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Equity Perspectives

One reason the health care sector has performed so well this year is advances in complementary therapies with the potential to help patients live longer.

 

In Brief

  • Significant innovation in targeted therapy, immunotherapy, and cell therapy has helped biotech stock indexes outpace broader equity benchmarks by a substantial margin (as of October 20, 2017).  Some individual stocks in this sector have doubled or tripled in that period.
  • Another driver of biotech stocks has been mergers and acquisitions. When innovation is developed at smaller companies, the large companies that are watching it develop may acquire those assets to fill gaps in their own portfolios.
  • Lord Abbett aims to invest in developers of cancer drugs that it believes have a chance of changing the standard of care for a certain disease.
  • Risk management in this sector is essential, since the odds of a drug receiving approval are relatively slim. Assessing clinical evidence and commercial potential is key.
  • Even after a drug is commercialized, patients may develop unforeseen side effects, which would prompt the FDA to issue a safety alert, or the manufacturer might withdraw the drug from the market.

 

Cancer is an expansionist disease; it invades through tissues, sets up colonies in hostile landscapes, seeking “sanctuary” in one organ and then immigrating to another. It lives desperately, inventively, fiercely, territorially, cannily, and defensively—at times, as if teaching us how to survive. To confront cancer is to encounter a parallel species, one perhaps more adapted to survival than even we are.  
Siddhartha Mukherjee, The Emperor of All Maladies

Of all the innovation driving performance in the health care sector this year, nothing quite compares to the scientific advances achieved in the war on cancer. Chemotherapy and radiation may still be the first line of defense in many cases, but with various combinations of targeted therapy, immunotherapy, and cell therapy, patients with diseases once considered a death sentence can now look forward to longer lives (see Chart 1)—all of which helps explain why biotech stock indexes have outpaced broader equity benchmarks by a substantial margin (as of October 20, 2017). 

At Lord Abbett, the responsibility for cancer updates on major oncology conferences, clinical studies, research and development (R&D), and government approvals often falls to Portfolio Manager Matthew DeCicco and Research Analyst Samantha Shevins. DeCicco helps manage the firm’s micro-cap growth and growth equity strategies. In addition, he is a research analyst responsible for covering the health care sector for the firm’s small-cap growth strategy. Shevins has been in the financial services business for 17 years, and covers a wide variety of biotechnology and pharmaceutical companies.  

Of course, biotech investing is not for the faint of heart. And when it comes to assessing the prospects of new combatants in battling cancer, it’s important to note that some biotech companies whose stocks have more than doubled in less than a year have yet to earn a profit, and the odds of developing a blockbuster drug are slim. As William Osler, one of the founders of Johns Hopkins Hospital, put it, “Medicine is a science of uncertainty and an art of probability.”

DeCicco and Shevins have no illusions about the process of the evaluating potential breakthroughs in oncology. Risk management and diversification are key.

“There is sizable risk in development-stage cancer drugs,” DeCicco said. “You could wake up some morning and find that someone else has come out with a better drug or that the drug another company is developing won’t be as effective as first thought.”

Shevins adds, “When a compound enters phase 1 studies, the odds of it making it across the finish line to become an approved drug are 10–15%. While the odds improve as a drug goes through each phase of development, you really want to make sure the evidence is there and see who the competition is. The question you’re always asking yourself is: ‘Is this a drug?  Is the benefit clinically relevant to doctors and patients? Is there value here? Are the drugs in question doing something important and meeting an unmet need? Because over time, these kinds of drugs tend to be rewarded by investors.”

One driver of such rewards is mergers and acquisitions. As DeCicco put it, “When innovation is developed at smaller companies, the large companies often monitor its progress, and may be willing to acquire that innovation. One company that we owned in targeted therapeutics was acquired at the beginning of this year, and another company we owned in cellular therapy was acquired in the middle of the year.”

DeCicco and Shevins routinely pore through volumes of data on early clinical trials, and then confer with physicians to determine if a drug with a certain profile would offer significant benefit to patients if it were available.

“We try to make selective bets on drugs we think have a chance of changing the standard of care for a certain disease,” said Shevins. “But even after a drug is commercialized, there’s always an element of risk. For example, if the drug triggers unforeseen side effects in patients, the FDA might issue a safety alert, or the manufacturer might withdraw the drug from the market.”

 

Chart 1. Five-Year Survival Rates for Various Cancer Types and Improvements, 1971–2011 


Source: Cancer Research UK.

 

Targeted Therapy
According to the National Cancer Institute, targeted therapies are drugs or other substances that block the growth and spread of cancer. Unlike standard chemotherapy, targeted therapies may block tumor-cell proliferation, whereas most standard chemotherapies act on all rapidly dividing normal and cancerous cells.

