The R&D Tax Credit Aspects of Zika



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Zika         According to The Centers for Disease Control and Prevention (CDC) there is now enough evidence to definitively say that Zika virus is a cause of microcephaly and other severe fetal brain defects.  Top health officials have stated that new findings “are not reassuring” and lead to believe that the Zika threat is “scarier” than initially thought.

        Even though continental U.S. infections so far have been travel-related, the CDC confirmed that Aedes aegypti, the primary mosquito species to transmit the virus, is present in 30 U.S. states, rather than 12, as previously thought. The increased geographical range of mosquitoes as well as the possibility of sexual transmission point towards the imminence of local infections, which are expected to peak during summer months. 

        It is even scarier to acknowledge the uncertainties surrounding Zika, particularly the great number of unanswered questions regarding how this unusual virus works and the extent of the public health threat it represents. In the midst of so many doubts, the unquestionable fact is that Zika research must urgently become a global priority. The present article will discuss ongoing efforts to contain the dissemination of Zika, including mosquito eradication and vaccine research. It will also present the R&D tax credit opportunity available to support those investing in this line of research.


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 $250,000 per year in payroll taxes.


Zika: From Medical Curiosity to Global Threat

        Primarily transmitted through the bite of infected A. Aegypti mosquitoes, Zika virus disease is characterized by mild symptoms that include fever, rash, joint pain, and conjunctivitis. Many of those infected might not even realize their
condition, as symptoms are often similar to the ones of other diseases and are seldom serious enough to require hospitalization. People who have been infected are likely immune to future infections.

        The virus was discovered in 1947 in Uganda and had since been limited to tropical Africa, Southeast Asia, and the Pacific Islands. In 2015, however, Zika crossed the Atlantic to what would be its largest outbreak ever, which began in Brazil and, as of June 2, reached more than 39 countries and territories in the region of the Americas alone.

        For decades, Zika had been considered a fairly benign virus. Yet, as pointed out by the World Health Organization (WHO) Director-General Margaret Chan, recent developments have rapidly changed its status “from a mild medical curiosity to a disease with severe public health implications.” In response to the ongoing crisis, the WHO declared Zika virus a public health emergency for international concern. 

        There is growing scientific consensus around the fact that Zika can cause a variety of neurological and autoimmune disorders. If infection occurs during pregnancy it can damage entire regions of the baby’s brain tissue, potentially generating a broad set of severe birth defects and heightening the risk of prematurity, miscarriage, and fetal death. The most serious of such conditions is microcephaly, in which the baby’s head is smaller than expected, due to abnormalities in brain development. Depending on its severity, microcephaly can be accompanied by a range of health problems, including seizures, developmental delays, intellectual disability, as well as difficulties in movement and balance.






        On May 25, researchers at the CDC and Harvard T.H. Chan School of Public Health published a study according to which the microcephaly risk for Zika infections in the first semester of pregnancy may be as high as 13 percent.   The first baby with Zika-related severe microcephaly was born in continental U.S. on May 31. Doctors at Hackensack University Medical Center in New Jersey believe that the mother contracted the virus while in Honduras, her home country.

        Even though the threat to unborn babies has gained most of the public attention, Zika can affect adults as well. According to the WHO, there is substantial evidence that the virus can cause Guillain-Barré syndrome (GBS), an autoimmune disease in which the immune system attacks nerve cells, generating acute weakness and temporary paralysis. The ongoing Zika outbreak has been correlated with a surge in GBS diagnoses in at least 13 affected countries. 


Zika in the U.S. and the World

        The ongoing Zika outbreak is a clear example of globalized public health threat. Traveling, climate change, and mass air movements are enabling the spread of a disease that was initially confined to tropical countries. According to the latest available data, a total of 60 countries and territories report continuing mosquito-borne transmission, 46 of which have experienced a first outbreak of the Zika virus since 2015, with no evidence of prior cases.

        Considered the epicenter of the ongoing Zika outbreak, Brazil has registered over 91 thousand likely cases of Zika infection in 2016 and 1,489 confirmed cases of microcephaly as of May 28, 2016. Other 3,162 suspected cases of brain malformation are under investigation.  Experts predict that the Latin American country will have more than 2,500 babies born with microcephaly if current trends persist. According to the WHO Director-General, if the ongoing pattern of Zika-related health complications spreads beyond Latin America and the Caribbean, “the world will face a severe public health crisis”

        The following map by the CDC presents an overview of countries and territories with active local Zika virus transmissions as of May 26, 2016.


