Reaching for the Moon: The R&D Tax Credit Aspects of Conquering Cancer



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Conquering-Cancer        
        In his 1971 State of the Union address, President Richard M. Nixon urged the nation to turn “the same kind of concentrated effort that split the atom and took man to the moon” towards conquering cancer.  Over four decades later, the lunar landing reference is again tied to the battle against cancer through the launching of the National Cancer Moonshot Initiative. Even though the analogy is the same, the current level of knowledge about cancer is higher than ever before. By understanding and tackling the complexity of cancer, present-day efforts are bound to enable astronomical progress.
       
        Published in January 2014, our previous R&D cancer article was very well received by readers as it presented an overview of important research efforts at the time.   So much innovation has occurred since then, however, that we decided to write this follow-up piece, which will explore recent developments in cancer research and ongoing efforts to translate new scientific discoveries into improved treatments.


The R&D Tax Credit

        Enacted in 1981, the Federal Research and Development (R&D) Tax Credit allows a credit of up to 13 percent of eligible spending for new and improved products and processes. Qualified research must meet the following four criteria:

  • New or improved products, processes, or software
  • Technological in nature
  • Elimination of uncertainty
  • Process of experimentation

        Eligible costs include employee wages, cost of supplies, cost of testing, contract research expenses,  and costs associated with developing a patent.

        On December 18, 2015, President Obama signed the bill making the R&D Tax Credit permanent. Beginning in 2016, the R&D credit can be used to offset Alternative Minimum tax and startup businesses can utilize the credit against payroll taxes.


The Complexity of Cancer

        Accounting for nearly 1 in every 4 deaths in the U.S., cancer is the second most common cause of mortality in the country, exceeded only by heart disease. The American Cancer Society estimates that, in 2016 alone, there will be more than 1.6 million new diagnoses of cancer and approximately 600,000 cancer deaths in the U.S.

        Decades of research have shed light on the complexity of cancer, which is now seen not as one single disease, but as more than 200 different ones. It is also known that most cancers are the result of multiple mutations and that each patient’s tumor is unique. For these reasons, it has become
that one therapeutic approach alone is not enough. On the contrary, an effective strategy against cancer must rely on advances in multiple fronts.

        On February 1, the White House announced a new $1 billion initiative to jumpstart the National Cancer Moonshot efforts, which aim to double the rate of progress against cancer, realizing a decade’s worth of advances in five years. Led by Vice President Biden, the Cancer Moonshot Task Force will focus on fostering collaborations and enhancing Federal investments, targeted incentives, private sector efforts, patient engagement initiatives, along with other mechanisms designed to support cancer research and enable progress in prevention, diagnosis, and treatment.  

        The future of cancer research is certainly a multifaceted one. It is virtually impossible to predict all the different and surprising ways in which treatment and care will evolve. However, two important trends will certainly be at the basis of innovation moving forward:

Precision Medicine
        The National Institutes of Health defines precision medicine as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.”  By acknowledging the complexity and uniqueness of each patient’s condition, this personalized approach to healthcare aims to overcome the notions of the “average patient” or “one-size-fits-all medicine” and to gradually create a new taxonomy of diseases in which they are no longer defined by physical signs and symptoms, but rather by their molecular and environmental causes.    
 
        In the case of cancer, uniqueness is indisputable. Understanding the distinctive nature of each patient’s body and the key genetic mutations behind his disease is essential to identifying the most promising avenues for treatment. By enabling the development of unique therapies specially conceived to target the genetic abnormalities involved, precision medicine gives new hope against treatment-resistant and difficult-to-treat cancers.

Big Data
        Access to massive amounts of data opens the way for an unprecedented understanding of how cancer evolves. Two aspects determine how big data can actually benefit cancer research. On the one hand, there is a need for high-performance analytics, which includes advanced software and machine-learning capabilities. On the other hand, there must be cooperation and enhanced sharing of data. The White House fact sheet on the National Cancer Moonshot Initiative underlines that “data sharing can break down barriers between institutions, including those in the public and private sectors, to enable maximum knowledge gained and patients helped.”  

        Built upon these two overarching trends, the fields of immunotherapy and next-generation genomic analysis stand out as promising areas in cancer research. The following sections will present recent advancements in both these domains.


Cancer Immunotherapy

        Immunotherapy is arguably the most promising and rapidly evolving alternative for treating cancer. Increasingly seen as a potential new pillar of cancer therapy, this revolutionary field of research is based on a simple strategy: harnessing the body’s immune system to combat cancer.

