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Category Archives: Regenerative Medicine

Another > $100M month for companies in the cell therapy space

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Last month we reported here on this blog that March was more than a $100M month for companies in the stem cell and cell-based regenerative medicine space in terms of monies raised.  

What we missed was a $15M grant from Cancer Prevention and Research Institute of Texas (CPRIT) for UK-based CellMedica.  This pumps last month's total to just under $140M.

This month, according to our sources, betters even March's better numbers by coming in at just over $170M though that is largely on the back of one large deal in Asia.  Here's how the numbers break down.

Allocure kicked off the month with a decent $25M Series B round from new syndicate member Lundbeckfond Ventures, as well as previous investors SV Life Sciences and Novo A/S.  Allocure is headed into phase 2 for acute kidney injury with an allogeneic mesenchymal stem cell therapeutic they currently call AC607.  


Little-known Canadian-based, Sernova then announced a $3.6M PIPE to fund continued development of its proprietary Cell Pouch System(TM), and, in particular, to fund the upcoming first-in-man clinical trial for patients with diabetes receiving an islet transplant.  The application to proceed with this trial is currently under review by Health Canada.


Next up was NeoStem closing a $6.8M public offering for "expanding" their contract manufacturing business, Progenitor Cell Therapy, and "enrolling the PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack".  


The biggest deal of the month was a $65M convertible debt financing of China Cord Blood by none other than global powerhouse Kohlberg Kravis Roberts (KKR) through it KKR China Growth Fund L.P., a China-focused investment fund managed by KKR.  We believe this is deal is certainly an investment in the future of China's healthcare market potential but that it is bigger than that.  We believe a significant driver for this deal may likely have been the opportunity to consolidate this sector globally - to use a significant operation and 'war chest' to fund mergers and acquisitions on both the public and private cord blood banking sector worldwide.


The only classic first-round venture raise this month was a milestone-based $5M Series A by Bay City Capital into Phil Coelho's new company, SynGen, to fund his latest iteration of stem cell processing devices.


Forbion Capital then announced that it was leading a series D round, joined by fellow existing investors TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group, and Aurora Funds, of $25M into Argos Therapeutics in order to kick them into their phase 3.  The hope here is that with some early phase 3 data they may be able to attract the elusive partner they couldn't land with a mere bucket of phase 2 data.


Innovacell landed the only European deal by announcing an 8.3M Euro (~$11M) investment by Buschier, Fides, HYBAG, and Uni Venture.  This will be used for the continued clinical development of its cell-therapy (ICES13) for the treatment of stress-urinary incontinence currently in a ph 3 study in several European countries.


ReNeuron announced a private placement also open to existing shareholders that brought in just under $10M (£6.1M) to support their phase 1 trial in stroke and other pre-clinical, clinical, and regulatory milestones. 


Finally, the Bio-Matrix Scientific Group, in an apparent ongoing quest to continuously reinvent itself, announced at month's end that they had formed a new subsidiary named Regen BioPharma and that they had raised $20M in a financing commitment from Southridge Partners II to purchase its common stock as required over the term of the agreement at a price set by an agreed formula.  This money is said to be dedicated to the acquisition of discovery-stage intellectual property and driving it through to phase 2 trials in an exercise of maximum value creation over a period they claim to be as short as 18-24 months.


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So in the end, the month saw companies in the space raise just over $170M and even if you back out the stem cell banking deal its still over $100M for cell therapy companies.  


Over the 2 months, then, we've seen just over $311M raised through a variety of means by companies at every stage of maturity and for intended purposes ranging from acquisition, consolidation, early stage clinical development, and phase 3 testing.


--Lee


p.s. If you are aware of other deals in the sector this month, let us know and we'll update this accordingly.


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2011 EMA Committee for Advanced Therapies (CAT) classification record. What can be learned?

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What follows is the record of "classifications" done by the ATMP CAT in 2011 related to anything I would call "cell therapies". 


