|Three micro-caps set to benefit from Dendreon's good news|
|Monday, 22 November 2010 09:20|
Just as industry-watchers had predicted, Dendreon (Nasdaq: DNDN) not only cleared a hurdle for themselves last week after a special panel of experts advised Medicare and Medicaid that the federal government should pay for its $93,000 prostate-cancer treatment, the victory for Dendreon may have just helped paved the way for other up-and-coming immunotherapy companies and their product candidates.
Some industry observers pointed out that the review of the pricey treatment smelled like a cost-cutting crusade, but the nod for Medicare reimbursements is an extremely important step, especially since Dendreon expects Provenge to generate more than $1 billion in annual sales and because the reality is that most prostate cancer patients are over 65 and thus covered by Medicare. While the Centers for Medicare and Medicaid Services panel backed Dendreon's cancer vaccine it was very careful to only allow the expensive reimbursement for the use specified on its label.
The biopharmaceutical industry is marked by rapid and significant technological changes and advancements whose perceived victories and defeats often affect other companies working on similar indications or treatment candidates, so while others may have missed the implications for the entire sector, it wasn’t news that went unnoticed at other firms which are working on their own immunotherapy treatment candidates against cancer- especially since Medicare coverage decisions often also influence private insurers’ decisions on drug coverage.
One company that must have been very excited to hear the news was Northwest Biotherapeutics (OTC: NWBO) whose cancer therapy technology platform, DCVax® utilizes the biology of a patient's own dendritic cells, which are a type of white blood cell that activate the immune system.
Loaded with tumor proteins or antigens, injection of these cells are put back into the body and the patient initiates a potent immune response against said cancer cells, resulting in delayed time to progression and prolonged survival for patients with Glioblastoma multiforme (GBM)- one of the most aggressive and lethal forms of cancer.
Thus far in Phase I and Phase II clinical trials, the drug candidate showed both substantially greater survival data as well as substantially improved recurrence rates.
In addition, there are several rumors circulating that NWBO is in discussions with major international pharmaceutical players who have focused in on DCVax’s significant advantage in costs and simplicity of delivery. Such discussions and developments as they emerge in the coming months, could serve to validate the strength of the data that NWBO has already presented at various conferences and in print. In the United States, the incidence of GBM is about 10,000 -12,000 cases per year, prevalence is approximately 25,000. Worldwide, the incidence and prevalence is approximately double that number.
The case for NWBO is also intriguing because of the company’s unique batch manufacturing process, which they have developed over the last decade, may someday allow NWBO’s treatment candidate to come in well below half of what Dendreon’s treatment costs.
The stock has seen a 52 week range trading between $0.64 and $1.72. Shares are near the lows of the year ($0.75) and likely set for another cycle back in the other direction.
See the story of one cancer survivor who was treated with NWBO’s DCVax: http://alturl.com/mk85p
ImmunoCellular Therapeutics (OTC:IMUC) is another worthy contender for consideration. It’s treatment candidate, ICT-107, is similar to Dendreon’s Provenge in that it is also made by harvesting a patient’s own dendritic cells and programming them to attack cancer. But unlike Provenge, multiple doses of ICT-107 may be produced from a single batch of dendritic cells thanks to the company’s new manufacturing methods which were developed with the University of Pennsylvania. According to ImmunoCellular’s president and CEO Manish Singh, PhD, this proprietary manufacturing method will provide significant cost and convenience benefits over methods currently used to manufacture dendritic cell-based vaccines.
As promising as ICT-107 is, ImmunoCellular is no one-trick pony. In its pipeline is an off-the-shelf vaccine targeting multiple antigens expressed by cancer stem cells, which is expected to begin Phase I testing early next year. The company is also developing a range of monoclonal antibodies with broad therapeutic and diagnostic applications.
Shares are currently trading at just over $1 with a 52 week range between $ 0.76 and $2.44 and with ImmunoCellular starting a Phase II clinical trial for ICT-107, I would expect that shares are also in a position to start climbing.
See Daily Finance's recent write-up on IMUC: http://alturl.com/jk4yx
Finally, an early candidate which is expected to move into human trials either later this year or during the first quarter of next year is TapImmune Inc. (OTC:TPIV).
The company’s ‘Elegantly Simple’ cancer and infectious disease vaccine has been getting not only increased media attention (see links from recent articles below), but the company recently signed a licensing option agreement with the Mayo Clinic for a breast cancer antigen technology complementary to the company’s TAP (AdhTAP) immunotherapy innovation. In a novel approach, TapImmune and the Mayo Clinic will co-develop a specialized vaccine for patients with very aggressive HER2/neu breast cancer.
AdhTAP is a TAP1 Cancer Vaccine consists of the human TAP gene. It delivers the human TAP gene into cells to initiate and enhance the immune response towards cancer cells, in fact in animal trials, the vaccine spurred remarkably aggressive immune response, offering broad reaching therapeutic possibility.
“In the case of the infectious disease if you just increase the normal level of TAP in cells you could in animal models for example, small pox, increase the potency of a small pox vaccine by 100 to 1000 fold, “ explains the company’s Chairman and Principal Executive Officer, Dr. Glynn Wilson. “What we are dealing with here is a central component of the immune system which we are putting back and it is a very specific platform and we are now getting towards the clinical studies that will demonstrate this effectiveness in man.”
As an an internationally renowned expert in drug delivery technologies, Dr. Wilson should know. He was the former Head of Drug Delivery at SmithKline Beecham Pharmaceuticals.
After cleaning up debt, placing new management, securing 100% ownership of the all of the IP and technology related to their pipeline as well as securing some key partnerships, TPIV’s very low and tightly held float should see a significant rise from these greatly discounted price levels which saw shares close at $0.18 last week.
TPIV’s 52 week trading range has been between $ 0.08 and $0.85 and increased attention from the investment and scientific community plus the pending move into human clinical trials has shares set to significantly appreciate in price from these levels.
See Pharma Magazine's recent article on TPIV: http://alturl.com/bwrd3
Disclosure: Long NWBO, TPIV