 


        According to a recent Time Magazine article, an estimated 40 million Americans travel to Zika-affected countries every year, 500 thousand of which are pregnant women. As, of June 1, Puerto Rico has confirmed 1,072 cases in what is considered the beginning of an epidemic that could eventually reach 20 percent of the island, likely finding its way to mainland U.S. over the summer.  According to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, local transmissions could begin taking place in continental U.S. any time now.

        The following table summarizes the most recent data available for Zika virus disease in the U.S., as of June 1, 2016:




        U.S. southern states and Hawaii have traditionally been considered higher-risk locations, due to weather and geographical conditions that are favorable to A. aegypti reproduction. However, recent findings have expanded the potential risk range for Zika. In April, researchers at the Pan American Health Organization have detected the virus in Aedes albopictus mosquitoes, known as “Asian tigers”. This species is more ubiquitous in the U.S. than the A. aegypti and can be found as far north as New England and the lower Great Lakes. Further investigation is necessary to determine how competent a vector the Asian tiger is. Nonetheless, U.S. health officials have urged state and local governments within its range to plan for anti-Zika efforts. 

        The following maps, created by the CDC, present the estimated range of A. aegypti and A albopictus in the U.S. 







       
        On February 3, the CDC moved its Atlanta, Georgia-based Emergency Operations Center to the highest level of activation for Zika response. Similar measures had only been taken in three previous occasions, namely, Hurricane Katrina, the H1N1 flu outbreak, and the Ebola crisis. According to the agency, this reflects “need for an accelerated preparedness to bring together experts to focus intently and work efficiently in anticipation of local Zika virus transmission by mosquitoes in the Continental U.S.”  

        Besides health implications, Zika represents a major economic burden, particularly due to the possibility of severe birth defects. Time Magazine points out that raising a baby with microcephaly can cost up to $2 million in the first few years alone - though many don’t even live that long. The World Bank estimates that the economic cost of Zika in Latin American will reach $3.5 billion in 2016 alone, with critical effects over regions that are highly dependent on tourism. 

        As this article goes to press, the issue of Zika research and prevention funding by the Federal Government remains unresolved. In February, President Obama asked Congress for $1.9 billion in emergency funding to help combat the virus. On May 17, the Senate endorsed a compromise bill that allocates only $1.1 billion towards this cause. Since then, the matter remains in the House of Representatives, where skepticism and political interests threaten to widen the funding gap. 


The Olympics

        Over a half-million people are expected to visit Rio de Janeiro during the upcoming Summer Olympics in August. Many have called for the postponement or relocation of the games, arguing that this number of international visitors could lead to the beginning of a worldwide Zika epidemic. In June 4, cyclist Tejay van Garderen became the first American athlete to withdraw his name from Olympic consideration because of the virus.

        Even though the WHO initially said there was no “public health justification” for postponing or moving the games, increased international pressure has led the organization to agree to reassess the risks involved. Over 150 experts, including physicians, lawyers, bioethicists, academics, and public health officials have recently signed an open letter to the WHO, accusing it of acting irresponsibly in the face of a global threat.

        In preparation for the games, South Korea has developed an innovative way to protect its athletes. The so-called “Zika-proof” uniforms are treated with insect repellent and will be worn during ceremonies and at the athletes’ village.


Unanswered Questions about Zika

        Even though Zika-related research efforts have multiplied considerably over the last months, in many instances the virus remains mysterious. Several questions are still to be answered in order to build a comprehensive understanding of the current outbreak.

        Ongoing research aims to understand how Zika affects pregnant women and fetuses. Urgent questions relate to the exact probability of a Zika-infected fetus to be born with birth defects, the level of fetal vulnerability throughout the different stages of pregnancy, and how early the virus can be detected. When it comes to microcephaly, it remains unclear how exactly the virus affects brain development and what is the survival rate for babies born with the disease.

        Aiming to answer these questions, researchers at Johns Hopkins University are currently investigating the effects of Zika in a three-dimensional model, or organoid, made of stem cells that mimic early brain development. They have discovered that the virus attacks and kills so-called progenitor cells, a type of cell present during early fetal development that is responsible for generating neurons in the brain. In the experiment, a reduced number of neurons resulted in undersized brain organoids, which are consistent with microcephaly.