“Targeted therapies have become a cornerstone of precision medicine,” said DeCicco. “These therapies use information about a person’s genes and proteins to prevent, diagnose, and treat disease. But much depends on the identification of good targets—that is, targets that play a key role in cancer cell growth and survival.”

Targeted therapies that have been approved for use in cancer treatment include hormone therapiessignal transduction inhibitorsgene expression  modulators, tyrosine kinase inhibitors, apoptosis inducers, angiogenesis inhibitors, certain forms of immunotherapies, and toxin-delivery molecules.

Among the stocks that have advanced the most this year on their strength of their targeted therapies are:

  • A young company that is developing a new generation of highly selective and potent kinase (protein) inhibitors based on a deep understanding of the genetic blueprint of cancer. The company believes its ability to identify novel drivers of disease, coupled with its proprietary library of novel and diverse chemical compounds, helps it develop kinase therapies against new and difficult-to-drug targets.
  • A firm that specializes in highly selective medicines for patients with genetically defined cancers.  Based on clinical studies, some investors are betting that kinase inhibitors developed in this fashion might eventually be able to combat two or more cancers that are uniquely dependent on single gene abnormalities in the same patient. “The way technology is advancing, it won’t be long before doctors stop talking about cancer by saying it’s a primary tumor, such as breast cancer or a lung cancer,” said Shevins. “The focus instead may shift to what are the underlying genetic mutations responsible for causing those tumors and determining which drugs address those mutations.”    
  • A “molecular insights” company with a massive genomic profiling platform that helps it understand the minutest intricacies of a patient's tumor. Its tests provide biomarker information, which in turn can steer doctors and patients toward approved targeted therapies, immunotherapies, and clinical trials. “This approach is just starting to gain momentum,” said DeCicco.  

Immunotherapy
Cancer immunotherapy—a treatment designed to boost the body’s natural defenses against cancer—can be traced back to 1893, when William Coley, a bone surgeon at New York’s Memorial Hospital, discovered that treating cancer patients with a mixture of heat-killed bacteria helped shrink their tumors.

Now such treatments come in two forms. Passive immunotherapy typically involves the administration of agents such as monoclonal antibodies or adaptive cell therapy that directly target tumors. Active immunotherapy typically attempts to stimulate the patient’s own immune system to generate antibodies with a greater potential to eradicate or inhibit cancer.1

The most advanced antibodies aim to block a cancer cell protein called “programmed death-ligand 1” (PD-L1, for short). Major pharmaceutical companies have developed drug agents that block the PD-L1 protein, which may prevent cancer cells from inactivating T cells (which is a form of white cell critical to the body’s immune system). Several of these drugs, known as immune checkpoint inhibitors, recently received FDA approval for treating certain types of cancer and are being tested in a variety of other tumor types.

While such advances have driven up the prices of certain biotech companies, Shevins says the jury is still out on the efficacy of other immune checkpoint inhibitors beyond anti-PD-1. “Leading cancer hospitals like Sloan-Kettering, MD Anderson, and Dana-Farber are doing very impressive work on other checkpoint inhibitors like CTLA-4, IDO, LAG-3, GITR, TIM3, and OX40, but there are few answers,” said Shevins. “Nothing has declared itself to have the same efficacy profile as PD-1 inhibitors thus far.”

“PD-1 and PD-L1 antibodies are giving a relatively small portion of the patient population a longer period of time in which their cancer is held at bay before it progresses and needs a different line of treatment,” DeCicco added. “Now researchers are combining therapies as a way to extend the profound benefits seen with PD-1/PD-L1 antibodies to more patients.”

Cell Therapy
Down to their innate molecular core, cancer cells are hyperactive, survival-endowed, scrappy, fecund, inventive copies of ourselves. ―Siddhartha Mukherjee 

Like immunotherapy, cell therapy typically involves the injection of modified cells into a patient. One significant example of how far cell therapy has come in a short amount of time involves multiple myeloma, a blood cancer long known for its low survival rate. According to the NCI, two early-phase clinical trials suggest that a form of immunotherapy that uses genetically engineered immune cells may be highly effective in patients with advanced multiple myeloma. Both trials used CAR T cells to target a protein on myeloma cells called B-cell maturation antigen (BCMA).

DeCicco pointed to encouraging data that shows that the five-year survival among multiple myeloma patients over the age of 65 has nearly doubled with combinations of new medicines. (See Chart 2.) While it’s too early to determine whether this approach will become the standard of care for multiple myeloma, if successfully developed, the BCMA approach could improve survival further, DeCicco added.

 

Chart 2. Multiple Myeloma Survival Is Improving with Novel Agents 



Source: Shaji Kumar, MD, Multiple Myeloma Research Foundation.

