October 15th, 2018 (BOSTON, MA) — Aldatu Biosciences, an early-stage biotechnology company developing diagnostic assays for the detection of infectious diseases and antimicrobial resistance, today announced it has been awarded a $3 million, three-year Phase II Small Business Innovation Research (SBIR) contract from the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). The award will fund the continued advancement of the company’s proprietary platform technology, PANDAA™, and its specific application to the rapid and ultrasensitive detection of drug-resistant HIV minority variants.
Antiretroviral therapy (ART), which is now widely available to the majority of the 33 million people living with HIV today, dramatically reduces mortality and morbidity in infected persons. With successful therapy, the virus becomes fully suppressed in the infected individual’s body; unfortunately, in some cases, drug resistance may arise over time or even be transmitted to newly-infected individuals, and this can render ART ineffective. Specific HIV mutations are associated with resistance to single drugs or entire drug classes, and these mutations can be detected through standard genotypic resistance tests once they are present at 15-20% of the virus population within an individual. However, it is now known that even when present at a very low concentration within a patient’s mixed virus population (1% or more), certain resistance mutations can contribute to treatment failure.
“With the growing body of evidence that demonstrates the clinical impact of low abundance drug-resistant HIV variants, it is more important than ever that the diagnostic tools to detect them be made available to care providers,” noted David Raiser, CEO at Aldatu. “Our highly sensitive test will enable the early detection of these minor variants, alerting providers and patients of the emergence of resistance much sooner than currently available tests. With tools for earlier detection of drug resistance, clinicians can both prospectively identify low abundance resistant variants prior to ART initiation and, when treatment failure is suspected, consider possible drug regimen changes in a timely manner. Ultimately, early detection should contribute to a decrease in the spread of infection.” As the WHO, UNAIDS, and other global leaders target the elimination of HIV as a public health threat by 2030, methods to avert HIV transmission are at the forefront of conversation.
As the first technology that enables quantitative real-time PCR (qPCR) to accurately and sensitively detect genomic targets in highly variable regions, PANDAA™ has considerable speed, sensitivity, cost, and workflow benefits relative to existing detection methods like Sanger sequencing and next-generation sequencing (NGS). “This contract will enable us to really demonstrate the unique capabilities of the PANDAA™ technology platform. By enabling qPCR for HIV minor variant detection, PANDAA™ can generate quality genotyping results in a matter of hours as compared to several days, which is the current status quo,” stated Iain MacLeod, CSO at Aldatu.
This Phase II development will build upon the completed Phase I contract work, also funded by NIAID, wherein Aldatu successfully developed ultrasensitive PANDAA™ assays for resistance mutations relevant to all four major antiretroviral drug classes (NNRTI, NRTI, PI, and INSTI); this work was funded in part by the Massachusetts Life Sciences Center (MLSC) MassRamp program, of which Aldatu is an awardee. The focus of this Phase II work will be to develop a simple qPCR-based HIV genotyping kit capable of detecting a panel of drug-resistant HIV minority variants with a time-to-result (sample-to-answer) of less than 8 hours.
Aldatu Biosciences (www.aldatubio.com) is a Boston, MA-based, early-stage 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.
Aldatu is a current resident of the Pagliuca Harvard Life Lab in Boston, MA, a former resident of LabCentral in Cambridge, MA, and a graduate of the MassBio MassCONNECT program. Inquiries can be sent to firstname.lastname@example.org.
This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract Nos. HHSN272201600022C and HHSN272201800050C.