        The study suggests that even short exposures to small quantities of the virus can hinder brain development, with more acute cases happening during the first three months of pregnancy even though damages can also happen during the second trimester.    Research further revealed that infected progenitor cells become “factories” that not only produce more virus but also have a “bystander effect”, which can kill or damage neighboring, uninfected counterparts.

        Corroborating these findings, researchers at the University of Texas Southwestern Medical Center found that Zika virus infects approximately 20 percent of progenitor cells. It does so while evading immune system detection, which allows replication to go on for weeks.  

        These preliminary discoveries are at the basis of emerging efforts to develop drugs especially designed to protect neural progenitor cells. The National Center for Advancing Translational Sciences is testing a wide variety of compounds that aim to block the surge in caspase-3 enzyme, which characterizes progenitor cell infection. Even if a compound is found, however, further research will be necessary to determine whether it would be safe for pregnant women and in which cases it would be recommended, since many infected women have healthy babies.

        The Johns Hopkins research also begins to shed light on the link between Zika and adult neurological disorders, such as GBS. According to the study, the virus can affect glial cells, which are present in the brain throughout life and are responsible for supporting and insulating neurons.

        Yet another pressing subject of research is transmission. Zika is the first mosquito-borne disease that can be transmitted through sex, fact that has been verified in over ten countries. Even though it is already known that sexual transmission occurs by infected men, it remains to be determined how long the virus can stay in the semen. It is also unclear whether women can spread Zika and whether it can be transmitted through other body fluids, such as saliva. An article published on June 2 by The New England Journal of Medicine suggested that Zika may be transmitted by oral sex, and even by kissing.


Diagnosing Zika

        Developing a reliable diagnostic test for Zika is among the top priorities for handling the ongoing outbreak. Since many of those infected with Zika experience symptoms similar to the ones of other diseases, it has been particularly difficult to map and control the epidemic. The development of more effective and more widely accessible tests could help improve the understanding of Zika infectivity and transmission.

        In March, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization to a three-in-one laboratory test for Zika, dengue, and chikungunya, all of which are transmitted by A. aegypti mosquitoes. Developed by the CDC the Trioplex Real-time RT-PCR Assay allows doctors to identify these three infections with one single test, instead of having to perform three different exams. The innovative tool has been distributed to qualified facilities in the Laboratory Response Network.

        According to the WHO, there are over thirty companies currently working on Zika-diagnosing tools.  Headquartered in Madison, New Jersey, Quest Diagnostics was the first of these companies to receive, on April 28, an emergency authorization from the FDA to sell a commercially developed diagnostic test for Zika. It consists of a molecular test designed to detect RNA from the virus in human serum specimens. This authorization is expected to broaden the availability of Zika diagnosing tools, which had been restricted to qualified laboratories designated by the CDC.

        Similar to other molecular exams, Quest test’s ability to detect Zika is limited to the period in which the virus remains in the patient’s blood, which lasts only about seven days. This means that serological tests that identify antibodies produced in response to the virus may also be necessary in order to definitively rule out an infection. Zika-specific antibody Immuglonin M remains in the body for up to 12 weeks after the infection and is considered, therefore, a better indicator for precise diagnosis.

        Even though the advantages of serological Zika tests have been demonstrated, lack of access to blood samples containing Zika virus antibodies has undermined their development. Aiming to overcome this barrier, the U.S. Department of Health and Human Services (HHS) has launched a six-month, $692,000 project that will collect blood samples from people with confirmed Zika infection and make these samples available to diagnostic companies willing to assess the performance of their potential products. Zika antibody tests could allow for a better monitoring of pregnant women and their sexual partners.

        Though progress has been made, the most significant limitation to existing Zika blood and antibody tests remains the delay in results, which can take days or even weeks. Moreover, samples often require special conditions for storage and transportation, which are difficult to replicate in isolated areas. Tests can also fail to discriminate between Zika and other related viruses, such as dengue.

        Aiming to overcome these deficiencies, a research effort funded by the Wyss Institute for Biologically Inspired Engineering, MIT’s Center for Microbiome Informatics and Therapeutics, the Defense Threat Reduction Agency, and the National Institutes of Health has developed a paper-based device for Zika diagnose. Using technology recently developed to detect the Ebola virus, researchers embed small discs of paper with synthetic gene networks programmed to change color when in contact with a particular genetic sequence. The sensors are able to detect 24 different RNA sequences found in the Zika viral genome and can accurately distinguish Zika from dengue. In addition to being inexpensive, the innovative platform can diagnose Zika within just a few hours. It can be stored at room temperature and easily shipped to any location. Initial tests were successful in detecting even low concentrations of Zika virus in the blood and saliva of infected monkeys. 

