Challenge for pharma firms: Funding for HIV research

By Bob McNally
Robert McNally

According to numbers circulated by UNAIDS and the World Health Organization in November, the worldwide population of individuals living with HIV/AIDS in 2010 stood at 34 million.

Yet despite the continuing importance of developing HIV vaccines, a range of research groups and small biopharma companies are finding challenges in obtaining the amount of funding that is required to conduct effective research and clinical trials.

As an example, HIV researchers in India recently asked that nation’s government to raise funding levels for their programs, and researchers at an international symposium on HIV and infectious diseases in Chennai pronounced funding levels “largely insufficient and disappointing” in light of the number of individuals with the virus. Elsewhere, the National Research Council of Canada recently awarded Sumagen Canada Inc. $728,000 for a Phase 1 human clinical trial for its HIV vaccine candidate; yet the lead researcher, Chil-Yong Kang, remarked that the entire trial is “going to take almost ten times that amount.”

The challenges being experienced by scientists and small biopharma companies working on HIV vaccine research can be ascribed to a variety of sources, but three stand out: First, the idea that the epidemic has improved since it initially came to the public’s attention in the early 1980s; second, the opinion that the absence of a viable vaccine up to the present time means that none is forthcoming; and third, the nature of financial support from the National Institutes of Health and potential investors.

Let us analyze each of these views.

First, why has the HIV/AIDS crisis diminished in the public consciousness, domestically and elsewhere, despite the continued high cost of present treatment regimens?

Consider sentiments within the United States. There are portions of the American populace that think HIV is a non-issue, rooted in the fact that antiretroviral therapy drugs can be effective and provide an extended life to those with HIV. What they seem not to realize is that the expense and considerable side effects of these treatments are still problematic — not a long-term solution, and definitely not a solution for developing regions worldwide.

The populations of developed nations in 2012, and their governments, may be tempted to believe the HIV/AIDS crisis is an issue for other regions of the globe. Yet this is contradicted by facts. Note, for example, that in the U.S. there are 55,000 new HIV infections annually, a number that has stayed the same since the mid-1990s in spite of the use of counseling, medications and protective measures.

In this sense, government sentiment may be echoing media coverage of HIV/AIDS, which, according to a recent study, fell more than 70 percent in developed nations during the last two decades. This study — the Trends in Sustainability Project — tracked coverage of a range of sustainability issues in 115 leading broadsheet newspapers in 41 countries from 1990 until May 2010.

Although newspaper readership has been steadily eroding over the past decade due to the rise of online news, this study is still a powerful indicator of the priority that traditional news organizations assign to various subjects. In the early 1990s, an average of 1.5 articles about HIV/AIDS was found in every issue of these newspapers; since 2008, that average has fallen to less than 0.5.

Now consider the second principal factor possibly driving government reluctance to provide long-term HIV/AIDS research funding: the spotty record of vaccine efforts to date. Over the last couple of decades, there have been several false hopes, and plenty of failures, on the road toward a vaccine. Consequently, it is tempting to doubt that a cure or treatment lies in our future.  But those in government with this belief are disregarding good news from clinical studies that shed a very real ray of hope on finding a safe, inexpensive, universal treatment.

Substantial advances are being made toward the creation of a viable vaccine. In autumn 2009, a collaboration between the Ministry of Health in Thailand, the U.S. military, and the U.S. National Institute of Allergy and Infectious Disease (NIAID) announced the first encouraging results from an efficacy trial — 31 percent prevention of infection in a 16,402 person community-based trial in Thailand. This result achieved significance in an analysis that excluded seven subjects who were determined to have been infected at the time of the initial vaccination, showing for the first time that an HIV vaccine could prevent infection.

Meanwhile, an Emory University research group may be one step closer to finding a vaccine that will provide long-lasting protection against HIV/AIDS. Dr. Harriet L. Robinson, senior vice president for research and development at GeoVax Inc., our biotech company specializing in the development of HIV/AIDS vaccines, along with her team at Emory University, showed that a novel class of vaccines against HIV has demonstrated significant protection against the most potent strains of HIV infections in animal models.

The novel class of vaccines is a combination vaccine. Using a vaccine candidate in monkeys, Dr. Robinson’s team has been able to demonstrate that this combination is capable of achieving a highly encouraging prevention of infection. Most notably, the GeoVax candidate has shown effectiveness against SIV251, the most difficult simian version of HIV in humans. Such an encouraging result demands attention by funding decision makers.

Finally, consider the nature of National Institutes of Health (NIH) funding for biopharma companies, as well as the tendencies of investors.

The NIH is very supportive of new protocols and the running of clinical trials.  However, during the long clinical trial period, the company must separately fund general overhead and vaccine production.  Once a vaccine candidate exhibits human efficacy in later stage trials, equity investors and partnering opportunities are more prevalent.  Meanwhile, finding equity investors is a challenge due to the long time scales involved in developing a viable vaccine; investors are more likely to seek out opportunities that pay off in a relatively shorter term.

As argued above, there are certain factors behind the roadblocks currently faced by small biopharma companies engaged in HIV/AIDS vaccine research.  An enhanced recognition of these and other factors could lead to a more suitable level of funding for a disease that still threatens millions worldwide.

Robert McNally is president and CEO of GeoVax, an Atlanta-based biotech company that is developing vaccines that prevent and fight HIV infections.