 

One of the leading companies in cancer cell therapy was acquired at a substantial premium by a large biopharmaceutical company in a deal that helped its stock triple during the period of January 1–October 27, 2017. Two other developers of such therapy have seen their stocks advance between 129% and 145% during that same period, which helps to explain why larger pharma companies have been eager to form joint ventures with such cutting-edge innovators to round out their product lines and maintain market share.

The Battles Ahead
While the American Cancer Society estimates that 1,688,780 new cancer cases will be diagnosed in 2017 and that 600,920 cancer patients will die in the United States, the survival odds for many cancers have greatly improved, and the rate of new diagnoses is slowly declining. But as environmental health expert Curt Dellavalle put it earlier this year, the number of people diagnosed with cancer every year continues to rise, and there has been no decline in the number of people dying from cancer.2  

As scientists and economists debate the extent to which toxic substances in the environment contribute to cancer, there also is growing concern about the role of diet and nutrition. The Centers for Disease Control and Prevention (CDC) recently reported that overweightness and obesity are associated with an increased risk of 13 types of cancer. Further, the CDC found that these cancers accounted for about 40% of all cancers diagnosed in the United States in 2014.

While it remains to be seen whether innovation will keep driving up already exorbitant prices of treating such chronic diseases, the debate over drug pricing is likely to heat up. A recent investigation by the Journal of the American Medical Association (JAMA) challenged the pharmaceutical industry’s claim that it takes $2.7 billion in research and development (R&D) spending to bring a cancer drug to market.  Cancer physicians Vinay Prasad (Oregon Health and Science University) and Sham Mailankody (Memorial Sloan Kettering Cancer Center) argued that figure was quite overstated based on a study of Securities and Exchange Commission filings for the manufacturers of 10 cancer drugs. The cost to develop a cancer drug is $648.0 million, they said, while the revenue since approval is far greater, with the median at $1.658 billion (and the range of $204.1 million to $22.275 billion).3

When National Public Radio reported on that JAMA study, the pharmaceutical industry issued a highly critical response. “Ignoring the R&D costs from the many companies that have not received a U.S. Food and Drug Administration approval indicates a lack of understanding of the risk companies' face at the outset of an uncertain project, and the role of economic incentives in ensuring investment despite steep odds,” the industry group PhRMA said. “The risk inherent in R&D is the key reason why 90% of publicly traded biopharmaceutical companies in 2014 did not make a profit."

Profit or no profit, DeCicco and Shevins can attest that cancer drugs can either make or break a biotech portfolio. The key is astute research, solid theses, and contrarian views known as “variant perceptions” that entice their investment colleagues, all with a focus on risk management.

 

1 Source: Dana-Farber Cancer Institute.
2  Curt Dellavalle, “The War on Cancer: Progress, but Still a Long Way to Go,” www.ewg.org, February 27, 2017.
3 Vinay Prasad, MD, MPH, and Sham Mailankody, MBBS, “Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues after Approval,”
JAMA Internal Medicine, September 11, 2017.

 

The information provided is not directed at any investor or category of investors and is provided solely as general information about Lord Abbett’s products and services and to otherwise provide general investment education.  None of the information provided should be regarded as a suggestion to engage in or refrain from any investment-related course of action as neither Lord Abbett nor its affiliates are undertaking to provide impartial investment advice, act as an impartial adviser, or give advice in a fiduciary capacity.   If you are an individual retirement investor, contact your financial advisor or other fiduciary about whether any given investment idea, strategy, product or service may be appropriate for your circumstances.

This material is provided for general and educational purposes only. It is not intended as an offer or solicitation for the purchase or sale of any financial instrument, or any Lord Abbett product or strategy. References to specific asset classes and financial markets are for illustrative purposes only and are not intended to be, and should not be interpreted as, recommendations or investment advice. The examples provided are hypothetical, are for illustrative purposes only, and are not indicative of any particular investor situation.

This commentary may contain assumptions that are “forward-looking statements,” which are based on certain assumptions of future events. Actual events are difficult to predict and may differ from those assumed. There can be no assurance that forward-looking statements will materialize or that actual returns or results will not be materially different from those described here.

Statements concerning financial market trends are based on current market conditions, which will fluctuate. All investments involve risk, including possible loss of principal. No investing strategy can overcome all market volatility or guarantee future results.

The opinions provided in this posting contains the current opinions of the author are as of the date of publication, are subject to change based on subsequent developments, and may not reflect the views of the firm as a whole. This commentary is not intended to be relied upon as a forecast, research, or investment advice regarding a particular investment or the markets in general. Nor is it intended to predict or depict performance of any investment. This commentary is prepared based on information Lord Abbett deems reliable; however, Lord Abbett does not warrant the accuracy and completeness of the information. Consult a financial advisor on the strategy best for you.

Past performance is not a guarantee or a reliable indicator of future results. All investments contain risk and may lose value.

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