        When compared to traditional cancer treatments, immunotherapy has often provided more durable control of tumor growth and fewer side effects. While chemotherapy, for instance, kills both healthy and diseased cells, immunotherapy enables the body to identify and target only cancerous ones.

        Recent advances in immunotherapy are staggering, particularly when it comes to treatment-resistant and advanced-stage cancers. The effectiveness of immunotherapy for hard-to-treat cancers is increasingly evident, with positive results in a rapidly broadening range of diseases, including advanced melanoma, lung, kidney, bladder, and head and neck cancers. Preliminary successful results have also been reported for certain blood cancers and glioblastoma, a particularly deadly brain cancer, as well as for rare and intractable tumors caused by viruses. In fact, ongoing clinical trials suggest that immunotherapy could benefit more than two-dozen types of cancers.
    
        Such a promising area of research has attracted the attention of important philanthropists. On April 13, tech billionaire Sean Parker announced a $250 million grant to launch the Parker Institute for Cancer Immunotherapy, which will bring together over 300 researchers working at 40 different laboratories in six U.S institutions – Stanford, the University of California, San Francisco, and University of California, Los Angeles, the University of Pennsylvania, MD Anderson Cancer Center, and Memorial Sloan Kettering Cancer Center. The partnership, which will also involve patient advocacy groups and private companies, aims to coordinate research efforts, removing the obstacles related to bureaucracy and funding.

        This is the largest donation ever for cancer immunotherapy. It happened just a few days after former New York City mayor Michael Bloomberg, Jones Apparel Group founder Sidney Kimmel, and other philanthropists announced a $125 million contribution devoted to create a cancer immunotherapy research center at the Johns Hopkins University medical school. The Bloomberg–Kimmel Institute for Cancer Immunotherapy will gather more than 100 scientists and clinicians from the immunology, genetics, microbiology, and biomedical engineering fields. Research will focus primarily on melanoma, colon, pancreatic, urologic, lung, breast, and ovarian cancers.

        The following paragraphs present an overview of recent advances in five different areas of immunotherapy research.

Checkpoint Inhibitors
        Immune checkpoints work as “immunological brakes” that help the body control immune responses in order to limit the unwanted and dangerous consequences of overreactions, such as excessive inflammation and autoimmune disorders.

        By producing these same molecules, some tumors “push the brakes” and trick the immune system into not properly responding to the disease. Immune checkpoint inhibitors are designed to prevent tumor-induced brakes, restoring the immune system’s ability to attack cancer cells.

        There are currently three checkpoint inhibitors available on the market. They have enabled unprecedented results in treating some advanced-stage cancer patients, considerably increasing their life expectancy and avoiding relapses.

        Released on April 17, long-term follow-up survival data for Bristol-Myers Squibb Co.’s checkpoint inhibitor Opdivo showed that more than a third of advanced-melanoma patients participating in the trial have survived at least five years. According to the National Cancer Institute, only 16.6 percent of advanced-melanoma patients lived that long between 2005 and 2011. In other words, immunotherapy has more than doubled the survival rate.

        These results attest to the effectiveness and durability of immunotherapy for some patients, even those resistant to conventional treatments. Opdivo was approved by the FDA in 2014 and can be used to treat both melanoma and lung cancer. It targets a “brake” called PD-1, which prevents T cells from fighting cancer. F. Stephen Hodi, director of the Melanoma Center at Dana-Farber Cancer Institute and an investigator at Harvard Medical School's Ludwig Center points out that “The data provide a foundation for using anti-PD-1 drugs as standard treatment for melanoma patients […]. Hopefully this would translate to other cancers as well.”

        Cancer cells can also suppress immunological responses by turning off T cells, the “foot soldiers” in the battle against cancer. They do that by pushing a “brake” located on the surface of such cells, a protein called CTLA-4. Researchers at Baylor College of Medicine have recently discovered that, contrary to what was previously thought, CTLA-4 is not only present on T cells and other cells of the same lineage, but that it is also produced and secreted by antigen processing cells called dendritic cells.

        Dendritic cells work as “generals” that direct T-cell activity. The study revealed that CTLA-4 has the power to turn off dendritic cells and prevent them from activating T cells. In the words of William Decker, senior author, “These results are relevant to the battle against cancer because we showed that dendritic cell CTLA-4 performs a very critical regulatory function. Its presence inhibits the generation of downstream anticancer responses, whereas its absence permits robust priming of such responses.”