        West Lafayette, Indiana-based Novilytic is also working on innovative Zika diagnostic tools. In 2014, the company introduced the Noviplex Card, which uses blood sample from the prick of a finger to separate plasma and upload its digital image to a laboratory for analysis. Novilyic co-founder and researcher at University of Nebraska-Lincoln Jiri Adamec is cooperating with Brazilian officials to distribute the groundbreaking card to over eight South American states throughout the Amazon rainforest, where it will be used as a prescreening technology. Access to Noviplex cards can be a game-changer in isolated communities, where healthcare infrastructure is significantly limited. 

        In a similar effort, Ithaca, New York-based Rheonix, Inc. is working in partnership with New York University College of Dentistry (NYUCD) to develop an automated system for rapid Zika virus diagnostic. The collaboration has received over $600 thousand in funding from the National Institute of Dental and Craniofacial Research of the National Institutes of Health. The innovative initiative aims to create a fully automated system that combines RNA and antibody tests for simultaneous Zika detection and confirmation in both early and late infections. By combining the different automated solutions, the test will autonomously manage the processes of sample extraction, purification, amplification, and detection with no user intervention. This level of automation is expected to make Zika diagnoses quicker, more efficient, less expensive, and less prone to human error.


Mosquito Control

        According to the CDC, mosquitoes are among the top deadliest animals in the world due to the diseases they spread. A mosquito infected with Zika can transmit the virus for 30 to 45 days, being able to infect over 300 people.  For this reason, many of the efforts to control the ongoing Zika epidemic focus on its primary transmitter, the A. aegypti mosquito. A simple and widely recommended strategy consists of getting rid of standing water, which can serve as breeding sites. A bottle-cap-size pool of water is enough to receive as many as 200 eggs, which can remain dormant for up to a year even after the water is removed.

        There are, however, more ambitious strategies for mosquito control. For instance, in a study published on May 4, the Oswaldo Cruz Foundation found that injecting mosquito eggs with common bacteria called Wolbachia drastically increases the eventual adult insect’s resistance to the Zika virus, thus limiting its ability to spread the virus. The Brazilian foundation is planning to release Wolbachia-infected mosquitoes in Brazil and Colombia so that they breed and eventually replace non-carrying counterparts. Similar efforts are already at place for controlling dengue in Australia, Vietnam, Indonesia, and Brazil. Preliminary results show that, when Wolbachia-carrying mosquitoes become prevalent, new locally-acquired cases cease to emerge. Ongoing studies suggest that a similar effect could be verified for Zika. However, further research is necessary to assess for how long the bacteria can suppress Zika virus infection. Experts are highly optimistic, particularly due to the vast number of Wolbachia strains to be explored.

        Though highly controversial, genetic editing could be a valuable instrument for mosquito control. Two different approaches to genetically modified mosquitoes stand out. The first one was developed by British biotechnology company Oxitec and promises to reduce A. aegypti populations by up to 90 percent. Working only with male insects, which cannot bite, the company has developed a “lethal gene” that makes sure all future offspring is nonviable and dies before reaching adulthood.

        Oxitec has already conducted field tests in Brazil, Panama, and the Cayman Islands. The company is currently seeking federal permission to perform its first U.S. trial with “self-limiting” mosquitoes in Key Haven, Florida. Even though a preliminary FDA assessment found a “negligible or low” likelihood of harm to humans, animals or the environment, residents remain wary of potential unintended consequences. A nonbinding public vote is schedule for August. According to financial services firm Wunderlich Securities Inc, the U.S. market could represent $100 million in sales for Oxitec, which is owned by Virginia-based Intrexon Corp.

        The FDA has fully reviewed the potential impact of utilizing Oxitec’s OX513A by an environmental assessment (EA) and finding of no significant impact (FONSI) and determined that there are no significant impacts that would occur from this study to humans or the environment.  The FDA has approved field trials to be conducted in Key Haven, Florida to examine if the release of the genetically modified insects will be able to control the amount of Aedes aegypti mosquitoes. Oxitec is hoping that the field test will result in the reduction of the specified mosquitoes by 90% throughout a period of six months. If the field test is successful, then the OX513A will be able to be sold and distributed throughout the United States.

