PRNewswire | August 24, 2023
Vial, a global tech-driven CRO providing next-generation clinical trial management services, has announced a partnership with Documenso, an innovative open-source digital signing platform. The collaboration marks a significant step forward in revolutionizing document signing practices within the life science sector, providing a compelling alternative to traditional solutions like DocuSign.
In an era where digital transformation is reshaping industries, Vial's partnership with Documenso is set to drive innovation in electronic document management, particularly in meeting the rigorous requirements of CFR Part 11 compliance. CFR Part 11 is a section of the Code of Federal Regulations (Title 21) established by the FDA. It lays out guidelines for electronic recordkeeping and signatures, ensuring data integrity and security in regulated sectors such as pharmaceuticals, biotechnology, and medical devices.
"Vial's unwavering commitment to technological advancement has always been at the core of our mission to reimagine clinical trials. Our partnership with Documenso signifies an exciting leap towards innovation by addressing a critical need in the life science sector. Currently, very few providers offer solutions that align with the rigorous requirements of 21 CFR Part 11. We aim to collaborate with Documenso to develop one of the industry's first open-source document-signing products that meet the demands of 21 CFR Part 11. Together, we are poised to reshape how critical documents are managed and signed, driving us closer to a future where technology empowers every facet of scientific progress," said Simon Burns, CEO and Co-Founder of Vial.
Vial's mission is to reimagine clinical trials to empower scientists to cure all human disease. Vial's driver for accomplishing this mission is applying a technology-forward approach. By deploying technology at every step, Vial is able to drive efficiencies in speed and cost savings for innovative biotech companies of all sizes. The Vial CRO distinguishes itself by leveraging its Vial Technology Platform, TrialOS, combining site start-up, visit data capture, and study analytics into one connected system. These best-in-class CRO services, combined with top vendor partnerships like Documenso, help accelerate the development of new therapies and devices for sponsors and patients.
On the partnership, Timur, CEO, and Co-Founder of Documenso, commented, "Documenso is more than just a digital signing solution; it's a global commodity designed for longevity and scalability. We're excited to work alongside Vial in this endeavor, leveraging the power of Commercial Open Source (COSS) principles to provide a robust alternative to traditional solutions."
Vial is a tech-first, next-generation CRO that promises faster and higher-quality execution of trials for less cost. The Vial Contract Research Organization (CRO) delivers on the promise of more efficient trials through its innovative technology platform that powers trials end-to-end from site startup to database lock. Vial's technology platform combines modern, intuitive eSource, EDC, and ePRO into one connected system, streamlining site processes and enabling considerable efficiencies. Vial operates across multiple Therapeutic Areas (Dermatology CRO, Ophthalmology CRO, Oncology CRO, Gastroenterology CRO, Neurology CRO, Cardiology CRO, Medical Device CRO, Rare Disease CRO, and Digital Therapeutics CRO). Vial is a San Francisco, California-based company with over 100+ employees.
Documenso is a groundbreaking open-source digital signing platform and alternative to traditional solutions like DocuSign. With a strong emphasis on customization and scalability, Documenso seamlessly integrates into business operations, offering extensive options for adaptation and an open API. Documenso was built for longevity and scale by embracing the capital efficiency and inclusiveness of the Commercial Open Source (COSS) movement. Documenso aims to create a global standard for digital signing that prioritizes inclusiveness and innovation.
Globenewswire | August 23, 2023
Cabaletta Bio, Inc. a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that it has entered into certain work orders relating to Good Manufacturing Practice (GMP) manufacturing under its existing master services agreement with WuXi Advanced Therapies (WuXi ATU), a global Contract Testing, Development and Manufacturing Organization (CTDMO). As part of the agreement, WuXi ATU will serve as a cell processing manufacturing partner for the planned global clinical development of CABA-201 in multiple indications, including potential late-stage clinical trials and commercial readiness activities for CABA-201.
“We have had a successful collaboration with WuXi ATU over the past two years for the GMP compliant production of novel cell therapies. Based on this initial collaboration, we chose to expand our partnership to include WuXi ATU as a manufacturer for our CABA-201 clinical programs,” said Gwendolyn Binder, Ph.D., President of Science and Technology of Cabaletta. “WuXi ATU’s dedicated production capacity for CABA-201 supports our planned global expansion and commercial preparedness efforts and will enable us to dose patients in multiple clinical trials with separate parallel cohorts, while maintaining a capital-efficient manufacturing strategy.”
Under the terms of the agreement, WuXi ATU will provide GMP manufacturing of CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, to support any of Cabaletta’s planned clinical trials, including the previously announced separate Phase 1/2 clinical trials of CABA-201 for the treatment of patients with systemic lupus erythematosus and idiopathic inflammatory myopathies, or myositis. In addition, WuXi ATU will continue to serve as the Company’s cell processing manufacturing partner for the MusCAARTes™ Phase 1 clinical trial of MuSK-CAART.
“We are delighted to expand our partnership with Cabaletta to advance the development of CABA-201 for patients with autoimmune diseases,” said David Y. H. Chang, Ph.D., President and Chief Technology Officer of WuXi ATU. “We look forward to applying our expertise in cell and gene therapy manufacturing to better support our customers to bring potentially life-saving treatments faster to patients in need.”
About Cabaletta Bio
Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in systemic lupus erythematosus and myositis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA.
About WuXi Advanced Therapies (WuXi ATU)
As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world.
PRNewswire | July 27, 2023
Invivoscribe is excited to announce that the LeukoStrat® CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo's VANFLYTA® (quizartinib).
The LeukoStrat CDx FLT3 Mutation Assay identifies FLT3-ITD positive AML patients who may be treated with this newly approved targeted therapy.
US Intended Use
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered.
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib) treatment is being considered.
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with FLT3-ITD+ AML for whom VANFLYTA® (quizartinib) treatment is being considered.
The test is for use on the 3500xL Dx Genetic Analyzer.
"FDA approval of the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic to VANFLYTA is a significant milestone for patients with newly diagnosed FLT3-ITD positive AML," said Invivoscribe CSO, CEO, and founder Jeffrey Miller. "Timely and accurate testing for FLT3-ITD mutations in newly diagnosed patients is critical to identify those who may be eligible for treatment with VANFLYTA, and we are happy to collaborate with Daiichi Sankyo to help bring this important new therapy to patients."
AML is a blood cancer that affects the blood and bone marrow and is characterized by the rapid growth of abnormal white blood cells.1 AML has the lowest 5-year survival rate (31.7%) among people diagnosed with leukemia.2 About 25% of AML patients have a FLT3-ITD mutation which contributes to the growth and survival of cancer cells and is associated with a poor prognosis.
Previously, the LeukoStrat CDx FLT3 Mutation Assay was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as a companion diagnostic to select FLT3-ITD positive AML patients eligible for VANFLYTA in Japan.
Invivoscribe is a global, vertically-integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For nearly thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies interested in developing and commercializing companion diagnostics, and provides expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization.