Medical, Industry Outlook
PRNewswire | July 31, 2023
TriRx Pharmaceutical Services, LLC, a Contract Development and Manufacturing Organization (CDMO), welcomed the UK Government's recent announcement on England's second Investment Zone, focused on Life Sciences in the Liverpool City Region.
TriRx Speke Ltd. is the first investor and is well-positioned to further advance its capabilities by adding upstream technologies to manufacture monoclonal antibodies to an existing large-scale biotech purification facility. The current facility has significant capacity to support the high-growth large-molecule pharmaceutical market. Monoclonal antibodies (also referred to as mAbs) are a type of immunotherapy that work by blocking certain diseases from affecting healthy cells and are used to treat numerous types of diseases including cancers, arthritis and skin conditions. This additional investment to augment the TriRx facility at Speke will foster economic growth, create high-value jobs and complement the existing Speke Biopharmaceutical cluster in the region.
"We are delighted to be expanding our capability in this critical immunotherapy area, to become a worldwide center of technical excellence located in the UK in the monoclonal antibody development and manufacturing field to serve the human and animal pharmaceutical markets," said Tim Tyson, Chairman and CEO of TriRx.
About TriRx Pharmaceutical Services
TriRx Pharmaceutical Services is a global contract development and manufacturing organization (CDMO) serving global pharmaceutical, biopharmaceutical and animal health markets. Headquartered approximately 50 miles outside of New York City in Norwalk, Connecticut, TriRx operates facilities in multiple regions providing state-of-the-art laboratory, manufacturing, packaging, warehousing, and technical service capabilities. Founded and led by a team of pharmaceutical industry executives, who have served as both contract service providers and outsourcing customers, TriRx has a profound and multifaceted understanding of client needs.
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Industry Outlook
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.
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MedTech, Medical
Businesswire | August 21, 2023
BioSkryb Genomics, a company transforming single-cell analysis by enabling the most complete multiomic view of the cellular ecosystem, from discovery to diagnostics, today announced the issuance of a composition of matter patent, US Patent 11,643,682 by the U.S. Patent and Trademark Office related to its novel Primary Template-Directed Amplification (PTA) method and applications for research, diagnostics, and treatment. The patent is exclusively licensed to BioSkryb by St. Jude Children’s Research Hospital.
As science continues to evolve, somatic mosaicism (variants accumulated in DNA after fertilization) has become more broadly accepted as a key influencer of biology and disease, including cancer, cardiovascular disease, and neurological disorders. The challenge in understanding this clonal differentiation and how it influences biological change has been underpinned by the lack of technologies that can provide a precise and holistic view of genomes of individual cells without artifacts or bias.
Primary template-directed amplification was invented to address these challenges by providing a highly accurate, scalable, and efficient nucleic acid amplification and sequencing method for research, diagnostics, and treatment. PTA is the flagship technology that drives BioSkryb’s industry-leading products, including ResolveDNA® and ResolveOME™, a first of its kind multiomic solution that provides whole genome and whole transcriptome analysis from the same single cell in a single workflow.
Since the founding of BioSkryb when the PTA technology was licensed, the company has dramatically improved the chemistry in terms of performance, throughput, and modality with these products, including the ability to utilize the chemistry for whole genome, whole exome, and panels across varying cell types and nuclei. In addition to optimizing the DNA-based chemistry, BioSkryb has further developed the technology by layering on the ability to analyze the corresponding transcriptome and proteome within individual cells allowing researchers and clinicians a complete and integrated view of the microenvironment of a cellular ecosystem, empowering breakthrough discoveries and ultimately improved understanding and treatment of complex diseases.
“This patent serves as not only as a cornerstone of BioSkryb’s IP portfolio, but as the foundation of our best-in-class single-cell analysis products,” said Suresh Pisharody, CEO, BioSkryb Genomics. “PTA is the unique engine that drives our ability to deliver comprehensive integrated multiomics and paves the way for next generation single-cell analysis and research that could lead to better outcomes for patients.”
“The performance of PTA, even in its infancy, was so remarkable that the BioSkryb founding team believed it could serve as the foundation for a company that could transform genomics,” said Jay West, CTO and Co-Founder of BioSkryb Genomics. “Since the filing of this original patent application, we have generated approximately 60 other patents and patent applications in several key geographical markets that have allowed us to build upon the original power of this transformational technology.”
As of August 2023, BioSkryb Genomics, Inc., owns or exclusively licenses one issued U.S. patent and three issued international patents (Europe, Australia, and Hong Kong). There are 58 pending patent applications, including 12 in the United States, 39 international applications, and 7 applications filed under the Patent Cooperation Treaty.
About BioSkryb Genomics
BioSkryb Genomics is a rapidly growing organization that is transforming single cell molecular discovery and analysis. Through its single cell whole genome and whole transcriptome amplification tools, scientists and clinicians can gain an unprecedented view of the genome, transcriptome, and proteome within a single cell to better understand the drivers, mechanisms, and management of complex disease. The company is headquartered in Durham, North Carolina.
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