Cambridge, Mass. (May 18, 2016) – Aldatu Biosciences, Inc. (Aldatu), an early-stage diagnostics development company, today announced that it has entered into a licensing agreement with Harvard University’s Office of Technology Development based on intellectual property developed in the laboratory of Professor Myron (Max) Essex, DVM, PhD, at the Harvard T.H. Chan School of Public Health.
The license provides rights to Harvard patent applications filed on a novel genotyping platform, Pan-Degenerate Amplification and Adaptation (PANDAA), which represents a series of innovations in quantitative polymerase chain reaction (qPCR) technology that enable its use in the development of new diagnostic applications, primarily for infectious disease. PANDAA overcomes challenges presented by highly polymorphic pathogens by stripping away sequence variation near SNPs of interest while leaving the SNPs intact, thus allowing for highly sensitive qPCR-based detection of clinically relevant SNPs without any reduction in specificity. Aldatu’s license broadly covers application of the PANDAA technology in the fields of clinical diagnostics and in vitro research.
The inventors include Dr. Essex, the Mary Woodard Lasker Professor of Health Sciences at the Harvard Chan School and Chair of the Botswana Harvard AIDS Institute Partnership; Iain MacLeod, LLM, PhD, Research Associate in the Department of Immunology and Infectious Diseases at Harvard Chan; and Christopher Rowley, MD, MPH, Assistant Professor of Medicine at Harvard Medical School, Research Associate at Harvard Chan, and Attending Physician in the Department of Infectious Diseases at Beth Israel Deaconess Medical Center. Dr. MacLeod is a co-founder of Aldatu and has served as its Chief Science Officer since June 2015.
Drs. MacLeod and Rowley initially developed the PANDAA technology to address inadequacies in available options for HIV drug resistance genotyping, which allows clinicians to match HIV-infected patients with effective antiretroviral medications (ARVs). The researchers were performing work as part of a study meant to assess rates of transmitted HIV drug resistance in recently infected pregnant women, in collaboration with the Botswana Harvard AIDS Institute Partnership in Gabarone, Botswana, where work on PANDAA continues today. Aldatu was co-founded by Dr. MacLeod and Dr. David Raiser in 2014 with the purpose of commercializing the PANDAA technology and bringing it to patients.
“The PANDAA technology represents a better, faster, and cheaper way of performing drug resistance testing for HIV-infected patients, and as such it allows us to address a serious clinical and public health need.” Dr. Raiser, Aldatu’s Chief Executive Officer
“PANDAA has great potential for patient impact, especially in those parts of the world with high HIV burden and limited healthcare resources. We are extremely pleased to have entered into this license agreement with Harvard, and to be moving full steam ahead with our plans to bring PANDAA-based diagnostics to the market.” said Dr. Raiser, Aldatu’s Chief Executive Officer.
HIV drug resistance is a serious global problem that could undermine ongoing efforts by organizations like UNAIDS and the WHO to expand treatment access from the current 15 million patients to more than 30 million patients worldwide by 2020.
Dr. MacLeod explained, “A sensitive and affordable PANDAA drug resistance test could help ensure that HIV-infected patients are taking effective medications, help clinicians make informed and cost-efficient decisions about drug prescriptions, and help resource-constrained healthcare systems save money and treat more patients.”
“We’re talking multiple millions of dollars in potential cost savings for an individual country,” Dr. Raiser added. “That can go a very long way in a resource-constrained HIV treatment program.”
Aldatu has leveraged existing cost-effectiveness models to show that in South Africa, the country with the single largest HIV-infected population in the world, an affordable PANDAA-based drug resistance genotyping test could save the healthcare system upwards of $125 million over the first five years of implementation.
“We invented PANDAA to solve the problems we had observed first-hand through our work in Botswana, and we’re committed to translating PANDAA into real diagnostic solutions that can both help patients stay healthier and help resource-limited HIV treatment programs be more cost-efficient.” Dr. Iain MacLeod, Aldatu’s Chief Science Officer
“I feel fortunate to have the opportunity to play an active role in bringing our PANDAA technology to patients through Aldatu, and to be able to continue working with Harvard to do so,” said Dr. MacLeod.
Dr. Raiser added, “PANDAA development has advanced considerably as a result of the work of Dr. MacLeod and his colleagues at Harvard, and more recently with our scientific team at Aldatu. We are currently establishing a strong R&D foundation with our ongoing product development efforts, which will allow us to rapidly apply PANDAA to the development of diagnostic tools, both for additional HIV applications and for other high-need infectious diseases such as tuberculosis and Zika virus.”
Aldatu has received seed funding from the National Institute of Allergy and Infectious Disease, as well as from Charles Hood Innovations (an affiliate of the Charles H. Hood Foundation), the Harvard Deans’ Health and Life Sciences Challenge, and the Verizon Powerful Answers Award Program. The company is based at LabCentral in Cambridge, Mass., and is currently developing its lead product, an HIV drug resistance genotyping test for patients failing first-line ARV therapy in low- and middle-income countries.
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About Aldatu Biosciences
Aldatu Biosciences is a Boston-based, seed-funded biotechnology company developing innovative diagnostic tools based on its proprietary genotyping platform, PANDAA. Aldatu is committed to commercializing products that address diagnostic challenges in global health, primarily in HIV and other infectious diseases, and which improve both the quality of patient care and healthcare cost-efficiency. Inquiries can be sent to change@aldatubio.com, and more information can be found at www.aldatubio.com.
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