PharmaMar/Jazz Pharmaceuticals get NDA priority for lung cancer drug

European Biotechnology | February 17, 2020

PharmaMar and Jazz Pharmaceuticals have received FDA Priority Review of a NDA for lurbinectedin in relapsed SCLC (Small Cell Lung Cancer). The PDUFA date was set for August 16, 2020 by the US Food and Drug Administration (FDA) for lurbinectedin as second-line treatment for patients with SCLC who relapsed following platium-based chemotherapy. The synthetic drug developed by PharmaMar SA (Madrid, Spain) and exclusively licenced by Jazz Pharmaceuticals plc (Dublin, Ireland) in December 2019 works by blocking RNA Polymerase II dependent oncogenic transcription programmes and modulating activity of tumour-associated macrophages.

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With the Industrial Biotechnology Showcase coming up, we spoke to Steve Bagshaw, Chief Executive Officer at Fujifilm Diosynth Biotechnologies and Chair of the Industrial Biotechnology Leadership Forum to learn a little more about the world of industrial biotechnology.


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CELL AND GENE THERAPY

SOPHiA GENETICS Launches New Deep Learning Capabilities to Support the Detection of Homologous Recombination Deficiencies

SOPHiA GENETICS | March 08, 2022

SOPHiA GENETICS (Nasdaq: SOPH), a leader in Data-Driven Medicine, announced today the launch of their SOPHiA DDM Homologous Recombination Deficiency (HRD) Solution, opening new doors for cancer research. The application provides a unique approach for molecular cancer testing by combining the identification of HRD-causing mutations with the analysis of HRD-induced genomic instability across the whole genome of tumor samples. HRD is caused by a cell's impaired ability to repair DNA double-stranded breaks through the homologous recombination repair (HRR) pathway and is linked with the development of certain cancers. It is also an important predictor of tumor response to treatment with PARP inhibitors. Molecular testing of tumor samples using SOPHiA DDM enables simultaneous detection of both HRR mutations that can cause HRD, including those in the BRCA1 and BRCA2 genes, and the accumulated damage to genomic integrity that can result from them, using shallow whole-genome Next Generation Sequencing. SOPHiA GENETICS is collaborating with AstraZeneca, aiming to expand access to in-house HRD testing across European laboratories and institutions. Providing laboratories with innovative solutions to enable locally-delivered HRD testing is critically important, particularly in settings such as advanced ovarian cancer, where approximately half of all newly diagnosed patients have HRD-positive tumors, We are pleased to work with SOPHiA GENETICS in their mission to empower their laboratory customers and increase the range of options available for HRD detection." Kristina Rodnikova, SVP Global Oncology Diagnostics at AstraZeneca. To combat current challenges with HRD detection offerings, the SOPHiA DDM HRD Solution provides laboratories and institutions with a decentralized approach to HRD testing for tumor samples. The SOPHiA DDM HRD Solution allows the user to retain full ownership of their data and save time and expenses, while also offering comprehensive genomic insights powered by deep learning algorithms. We at SOPHiA GENETICS have always been on a mission to improve health outcomes by advancing data-driven medicine, which is why I am extremely excited to announce the launch of our new HRD research solution, Our SOPHiA DDM HRD Solution will provide researchers and other healthcare professionals with a decentralized approach to fully integrated HRD testing, enabling the HRD status of more advanced ovarian cancer cases to be determined without reliance on send-out testing solutions." Dr. Jurgi Camblong, Co-founder and CEO of SOPHiA GENETICS. About SOPHiA GENETICS SOPHiA GENETICS (Nasdaq: SOPH) is a healthcare technology company dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. It is the creator of the SOPHiA DDM™ Platform, a cloud-based SaaS platform capable of analyzing data and generating insights from complex multimodal data sets and different diagnostic modalities. The SOPHiA DDM™ Platform and related solutions, products and services are currently used by more than 790 hospital, laboratory, and biopharma institutions globally.

