Charles River Laboratories (CRL) and Curigin, a Korean biotechnology company developing oncolytic ribonucleic acid interference (RNAi) gene therapies, agreed to collaborate on adenoviral vector production. The gene therapy developer will leverage Charles River’s expertise in contract development and manufacturing organization (CDMO) solutions to support its preclinical and clinical trials.
Separately, CRL signed an agreement with the INADcure Foundation, a nonprofit organization whose mission is to support the development of treatments for Infantile Neuroaxonal Dystrophy (INAD) and other forms of PLA2G6-related neurodegeneration (PLAN), to form a plasmid DNA manufacturing alliance.
CRL will manufacture INAD’s leading candidate for Phase I/II clinical trials. In INAD patients, a mutation or genetic alteration in the PLA2G6 gene causes mitochondrial and axonal membrane defects that lead to neuronal damage with axonal swellings and accumulation of pre-synaptic spheroids.
Curigin develops anticancer gene therapy products that utilize genetically engineered viruses and RNAi technology to block key disease-specific genetic signal pathways, to switch off genes responsible for tumor growth. These gene therapies serve an unmet clinical need and can be offered to patients who have not been treated with conventional cancer drugs.
Curigin’s lead candidate is CA102, a genetically engineered adenovirus for bladder cancer which, according to the World Cancer Research Fund, is the 10th most common type of cancer worldwide. Based on preclinical evaluation data for CA102, Curigin expects to submit an Investigational New Drug (IND) application to the FDA within the year.
“This collaboration with Curigin will tap into our industry-leading gene therapy CDMO capabilities and we are thrilled that our expertise will help bring potentially curative therapies to patients,” said Kerstin Dolph, corporate senior vp, biologics solutions, CRL.
“Developing innovative therapeutics is our mission and we are steadily working towards that goal. We are excited to work with Charles River in the manufacturing phase as we continue to race on the path to drug development for oncology patients,” added Jae-Gyun Jeong, president, Curigin.
INAD
INAD, otherwise known as phospholipase-associated neurodegeneration (PLAN), is a rare disease with no known treatment or cure. Like other neurodegenerative diseases, INAD is progressive, and symptoms include poor motor function, involuntary eye movements, seizures, hearing loss, and difficulty swallowing and breathing. INAD affects over 150 children worldwide with a life expectancy of 10 years or less.
“The opportunity to work with INADcure is exactly why we do the work we do. Their work is incredibly important to patients with this ultra-rare disorder. We are excited for the INADcure team to achieve this next stage of treatment development,” said CRL’s Dolph.
“Our collaboration with Charles River brings us closer to accomplishing our goal of delivering breakthrough treatments for INAD. We are excited to begin plasmid DNA manufacturing to further develop our treatment with their experienced team,” stated Leena Panwala, founder and executive director at INADcure.
