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Charles River (CRL) to Support Cure AP-4's Clinical Trials

Charles River Laboratories International, Inc. CRL recently entered into a manufacturing collaboration with a non-profit foundation, Cure AP-4. The partnership will utilize Charles River’s High-Quality (HQ) plasmid DNA production to support Cure AP-4’s Phase I/II gene therapy trials for Adapter-Protein 4 Hereditary Spastic Paraplegia (AP-4 HSP).

AP-4 HSP, also referred to as AP-4 Deficiency Syndrome, is a rare neurodegenerative disorder. It consists of four sub-types of HSP, including SPG47, SPG50, SPG51 and SPG52, which are linked to a defective autosomal recessive gene causing a failure in the AP-4 Adaptor Complex. Symptoms like global developmental delay, microcephaly, seizures, brain malformation, and hypotonia (low muscle tone) are generally observed in patients with any AP-4 HSP genetic disorders.

To join the fight against this extremely rare disorder, Cure AP-4 has developed a gene therapy treatment that will look to address the root cause of AP-4 HSP. This gene therapy is intended as a one-time, curative treatment for patients diagnosed with AP-4 HSP.

More on the News

Charles River’s market-leading expertise in plasmid DNA production, particularly HQ plasmid, integrates the key features of Good Manufacturing Practice (GMP) manufacture with rapid turnaround times to speed up the timeline to clinic. DNA plasmids are an essential starting material for several cells and gene therapy therapeutics. However, the demand for DNA plasmids continues to be insufficient compared with its current supply.

To meet the supply-related challenges and support the growing needs of the cell and gene therapy field, Charles River opened a state-of-the-art HQ plasmid manufacturing center of excellence. The company’s acquisitions of Cognate BioServices, Cobra Biologics, and Vigene Biosciences have expanded its comprehensive cell and gene therapy portfolio with the addition of contract development and manufacturing organization (CDMO) capabilities. The new CDMO capabilities span viral vector, plasmid DNA and cellular therapy production for clinical to commercial supply.

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Under this collaboration, Charles River would play a small but critical role in delivering a potentially transformative therapy to a patient population that is severely underserved.

Industry Prospects

Per a report by MarketsandMarkets, the global cell and gene therapy manufacturing services market is expected to see a CAGR of 12.4% from 2022 to 2026. Factors such as the growing incidence of cancer and other target diseases and greater investments in developing novel drugs by pharmaceutical companies can be attributable to market growth.

Given the market prospects, Charles River’s latest manufacturing collaboration seems strategic.

Other Notable Developments

In August 2022, Charles River gained regulatory approval from the European Medicines Agency (EMA) in the form of GMP certification to commercially produce allogeneic cell therapy drug products for distribution in Europe. This certification complements an existing GMP license for Charles River’s Memphis contract development and manufacturing facility for Investigational Medicinal Product (IMP) production.

In June 2022, the company inked an agreement with Ziphius Vaccines to manufacture starting materials critical to clinical-stage research. This collaboration will enable Ziphius Vaccines to develop a proprietary self-amplifying mRNA (saRNA) technology platform combined with innovative lipid formulations for delivery.

The same month, the company signed another agreement with ASC Therapeutics, a privately-held biopharmaceutical company, to manufacture a second-generation gene therapy for hemophilia A, ASC618. The ASC618 program has gained IND clearance and other key regulatory designations in the United States and Europe.

Share Price Performance

The stock has underperformed its industry in the past year. It has declined 49.2% compared with the industry’s 33.4% fall.

Zacks Rank and Key Picks

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

A few better-ranked stocks in the broader medical space that investors can consider are AMN Healthcare Services, Inc. AMN, ShockWave Medical, Inc. SWAV and McKesson Corporation MCK.

AMN Healthcare has a long-term earnings growth rate of 3.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 15.7%, on average. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

AMN Healthcare has outperformed its industry in the past year. AMN has lost 8.1% against the industry’s 33.4% fall.

ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.1% for 2023. The company’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.

ShockWave Medical has outperformed its industry in the past year. SWAV has gained 33.1% against the industry’s 27% fall over the past year.

McKesson has an estimated long-term growth rate of 10.1%. The company surpassed earnings estimates in the trailing three quarters and missed in one, delivering a surprise of 13%, on average. It currently carries a Zacks Rank #2 (Buy).

McKesson has outperformed its industry in the past year. MCK has gained 77.2% against the industry’s 10.7% fall.

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