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.

--

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.  

Cell Therapy HiLites 2008-11-28

For what is typically a slow business week in the US, the cell therapy sector had some big news. More money, more deals, and some interesting developments to watch.

Argos Therapeutics completed a second and final tranche of a $35.2 million Series C financing from new and existing investors (the first tranche was completed in April 2008) to support ongoing phase II trials of its RNA-loaded dendritic cell product in renal cell carcinoma and HIV as well as support the further pre-clinical development of its CD83 soluble protein for transplant rejection/autoimmune disorders

In a move I'd say has some elements of "perfect timing", Novocell CEO, Alan Lewis, announced he plans to leave the company after 3 years at the helm to head up the well-funded and well-connected JDRF. Alan positioned the company well and leaves it with a healthier cash balance than many in its position. Due to the nature of ESC work and the financial markets Novocell has an arduous road ahead of it but they are at the forefront and have the backing from some heavy hitter investors.

Sigma-Aldrich entered into a research collaboration with South Carolina's D-Finitive Cell Technologies, Inc. The collaboration is expected to support the development and commercial offering of 14 products over a two-year span with a planned launch of many of these products in 2009 expected to consist of serum-free media for bone marrow and umbilical cord stem cells, mesenchymal stem cells and neural stem cells; cytokine cocktails for stem cell expansion and differentiation; novel formulations for cyropreservation of stem cells; and specialized products to conduct clonogenic assays of the various stem cells. Paul Price, the man behind the science at D-Finitive, is a key component to the deal.

James Thomson's Cellular Dynamics International- focused initially on creating cells for pharma toxicity testing - merged with its two sister companies, Stem Cell Products Inc. and iPS Cells Inc. and raised $18 million (link).

t2cure acquired a patent family in in vitro potency testing patents for testing of stem cells for cardiovascular applications which it intends to use in its phase III trial starting next year.

Cytori announced it is strengthens it European Union sales, training and service operations with key hirings and expansions. The company is introducing its Celution^® 800 System in Europe into the reconstructive surgery market. The Celution® Technology has been developed as a bedside device to enable real-time, adult stem and regenerative cell processing. The technology automates and standardizes the separation and concentration of a patient’s own (autologous) adult stem and regenerative cells from body fat (adipose) for real-time redelivery to the same patient - at the moment primarily patients recovering from the effects of breast cancer treatment.

Something's up at Stem Cell Sciences. Last week they announced they had signed a Master Service Agreement of up to five years with Pfizer Limited, the UK operating unit of the global research-based pharmaceutical company Pfizer, Inc. (NYSE: PFE - News). Under the terms of the agreement, SCS will provide research services, cell lines, media and reagents to support Pfizer's R&D efforts in the field. It is no secret the company has been busily reinventing itself and signing of a major deal with a pharmaceutical has been one of their stated goals since they did a major re-org of the company. Nevertheless, on the heals of the deal the company announced that they requested a temporary suspension in the trading of its shares ahead of what it described as a review of its financial position and strategic options. It will be curious to see what transpires.

As Jon Rowley pointed out, last week I missed Aastrom's announced treatment of the first patient in its U.S. Phase II trial of their Cardiac Repair Cells (CRCs) in the treatment of dilated cardiomyopathy (DCM).

That's just the way I saw cell therapy this week...