Medical, Industry Outlook
PRNewswire | July 14, 2023
Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Limited, committed to cutting-edge antibody technology innovation and provider of integrated solutions from "Idea to IND" (I to ITM) announced that, DualityBio, a collaborator of Nona Biosciences, and BeiGene entered into an agreement for BeiGene to acquire an exclusive option for a global clinical and commercial license to an investigational, preclinical ADC program for patients with select solid tumors. This program was developed under the collaboration agreement commenced between Nona Biosciences and DualityBio.
Nona Biosciences entered into a collaboration agreement with DualityBio in 2022, pursuant to which Nona Biosciences granted the exclusive rights of its monoclonal antibodies for specific tumors to DualityBio to develop the world's first-in-class ADC. The collaboration between Nona Biosciences and DualityBio will continue in accordance with the terms of the collaboration agreement.
Nona Biosciences has established considerable experience and expertise in ADC field. While continuously optimizing its advanced platform technology, Nona Biosciences has actively established an ADC cooperation ecosystem and closely cooperated with multiple innovation pioneers, to fully unleash its innovation capability and accelerate the innovations of novel ADC therapeutics globally. Nona Biosciences will further expand its networks in ADC innovation as one of its core strategies, continue to enhance the value of innovation, and fulfill global medical needs.
About Nona Biosciences
Nona Biosciences is a global biotechnology company committed to cutting edge technology innovation, and providing a total solution from "Idea to IND" (I to ITM), ranging from target validation and antibody discovery through preclinical research. The integrated antibody and antibody-related discovery services with multiple modalities range from antigen preparation, animal immunization, single B cell screening, to antibody lead generation and engineering, developability assessment and pharmacological evaluation, leveraging advantages of Harbour Mice® platforms and the experienced therapeutic antibody discovery team.
Harbour Mice® generates fully human monoclonal antibodies in classical two light and two heavy chain (H2L2) format, and heavy chain only (HCAb) formats. Integrating Harbour Mice® and a single B cell cloning platform, Nona Biosciences is focused on driving global inventions of transformative next-generation drugs.
DualityBio is a clinical-stage company focusing on the discovery and development of the next generation ADC therapeutics for patients with cancer and autoimmune diseases. DualityBio has successfully established a number of next-generation ADC technology platforms with global intellectual property rights. Building upon deep understanding of disease biology and translational capability, DualityBio has advanced four assets into global clinical studies, and developed more than 10 innovative product candidates that are currently in preclinical stage. Additionally, DualityBio is continuing to evolve its novel protein engineering and ADC technology platforms for the next wave of "super ADC" molecules including diverse payload classes, bispecific ADCs and dual-payload ADCs.
Cell and Gene Therapy, Industry Outlook
Businesswire | July 17, 2023
Slingshot Biosciences, Inc. a leading provider of cell mimic control products, is proud to announce the launch of its new SpectraComp fluorescent protein series collection. This groundbreaking series provides scientists with a cutting-edge fluorescent protein control platform for use in flow cytometry analysis.
By genetically modifying T cells and other immune cells in humanized mice to express fluorescent reporter proteins, including eGFP and mCherry, scientists are able to observe live cell, tissue locations, and track protein trafficking. These mechanisms are important when exploiting and redirecting synthetic chimeric antigen receptors (CARs). These tools also serve as effective reporters for gene deletion/expression in modified mice. Explore the endless possibilities of our on-demand cell mimic control platform and unlock new discoveries today. Slingshot’s new SpectraComp series collection of cutting-edge fluorescent proteins: SpectraComp eGFP and SpectraComp mCherry, exceptional controls for unmixing, compensation, and benchmarking for flow cytometry analysis.
“We are thrilled to bring this revolutionary technology to the scientific community,” says Dr. Jeffrey Kim, CEO of Slingshot Biosciences. “Our SpectraComp eGFP and mCherry will provide researchers with an on-demand cell mimic control platform that will allow them to explore the endless possibilities of flow cytometry analysis and unlock new discoveries today.”
This launch of the SpectraComp eGFP and mCherry reaffirms Slingshot Biosciences' commitment to delivering innovative solutions that empower researchers worldwide. These fluorescent proteins will provide scientists with the tools they need to unlock new insights, accelerate discoveries, and push the boundaries of scientific exploration.
About Slingshot Biosciences
Slingshot Biosciences is a leading biotechnology company dedicated to advancing scientific research through innovative solutions. With a focus on developing cutting-edge tools for fluorescence imaging, the company aims to revolutionize how scientists explore and understand the intricate mechanisms of life. Slingshot Biosciences is committed to empowering researchers with exceptional products that enable groundbreaking discoveries and shape the future of bioscience.
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.