Cell-based Cancer Immunotherapies. Some metrics..

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Whatever one makes of Dendreon's challenges in bringing Provenge to market and then its ups and downs in the market, the whole affair has brought a much bigger spotlight to cancer immunotherapies and cell-based immunotherapies in particular.

This is true on all fronts.  Cancer immunotherapy conferences are popping up everywhere.  A growing number of of analysts are now covering a growing number of companies in the space with coverage ranging from bearishly critical to ebullient bullishness. Some venture capital firms are now loosening their purse strings for immunotherapy plays and both pharma venture funds and business development departments are now spending an increasing amount of time actively monitoring and exploring potential plays in the sector.

One of the best annual industry summaries of what is happening in the sector is sponsored by MD Becker Partners through its annual Cancer Immunotherapy: A Long Awaited Reality conference held each in New York, this year on October 4 and select video replays it hosts on its YouTube channel.

Some Segment Metrics

As part of our ongoing industry intelligence and consulting services we actively track the activity and progress of industry-sponsored clinical trials of all cell therapies in addition to the products already on the market.  Here's how our data stacks up regarding the cell-based immunotherapies segment of the sector:

Commercial:

• Dendreon's Provenge
• Autologous immunotherapy for prostate cancer (1 monthly dose for 3 months)
• Efficacy: prolongs survival
• Markets: only the United States (approved April 2010)
• Next markets: submitted the marketing authorisation application to the EMA (European Medicines Agency) in early 2012 and hopes to introduce Provenge in the European market in 2013
• 2011 Revenue $290M
• Projected 2012 Revenue: ~$380M

Phase III or II/III:

• Argos Therapeutics' AGS-003
• phase III trial not yet recruiting
• Indication: advanced renal cell carcinoma
• Estimated enrollment: 450
• Estimated primary completion: June 2014 

• Cell Medica's Adoptive Cellular Therapy (ACT) 
• phase III trial actively recruiting
• Indication: cytomegalovirus infection following allogeneic stem cell transplantion
• Estimated enrollment: 90
• Estimated primary completion: June 2013

• JW Creagene's CreaVax-RCC 
• phase III trial actively recruiting
• Indication: metastatic renal cell carcinoma
• Estimated enrollment: 54
• Estimated primary completion: unknown

• Kiadis Pharma's alloreactive T-cells (ATIR)
• phase II/III trial currently suspended
• Indication: infections and relapse assoc’d w/ SCT for leukemia and other hematologic malignancies
• Estimated enrollment: 70
• Estimated primary completion: TBD

• MolMed's TK
• phase III trial actively recruiting
• Indication: acute leukemia
• Estimated enrollment: 170
• Estimated primary completion: January 2014

• Newlink Genetics' HyperAcute®-Pancreas (algenpantucel-L)
• phase III trial actively recruiting
• Indication: pancreatic cancer
• Estimated enrollment: 722
• Estimated primary completion: January 2014

• NovaRx's Lucanix
• phase III trial actively recruiting
• Indication: non-small cell lung cancer
• Estimated enrollment: 506
• Estimated primary completion: June 2012

• PrimaBioMed's Cvac
• phase II/III trial actively recruiting
• Indication: epithelial ovarian cancer
• Estimated enrollment: 1,000
• Estimated primary completion: March 2015

Phase II or I/II

• 50 industry-sponsored clinical trials of cell-based immunotherapies actively recruiting, active no longer recruiting, active not yet recruiting, or anticipated to commence yet in 2012
• ~10 of these are expected to have readouts yet this year
• Trial sites in US, Canada, UK, continental Europe, Israel, South Korea, India, Australia
• Expected enrollment of 3,500+

Investment:

The following are notable cash infusions into the sector for 2012 to-date:

• Bellicum Pharmaceuticals.  $20M series B. 
• CellMedica. $15M grant from CPRIT in Texas.
• Argos Therapeutcs. $25M Series D.
• Northwest Bio.  $5.5M grant from German gov't Saxony Development Bank

Hope this is useful.

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This post has been brought to you by your friends at CTG.  All cell therapy. All the time. :)  

-- Lee @celltherapy

p.s.  As always we welcome your feedback, comments, and corrections.