        The second possibility is using a revolutionary new technology called gene drive, which enables the rapid dissemination of genetic mutations among animal populations. In a gene drive system, lab-engineered mosquitoes are released in the wild and begin to pass on their genetic traits to all their descendants. Such traits can include sterility and immunity to viruses, such as Zika. Though still in its infancy, the technology could be ready for use in less than a year, according to biologist Anthony James of the University of California, Irvine, and, once deployed, could lead to the extinction of the A. aegypti species in a couple of years. Fear of unforeseen ecological consequences, however, have prevented a more widespread acceptance of this innovative approach.


Vaccines

        The longstanding misconception of Zika’s supposedly benign nature has led the scientific community to believe it wasn’t worth the resources necessary to investigate potential treatments. Consequently, there is currently no vaccine or medicine for Zika.

        However, numerous efforts aim to make up for the lost time, particularly with regards to prevention. According to a March 2016 article from British interdisciplinary scientific journal Nature, there are at least 18 agencies and companies currently developing a Zika vaccine.  Two different strategies stand out:

Inactivated Vaccines
        Considered the safest type of inoculation for pregnant women, these vaccines are based on killed, purified Zika virus. The Butantan Institute in Brazil is currently investing on this prevention strategy, which is considered a top research priority by the WHO. The Brazilian institute expects to begin human testing in two to three years.

Live Attenuated Vaccines
        Using weakened Zika virus, this kind of inoculation enables a close reproduction of the natural course of infection and is thus considered potentially more effective. The National Institutes of Health is investing on this strategy by developing a DNA-based vaccine that uses Zika virus genetic material to stimulate immune response. The effort consists in modifying an existing vaccine initially targeted at the West Nille virus. Human testing could begin as early as September.

        The race for developing a Zika vaccine has attracted various U.S. biotechnology companies, which may be eligible to significant R&D tax credits. Examples include Inovio, the creator of a synthetic DNA vaccine that targets multiple Zika virus antigens. The Plymouth Meeting, Pennsylvania-based company has had significantly positive results in tests involving non-human primates and intends to implement a human trial in 2016.

        Inovio’s DNA vaccine (GLS-5700) was approved by the FDA for a human trial in June 2016.   The Phase I trial will be conducted on 40 participants, which will ultimately test the safety of the vaccine and find the proper dosage. The procedure of injecting the DNA vaccine consists of utilizing a device that produces electrical pulses at the injection area in order to guide DNA into cells. Once the vaccine is distributed within the cells, it controls the immune system to produce antibodies which target the Zika virus since it is seen as a harmful invader to the body.

        Yet another example is Pharos Biologicals, which has been awarded worldwide licenses for a patented DNA vaccine technology and for certain vaccine-delivery nanotechnologies developed at the Johns Hopkins University School of Medicine. The Baltimore, Maryland-based company is working on a non-live virus vaccine that should be available for human trials this fall.


Treatments

        There are currently no treatments available for Zika infection. However, ongoing R&D efforts shed light on promising alternatives. Working in partnership with Brazilian pharmaceutical company Auramedi, El Paso, Texas-based Premier Biomedical has developed an innovative process called sequential dialysis, which could help reduce the viral load in infected patients. In the words of Mitchell S. Felder, MD, Premier Biomedical’s Scientific Advisory Board Chairman,

“(...) by lowering the viral load on the mother’s system, her own immune system can better fight the virus in her body and therefore, that of her fetus, thereby increasing the chances of her delivering a normal, healthy baby without microcephaly. The larger the viral load on the mother, the higher the chances of her baby having severe disabilities or being still-born.”

        Another potential line of treatment is the use of a protein naturally present in the human body that, according to researchers at the University of Massachusetts Medical School, can “swallow up and quarantine” the Zika virus. By doing so, the interferon-induced protein 3 (IFITM3) reduces the virus’s ability to infect and, in some cases, prevents it from killing other cells. The study has found that high levels of IFITM3 seem to hamper Zika infiltration into the cell interior thereby blocking infection. If these findings are confirmed, the protein could be used as an “early front line defender” for infected patients. 


Conclusion

        The world has been caught off guard by the recent Zika virus outbreak. Considered for decades a rather benign virus, Zika became a global health threat with devastating impact. As researchers try to catch up, unanswered questions stand on the way of more effective prevention, diagnosing, and treatment strategies. The advances presented in this article, however, show how R&D efforts can help us win the battle against Zika.  

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.

Lara Tomiko is a Tax Analyst with R&D Tax Savers.


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