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

WILMINGTON, Mass. / Apr 04, 2024 / 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.