Immunotherapy in the News

Cancer immunotherapy ETF tracks the hottest area of biotech

Launching a biotech exchange-traded fund after a big sell-off in the sector isn’t the best timing. But Brad Loncar, a popular biotech blogger and investor, hopes people will be intrigued by the very specific and very hot slice of the biotech sector his new ETF focuses on – cancer immunotherapies.

The Loncar Cancer Immunotherapy ETF (CNCR), which started trading Wednesday, invests in companies that treat cancer by using drugs that modify the body’s immune response so it goes after solid tumours such as melanoma or lung cancer, or that alter immune cells to combat blood malignancies.

To give investors access to this corner of the biotech world, the ETF holds 30 pharmaceutical and biotech companies. They range from household names such as Pfizer Inc. and Bristol-Myers Squibb Co. to names that many investors have never heard of, including Ziopharm Oncology Inc. and Bluebird Bio Inc.

Whenever a niche ETF comes out, one way to check whether it’s really providing value is to see how much its holdings overlap with broader ETFs in its sector. CNCR stands up well here: Its holdings have about a 22-per-cent overlap with the $8-billion (U.S.) iShares Nasdaq Biotechnology ETF (IBB).

A lack of overlap is one reason the PureFunds ISE Cyber Security ETF (HACK) was a hugely successful niche ETF when it was created in late 2014. Investors weren’t getting the exposure HACK offered in the mainstream tech ETFs. Also, HACK had impeccable timing, launching two weeks before the big Sony hack.

CNCR’s timing isn’t as good, coming after a biotech sell-off sparked by a Sept. 21 tweet from Hillary Clinton in which she promised to fight “price gouging.” Still, biotech remains the best-performing industry in the past 10 years, with a 300-per-cent return. That’s triple the return for the Standard & Poor’s 500 index.

CNCR gives each stock in its portfolio an equal weighting, which means smaller companies have the same impact on performance as do much larger ones. This tilt toward small caps increases volatility, so investors should expect a bit more jumpiness in CNCR than in IBB, where larger stocks will drive performance. CNCR charges investors 0.79 per cent of assets in annual fees.

Mr. Loncar, a biotech investor for more than eight years, said he finds biotech ETFs too broad and confusing. “A goal is to take biotechnology and break it down into one of its individual components – like cancer immunotherapy – that people are specifically interested in,” he said. “It’s a more straightforward and efficient way of looking at a sector.”

One could argue this isn’t technically the first cancer ETF. About a decade ago, HealthShares Cancer ETF (HHK) opened and liquidated in a little more than a year due to lack of interest. It might have been ahead of its time; 10 years ago, biotech ETFs had just $1.5-billion in assets. Today, they have $14-billion.

Chinese immunotherapy biotech BeiGene sets terms for $127 million IPO

BeiGene, a Chinese biotech developing immunotherapies based on kinase inhibitors, announced terms for its IPO on Tuesday.

The Beijing, China-based company plans to raise $126.5 million by offering 5.5 million ADSs at a price range of $22 to $24. Insiders intend to purchase 50% of the offering. At the midpoint of the proposed range, BeiGene would command a fully diluted market value of $756 million.

BeiGene was founded in 2010 and booked $6 million in sales for the 12 months ended September 30, 2015. It plans to list on the Nasdaq under the symbol BGNE. Goldman Sachs, Morgan Stanley and Cowen & Company are the joint bookrunners on the deal. It is expected to price during the week of February 1, 2016.

The article Chinese immunotherapy biotech BeiGene sets terms for $127 million IPO originally appeared on IPO investment manager Renaissance Capital’s web site renaissancecapital.com.

Investment Disclosure: The information and opinions expressed herein were prepared by Renaissance Capital’s research analysts and do not constitute an offer to buy or sell any security. Renaissance Capital, the Renaissance IPO ETF (symbol: IPO) or the Global IPO Fund (symbol: IPOSX) , may have investments in securities of companies mentioned.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

 

Biotech Breakthrough: The Age of Immunotherapy

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, 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 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).

5 Immunotherapy Stocks to Watch for Treating Cancer

Interest in immunotherapies continues to build up – earlier this week, Loncar Cancer Immunotherapy ETF (CNCR – ETF report), the first ETF dedicated only to stocks involved in the research and development of immuno-oncology treatments, started trading on NASDAQ.

