When investors think "immunotherapy", they tend to think of companies like Amgen, Inc. (NASDAQ:AMGN) or Dendreon Corporation (NASDAQ:DNDN). And well they should. Dendreon was the first biotech outfit to come up with a big - and approved - potential game-changer (prostate cancer therapy Provenge) in the immunotherapy world, and the deep-pocketed Amgen is turning heads with T-Vec - an immunotherapy that fights tumors, currently in Phase 3 trials. Sometimes though, being big or being the first to market doesn't necessarily make a stock an investment-worthy ticker. Sometimes it's the little guy that actually has the better technology, and learns from the mistakes made when other biotechnology companies may have rushed in, if not with relatively ineffective medicines, than at least errors in judgment. TNI Biotech Inc. (OTCMKTS:TNIB) may well be one of those "second wave" names that isn't getting a lot of attention now, but has an immunotherapy in the works that could up-end bigger players like DNDN or AMGN.
First and foremost (and to give credit where it's due), kudos to Dendreon as well as Amgen. Dendreon's Provenge was the first cancer immunotherapy to hit the market, and even if Amgen never has any intentions of introducing a cancer immunotherapy, it would still be one of the pharma market's most successful companies. Still, with more than two years of sales-time under its belt, it's fairly clear that either Provenge (at $96,000 per patient) is too costly and/or too ineffective to draw a real buying frenzy, while Amgen's first tumor immunotherapy, T-Vec, only showed significant improvement in treatment outcomes with a small set of melanoma patients; stage 3 patients observed a 33% improvement in response, versus less impressive responses for patients with other stages of cancer. And, there were serious adverse reactions with about twice as many T-Vec takers as there were compared to the control group.
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Though the underlying biotechnology is worth studying in the future, we now know there's still some work to be done on both fronts. Enter TNI Biotech.
While most investors may understand that cancer immunotherapy is the art and science of tweaking a patient's own immune system to fight an ailment on its own (agreed by most everyone that this could be the most potent way to fight any cancer), what most investors don't realize is just how complicated the human body's immune system is. The biopharma industry sill doesn't know as much as it does know about it, and it still discovering how and where those tweaks can be and should be made. It's entirely possible for an unknown, small company like TNI Biotech Inc. to be sitting on the breakthrough that most investors might expect an Amgen or a Dendreon to make. In fact, it's starting to look that way already.
The work TNI Biotech is doing focuses on LDN (low-dose naltrexone) and MENK (methionine-enkephalin). These two drugs have been shown to boost and even restore an immune system simply by increasing the T and NK cell count, which prompts a person's internal immune response. What's so compelling about LDN and MENK is their adaptability. They're believed to be more "core" to a person's own defenses, and therefore may create a more foundational and more effective immune response. Said a different way, while Amgen or Dendreon may be landing punches all around the target, TNIB may be landing them right on the bulls-eye... perhaps without even realizing it yet.
More work needs to be done to be sure, but TNI Biotech is doing that work. Indeed, it's already done or acquired much of that work. It's ready to start phase 3 trials of LDN as a treatment for Crohn's. It's near-ready to start phase 2 trails of LDN as a therapy for multiple sclerosis. Trials of MENK as a treatment for cancer are near-ready to begin phase 2 as well. Not bad for a $137 million company nobody saw coming, or a company that most people still don't see coming. It just goes to show you that good things can come in small packages.
While TNI Biotech is certainly willing and able to go the distance with all of its planned trials, odds are good it would be acquired before even needing to do so - "big pharma" is still looking to fill up its depleted pipeline. You can learn more about TNI Biotech at its website.
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