LIMERICK, PA — Rockland Immunochemicals, Inc., in collaboration with researchers from the Nucleic Acid Therapeutics Accelerator (NATA) in the United Kingdom, has co-authored a groundbreaking peer-reviewed article describing innovative bioanalytical approaches to enhance the safety and efficacy of oligonucleotide therapeutics (ONTs). Published in the prestigious journal Nucleic Acid Therapeutics, the study introduces antibody-based immunoassays as an advanced analytical tool for the localization and quantification of ONTs, complementing traditional methods like LC-MS/MS and ligand binding assays.
Oligonucleotide therapeutics, including antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs), represent a rapidly growing class of drugs targeting a wide range of diseases such as cancer, neurological disorders, and infectious diseases. Despite their promise, the development of ONTs is hampered by significant challenges related to stability, delivery, immunogenicity, and off-target effects. The research addresses these hurdles by proposing novel antibody-based assays designed to improve drug tracking and pharmacokinetic evaluations, thereby ensuring safer and more effective therapeutic use.
“The rapid evolution of oligonucleotide therapeutics presents exciting opportunities but also requires novel analytical methods to ensure their successful clinical translation,” said Dr. Carl Ascoli, Chief Science Officer at Rockland Immunochemicals. “Our research underscores the importance of reliable assays to address ONT-specific challenges and build confidence in their progression from development to clinic.”
The study highlights the susceptibility of ONTs to degradation by nucleases and their reliance on sophisticated delivery systems for effective cellular uptake. Regulatory bodies like the U.S. Food and Drug Administration (FDA) have emphasized the need for robust pharmacokinetic and immunogenicity evaluations tailored to these therapies. By developing antibodies uniquely designed to recognize ONTs, the research team demonstrates that antibody-based assays offer a promising orthogonal solution to existing bioanalytical techniques, enabling more precise assessments of ONT safety and efficacy.
Nick Lench, Director of NATA, shared his excitement about the collaboration, saying, “We are very pleased to be working with Rockland Immunochemicals Inc. to facilitate the benchmarking of these new reagents that will be a great asset to the nucleic acid therapeutics field.”
This milestone publication not only reflects the growing importance of innovative bioanalytical strategies in advancing ONTs but also paves the way for further research to unlock their full potential. With hundreds of clinical trials already underway for nucleic acid therapies globally, the need for improved monitoring tools is urgent.
Looking ahead, the development of antibody-based immunoassays promises to bolster the overall therapeutic landscape for ONTs, addressing critical barriers to their clinical success. This pioneering research marks a significant step forward in the evolution of nucleic acid-based therapies, offering hope for more effective treatments and improved outcomes for patients worldwide.
The full article can be accessed in the latest issue of Nucleic Acid Therapeutics.
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