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Charles River Launches New Retrogenix® Non-Human Protein Library

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Charles River Laboratories International, Inc. (NYSE: CRL) has launched the Retrogenix® Non-Human Protein Library, a first-in-class in vitro library designed to assess off-target binding and de-risk in vivo studies. This innovative tool helps biopharmaceutical clients evaluate how therapeutics interact with non-human protein targets, providing early insights without the lead time and expense of ex vivo or in vivo studies.

The library builds on the established Retrogenix® platform, which offers the industry's largest library of human proteins for screening. By confirming whether potential off-targets are conserved across species, the new non-human library enhances the interpretability of in vivo results and aids in selecting appropriate models for safety studies. This approach aligns with the 3Rs principles (Reduction, Refinement, Replacement) in animal research and supports Charles River's Alternative Methods Advancement Project (AMAP).

Positive
  • Launch of innovative Retrogenix® Non-Human Protein Library for off-target binding assessment
  • Potential to reduce time and costs associated with ex vivo and in vivo studies
  • Enhances interpretability of in vivo results and aids in species selection for safety studies
  • Aligns with 3Rs principles in animal research
  • Supports the company's Alternative Methods Advancement Project (AMAP)
Negative
  • None.

Insights

The launch of Charles River's Retrogenix® Non-Human Protein Library represents a significant advancement in preclinical drug development. This in vitro screening tool allows for early assessment of off-target binding in non-human proteomes, which is important for de-risking in vivo studies and optimizing species selection for safety testing.

Key benefits include:

  • Potential for reduced animal testing by identifying suitable models earlier
  • Improved interpretability of in vivo results
  • Faster progression to safety studies and IND applications
  • Complementary or alternative to traditional tissue cross-reactivity studies

This innovation aligns with the 3Rs principle (Replacement, Reduction, Refinement) in animal research, potentially reducing the number of animals used in preclinical studies. For Charles River (CRL), this launch enhances their drug discovery portfolio, potentially attracting more clients and strengthening their position in the preclinical CRO market.

The introduction of the Retrogenix® Non-Human Protein Library by Charles River Laboratories is a strategic move that could significantly impact the drug development process. This technology addresses a critical need in the industry for more efficient and cost-effective preclinical testing methods.

From a business perspective, this launch:

  • Enhances CRL's competitive edge in the preclinical CRO market
  • Potentially increases revenue streams through new service offerings
  • Aligns with industry trends towards more ethical and efficient drug development
  • Strengthens relationships with biopharmaceutical clients by offering innovative solutions

The platform's ability to provide early insights without the need for immediate ex vivo or in vivo studies could lead to significant cost savings and accelerated timelines for drug developers. This value proposition is likely to be attractive to both large pharma and smaller biotech companies, potentially expanding CRL's client base and market share in the preclinical services sector.

First-in-class in vitro library assesses off-target binding to de-risk in vivo studies

WILMINGTON, Mass.--(BUSINESS WIRE)-- Charles River Laboratories International, Inc. (NYSE: CRL) today announced the launch of the Retrogenix® Non-Human Protein Library. The non-human protein library helps biopharmaceutical clients assess off-target binding to a non-human proteome to de-risk in vivo studies and aid in non-human species selection.

“Developed in-house using the innovative and unique Retrogenix® platform, the new library provides early insights into how therapeutics interact with non-human protein targets in vitro,” said Aidan Synnott, Ph.D., Corporate Vice President, Global Discovery. “These early insights are generated without the lead time and expense associated with ex vivo tissue or in vivo research model studies, allowing clients to progress to safety studies, clinical trials, and IND applications with highly relevant data and increased confidence.”

Confirming whether potential off-targets are conserved across species increases the interpretability of in vivo results and ultimately reduces risk by ensuring safety studies are conducted in an appropriate model from the outset. In addition to offering the non-human protein library, Charles River can also screen observed human off-targets against any suitable non-human homologous proteins to help inform next steps for client drug development.

