Innovative Research to Advance Oligonucleotide Therapeutics now published in the Journal of Nucleic Acid Therapeutics

LIMERICK, Pa., Feb. 25, 2025 /PRNewswire/ -- Rockland Immunochemicals, Inc. is pleased to announce that Dr. David P. Chimento, Vice President of Research and Development, Amy L. Anderson, Technical Applications Specialist, and Dr. Carl Ascoli, Chief Science Officer, working with Inês Fial, Research Assistant at the Nucleic Acid Therapeutics Accelerator (NATA, Oxford, United Kingdom), have co-authored a peer-reviewed article describing novel technology to demonstrate the safety and efficacy of oligonucleotide therapeutics. Their work was recently published in the February 2025 issue of Nucleic Acid Therapeutics, a prestigious journal focused on the cutting-edge science of nucleic acid-based drug development. The article, titled "Bioanalytical Assays for Oligonucleotide Therapeutics: Adding Antibody-based Immunoassays to the Toolbox as an Orthogonal Approach to LC-MS/MS and Ligand Binding Assays," provides a comprehensive review of the current landscape in oligonucleotide therapeutics (ONTs), specifically focusing on antibody-based analytical assays for the localization and quantification of these promising drugs.

As the global biopharmaceutical industry continues to see an unprecedented rise in the development of nucleic acid therapies, ONTs have emerged as the third major class of drugs after small molecules and therapeutic antibodies. Currently hundreds of clinical trials are ongoing worldwide. These therapies, which include antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs), hold tremendous potential for the treatment of diseases ranging from cancer and neurological disorders to infectious diseases. However, the path to their successful development faces several critical challenges, particularly related to their stability, delivery, off-target effects, and immunogenicity.

The article highlights key hurdles faced by ONTs, such as their susceptibility to degradation by nucleases in tissues and fluids, inefficient cellular uptake, and the need for precise drug delivery systems. The review also discusses the evolving guidance from regulatory bodies, including the U.S. Food and Drug Administration (FDA), which emphasizes the importance of immunogenicity assays and pharmacokinetic evaluations tailored to the unique characteristics of ONTs.

One of the most innovative aspects of the study is the exploration of antibody-based assays, which could play a pivotal role in improving the analysis of ONTs. The authors propose that the development of highly specific antibodies to ONTs could enhance researchers' ability to track these therapies in the body, quantify their presence, and assess their safety and efficacy with greater precision.

"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, CSO at Rockland Immunochemicals Inc. "Our research underscores the need for advanced, reliable assays to address the unique challenges posed by ONTs and move these therapies from the lab to the clinic with confidence."

The Director of NATA, Nick Lench says: "We are very pleased to be working with Rockland Immunochemicals Inc. to facilitate the benchmarking of these new reagents that will be great asset to the nucleic acid therapeutics field."

As ONTs continue to advance through clinical trials and gain regulatory approvals, the need for effective analytical tools and methods to monitor their pharmacokinetics, metabolism, and potential immunogenicity will be critical. This publication is a step forward in the development of those tools, paving the way for safer and more effective nucleic acid-based therapies.

The full article can be accessed in the latest issue of Nucleic Acid Therapeutics.

About Rockland Immunochemicals, Inc.

Established in 1962, Rockland is a global biotechnology company manufacturing leading-edge tools for basic, applied, and clinical research for academic, biopharma, diagnostic, and agbio industries. We strive to be an invaluable partner to the life science community advancing the development and delivery of therapies and diagnostics worldwide. Rockland is a privately held company, operating facilities with antibody and protein production capabilities near Philadelphia, Pennsylvania, USA.

About NATA

The Nucleic Acid Therapy Accelerator (NATA) is a UK Research & Innovation (UKRI)/Medical Research Council funded research unit, based at the Harwell Science and Innovation Campus. NATA's mission is to advance the development of nucleic acid therapies and associated technologies through high-quality science, collaborations and interdisciplinary research. NATA works with world-leading academics, clinicians, businesses and charities, bringing together a diverse network of expertise, skilled and innovative technologies to bridge translational gaps in NAT development.

SOURCE Rockland Immunochemicals, Inc.