In my opinion there are a couple surprises. I'm surprised at the non-cardiac cells (MNCs, CD133s, and MSCs) for cardiac disease/repair being designated TEPs. I'm also surprised at the islets not being classified as an ATMP.


I've tapped into my European and/or regulatory colleagues to help explain those two as well as help us draw any other conclusions or observations we can make in terms of how the CAT is thinking based on the compendium of classifications we have to-date.  I'll post an update here when I have something useful.
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In January, the following product was classified as a tissue engineered product - not combined:

  • Layer of autologous corneal epithelium containing stem cells intended for the treatment of extended corneal lesions



In April, the following product was classified as a tissue engineered product, combined: 

  • Allogeneic human fibroblasts cultured onto a biodegradable matrix, intended for use of conditions in the therapeutic area of dermatology



In May, the following product was classified as a somatic cell therapy medicinal product: 

  • Heterologous human adult liver-derived progenitor cells, intended for the treatment of inborn errors of liver metabolis



In July, the following product was classified as a Tissue Engineered Product, non-combined:

  • Suspension of allogeneic bone-marrow derived osteoblastic cells, intended for the treatment of non-union, delayed union or other fractures. 



In September, the following product was classified as a Tissue Engineered Product, non-combined:

  • Autologous mesenchymal stem cells (MSC), intended for the treatment of chronic heart failure symptoms by improvement in exercise capacity of NYHA class II and III chronic heart failure patients receiving standard therapy

     and the following product was not classified as an ATMP: 

  • Human islets of Langerhans, intended for: Post pancreatectomy for benign pancreatic pathologies (autologous); Treatment of severe forms of type 1 diabetes (Allogeneic)



In October, the following product was classified as a somatic cell therapy medicinal product: 

  • Autologous dendritic cell (DCs) immunotherapy consisting of autologous mature DCs coelectroporated with autologous RCC IVT RNA and synthetic CD40L IVT RNA, intended for the treatment of patients with advanced renal cell carcinoma



In November, the following products were classified as tissue-engineered products:

  • Concentrate of autologous bone marrow mononuclear cells (MNC), intended for improvement of heart function and quality of life in patients with chronic ischaemic heart disease and after MI.
  • CD 133+ Autologous bone marrow derived stem cells, intended for Improvement of heart function (LVEF) and quality of life in patients with chronic ischemic heart disease and after MI



In December, the following product was classified as somatic cell therapy medicinal product:

  • Autologous CD4+ T cells targeted to cells presenting class II restricted epitopes, intended forthe treatment of autoimmune diseases with MHC restricted specific immunity e.g. multiple sclerosis, type I diabetes or graft rejection.

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Inactive and recently failed or terminated phase III or II/III cell therapy trials



In the two previous posts I have outlined what I believe to be the active phase III and II/III cell therapy trials, as well as the cell therapy products to have 'recently' obtained formal regulatory market approval in some jurisdiction.


In the course of doing that work, I came across the following industry-sponsored phase III cell therapy trials which appear to be inactive and those which failed or were terminated.


INACTIVE INDUSTRY PHASE III    

  •     Aastrom              BRCs
  •     Aldagen              ALD-101
  •     Arblast               AMT-301
  •     Avax                  Mvax
  •     HepaLife Tech      HepaMate
  •     KeraCure             KeraPac
  •     t2cure                BMCs
  •     TVAX                 TV-Brain
  •     TVAX                 TV-Kidney-1

   
RECENTLY FAILED /TERMINATED INDUSTRY PHASE III   

  •     ABH (now Shire)        Dermgraft
  •     Cellerix                    Cx401

I don't imagine this is an exhaustive list but as I have encouraged in previous posts, I welcome feedback as to errors, corrections, or omissions.   I'm using the 2009-11 time-frame here.  I'll update the post accordingly.

