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Charles River (CRL) Teams Up to Aid Stargardt's Disease Therapy

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Charles River Laboratories International, Inc. (CRL - Free Report) recently announced a contract development and manufacturing organization (CDMO) agreement with the Italy-based clinical-stage biotechnology company, AAVantgarde. The collaboration will produce GMP plasmid DNA to help advance AAVantgarde’s platform for treating Stargardt’s disease — a condition with significant unmet needs.

The latest development will significantly boost Charles River’s Manufacturing Solutions segment. Over the years, the company has grown its cell and gene therapy portfolio to simplify complex supply chains and meet the increasing demand for plasmid DNA, viral vector and cell therapy services.

Significance of the Partnership

Stargardt’s is an autosomal recessive genetic disorder resulting from mutations in the ABCA4 gene. The most widespread inherited macular dystrophy is characterized by the progressive loss of central vision, starting from childhood or adolescence, leading to profound vision loss. Affecting nearly one in 6,500 people worldwide and with no existing treatments, the condition underscores a crucial need to increase the therapy options for this patient group. 

Charles River will leverage its two-decade-long expertise in manufacturing GMP plasmid DNA to support AAVantgarde’s Stargardt disease program. AAVantgarde has two proprietary AAV-based large gene delivery platforms, both of which aim to enable the efficient delivery of large genes to tissue and cells in vivo. Under the collaboration, CRL will develop the plasmid DNA for AAVantgarde’s Stargardt disease program (AAVB-039) using the AAV-intein platform, which has demonstrated highly efficient recombination to deliver therapeutically meaningful protein levels.

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Moreover, Charles River’s GMP plasmid DNA CDMO center of excellence, based in Keele, United Kingdom, will spearhead the collaboration and also evaluate off-the-shelf Rep/Cap and pHelper plasmid products. Additionally, the center will provide GMP manufacturing services to support therapeutic development.

Industry Prospects

Per a Grand View Research report, the global plasmid DNA manufacturing market was valued at $1.80 billion in 2023 and is expected to witness a 21.01% CAGR by 2030.

Rising awareness of cell and gene therapy is driving industry growth. Plasmid DNA is the foundation for gene therapies and vaccines for several infectious, genetic and acquired diseases, enteric pathogens and influenza. Various companies and research organizations are speeding up R&D efforts for advanced therapies, targeting diseases at a genomic level, leading to increased demand for plasmid DNA.

Recent Developments in the Manufacturing Division

Last month, Charles River announced a partnership with Captain T Cell, a spin-off from the renowned Max Delbrück Center in Berlin, Germany, to develop plasmid DNA and retrovirus vectors.  Through Charles River’s Cell and Gene Therapy Accelerator Program, Captain T Cell will have access to established plasmid and viral vector CDMO capabilities and advisory services to manufacture a TCR-T cell therapy for solid tumor patients for a Phase I clinical trial.

Furthermore, the company’s CDMO expertise will be leveraged by the Gates Institute at the University of Colorado Anschutz Medical Campus to develop GMP-grade lentiviral vectors for use in novel chimeric antigen receptor T-cell therapies for hematological cancers. The materials produced within the collaboration will support an upcoming Investigational New Drug application for Phase I clinical trials.

Price Performance

Over the past year, Charles River shares have declined 3% against the industry’s growth of 4.4%.

Zacks Rank and Key Picks

Charles River currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Hims & Hers Health (HIMS - Free Report) , Medpace (MEDP - Free Report) and DexCom (DXCM - Free Report) . While Hims & Hers Health and Medpace sport a Zacks Rank #1 (Strong Buy) each, Dexcom carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks Rank #1 stocks here.

Hims & Hers Heath shares have surged 138.2% in the past year. Estimates for the company’s earnings have increased from 18 cents to 20 cents in 2024 and from 33 cents to 38 cents in 2025 in the past 30 days.

HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.

Estimates for Medpace’s 2024 earnings per share have remained constant at $11.29 in the past 30 days. Shares of the company have surged 67.7% in the past year compared with the industry’s 4.4% growth.

MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 12.8%. In the last reported quarter, it delivered an earnings surprise of 30.6%.

Estimates for DexCom’s 2024 earnings per share have remained constant at $1.78 in the past 30 days. Shares of the company have plunged 15% in the past year against the industry’s 0.6% growth.

DXCM’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 34.1%. In the last reported quarter, it delivered an earnings surprise of 18.5%.

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