the first patient in a new trial of its cell therapy for Crohn’s disease which aims to demonstrate that 160 patients with refractory disease can experience relief. Crohn’s is an inflammatory bowel disease affecting the gastrointestinal tract.
Israel-based Pluristem Therapeutics Inc has entered into a long-term collaboration with the Hadassah Medical Center in Jerusalem to assess the potential efficacy of a cell therapy for the treatment of complications arising from bone marrow transplantations.
Promethera Biosciences SA, a Belgian company developing cell-based treatments for in-born errors of metabolism and acquired liver disease, has raised €20.3 million in a Series C venture capital round and €5 million in loans and subsidies from the regional government of Wallonia.
London-based Cell Medica Ltd has raised £50 million from institutional investors to support development of its lead oncology product, CMD-003, for the treatment of patients with advanced lymphomas associated with the Epstein Barr virus.
Scientists expect to have readouts next year from cell and gene therapy trials that could show that regenerative medicine is finally gaining traction.
The US Food and Drug Administration has granted ‘breakthrough therapy’ status to a gene therapy that is in Phase 3 development for patients with an inherited eye disorder that can lead to blindness. The developer is Spark Therapeutics of Philadelphia, Pennsylvania.