Cell-based Cancer Immunotherapies. Some metrics..

By Dr. Matthew Watson

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 $290,000
Projected 2012 Revenue: ~$380,000

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: