Charles River Laboratories International, Inc. CRL recently announced a collaboration with an Australian non-profit foundation, Genetic Cures for Kids Inc. (“GC4K”). Under the partnership, the company will perform plasmid DNA production in support of GC4K’s early phase trials for Hereditary Spastic Paraplegia Type 56 (“SPG56”).
Charles River’s contract development and manufacturing organization business provides comprehensive contract development and manufacturing solutions for cell and gene therapies. The latest collaboration with GC4K will also boost the company’s Biologics Solutions business within the Manufacturing segment.
About GC4K and SPG56
Founded in 2021, the Australian not-for-profit charity raises funds that explicitly go to rare disease research programs and clinical trials to find cures for rare diseases. GC4K’s lead campaign, Our Moon’s Mission, has been dedicated to the pursuit of innovative gene therapy solutions for SPG56 — a rare neurodegenerative disease with no treatment presently.
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SPG56 is progressive and is characterized by varying degrees of spasticity and muscle weakness, which typically begins with motor and cognitive regression in childhood and continuously worsens through life. Additional clinical manifestations include intellectual disability, dystonia, cerebellar ataxia, subclinical peripheral neuropathy, seizures and visual impairment.
In addition, limited access to genetic testing has pertained to diagnoses that are hard to achieve, and as such, fewer than one in one million people have ever been diagnosed with SPG56 globally. The foundation is not only committed to developing a cure for SPG56 but also to creating a replicable framework that paves the way to develop treatments for some of the 7,000 other genetic diseases in the world.
More on the News
Through the partnership, GC4K will leverage Charles River’s established plasmid platform, eXpDNA, and premier expertise in plasmid DNA production, including High-Quality (HQ) plasmid, which combines key features of good manufacturing practice manufacture with a rapid turnaround to accelerate time to clinic.
Plasmid DNA is a critical starting material for many cell and gene therapy therapeutics, and demand continues to outstrip supply. In response to this, the company opened a state-of-the-art HQ plasmid manufacturing center of excellence in 2022 to address these supply shortages and support the growing needs of the cell and gene therapy field.
Per a Research report, the global cell and gene therapy market was valued at $22.7 billion in 2023 and is expected to witness a CAGR of 28.7% by 2030.
Other Developments in Biologics Solutions
In recent years, the company has significantly broadened its cell and gene therapy portfolio with several acquisitions and recent expansions to simplify complex supply chains and meet the growing global demand for plasmid DNA, viral vector and cell therapy services. Combined with the company’s legacy testing capabilities, Charles River offers a comprehensive “concept-to-cure” advanced therapies solution.
In September 2023, the company announced the launch of its lentiviral vector manufacturing platform, Lentivation, which can reduce lentiviral vector production timelines from 18 months to less than seven months. CRL’s collaboration with INADcure Foundation will also leverage its market-leading CDMO expertise in HQ plasmid DNA production to manufacture its leading candidate for Phase I/II clinical trials for Infantile Neuroaxonal Dystrophy.
Over the past six months, Charles River shares have decreased 0.4% compared with the industry’s fall of 2.1%.
Zacks Rank and Key Picks
Charles River carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Haemonetics HAE, Insulet PODD and DexCom DXCM. Haemonetics and DexCom each presently carry a Zacks Rank #2 (Buy), and Insulet sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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