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INDUSTRIAL IMPACT

Canopy Biosciences Launches Next-Generation ChipCytometry™ Instrument for Spatial Biology with Sub-Cellular Resolution

Canopy Biosciences | March 04, 2022

Canopy Biosciences, a Bruker Company, announced the commercial launch of the CellScapeTM system, the next generation in ChipCytometryTM instrumentation, advancing the cutting-edge for quantitative in situ spatial phenotyping. ChipCytometry delivers single-cell targeted spatial proteomics for complex whole-tissue analysis of the tumor microenvironment, as well as deep immune profiling for applications in immunology, neuroscience, and infectious disease. The new benchtop CellScape system builds on the existing core strengths of the original ChipCytometry instrument, the ZellScannerONE™, which has enabled spatial biology research with sub-cellular resolution and a large field of view suitable for whole slide pathology imaging, on both tissue samples and cell suspensions since 2016. The CellScape system , with its multiplexed fluidics integration, adds complete walk-away automation, improved optical performance, sub-cellular resolution and massively increased throughput for whole slide imaging of millions of cells, while maintaining the key features of the core ChipCytometry technology, including high-plex phenotyping with single-cell resolution, very high dynamic range imaging for detection and quantification of both high- and low-expressing targets, and compatibility with standard commercially available fluorescently labelled antibodies, requiring no proprietary antibody conjugation. This powerful combination of features will significantly improve researchers’ workflow, accelerate spatial biology discovery, and drive broader adoption of high-plex spatial omics for translational and clinical applications. “The ChipCytometry platform has been a great tool for us in developing high content staining approaches for in-depth spatial immune profiling of human tissue samples. The improvements to throughput and automation of the CellScape system gives the opportunity to scale up studies and explore larger cohorts – and accelerate studies aimed at improving patient care.” Paul Klenerman, Ph.D., Professor of Gastroenterology at The University of Oxford “Following the acquisition of Canopy Biosciences by Bruker in 2020, we were able to leverage Bruker’s advanced fluorescence microscopy expertise to design the CellScape instrument as an integrated, multiplexed imaging system that is highly optimized for the application of high-throughput quantitative spatial omics with sub-cellular resolution,” added Thomas Campbell, Ph.D., Product Manager at Canopy Biosciences. “The improved optical performance of the system builds on the high resolution and high dynamic range that was already best-in-class with our ChipCytometry technology.” About the CellScape Instrument Through enhanced optics and automation, the throughput of CellScape is markedly improved compared to the previous generation of ChipCytometry instrumentation. Combined with multi-sample automated processing, which is available standard with every CellScape, the platform will have among the highest throughput of any highly multiplexed spatial proteomics system available today. CellScape will also be available with an optional FalconFastTM configuration, which provides an even greater increase in throughput, bringing into reach large-scale clinical studies that have previously not been possible at a high plex. About Canopy Biosciences, a Bruker Company Canopy Biosciences was formed in 2016 and rapidly built a comprehensive portfolio of products and services for spatial biology, multi-omics, and bioprocessing. Canopy offers its ChipCytometry technology for precise spatial multiplexing in cells and tissue samples, along with other technologies of ultrasensitive DNA sequencing (RareSeq), RNA-Seq, and gene expression analysis for services. Canopy Biosciences is headquartered in St. Louis, Missouri, with a CLIA site in California, and a site in Germany to serve researchers at universities, research institutions, and biotechnology and pharmaceutical companies worldwide. Canopy was acquired by Bruker Corporation in 2020.

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MEDICAL

AXIM Biotech Develops Rapid Quantitative Tear Test for MMP-9, An Inflammatory Biomarker of Dry Eye Disease