The Loncar Cancer Immunotherapy ETF comprises both large pharma and growth-oriented biotech companies working on immuno-oncology treatments.
Understanding Immuno-Oncology
The basic concept of cancer immunotherapy or immuno-oncology is to utilize certain parts of the immune system to fight the disease. This can be done by stimulating the immune system to attack cancer cells or by introducing immune system components into the body. While some immuno-oncology treatments have the potential to be effective as monotherapies, others may be more effective when combined with other treatments.
Different types of immunotherapies include monoclonal antibodies/mAbs (man-made versions of immune system proteins which can be designed to attack a very specific part of a cancer cell), immune checkpoint inhibitors (recognize and attack cancer cells), vaccines (help prevent or treat cancer) and others that boost the overall immune system.
Encouraging results generated by some companies demonstrating partial and complete responses in late-stage cancer patients has raised hopes for cancer patients and increased interest in the investor community.
5 Promising Immuno-Oncology Focused Stocks
Given the growing interest in immuno-oncology treatments, let’s take a look at some pharma and biotech companies that are looking to change the way we treat cancer.
First on the list is Amgen (AMGN – Analyst Report), one of the biggest and most well-known names in biotech. The company saw its immunotherapy, Blincyto, gain FDA approval in Dec 2014, making it the first approved drug that engages the body’s T-cells to destroy leukemia cells. Amgen also has immuno-oncology focused collaborations with companies like Roche and Merck (MRK – Analyst Report) for its experimental cancer treatment talimogene laherparepvec.
AstraZeneca (AZN – Analyst Report) is another large-cap company looking to redefine the cancer-treatment paradigm. The company’s focus is on four key platforms — immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates — supported by personalized healthcare and biomarker technologies.

Seattle, WA-based Juno Therapeutics, Inc. (JUNO – Analyst Report) is looking to revolutionize cancer treatments by engaging the body’s immune system to treat cancer. Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptors (CARs) and high-affinity T cell receptor (TCR) technologies – the goal is to activate a patient’s own T-cells to recognize and kill cancer cells. According to the company, genetically-engineered T-cells have the potential to meaningfully improve survival and quality of life for cancer patients.
Lead candidate, JCAR015, is currently in a phase I study in relapsed/refractory B cell acute lymphoblastic leukemia (r/r ALL) patients – data so far is encouraging and the company is looking to commence a pivotal phase II study in adult r/r ALL patients shortly that could support accelerated approval in the U.S. in 2017.
Kite Pharma, Inc. (KITE – Analyst Report) is another company focused on the development of immuno-oncology treatments. Kite uses its engineered autologous cell therapy (eACT) to genetically modify T-cells to express either CARs or TCRs. These modified T-cells are designed to recognize and destroy cancer cells. The Santa Monica, CA-based company has tied up with companies like Amgen and bluebird and could well see its most advanced pipeline candidate, KTE-C19, launching in 2017.
Incyte Corp. (INCY – Analyst Report) has an extensive oncology pipeline and is well positioned with both large and small molecule approaches to immuno-oncology. In order to maximize the value of its pipeline programs, Incyte has collaboration agreements with companies like Merck, Roche, AstraZeneca, Agenus and Bristol-Myers Squibb.
The company’s immuno-oncology pipeline includes IDO1 inhibitors (IDO1 inhibition shifts the immune system from an immunosuppressive state to an activated state thereby allowing the body to mount a more effective anti-tumor immune response), PI3K-delta inhibitors (PI3K-delta pathway mediates oncogenic signaling in B cell malignancies), and JAK inhibitors (JAK promotes tumor growth by integrating pro-inflammatory cytokine signals).
The Allure of Immuno-Oncology
Immuno-oncology treatments hold huge commercial potential and have the ability to change the treatment paradigm. With companies working on bringing improved treatments with fewer side effects to market, it may be a good idea to keep an eye on these stocks which may revolutionize cancer treatments.
Looking for the next stocks that will revolutionize their industries? Make sure to read more about the newest Zacks portfolio, Game Changers, and how this service will find companies poised to disrupt their markets.

Cancer Immunotherapy Is All Over The Science News — And Now It Has Its Own Stock Index

One of the hottest ideas in science is that you can stimulate the immune system to fight cancer. There has been such a surge in pharmaceutical R&D in this field that someone has come up with a single place for investors interested in cancer immunotherapy stocks.

