Biotech Breakthrough: The Age of Immunotherapy

By Ray Blanco | The Daily Reckoning Dec 12, 2013, 8:07 AM 

Cancer is moving up in the world lately. It’s the leading cause of death in the United Kingdom, and it will soon become the biggest killer in the United States. I had my own brush with this threat at the ripe old age of 20. Thankfully, I’m still alive, thanks to technology that became available by the 1990s. Only a few decades sooner and I’d just be a memory.

Unfortunately, millions of lives are still prematurely ended by a disease caused by cells gone haywire. Today, I’m going to tell you one important way that will change — and how you will be able to profit in both wealth and health.

It isn’t so much that cancer is deadlier than it used to be in times past, by the way. I’m living proof of that. We are constantly improving our ability to fight the disease, and we make progress every year as new diagnostic tests or therapies become available. The reason cancer is moving up the ranks is because of relative improvement compared with other life-enders — we’ve become much better at dealing with other big killers, like heart disease, than with cancer.

Growing tumors would sometimes shrink after a bad fever caused by a systemic infectious disease.

Overall, we live longer, of course. But the flip side of living longer is that cancer rates tend to rise as we age. Since we now escape cardiovascular ravages at greater rates than ever before, our cells reach ages where they become more prone to malignant mutation.

Cancer is tough because it isn’t a single disease, but a group of diseases. The more we learn about it, the more complex it appears.

In addition, cancer is highly adaptive. Like the Borg, that alien race of cybernetic aliens from Star Trek, it can quickly adjust and neutralize our most powerful weapons. Not only is cancer complex at the cellular level, but we are also learning that a tumor can contain different kinds of cancer cells, making it much like an organism in that sense. We may be able to develop a drug that can wipe out one kind of cancer cell, but others can survive and regrow a tumor — I’ll tell you more about that shortly.

Some people think we’ll never vanquish this biological Borg. I believe they’re wrong and that we eventually will. Even if we don’t find a single magic bullet to end the relentless advance of mutant cells once they’ve appeared in the body, we can develop a suite of weapons that, if used in combination, can eventually slay the invaders in cases that are incurable today.

We are now, in fact, in the early stages of a huge change in how we treat cancer. An arms race is on to upgrade our own naturally present immune cells to overcome the shifting defenses used by cancer to survive. Like nearly all new technologies, there have been false starts and reversals over the past years, but serious progress is now being made.

The basic idea behind this technology isn’t new. Over 150 years ago, physicians began to notice how patients with cancer who also developed infections could get better. The infection did not even have to be at the same site as the tumor: Growing tumors would sometimes shrink after a bad fever caused by a systemic infectious disease.

This led some early oncology pioneers to devise injectable bacterial cocktails that occasionally worked. These researchers hypothesized that the pathogens worked either by directly attacking cancer cells or by waking up a sleepy immune system.

However, this form of therapy, which we’ve come to call immunotherapy, was eventually set aside in order to concentrate resources on other methods that were more promising with the technology of that time. Chemotherapy and radiation therapy became the principal weapons in the oncologists’ arsenal. We found it was easier to create therapies using chemicals or electromagnetic waves, rather than finding ways to functionalize our body’s defenses to fend off cancer cells.

As I mentioned, that’s now changing fast — and it’s the small biotechnology innovators that are leading the charge. We are reaching a turning point in immunotherapy research. With hundreds of programs under development, it is now a heavily researched oncology field.

There are still plenty of skeptics regarding the promise of this technology, but I’m not one of them. In fact, I believe biotechnology investors who don’t participate in this new wave of cancer therapy will be missing out on historic profit opportunities.

We’ve seen these epochal shifts in cancer technology before, so this isn’t something new. What is new is the rate of change, which is accelerating. Antibody-based therapies, for example, were almost science fiction-esque in the early 1980s. By the ’90s, however, we began to see the first approvals for these antibody therapies against cancer. Now there are dozens of marketed mAbs (monoclonal antibodies), with many more on the way — and the market is vast.

The immunotherapy market will also be enormous — and it is only just starting to take off. Citigroup analysts estimate that the market will generate $35 billion per year over the next 10 years as existing therapies grow market share and new therapies enter commercialization.

The way Provenge works is radically different. As an active immunotherapy, it is a kind of cancer vaccine.

There’s a lot of gold in those hills.

Only two approved immunotherapies exist right now. One, marketed by Bristol-Myers Squibb (BMY), I discussed in my Breakthrough Technology Alert newsletter. This immunotherapy was originally developed by my former portfolio recommendation Medarex.

The therapeutic agent itself is an antibody called ipilimumab (marketed as Yervoy). Unlike other antibody therapies, however, Yervoy works by activating immune system cells. It used existing antibody technology to do something new. (Medarex was subsequently purchased by Bristol-Myers Squibb in 2009, yielding our newsletter’s readers a 235% gain.)

The other marketed therapy is Dendreon’s (DNDN) sipuleucel-T (Provenge) for prostate cancer. The way Provenge works is radically different. As an active immunotherapy, it is a kind of cancer vaccine. With Provenge, a type of white blood cell called an antigen-presenting cell (APC) is taken from a patient’s blood. It is then modified to present a single prostate cancer antigen to the rest of the immune system when it is later re-injected into the patient.

While a great advance from a scientific standpoint, Provenge has faced real challenges in the marketplace. A blood draw must be processed in the lab for every dose, making it expensive from a cost-of-goods standpoint. In fact, most of Provenge’s hefty $90,000-per-course-of-therapy price tag is consumed by the cost of producing it. Furthermore, this therapy only delivers a survival benefit of about four months over not using it.

Still, Provenge has shown the path toward a new form of cancer therapy. Next-generation active immunotherapies will be able to improve on Provenge.

Sometimes, the advantage in the marketplace doesn’t go to the first mover, but to follow-on entrants who learn from the mistakes of their predecessors.

Keep your eyes on this space!

Ad lucrum per scientia (toward wealth through science).

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