AXIM Biotech | March 10, 2022

AXIM Biotechnologies, Inc (OTCQB: AXIM) (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare solutions company targeting dry eye disease (DED), today announced that it has successfully developed a rapid quantitative tear test for MMP-9, an inflammatory biomarker for Dry Eye Disease. Dry Eye Disease, though widespread, is under-diagnosed, in part because symptoms do not always correlate with objective signs. It has a highly variable symptom profile at different stages of the disease, and there is often a discordance between signs and symptoms. A patient can have severe symptoms yet show no sign of ocular surface damage, while others have advanced ocular surface damage, yet report no symptoms. This lack of correlation between clinical signs and symptoms of Dry Eye Disease makes diagnosing and treating patients a challenge. Often times, inflammation is present before the clinical signs of Dry Eye Disease. The challenge has been in early detection of inflammation. Matrix metalloproteinase-9 (MMP-9), an inflammatory biomarker consistently elevated in the tears of dry eye patients, may accelerate early diagnosis when detected. The central role of inflammation in ocular surface disease is widely recognized, but our ability to measure this in the clinic has been limited to the InflammaDry test that measures tear matrix metalloproteinase (MMP) levels and provides a positive/negative result around a threshold of 40ng/ml of MMP-9. This 'yes or no' report has clinical value, but it is limited. Currently available MMP-9 testing does not detect a reduction in tear MMP-9 levels until the concentration drops below 40ng/ml and thus may miss clinically significant improvement that did not reach that threshold.” Dr. Joseph Tauber, AXIM’s Chief Medical Officer. The clinical benefits of the quantitative test for MMP-9 as a tool for accurate diagnosis of Dry Eye Disease and subsequent treatment include more accurate pre-surgical and post-surgical outcomes. Post-surgical complications, such as corneal wound healing, is facilitated by identifying dry eye prior to surgery. The availability of quantitative tear MMP-9 testing would be a significant advance in our ability to measure the degree of inflammation affecting our dry eye patients, allowing for more objective classification of their disease, Equally important would be the ability to measure improvement in control of inflammation that is the goal of many of our therapies for ocular surface disease, including pharmaceuticals, thermal pulsation treatments and even light based therapies.” Dr. Joseph Tauber. Some reports indicate that nearly half of all U.S. adults experience dry eye symptoms and 33% of patients in eye care clinics present with complaints about dry eye. Given the size of the market, AXIM made the strategic decision to develop a test for MMP-9 to assist in early detection of Dry Eye Disease. Together with our Lactoferrin and IgE Tests and now with the addition of our MMP-9 Test, AXIM will be positioned to corner the market for Dry Eye Disease diagnostic testing.” John Huemoeller, AXIM’s CEO. About AXIM® Biotechnologies Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. Additionally, it owns IP and has conducted research on SARS-CoV-2 (COVID-19) rapid neutralizing antibody tests to detect levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells, as well as for oncological indications.

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DIAGNOSTICS

Evonetix Granted Patent for Technology Enabling Thermally-Controlled DNA Synthesis

evonetix | April 04, 2022

EVONETIX LTD (‘Evonetix’), the synthetic biology company bringing semiconductor technology to DNA synthesis, today announced it has been granted patent EP3551331B1 in Europe for its proprietary thermal control technology for DNA synthesis, as well as the design and manufacture of its silicon chips. This patent extends Evonetix’s IP portfolio and is a key step in the Company’s strategy to develop a benchtop DNA synthesis platform, to change how DNA is accessed, made, and used. Evonetix’s novel approach to parallel DNA synthesis is underpinned by precise, independent, control of temperature at thousands of individual synthesis sites across the surface of a silicon chip. In contrast to conventional approaches, which use acid deprotection to control the synthesis cycle, Evonetix uses thermal control with semiconductor-based arrays. This offers greater accuracy and selectivity to deprotect sequences at the correct point to add the next nucleotide and remove mismatching sequences. Thermal control of DNA synthesis enables highly parallel synthesis and gives the ability to work through sequences that are hard to synthesise using conventional techniques and to remove errors during the assembly of gene sequences through temperature mediated error removal. There is currently an unmet need in the synthetic biology industry for long, accurate, DNA sequences, and the ability to remove errors during assembly allows researchers to achieve longer strands of DNA, and run applications such as gene synthesis, CRISPR screening, and protein engineering. Securing this patent to cover our core technology adds further strength to our IP portfolio and underlines Evonetix’s position as leaders in our field. Our technology will give researchers the capabilities of service centres in their own lab, accelerating the advancement of synthetic biology and opening new possibilities in this exciting market.” Matthew Hayes, Chief Technology Officer at Evonetix.

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Spotlight

With the Industrial Biotechnology Showcase coming up, we spoke to Steve Bagshaw, Chief Executive Officer at Fujifilm Diosynth Biotechnologies and Chair of the Industrial Biotechnology Leadership Forum to learn a little more about the world of industrial biotechnology.

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