        A better understanding of dendritic cell CTLA-4 is expected to shed light on more effective combination therapies against cancer. A promising example is yet another checkpoint inhibitor developed by Bristol-Myers Squibb Co. called Yervoy (ipilimumab), which has been used to treat melanoma patients by binding to CTLA-4 on T cells and blocking the cancer signals that turn them off. Baylor College researchers argue that recent findings provide a strong rationale to use Yervoy “in new and better ways, for instance in conjunction with cancer vaccines.”  

        A recent report by Research and Markets predicts that the immune checkpoint inhibitors market will become a multi-billion dollar market over the upcoming decade with an expected annual growth rate of 27.7 percent. According to the report there are 26 novel checkpoint inhibitor drugs in clinical in clinical development.

        The untapped potential of the checkpoint inhibitors market has attracted major investments. In April 2015, Swiss drug maker Roche established a $555 million partnership ($25 million upfront and $530 million tied to milestones) with India’s Curadev Pharma for the development of IDO1 and TDO inhibitors.  This was just a few months after Roche’s subsidiary Genentech agreed to pay $150 million upfront and potentially $1 billion tied to milestones in a collaboration with Ames, Iowa-based NewLink Genetics also for the development of an IDO inhibitor.  

Bispecific T-Cell Engagers
        Responsible for seeking out and destroying targeted invaders, T-cells play a central role to the body’s immunity. In the battle against cancer, some immunotherapy approaches focus on facilitating the work of these valuable combatants.

        Bispecific T-cell engagers (BiTEs), for instance, help the immune system identify and attack malignant cells. With two different and simultaneous targets, these modified antibodies serve as mediators that redirect T cells towards tumor cells thus enhancing tumor destruction.

        Amgen’s Blincyto (blinatumomab) is a BiTE antibody construct designed to treat patients with acute lymphoblastic leukemia (ALL). Programmed to attach itself to two different proteins in white blood cells, one located in malignant B cells and the other in cancer-killing T cells, the antibody places T cells within reach of targeted cells thus facilitating their work.

        In 2014, the FDA granted Blincyto breakthrough therapy designation, priority review, and orphan product designation due to preliminary clinical evidence that the drug would offer a substantial improvement in safety and effectiveness over available therapies targeted at a serious and rare condition.

        On February 4, Amgen announced that a study demonstrated an overall survival benefit for relapsed and refractory ALL patients treated with Blincyto. This will allow the company to seek full approval from regulatory authorities.

Modified T-Cell Therapy
        Chimeric Antigen Receptor (CAR) T-cell therapy can be generally defined as an attempt to reprogram the patient’s immune cells to target specific cancer cells. A sample of the patient’s T cells is collected from the bloodstream and genetically modified to incorporate sensors, or antigen receptors, that can seek out certain cancers. When infused back into the patient, these engineered cells target and destroy cancer cells.

        Early experimental trials of CAR T-cell therapy for blood cancer have shown extremely promising results. According to British newspaper The Guardian, 94 percent of ALL patients went into remission and patients with other types of blood cancer had response rates greater than 80 percent, half of which saw symptoms disappear entirely.

        Though most studies thus far have focused on hematologic malignancies, recent findings suggest that t-cell immunotherapy could also be used to combat solid tumors. Researchers from Penn Medicine and Harvard University recently reported the success of a phase 1 study that used CAR T-cell therapy against glioblastoma. Genetically modified to target a tumor-specific protein, T cells used in the study were capable of safely migrating to and infiltrating tumors “even crossing the blood-brain barrier.”

        Studies have also suggested the existence of “memory” T cells that remain in the patient’s body for two to 14 years after the treatment. If confirmed, these persistent cells could translate into a long-term, living defense against cancer.

        Even though there have been remarkably positive results, modified T-cell therapy is still considered an effort of last resort due to the risk of dangerous side effects, such as cytokine release syndrome, a life-threatening, systemic inflammatory response. Further research is necessary to mitigate risks and allow for a more widespread application of this innovative treatment.

Cancer Treatment Vaccines
        Different from conventional vaccines, which focus on prevention, treatment vaccines target those who have already been diagnosed with cancer. By introducing antigens into the body, they stimulate the activation of T cells or the production of antibodies that will find and attack cancerous cells.

        Numerous pharmaceutical and biotechnology companies are currently working on cancer vaccines. Headquartered in Durham, North Carolina, Heat Biologics is the creator of a pioneering line of cancer vaccines called ImPact (Immune Pan-Antigen Cytotoxic Therapy), which have yielded very promising results in early trials. ImPact technology modifies human cancer cells into miniature pumps that, once infused into the patient’s body, secrete a range of cancer antigens that stimulate immunological response. Suited to treat various types of cancers, ImPact is an allogeneic, or off-the-shelf, immunotherapy that does not require invasive procedures and does not have storage or production limitations. Heat is currently conducting clinical trials for two ImPact-based products, targeting bladder cancer and non-small cell lung cancer, a potential $11 billion market.  

Combination Therapies
        In an effort to maximize the potential of immunotherapies, researchers are exploring innovative combinations both with different immunotherapy approaches and with traditional treatments, including chemotherapy and radiation. Cancer Research Institute CEO Jill O’Donnell-Tormey points out that success rates go up when immunotherapy is combined with other medications and treatments. Combination therapy allows for a more personalized approach tailored to each patient’s needs.  

        One of the most well known patients to resort to combination therapy is former President Jimmy Carter, who tested cancer free just a few months after being diagnosed with metastatic melanoma that had spread to his liver and brain. His treatment involved surgery, radiation and Merck’s immunotherapy drug Keytruda (pembrolizumab), which works as a checkpoint inhibitor.

        Even though recent advances in immunotherapy are very encouraging, further research is necessary to understand why benefits are restricted to certain subsets of patients and certain types of cancer. Roy Jensen, director of the University of Kansas Cancer Center, recently compared this period for immunotherapy to the 1960s for chemotherapy – "there is so much to do and to figure out. We're just at the start of this."


Genomic Analysis

        By enabling the creation of a personal roadmap towards effective treatment and prevention, innovative genomic testing promises to open the way for the future of precision medicine. The unprecedented volume of genetic data currently available to the research community has enabled major advances in next-generation genome sequencing, particularly for cancer-related applications. Extensive DNA libraries have allowed for previously unimaginable analyses, which can unveil new cancer biomarkers. Considerable reductions in the time necessary to obtain results, which can become available as soon as two days after the test, as well as a decrease in costs involved are also examples of recent progress.

        Genomic profiling is at the basis of so-called precision prevention strategies, which focus on high-risk individuals with certain genetic predispositions. These tests also allow for better-informed treatment choices, which maximize positive outcomes, and shed light on new and groundbreaking diagnosing tools.

Better-Informed Treatment Choices
        It has been widely demonstrated that a patient’s genetic profile directly influences the propensity to develop certain conditions as well as the likelihood of response to different therapies. Likewise, the genomic testing of tumors can considerably reduce uncertainties surrounding treatment choices. They enable doctors to assess the probability of success before submitting patients to expensive and strenuous therapies. When it comes to immunotherapy, for instance, genomic analyses are key to understanding why some patients present remarkable results while others are non-responsive.

        Aiming to predict the effectiveness of immunotherapy in brain cancer patients, researchers at the University of California, Los Angeles have created an innovative method that tracks changes in the immune response. They use advanced T-cell receptor sequencing to monitor the presence of biomarkers in T cells present both within the tumor and in peripheral blood throughout the treatment. The study has pioneered the use of high-throughput sequencing to track systemic T-cell receptor expression. Initial results showed that the level of T-cell infiltration in the tumor could be a good indicator of extended survival rates.

        In a similar effort, immuno-oncology biotechnology company BriaCell, creator of cancer therapeutic vaccine BriaVax, recently discovered a set of genes, or “gene signature”, that can potentially explain exceptionally positive results obtained in a clinical trial subject with stage IV breast cancer. The whole-cell vaccine is derived from a human breast cancer cell line and designed to secrete an immune system activator that generates strong T-cell response.

        On April 12, BriaCell announced the filing of a provisional patent application “outlining certain features thought to improve clinical efficacy of whole-cell cancer vaccines.” Based on the recently discovered gene signature, the company plans to create BriaDx, a companion diagnostic test designed to identify patients that are likely to benefit from BriaVax.

Next-Generation Monitoring and Diagnosing
        According to a July 2015 Grand View Research report, the next-generation sequencing market will reach $27.8 billion in 2022.  Advancements in genomic sequencing will likely be the basis of next-generation cancer diagnosis, which is expected to register a compound annual growth rate of 32 percent between 2015 and 2022, reaching $20.25 billion in the end of this period.  