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Recently approved cell therapy products

Following is a list of cell therapy products approved recently (2010-11):    

  •  Dendreon                           Provenge                           US
  •  FCB-Pharmicell                 Hearticellgram-AMI           Korea
  •  Fibrocell Sciences              Laviv                                  US
  •  Living Cell Technologies    DIABECELL                     Russia

 Honorable mention goes to TiGenix' ChondroCelect approved in late 2009 representing the first EMA approval of an ATMP:

  • TiGenix                              ChondroCelect                   EU

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Active phase III or II/III cell therapy trials

I know that the moment I publish anything that purports to be comprehensive there will be errors and omissions.  At the very least it will almost imminently be out-of-date in a fast-moving sector like cell therapy.
Nonetheless, because there is no other reliable repository of this information, I am daring to put this out there and hope you will feel obligated to assist me in ensuring its accuracy rather than critical of the effort.
What follows is what I currently believe to an current and relatively comprehensive list of phase III or II/III cell therapy trials around the world.  I am more confident of the industry list than the academic one.  More confident of its completeness and accuracy for North American and Europe than of Asia (particularly China). 
There is a spreadsheet behind this that includes more data fields like therapeutic category, cell/tissue source, cell type, expansion, indication, expected completion date, clinical trial site locations, etc.  If you want a copy of it, just email me (I'm not hard to find) or comment below.

INDUSTRY PHASE III or II/III (active or expected to be active in 1H 2012)  

       
    Aastrom                         Ixmyelocel-T
    Baxter                            ACT34-CMI
    Bioheart                         Myocell
    Cardio3 Biosciences         C-CURE
    Cardio3 Biosciences         C-CURE
    Cell Medica                     adoptive cellular therapy
    Cook Myosite                  AMDC
    Cytori                            ADRCs
    GamidaCell - Teva           StemEx
    Genzyme                        MACI
    Harvest Technologies       SmartPReP 2 BMAC
    Innovaell                        IES13 (Urocell?)
    Kiaidis Pharma                ATIR
    Miltenyi                         CliniMACS CD34 Selection System
    Medipost                       Cartistem
    MolMed                         TK
    Newlink Genetics            HyperAcute Pancreas
    NovaRx                         Lucanix
    Osiris                           Prochymal
    Osiris                           Prochymal
    Pervasis                        Vasugel
The 21 active or imminently active cell therapy industry-sponsored trials listed above break down as follows:
    • 52% (12) are autologous
    • 33% (7) are allogeneic
    • Two are gene-modified allogeneic
    • One involves autologous and allogeneic cells
    • 24% (5) are for cardiac-related indications
    • 33% (7) are for oncology or related indications
    • Two are for cartilage repair

 
* ACADEMIC PHASE III or II/III
  • Assistance Publique - Hôpitaux de Paris (France)
  • Association of Dutch Burn Centres (Netherlands)
  • Barts and The London NHS Trust (UK)
  • Erasmus Medical Center (Netherlands)
  • European Group for Blood and Marrow Transplantation (Europe)
  • Leiden University Medical Center (Netherlands)
  • Meshalkin Research Institute of Pathology of Circulation (Russia)
  • Meshalkin Research Institute of Pathology of Circulation (Russia)
  • Ministry of Health (Malaysia)
  • Royan Institute (Iran)
  • Rush University Medical Center, University of Sao Paulo, Uppsala University (US, Brazil, Sweden)
  • Third Military Medical University (Chia)
  • University of Minnesota, Masonic Cancer Center (US)
  • University of Minnesota, Masonic Cancer Center (US)
  • University Hospital of North Norway (Norway)
  • University of Utah (US)
* Active trials only - excludes trials which appear inactive, abandoned, and/or are stem cell transplant in oncology.  Primary source is CinicalTrials.gov.
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I will try to keep this list updated at least once-per-quarter and indicate the date of the last update at the top of the post.
I eagerly encourage all readers to comment below or email direct with any errors and/or omissions.

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