Screening for Off-Target Effects
The Retrogenix® platform offers the industry’s largest library of human proteins overexpressed in human cells, with over 6,500 human plasma membrane and secreted protein clones, providing a unique screening tool for discovering primary target receptors and reliably assessing potential off-target binding issues. With the new non-human protein library, Charles River is building on the Retrogenix® platform’s established technology, helping clients ensure they have the right models selected prior to beginning in vivo studies, saving time and helping deliver safer, more effective drugs.

Off-target screening is an established part of the IND submission process, and is traditionally performed using tissue cross reactivity (TCR) studies. Data from the Retrogenix® platform has become an established complementary or alternative data point across multiple modalities, therapeutic areas, and with international regulatory agencies.

Driving Innovation in the 3Rs
Designed in silico and synthetically generated, the biosynthetic non-human protein library incorporates important tenants of the 3Rs—reduction and refinement—leveraging technological innovations to responsibly progress research.

“The integration of the Retrogenix® Non-Human Protein Library into our drug discovery portfolio enhances the precision and effectiveness of lead candidate selection,” added Professor Julie Frearson, Ph.D., Corporate Senior Vice President & Chief Scientific Officer. “Technology is a cornerstone of innovation, and as we continue to drive forward change in drug development, these innovations allow us to refine our use of research models while supporting the discovery of novel medicines.”

Building on the imperative to deliver on the 3Rs (Replacement, Reduction, and Refinement of research animals), Charles River launched the Alternative Methods Advancement Project (AMAP), with a dedicated pursuit of scientific and technological innovation and by aligning the Company’s strategic efforts with the focus needed to advance animal alternatives.

About the Alternative Methods Advancement Project (AMAP)
The Alternative Methods Advancement Project (AMAP) is a Charles River initiative dedicated to developing alternatives to reduce the use of animals in testing. As we enter the next frontier of drug development, AMAP will facilitate strategic and purposeful investing to lead the way toward a future where more patients receive needed treatments and medicines safely, swiftly, and successfully. In keeping with our commitment to the 3Rs, we are dedicated to pursuing scientific and technological innovations to explore new and exciting ways we can further reduce the use of animals in testing. The guidance of AMAP will help us align our investments, partnerships, product and service initiatives, and advocacy efforts as we focus on our goal of investing $300 million over the next five years to further enhance this critical mission and drive industry-wide adoption of alternatives.

About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

Investor:

Todd Spencer

Corporate Vice President,

Investor Relations

781.222.6455

todd.spencer@crl.com

Media:

Amy Cianciaruso

Corporate Vice President,

Chief Communications Officer

781.222.6168

amy.cianciaruso@crl.com

Source: Charles River Laboratories International, Inc.

FAQ

What is the Retrogenix® Non-Human Protein Library launched by Charles River (CRL)?

The Retrogenix® Non-Human Protein Library is a first-in-class in vitro library that assesses off-target binding to non-human proteomes. It helps biopharmaceutical clients de-risk in vivo studies and aid in non-human species selection for drug development.

How does the new Retrogenix® Non-Human Protein Library benefit drug development?

The library provides early insights into how therapeutics interact with non-human protein targets in vitro, without the lead time and expense of ex vivo or in vivo studies. This allows clients to progress to safety studies and clinical trials with more relevant data and increased confidence.

What is the significance of the Retrogenix® platform in off-target screening for Charles River (CRL)?

The Retrogenix® platform offers the industry's largest library of human proteins for screening. It has become an established complementary or alternative data point for off-target screening across multiple modalities and therapeutic areas, recognized by international regulatory agencies.

How does the Retrogenix® Non-Human Protein Library support the 3Rs principles in animal research?

The library incorporates the 3Rs principles (Reduction, Refinement, Replacement) by leveraging technological innovations to refine the use of research models. It allows for more precise lead candidate selection, potentially reducing the need for animal studies in early-stage drug development.

Charles River Laboratories International, Inc.

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