Charles River to Perform Plasmid Production for Ship of Theseus

Rhea-AI Summary

Charles River Laboratories International, Inc. (NYSE: CRL) partners with Ship of Theseus to manufacture GMP plasmid DNA for therapeutic use targeting various indications. Ship of Theseus focuses on HOX family biologics for tissue repair and maintenance. The collaboration aims to develop treatments for diabetic and chronic wounds, neutropenia, psoriasis, androgenetic alopecia, women’s health, infertility, and epithelial cancers.

Insights

Biotech Industry Analyst

The recent contract development and manufacturing organization (CDMO) agreement between Charles River Laboratories and Ship of Theseus signifies a strategic move within the biotech industry, particularly in the therapeutic development space. Charles River's expansion into GMP plasmid DNA manufacturing aligns with the growing demand for advanced therapy medicinal products (ATMPs) and positions the company as a key player in the cell and gene therapy supply chain. The collaboration to produce GMP plasmid DNA for Ship of Theseus's lead candidate harnesses Charles River’s established eXpDNA™ platform, which is critical for advancing clinical trials and subsequent commercialization of therapies.

From an investment standpoint, this move could potentially lead to revenue growth for Charles River, considering the broad range of indications targeted by Ship of Theseus, including chronic wounds, neutropenia and various cancers. The ability to produce GMP-grade plasmid DNA is a valuable asset, as it ensures compliance with stringent regulatory standards, thereby reducing risks associated with therapy development. This partnership may also serve as a catalyst for further agreements and could attract additional biotech firms seeking reliable manufacturing partners.

Financial Analyst

Charles River Laboratories' expansion in the gene therapy sector through its agreement with Ship of Theseus should be examined for its financial implications. The deal could enhance Charles River's revenue streams and diversify its client portfolio. As a CDMO, Charles River offers a comprehensive 'concept to cure' solution, which may reduce costs and streamline production for its clients, a competitive advantage that could lead to increased market share.

Investors may view this agreement as a positive indicator of Charles River's growth trajectory and its ability to capture a larger share of the burgeoning gene therapy market. The emphasis on GMP-grade production is particularly noteworthy, as it highlights the company's commitment to quality and regulatory compliance, which are key factors in securing long-term contracts and sustaining profitability in the biotech industry.

Regulatory Affairs Specialist

The focus on Good Manufacturing Practice (GMP) compliance in the partnership between Charles River and Ship of Theseus is a critical aspect for stakeholders. GMP standards are essential for ensuring the safety and efficacy of biologics and meeting regulatory requirements. Charles River's capabilities in GMP plasmid DNA production may expedite the regulatory approval process for Ship of Theseus's therapies, thereby shortening the time to market and providing a competitive edge.

The broad indication range for the HOX family biologics also underscores the potential for significant regulatory scrutiny, given the complexity of gene therapies. Charles River's expertise in regulatory guidance and its established manufacturing processes could mitigate risks associated with regulatory compliance, which is a key consideration for investors who are concerned with the uncertainties of biotech product development.

GMP grade plasmid DNA to serve as a direct therapeutic targeting various indications

WILMINGTON, Mass.--(BUSINESS WIRE)-- Charles River Laboratories International, Inc. (NYSE: CRL) and Ship of Theseus, a therapeutics company developing degradation-resistant homeobox (HOX) family biologics, today announced a Good Manufacturing Practice- (GMP) plasmid DNA contract development and manufacturing organization (CDMO) agreement. Ship of Theseus will leverage Charles River’s premier expertise to manufacture GMP plasmid DNA to serve as the active drug substance for its lead candidate.

Ship of Theseus is developing a proprietary suite of biologics based on the HOX family of transcription factors, which are responsible for driving the differentiation of tissue stem cells towards their respective lineages to repair and maintain the correct function of tissues and organs. Proprietary modifications may enable these regulators to be used as therapeutics.

The collaboration between Charles River and Ship of Theseus will support therapeutic development for a broad variety of target indications such as diabetic and chronic wounds, neutropenia, psoriasis, androgenetic alopecia, women’s health and infertility, and epithelial cancers. Charles River’s GMP plasmid DNA CDMO center of excellence based in Keele, United Kingdom will lead the collaboration, providing services that include plasmid DNA backbone generation, plasmid synthesis, GMP master cell bank (MCB) generation, pre-production evaluation, and GMP plasmid DNA manufacture including in-house release testing.

Plasmid DNA Manufacturing Services
In recent years, Charles River has significantly broadened its cell and gene therapy portfolio with several acquisition integrations and expansions to simplify complex supply chains and meet growing demand for plasmid DNA, viral vector, and cell therapy services. Combined with the Company’s legacy testing capabilities, Charles River offers an industry-leading “concept to cure” advanced therapies solution.

With plasmid product and service offerings spanning off-the-shelf and custom production of research, High Quality (HQ) and GMP grade DNA, the Company leverages its eXpDNA™ plasmid manufacturing platform built on established processes and fine-tuned over decades successfully supporting vaccine and advanced therapy clients through clinical trials and beyond.

Available on-demand is a 30-minute case study webinar led by Dr. Andrew Frazer, Associate Director, Scientific Solutions, Gene Therapy CDMO Services, that explores the role of plasmid DNA as a critical starting material, the latest advancements in associated regulatory guidance to safeguard your therapeutic programs, and case studies demonstrating expedited development and manufacture of ATMPs: https://bit.ly/3Vl5rgu

Approved Quotes

• “We are thrilled to work with Ship of Theseus to produce GMP plasmid DNA to help advance the organization’s mission to develop HOX family biologics. Charles River’s robust plasmid DNA manufacturing portfolio and track record makes us the ideal candidate to produce this critical material which has the potential to impact numerous patient indications.” – Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River
• “Ship of Theseus is proud to collaborate with Charles River as our manufacturing partner of choice. We trust the team’s decades of success developing, producing, and reliably delivering plasmid DNA and look forward to bringing our therapies to patients.” – Jeremy Elser, Founding CEO, Ship of Theseus

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.

About Ship of Theseus
Ship of Theseus develops therapeutics across diverse indications by leveraging the homeobox (HOX) family of transcription factors. Utilizing the broad and powerful cell regulatory capabilities of the HOX family, Ship of Theseus and its indication-specific subsidiaries are targeting an array of indications, with early emphasis on topicals for chronic wounds. Proprietary modifications improve intracellular dynamics and half-life, overcoming prohibitive shortcomings in the endogenous sequences.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240404780001/en/

Charles River Investor Contact:

Todd Spencer

Corporate Vice President,

Investor Relations

781.222.6455

todd.spencer@crl.com

Charles River Media Contact:

Amy Cianciaruso

Corporate Vice President,

Chief Communications Officer

781.222.6168

amy.cianciaruso@crl.com

Ship of Theseus Investor Contact:

Jeremy Elser, PhD

Chief Executive Officer

jeremy@ship-of-theseus.com

Source: Charles River Laboratories International, Inc.

FAQ

What is the agreement between Charles River Laboratories International, Inc. and Ship of Theseus about?

The agreement involves the manufacturing of GMP plasmid DNA for therapeutic use targeting various indications.

What is Ship of Theseus focusing on in terms of biologics?

Ship of Theseus is developing biologics based on the HOX family of transcription factors for tissue repair and maintenance.

What indications are the therapies being developed by Ship of Theseus targeting?

The therapies are targeting diabetic and chronic wounds, neutropenia, psoriasis, androgenetic alopecia, women’s health, infertility, and epithelial cancers.

Where is Charles River's GMP plasmid DNA CDMO center of excellence located?

The center is based in Keele, United Kingdom.

What services does Charles River offer in collaboration with Ship of Theseus?

Services include plasmid DNA backbone generation, plasmid synthesis, GMP master cell bank generation, pre-production evaluation, and GMP plasmid DNA manufacture.