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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Medical, Industry Outlook
PRNewswire | July 19, 2023
BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, announced today that it has acquired PrecisionMed, LLC, a leading supplier of high-quality human biological material for genetics, drug discovery, and biomarker research and in vitro diagnostics.
Based in Carlsbad, CA, PrecisionMed has been collecting biospecimens for neurology and oncology research for more than 27 years, and it has the largest private, global repository of longitudinally collected human CSF for scientific research. Its collection contains both normal and diseased CSF samples together with other matched biofluids, such as plasma, sera, and whole blood.
"We are thrilled to announce BioIVT's acquisition of PrecisionMed. Our vision is to lead the biospecimen industry through expertise and innovation and our acquisition of PrecisionMed pushes us even closer to this goal. We are excited about the possibilities that lie ahead as we expand our supply network and inventory and strengthen our capacity to meet the increasing customer demand for CSF and liquid biopsy products. Together, we will drive even greater value for our customers and further our mission of enabling smarter science," said BioIVT Chief Executive Officer Richard Haigh, PhD.
"The vision at PrecisionMed has always been centered around positively impacting patients' lives through fueling innovation and scientific discovery. We have long viewed BioIVT as the gold standard in our industry with the track record and global reach to back that up. This partnership magnifies our collective ability to reach the research community and impact patient lives. We are proud to pair our talent and resources with the world-class team at BioIVT," said PrecisionMed CEO Eric Leach.
PrecisionMed's regulatory-compliant and privacy-protected biorepository contains more than 170,000 samples of CSF, whole blood, serum, plasma, PBMCs, and urine collected under Institutional Review Board-approved clinical protocols. This extensive collection of high-quality, well annotated biospecimens was amassed from PrecisionMed's sizable network of donors and collection sites. Each biospecimen includes detailed clinical data, such as the donor's diagnosis, demographics, family medical histories, treatment responses, and disease progression.
Underscoring the value of its contributions, PrecisionMed has received more than 120 citations in scientific journals and its collections have been part of U.S. NIH grants and have formed the basis of U.S. FDA submissions and subsequent U.S. FDA clearance for diagnostics.
Looking ahead, PrecisionMed will continue to operate out of its current headquarters and maintain its existing network of donor and collection sites. Financial details about this transaction were not disclosed.
About PrecisionMed, LLC.
PrecisionMed is a leading supplier of high-quality human biological material for research, and it is the largest private global source of longitudinally collected human cerebrospinal fluid (CSF) from living normal controls and diseased populations. Since 1996, its accurately annotated human biological samples have been utilized by more than 600 pharmaceutical and biotechnology companies, and academic research organizations worldwide.
About BioIVT
BioIVT enables smarter science and accelerates medical breakthroughs by delivering high-quality personalized biospecimen solutions and research services to the life science and diagnostic industries. Recognized as an industry leader, BioIVT specializes in control and disease state samples including human and animal tissues or preparations, ADME-Tox products and research services, cell and gene therapy products, blood, and other biofluids. By combining technical expertise and exceptional customer service with unmatched access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE®.
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MedTech
businesswire | August 31, 2023
Watchmaker Genomics, a supplier of innovative products for molecular analysis, today announced a multi-year, co-exclusive agreement with Exact Sciences Corporation, a leading provider of cancer screening and diagnostic tests, to develop and commercialize the breakthrough DNA methylation analysis technology, TET-assisted pyridine borane sequencing (TAPS). Watchmaker will apply its expertise in engineering DNA-modifying enzymes to further improve the TAPS chemistry, ultimately enabling advanced applications, including cancer screening and minimal residual disease (MRD) testing. Under the licensing agreement, Watchmaker may develop and commercialize the TAPS technology under its own brand.
DNA methylation patterns offer dynamic and rich insights into the status of both healthy and diseased tissue. These signatures are stable, relatively abundant, and often measurable in the blood, making them promising biomarkers in minimally invasive liquid biopsies. TAPS has the potential to dramatically improve DNA methylation analysis accuracy by enabling a direct readout of cytosine methylation with less template damage and noise when compared to existing methods.1
"Exact Sciences is a leader in cancer screening, and this agreement is a great fit with Watchmaker’s core competencies in next-generation sequencing and genomics applications," said Brian Kudlow, Ph.D., Chief Scientific Officer at Watchmaker Genomics. "It aligns with our belief that multimodal genomic and epigenomic assays represent the frontier of numerous liquid biopsy applications, including early cancer detection."
In addition to the development and licensing agreement, the companies have entered into a long-term strategic supply agreement. Under its terms, Watchmaker will provide Exact Sciences with access to its portfolio of best-in-class sequencing reagents and precision enzymes. These products have the potential to enhance the performance of Exact Sciences’ tests while significantly reducing associated costs.
“Our company’s mission is to develop and broadly commercialize tools that improve the efficiency of capturing and interpreting the biological information required for many advanced genetic testing applications,” said Trey Foskett, CEO of Watchmaker Genomics. “This arrangement provides us with an exciting opportunity to accelerate the development and commercialization of a game-changing technology to the benefit of the broader research and clinical genomics markets.”
About Watchmaker Genomics
Watchmaker Genomics applies advanced enzymology to enable breakthrough applications for the reading, writing, and editing of DNA and RNA. The company combines domain expertise in protein engineering with large-scale enzyme manufacturing to address the demanding quality, performance, and scale requirements of high-growth clinical genomics applications. Watchmaker's product portfolio includes enzymes and kits for next-generation sequencing, synthetic biology, and molecular diagnostics.
A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis.
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