Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today 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.
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 expertise, 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.
Under Aruvant's direction, Lonza has begun process development and technology transfer activities from its
About ARU-1801
ARU-1801 is designed to address the limitations of current curative treatment options, such as low donor availability and the risk of graft-versus-host disease (GvHD) seen with allogeneic stem cell transplants. Unlike investigational gene therapies and CRISPR gene editing approaches which require fully myeloablative conditioning, the unique characteristics of ARU-1801 allow it to be given with reduced intensity conditioning ('RIC'). Compared to myeloablative approaches, the lower dose conditioning regimen underlying RIC has the potential to reduce not only hospital length of stay, but also the risk of short- and long-term adverse events such as infection and infertility.
The MOMENTUM Study
Aruvant is conducting the MOMENTUM study, which is evaluating ARU-1801, a one-time potentially curative investigational gene therapy for patients with SCD. This Phase 1/2 study is currently enrolling participants, and information may be found at www.momentumtrials.com which includes a patient brochure, an eligibility questionnaire and information for healthcare providers.
About Aruvant Sciences
Aruvant Sciences part of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on developing and commercializing gene therapies for the treatment of rare diseases. The company has a talented team with extensive experience in the development, manufacturing and commercialization of gene therapy products. Aruvant has an active research program with a lead product candidate, ARU-1801, in development for individuals suffering from sickle cell disease (SCD). ARU-1801, an investigational lentiviral gene therapy, is being studied in a Phase 1/2 clinical trial, the MOMENTUM study, as a one-time potentially curative treatment for SCD. Preliminary clinical data demonstrate engraftment of ARU-1801 and amelioration of SCD is possible with one dose of reduced intensity chemotherapy.
About Roivant
Roivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch Vants - nimble and focused biopharmaceutical and health technology companies.
About Lonza
Lonza combines technological innovation with world class manufacturing and process excellence. Together, these enable Lonza's customers to deliver their discoveries in the healthcare, preservation, and protection sectors. Lonza is a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. Lonza works to prevent illness and promote a healthier world by enabling customers to deliver innovative medicines that help treat or even cure a wide range of diseases. In addition, Lonza offers a broad range of microbial control solutions, which help to create and maintain a healthy environment.
Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, Lonza is built from high-performing teams and of individual employees who make a meaningful difference to our the business, as well as the communities in which we operate. The company generated sales of
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