One Step Closer to Affordable HIV Drug–Resistance Test
Harvard recently entered into a licensing agreement with Aldatu Biosciences for exclusive use of the PANDAA technology. Using PANDAA, Aldatu, a biotech start-up based at LabCentral in Cambridge, is developing a rapid HIV drug-resistance test for patients failing first-line antiretroviral therapy (ART).
According to recent UNAIDS statistics, about 37 million people worldwide are infected with HIV. Of those infected, about 17 million are currently taking ART. The World Health Organization (WHO) recommends that everyone diagnosed with HIV begin treatment as soon as possible. Once on treatment, most HIV-infected people can expect to lead fairly normal lives.
But the treatment doesn’t always work. About 10% of patients fail their HIV regimens every year. Drug-resistance can happen naturally, as the highly mutable HIV virus changes within a person. Drug-resistance can occur if a patient doesn’t take drugs consistently. And drug-resistant HIV can be transmitted from one person to another.
Ideally, doctors would test and monitor all HIV-positive patients for drug resistance. This is standard practice in the U.S. But current tests cost about $300 each, making testing unaffordable for most developing countries. A cheaper test would have a large public health benefit, especially in southern Africa, the region with the highest prevalence of HIV. Aldatu is developing a less expensive test specifically for use in low- and middle-income countries.
The PAANDA technology was developed by Drs. Iain MacLeod and Christopher Rowley when they were working in the laboratory of Prof. Max Essex, Chair of the Harvard AIDS Initiative. MacLeod was a Research Fellow at the time and Rowley is an Assistant Professor at Harvard Medical School and Attending Physician in Infectious Diseases at Beth Israel Deaconess Medical Center. While conducting research on HIV drug-resistance in Botswana, MacLeod and Rowley became frustrated by the high cost and low sensitivity of available tests. So they made a better one, creating a genotyping technology for the detection of single nucleotide polymorphisms (SNPs) in pathogen genomes. Rowley named it PANDAA, short for Pan-Degenerate Amplification and Adaptation.
To commercialize PANDAA, MacLeod, teamed up with Dr. David Raiser, who holds a PhD in Genetics from Harvard Medical School. They founded Aldatu Biosciences in 2014, with Raiser as CEO and MacLeod as CSO. Rowley serves as a consultant. Aldatu is the Basque word for change.
Royalty-free in Developing Countries
Because PANDAA was developed at Harvard, the University controls licensing agreements. Harvard’s Office of Technology Development (OTD) structured its contract with Aldatu “to maximize the global impact of the test” by allowing Aldatu to use PANDAA royalty-free in the developing world.
“In this case, we wanted to lower as many barriers as we could to getting this product on the market in the developing world, and in particular in Botswana and Zimbabwe where Aldatu is planning to develop this product first,” said Grant Zimmermann, OTD’s Director of Business Development for the Life Sciences. “That’s consistent with the University mission and the mission of the Medical School and the School of Public Health.”
“The license is royalty free in low- and middle-income countries,” said Raiser. “What that means is that we will be able to keep our costs down and the price of our tests down.”
In addition, the inventors are generously turning over their shares of royalties to the Botswana Harvard AIDS Institute Partnership (BHP) to support HIV/AIDS research in Africa. Essex, MacLeod and Rowley have all lived and worked in Botswana. The samples used to develop PANDAA came from clinical trials conducted at the BHP.
“They’re all very committed to the public health mission in the developing world, so this is something they thought was appropriate and that they wanted to do,” said Zimmermann.
This isn’t the first time that patent income from a discovery made in the Essex Lab has been used to fund AIDS research. When the Harvard AIDS Institute (HAI) was established in 1988, initial funding came from patent royalties for the widely-used HIV-blood screening test developed from research conducted by Essex and his colleague, Dr. Tun-Hou Lee.
Profit with a Public Benefit
The Aldatu team won the 2014 Deans’ Health and Life Sciences Challenge, a start-up competition hosted by the Havard i-lab. Since then, they have received funding from the Verizon Powerful Answers Award Program, the National Institute of Allergy and Infectious Disease (NIAID), and the Charles Hood Foundation.
Aldatu recently changed their status from a traditional C-corporation to a public benefit corporation. The young company is still for-profit, but their charter now includes an explicit statement of their public benefit mission “to improve human health globally and create products that address diagnostic challenges in global healthcare.”
“Our goal with the public benefit corporation was to signal unequivocally that we are committed to our public health mission,” said Raiser.
“They’ve done a fantastic job taking this technology from the lab and very quickly securing capital resource to develop it,” said OTD’s Zimmermann.
Raiser and MacLeod hope to have an affordable HIV-drug resistance test on the market within three years.
Title image (l to r): David Raiser and Iain MacLeod