        The work of David Zhang, leading bioengineer at the Nucleic Acid Bioengineering Laboratory at Rice University, is an interesting example of how next-generation sequencing can lead to groundbreaking cancer diagnostic tools. Zhang, who was recently awarded two National Institutes of Health grants totaling $5.5 million, aims to develop molecular capture probes that will facilitate the detection of disease-causing DNA fractions that are very small compared to the overwhelming majority of healthy DNA in a patient’s sample.
       
        By binding to healthy DNA, which does not provide meaningful scientific or clinical information, the customized probes effectively remove unimportant sections of DNA and reveal unusual occurrences. If successful, this effort could enable the development of groundbreaking, rapid diagnostic tools for point-of-care applications.

        Advanced DNA sequencing is also at the basis of innovative blood tests that could potently revolutionize cancer care. Traditional biopsies are unable to keep up with the rapid transformation of tumors, forcing doctors to base their decisions on limited, outdated information. By offering a more effective alternative to surgical and needle biopsies, the so-called “liquid biopsies” open the way for new, personalized therapies. Instead of analyzing tissue from the tumor itself, this emerging technique allows for the identification and analysis of DNA fragments that tumors shed into the bloodstream.  

        These innovative tests are the first noninvasive way to monitor cancer.  They allow doctors to profile genes and effectively target drugs to mutations. They also provide a rapid and accurate assessment of a treatment’s effectiveness, enabling more informed adjustments as the disease evolves.

        Though still in its infancy, the market for liquid biopsies has outstanding potential for growth. A February 2015 study by CHI Insight Pharma Reports projects a 30 percent compound annual growth rate for the five-year period beginning in 2015.

        The rapidly growing number of companies exploring this emerging technology attests to the revolutionary potential of liquid biopsies. Redwood City, California-based Guardant Health is the creator of the Guardant360, an innovative blood test capable of detecting changes in the genetic structure of cancer cells. When an oncologist requests the test, Guardant sends out a kit for blood drawing; the samples are sent back for targeted DNA sequencing and results are made available in less than two weeks.

        According to CEO and co-founder of Guardant Helmy Eltoukhy, by January 2016, more than 20 thousand patients had used the company’s test. Eltouky estimates that the U.S. market for liquid biopsies could surpass $20 billion a year.  

        Recent studies have attested to the efficacy of blood-based biopsies. Researchers at Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) recently developed a blood test that can detect mutations in two important genes in non-small cell lung cancer (NSCLC). Reliability levels were demonstrated to such an extent that DF/BWCC decided to become the first medical facility in the country to offer the test to all its NSCLC patients.

        In addition to enabling quicker results – only three days versus 12 days for tissue biopsies in newly diagnosed patients and 27 days in drug-resistant patients, the innovative test also proved highly accurate. It demonstrated 100 percent predictive value for newly diagnosed patients and was capable of identifying cases that had not been detected during traditional biopsies.

        By analyzing free-floating DNA from cancer cells in the patient’s blood, the liquid biopsy provides a “snap-shot” of genetic abnormalities. The detection of mutations is key to enabling a personalized approach to treatment, in which drugs targeted at specific mutations are only administered to those who can actually benefit from them.  

        The procedure, technically referred to as rapid plasma genotyping, shows great promise as a clinical test for a variety of cancers. In the words senior author of the study, Geoffrey Oxnard, MD, thoracic oncologist and lung cancer researcher at DF/BWCC, “[It is] a rapid, noninvasive way of screening a cancer for common genetic fingerprints, while avoiding the challenges of traditional invasive biopsies."

        Researchers are hopeful that future developments will enable the use of blood tests not only as monitoring tools but also for very early cancer diagnosis. In the words of Antonious Schuh, from San Diego-based molecular diagnostic company Trovagene, "Why does there have to be a tumor? The tumor is the symptom. The disease is the DNA.”


Conclusion

        The ambitious Cancer Moonshot Initiative comes at a time of unprecedented hope. Major advancements in immunotherapy and genomic analysis fueled by a personalized, data-driven approach to cancer research make the “moon” seem closer than ever. R&D tax credits are a strategic tool to support innovative efforts in the war against cancer.

Article Citation List

   


Authors

Charles R Goulding Attorney/CPA, is the President of R&D Tax Savers.

Andressa Bonafé is a Tax Analyst with R&D Tax Savers.


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