Many approaches to cancer treatment sound good in theory and can even show early clinical promise, but the odds are typically stacked against them in later-stage studies. An important reason for the dicey odds of success in cancer-drug development was recently articulated by ASCO president, Dr. Sandra Swain: "We know cancers are smart," she said, explaining that cancers tend to find other ways of growing and spreading when one pathway is blocked.
As much as the smart, evasive nature of cancer is a challenge, however, it also provides a clue as to which approaches could be most successful at treating it. Since many cancers utilize multiple pathways at once, defeating it requires simultaneously blocking as many of those pathways as possible. Treatment regimens designed to inhibit multiple pathways at once are, therefore, highly promising in theory, and a number have also shown promise in practice. Earlier this month, GlaxoSmithKline (GSK) presented encouraging data from a small Phase I study of a combination therapy designed to target two pathways implicated in melanoma, BRAF and MEK.
Combination therapies seem to be such an intuitive solution to the problems of effective cancer treatment that it's easy to wonder why they aren't more common.
The simplified reason is that the benefits of combining drugs also come with the risks of the combined side-effects, which require careful regulatory evaluation, and often are too great to take in patients who are already sick.
The ideal cancer treatment, then, would be a single drug with multiple targets and a favorable safety profile - preferably one that would allow it to be combined with other drugs. Los Angeles-based ImmunoCellular Therapeutics (IMUC) has one such drug in clinicals, and based on current data and a number of upcoming milestones, this small company is on the verge of making some big waves. While their therapy isn't designed to target pathways, it is designed to target multiple antigens. This is important as it increases the number of cancers it can potentially target, and it enables the therapy to continue working in the event that the antigen expression changes for a specific cancer being treated.
IMUC is focused on the development of cancer vaccines that target and destroy malignant cells by harnessing the patient's native immune system, which makes them inherently safer than small molecules. Unlike other immunotherapy companies though, IMUC is pursuing a polyvalent strategy that, thanks to its proprietary vaccine technology, allows its products to target multiple cancer antigens at once.
Early-stage clinical data indicate that this strategy is working. In a Phase I study in 16 patients with the deadly brain cancer glioblastoma multiforme (GBM), IMUC's lead cancer vaccine candidate, ICT-107, combined with current standard of care, demonstrated a three-year progression-free survival rate of 38.5%. Three patients have now lived four years free of disease, and one an almost unheard of five years. The sample size is small, but considering GBM patients have only a 6% chance of surviving three years disease-free with standard of care alone, these findings should not be dismissed.
A larger Phase II trial is now underway, with completion of enrollment expected this quarter, and final data anticipated by the fourth quarter of 2013. At this year's ASCO, the company announced that it has already enrolled over 200 patients for the trial in only 15 months. This may not sound like anything special, but considering that previous trials for the treatment of glioblastoma multiforme have taken as long as 3 years to enroll as many patients, it speaks volumes to the level of physician support for this new therapy.
Cancer may be smart, but based on the evidence to date, it could be that IMUC's polyvalent vaccines are even smarter. Having recently listed on the NYSE, there can be no doubt that a lot more smart money will be flowing into this company's stock. If value-oriented investors are smart, they'll beat them to it. This is a company with a valuation of under $150 million - a true hidden gem despite YTD gains larger than 100%. As many investors often say, "volume precedes price." The uplisting to the NYSE gives the company exposure to a different group of retail investors as well as institutional investors. Volume cometh and could precede additional gains? Only time will tell what this company, its lead product and its common stock will do in 2012 and beyond.
Disclosure: I am long IMUC.