Brad Loncar, an independent investor in Lenexa, Kansas with a history of investing in cancer immunotherapy, is rolling out a new index that is the first to round up all the players in this emerging sector within biotech. He’s calling it the Loncar Cancer Immunotherapy Index. It contains 25 companies worth at least $100 million or more, including big, diversified companies like Bristol-Myers Squibb BMY -0.42% and Merck, as well as smaller companies focused entirely on immunotherapy, like Juno Therapeutics and Kite Pharma.

Like any other index, this one tracks the performance of the whole group, rebalances its components every so often (in this case every six months), and generally serves as a benchmark for how a certain sector performs when compared with other indices like the Standard & Poor’s or NASDAQ. The new immunotherapy index is now available on that workhorse terminal for sophisticated investors—the Bloomberg Professional service.

There are already specialized baskets of stocks focused on biotechnology, but Loncar said he saw a need for something new because biotech is so broad, and not well-defined in the public mind. Essentially, biotech is an umbrella term that includes a wide array of drug developers, diagnostics companies, biomedical toolmakers, and even agricultural applications and biofuels. It’s a field generally dominated by specialized investors with PhDs and MDs, and intimidating to many lay people.

Loncar is hoping to make the field more inviting to general investors by focusing on this one promising subsector that is focused on cancer–something everyone can relate to on some level.

“I want to repackage biotech in a way that ordinary people can understand it,” he said.

The timing couldn’t be better for such a thing, as investor interest has surged in cancer immunotherapy, or immuno-oncology, as it is sometimes called. Science magazine called immunotherapy its “breakthrough of the year” in 2013. Ken Burns just produced a PBS documentary on the subject. Major newspapers and magazines are churning out articles almost daily about the new wave in cancer therapy that builds on the long history in chemotherapy, radiation, surgery, and targeted molecular therapy.

One of the hottest ideas in science is that you can stimulate the immune system to fight cancer. There has been such a surge in pharmaceutical R&D in this field that someone has come up with a single place for investors interested in cancer immunotherapy stocks.

Brad Loncar, an independent investor in Lenexa, Kansas with a history of investing in cancer immunotherapy, is rolling out a new index that is the first to round up all the players in this emerging sector within biotech. He’s calling it the Loncar Cancer Immunotherapy Index. It contains 25 companies worth at least $100 million or more, including big, diversified companies like Bristol-Myers Squibb BMY -0.42% and Merck, as well as smaller companies focused entirely on immunotherapy, like Juno Therapeutics and Kite Pharma.

Like any other index, this one tracks the performance of the whole group, rebalances its components every so often (in this case every six months), and generally serves as a benchmark for how a certain sector performs when compared with other indices like the Standard & Poor’s or NASDAQ. The new immunotherapy index is now available on that workhorse terminal for sophisticated investors—the Bloomberg Professional service.

There are already specialized baskets of stocks focused on biotechnology, but Loncar said he saw a need for something new because biotech is so broad, and not well-defined in the public mind. Essentially, biotech is an umbrella term that includes a wide array of drug developers, diagnostics companies, biomedical toolmakers, and even agricultural applications and biofuels. It’s a field generally dominated by specialized investors with PhDs and MDs, and intimidating to many lay people.

Loncar is hoping to make the field more inviting to general investors by focusing on this one promising subsector that is focused on cancer–something everyone can relate to on some level.

“I want to repackage biotech in a way that ordinary people can understand it,” he said.

The timing couldn’t be better for such a thing, as investor interest has surged in cancer immunotherapy, or immuno-oncology, as it is sometimes called. Science magazine called immunotherapy its “breakthrough of the year” in 2013. Ken Burns just produced a PBS documentary on the subject. Major newspapers and magazines are churning out articles almost daily about the new wave in cancer therapy that builds on the long history in chemotherapy, radiation, surgery, and targeted molecular therapy.

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Investors who have paid attention to the news coming out of labs have been rewarded in the past few months. If the index had started on Jan. 1, it would be up about 28 percent year-to-date, Loncar said. That compares with about a 12 percent gain in the NASDAQ Biotechnology Index, a more broadly diversified set of stocks that includes cancer immunotherapy. Although Loncar isn’t an investment advisor and has no business relationships with the companies in the index, he does personally invest in some of them.

Loncar, a well-known commentator among biotech investors, executives and journalists on Twitter, got his first exposure to immunotherapy through an investment in Dendreon, a trailblazer in cancer immunotherapy. In 2011, he outlined a series of problems he saw at the company, and he led an Internet-based rebellion among shareholders to call for change. The company, three years later, went bankrupt.

