Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). Aruvant has chosen Lonza to help develop and manufacture ARU-1801 for its upcoming pivotal trial.
“We are partnering with Lonza, one of the world’s leading cell and gene therapy manufacturing organizations, to help us manufacture our gene therapy ARU-1801, a potential cure for sickle cell disease that can be given with one low dose of chemotherapy,” said Palani Palaniappan, Aruvant chief technology officer. “Our internal cell therapy process expertise combined with Lonza’s cell processing know-how provide the perfect combination to manufacture ARU-1801 for our pivotal study. As we advance our gene therapy through clinical trials, this partnership signifies a critical milestone in the development pathway.”
Aruvant is building a hybrid supply model that is led by the company’s cell and gene therapy scientists and leverages specialized external suppliers. The company has expanded the internal technical and operational organization with experts in vector and cell manufacturing, analytics, quality, supply and regulatory affairs. To complement the internal capabilities, Aruvant is partnering with world-leading contract development manufacturing organizations. The strategic long-term manufacturing agreement with Lonza is a critical step to advancing the clinical development of ARU-1801 for sickle cell patients.
“Our track record in the cell and gene therapy space makes us the ideal partner to help manufacture ARU-1801, a differentiated gene therapy that is an important future option for patients with sickle cell disease,” said Alberto Santagostino, senior vice president, head of cell and gene technology, Lonza. “Through a strong integrated team effort, together we can bring a life-changing medicine to patients.”
Under Aruvant’s direction, Lonza has begun process development and technology transfer activities from its Houston center of excellence to help establish robust manufacturing for ARU-1801. Once complete, Lonza will deliver cGMP material supply for the pivotal clinical trial.