TetraScience | September 03, 2021
TetraScience, the R&D Data Cloud company, announced today that Zymeworks Inc. has selected the Tetra Data Platform (TDP) to standardize and automate scientific data flow. As a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics, Zymeworks' R&D engine generates and analyzes large amounts of scientific data in its quest to revolutionize drug design.
"In order to take advantage of innovative data science applications including AI/ML, it's important to start with harmonizing R&D data in the cloud," stated Chad Garrett, TetraScience CRO, "We're excited to partner with Zymeworks on their data cloud initiative and help them deliver on their mission to enable patients to return home to their loved ones, disease free."
The initial Zymeworks deployment of Tetra Data Platform is in production and integrated with key systems and instruments supporting critical lab workflows. By automating and standardizing the flow of data across all sources and targets, the Tetra R&D Data Cloud will deliver faster and richer insights for Zymeworks' scientists. Additionally, Zymeworks will benefit from cloud-native architecture with greater uptime, security, redundancy, governance, and archival capabilities.
TetraScience is the R&D Data Cloud company with a mission to transform life sciences R&D, accelerate discovery, and improve and extend human life. The Tetra R&D Data Cloud provides life sciences companies with the flexibility, scalability, and data-centric capabilities to enable easy access to centralized, harmonized, and actionable scientific data and is actively deployed across enterprise pharma and biotech organizations. As an open platform, TetraScience has built the largest integration network of lab instruments, informatics applications, CRO/CDMOs, analytics, and data science partners, creating seamless interoperability and an innovation feedback loop that will drive the future of life sciences R&D.
Meridian Bioscience, Inc. | March 31, 2022
Meridian Bioscience, Inc. (NASDAQ: VIVO), a leading global provider of diagnostic testing solutions and life science raw materials, announced today the launch of two new master mixes that detect DNA and RNA in crude blood samples down to a single copy – enabling the earliest detection of cancer using non-invasive liquid biopsy. These two innovative mixes, Lyo-Ready™ Direct DNA qPCR Blood Mix and Lyo-Ready™ Direct RNA/DNA qPCR Blood Mix, are designed for applications that require ultra-sensitive detection, such as liquid biopsy. This breakthrough technology is the first blood-specific, inhibitor-tolerant, and lyophilizable chemistry that enables extraction-free qPCR/RT-qPCR for liquid biopsy analysis at a performance level on par with traditional qPCR from purified nucleic acids.
Liquid biopsy is a non-invasive alternative to tissue biopsy and offers ultra-sensitive detection of tumor-associated DNA or RNA from biofluids such as blood. Sample types like whole blood, serum, plasma, and the anticoagulants used for specimen stabilization contain PCR inhibitors that can significantly reduce detection sensitivity and may cause false-negative results. Inhibitors are usually removed by DNA/RNA extraction; however, that approach is very inefficient and increases assay time, cost, and the risk of contamination or error. Meridian's innovative Lyo-Ready™ Blood-Specific Master Mixes do not require extraction and are proven to excel with crude blood and its derivatives without the need to remove inhibitors. These groundbreaking mixes can help improve patient outcomes by enabling early cancer detection by delivering assay sensitivity down to one copy of DNA. Meridian's new mixes are formulated with lyophilization excipients, making them compatible with lyophilization to create room-temperature stable molecular diagnostic assays. Not only does this allow maximum sample input in the liquid biopsy analysis, but it also eliminates the need for cold chain storage of the finished test kit, limiting our customer's environmental impact.
We are excited to expand our sample-specific molecular range with the market's first lyophilizable, and inhibitor-tolerant master mixes designed for direct amplification of nucleic acids from liquid biopsy. It is a truly disruptive technology that makes the early detection of cancer biomarkers directly from liquid biopsy a reality. We are proud of being the technology innovator enabling efficient and more cost-effective diagnostic assay development to help clinicians deliver the quickest, most accurate diagnosis for patients."
Florent Chang-Pi-Hin, Ph.D., Vice President, Global Research and Development.
About Meridian Bioscience, Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy, and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries worldwide.
CELL AND GENE THERAPY
BeiGene | November 23, 2021
BeiGene a global, science-driven biotechnology company focused on developing innovative and affordable medicines, announced that the first patient has been dosed in a Phase 1 clinical trial of BGB-23339, a potent, allosteric investigational tyrosine kinase 2 (TYK2) inhibitor internally developed by BeiGene scientists.
TYK2 is a member of the JAK family and functions as a critical mediator in cytokine signaling pathways implicated in multiple immune-mediated disorders, such as psoriasis and inflammatory bowel disease. BGB-23339 is a potent, highly selective, investigational TYK2 inhibitor targeting the regulatory pseudokinase (JH2) domain.
“Discovered and developed by BeiGene, BGB-23339 is a highly selective, potent, allosteric TYK2 inhibitor that has shown promising activity in preclinical evaluation. Building on our proven track record in oncology, BeiGene is expanding its clinical focus to discover new modalities and platforms in areas of high unmet need, including inflammation and immunology, to bring innovative, impactful medicines to patients.”
Lai Wang, Ph.D., Global Head of R&D at BeiGene
The first-in-human Phase 1 trial (NCT05093270) is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of BGB-23339. The trial is expected to enroll up to 115 healthy volunteers in Australia and/or China.
In addition to its broad portfolio focused on hematological malignancies and solid tumors, BeiGene is applying its research excellence and clinical expertise to address inflammation and immunology, an area of high unmet medical need. BeiGene’s internally developed, highly selective next-generation BTK inhibitor BRUKINSA® (zanubrutinib) is currently being evaluated in a Phase 2 trial in patients with active proliferative lupus nephritis.
BGB-23339 is a potent, highly selective, allosteric, investigational tyrosine kinase 2 (TYK2) inhibitor discovered and being developed by BeiGene. TYK2 is a member of the JAK family and functions as a critical mediator in cytokine signaling pathways implicated in multiple immune-mediated disorders. Designed to target the regulatory pseudokinase (JH2) domain on TYK2, BGB-23339 has demonstrated strong selectivity in preclinical studies with potent inhibition of interleukin (IL)-12, IL-23, and Type 1 interferons (IFNs)—pro-inflammatory cytokines that play a determinant role in the induction of inflammation. BGB-23339 is currently being evaluated in a Phase 1 clinical study.
BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 7,700 colleagues across five continents.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding plans for the Phase 1 trial and development of BGB-23339, the potential for BGB-23339 to address unmet medical needs, BeiGene’s plan to expand its clinical focus to discover new modalities and platforms in areas of high unmet need, including inflammation and immunology, and BeiGene’s plans, commitments, aspirations and goals under “About BeiGene”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on the BeiGene’s clinical development, regulatory, commercial, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.