Immunotherapy still has many challenges, particularly with the high prices of some of the new therapies. But at scientifically, skepticism has turned into enthusiasm now that big companies like Bristol-Myers Squibb and Merck have won FDA approval of new drugs that are simpler to administer to patients, and which have shown ability to produce long-lasting remissions for certain types of cancer patients. The positive effects are beginning to appear in multiple forms of cancer.

Over time, Loncar said he can imagine the index laying the foundation for an exchange-traded fund (ETF) dedicated to cancer immunotherapy. That could provide individual investors with a way to invest in the immunotherapy movement without shouldering all the risk that comes with picking individual stocks, which can fail (like Dendreon).

Some people clearly are not too concerned about the technical risks in these complex enterprises, and are buying individual stocks based on the excitement they hear in the media. If nothing else, some of the new investors will be able to see who’s who in the field and do a little more homework before randomly buying some stock after seeing the latest headline.

Immunotherapy – the future of cancer treatment?

A new development in cancer treatment has been reported as showing impressive results for terminally ill patients with melanoma

For decades immunotherapy – getting the body’s own immune system to destroy cancerous cells in the body – has been little more than an aspiration.  It has been a longstanding mystery in the scientific community why the body’s own defensive immune system is not able to attack cancer cells in the same way that it would fight a cold virus.  After decades of research, scientists have discovered that cancer, just like the human immunodeficiency virus (HIV), is able to evade the T-cells that find and kill harmful cells, due to molecules from both types of cell interacting to persuade the T-cells not to attack.

In 1992, Japanese scientists identified a molecule on the T-cells that was partly responsible for their failure to attack cancer cells, which they named ‘programmed death 1’, or PD1. This discovery prompted further research into the behaviour of T-cells, why they were unable to destroy cancer cells and into how to tackle this problem. The new drugs are the eventual result of this research. At this early stage of the trial they seem to be working. Unlike similar drugs, their use is not likely to be restricted to treating melanoma, opening up possibilities for the treatment of numerous different types of cancer.

The international trial was led by the Royal Marsden Hospital in London. It involved 945 patients with advanced melanoma who were considered terminally ill with very short life expectancies. Ipilimumab and nivolumab was used to treat these patients and was found to shrink tumours in 58%. There is hope that these tumours might disappear altogether. Around a fifth of the patients responded to the drug ipilimumab when it was given in isolation from nivolumab.  Results from the trial were published in the New England Journal of Medicine and announced in Chicago, at the American Society for Clinical Oncology (ASCO) annual meeting in 2015.

There are currently two reasons to be cautious about the long-term viability of this treatment. First, the side-effects of utilising the body’s own immune system to fight off the cells have proved severe. Nell Barrie, of Cancer Research UK (CRUK), said “your immune system is designed normally not to attack your body’s own cells. You have to boost the immune system beyond its normal function and you are going to sensitise the immune system. It’s very, very complex.” Some patients were unable to cope with the severity of the side effects, which include feeling extremely sick, and were unable to continue with the trial. Dr Alan Worsley, also from CRUK, has said that the key to making this treatment successful is to identify which patients are most likely to benefit from combination immunotherapy.

Secondly, there is the question of whether these treatments can actually cure cancer or whether it is a question of determining the length of time during which the treatments prevent the cancer from progressing. There is an unfortunate precedent for taking a pessimistic view of this issue. There have been melanoma drugs in the past that were treated as ground-breaking cures. These ‘targeted drugs’, the BRAF inhibitors, caused tumours to disappear completely. However, after a few months, the cancer returned more aggressively than before and the patients died.

It is too soon for scientists to know whether or not these treatments will have a big impact on survival rates. But the ultimate aim is for immunotherapy to be used to teach the body’s immune system to recognise and destroy cancer cells, preventing the chance of recurrence of the cancer.

Ipilimumab was approved by NICE (the National Institute for Health and Care Excellence) for advanced skin cancer patients in December 2012, despite the cost, as the company selling it agreed to give the Department of Health a reasonable discount. Nivolumab is likely to get its licence in the summer of 2015, but whether an acceptable price for it can be successfully negotiated with the company remains to be seen.

Clinical negligence trainee at Leigh Day Kimberley Crangle said:

“This research is so exciting as it suggests immunotherapy treatments could be combined to support our immune systems in their fight against advanced melanoma.”