New 30-Plex Immuno-Oncology Protein Target Panel, Temple Medicine’s Pulmonary Artery Blood Clot Reduction Device, More

September 29, 2022 | A cloud-based software solution to streamline flow cytometry workflow; the world’s most extensive repeated set of highly-detailed, multi-organ images; a gene editing therapy for inflammatory cardiac diseases; and more. 

The U.S. Food and Drug Administration approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in the selection of patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer, RET-fusion positive advanced or metastatic thyroid cancer, and RET-mutation positive advanced or metastatic medullary thyroid cancer who may be eligible for treatment with Lilly’s Retevmo (selpercatinib). The Oncomine Dx Target test is a next-generation sequencing (NGS)-based test that can detect multiple alterations at once from a small sample size, helping to match patients with the appropriate targeted therapy quickly. The test is the only globally distributable NGS CDx solution that has received regulatory approval in 17 countries for 15 targeted therapies, covering more than 550 million lives globally. Press release.

Enzo Biochem announced the launch of the AMPIVIEW line, an RNA gene expression platform powered by Enzo’s LoopRNA in situ hybridization technology. The AMPIVIEW platform, with its first products for HPV detection and analysis, combines the precision of targeted, sequence-specific probes with the superior sensitivity of its novel LoopRNA ISH technology. This innovative design enables sensitive and specific detection of target genes in tissue or cell samples while preserving the morphology. Press release. 

PerkinElmer launched the Cellaca PLX Image Cytometry System. This first-of-its-kind benchtop platform enables researchers to assess multiple quality attributes of cell samples in a single automated workflow, including cell identity, quality, and quantity. The cutting-edge Cellaca PLX system combines best-in-class image cytometer hardware, software, validated consumables, and trackable data reporting. As a result, researchers can now detect multiple markers simultaneously (multiplexing) and perform immunophenotyping and viability assays in seconds. Press release. 

GenScript USA is collaborating with researchers at the Gladstone-UCSF Institute of Genomic Immunology to advance the development of new, non-viral cell therapies that modify genomic sequences in the pursuit of more effective cell therapy products while limiting the cellular toxicity that is typically associated with previously available methods. A new study, published in Nature Biotechnology (DOI: 10.1038/s41587-022-01418-8), detailed methods for achieving highly efficient non-viral knock-in using GenScript's GenExact single-strand DNA (ssDNA) modified with Cas9-target sequences. The team discovered that this combination of GenExact ssDNA with Cas9-targeted sequence offers up to 40% knock-in editing efficiency with minimal cellular toxicity. This approach can accelerate the development and manufacturing of novel, high-yield, and non-viral gene therapies at a lower cost. Press release. 

UK Biobank, the Medical Research Council, Calico Life Sciences, and the Chan Zuckerberg Initiative announced an ambitious project to conduct repeat imaging scans on 60,000 UK Biobank participants. This project will capture a repeated set of highly-detailed, multi-organ images from a large cohort of participants, allowing researchers to assess changes in physiology over time. The baseline imaging project is already the world's largest dataset of its kind. The addition of the repeat imaging data will provide a unique set of longitudinal measures for the scientific community to assess changes in participants’ health as they age. Press release. 

Akadeum Life Sciences announced a new early access program launch of an industry-first: the Microbubble Leukopak Human T Cell Isolation Kit. This new research use-only kit was developed to give scientists an essential solution to biological and workflow challenges in the lab. The product combines unique advantages of microbubbles with a Buoyancy Activated Cell Sorting (BACS) Separation Tube that is poised to transform large volume cell separation workflows. Akadeum’s BACS Separation Tubes create timesaving and performance benefits with the easy separation of target cells from the remainder of the sample and increased throughput. Press release. 

Propath UK and Nucleai announced their collaboration to develop and validate a 30-plex immunofluorescence panel focused on protein targets relevant to immuno-oncology. Nucleai’s proprietary AI-powered, pathology-based biomarker discovery platform combined with Propath’s multi-omic spatial biology and high-plex immunofluorescence will accelerate the pharmaceutical industry’s drug development and research programs. In addition, the combined expertise will allow computational analysis of the tumor microenvironment, feature selections to predict disease prognosis and drug response, and support early detection and prognosis. Press release. 

The Center for Breakthrough Medicines (CBM) and jCyte announced a multi-year manufacturing agreement wherein CBM would be the primary manufacturer of jCyte's U.S. Food & Drug Administration's Regenerative Medicine Advanced Therapy designated cell therapy, jCell. jCell is a first-in-class investigational treatment for retinitis pigmentosa involving a simple, minimally invasive intravitreal injection, which can be easily administered within an ophthalmologist's office. The principal mechanism of action is the sustained release of established neurotrophic factors which have been shown to reduce photoreceptor cell death and promote the function of surviving photoreceptors. Press release. 

"Cattolica TJU Research" is the new benefit society resulting from the agreement signed at Policlinico Universitario Agostino Gemelli IRCCS by Università Cattolica and Thomas Jefferson University. The organization aims to promote scientific research in neuroscience, allowing the creation of the Brain Center "Vickie and Jack Farber Institute for Neuroscience at Policlinico Gemelli in Rome." A new six-floor building will be built in front of Gemelli's main building. Radiotherapy will occupy the first floor, research labs will be on the second floor, and the other three floors will host day hospitals, outpatient clinics, and treatment rooms for neurology and neurosurgery. The building is expected to be completed within two years. Press release. 

Researchers at the University of Colorado led by a Nanoscope team were recognized as the winning top research team in the final phase of the 3D-Retinal Organoid Challenge by the National Eye Institute. They developed and characterized a retinal organoid with functional photoreceptors and retinal pigment epithelium cell layers for age-related macular degeneration, a leading cause of blindness in American adults. The second prize was awarded to a multidisciplinary team from the University of Colorado School of Medicine, Nanoscope, and Miami University for developing a highly reproducible retinal organoid model useful for high-throughput drug screening. Press release. 

Vizgen announced the launch of the MERSCOPE Protein Co-detection Kit, enabling subcellular spatial multi-omics measurement with the simultaneous detection of RNA and proteins during a standard MERFISH experiment. The MERSCOPE Protein Stain Reagent Kit offers high-quality protein staining, equivalent to protein immunofluorescence staining, and its oligo conjugated antibodies enable heightened detection of primary antibodies targeting proteins. In addition, the kit allows for next-level transcript staining with its MERFISH technology and provides multiplexed error-robust transcript detection and an impressive correlation with bulk RNA-seq data for high, medium, and low-expressing genes. Press release. 

GenScript USA and Avectas are partnering to develop an improved non-viral cell therapy manufacturing process to provide their customers with potent, new methods for developing cell therapies that offer an improved safety profile over viral and non-viral vector techniques. The research teams will apply SOLUPORE technology to permeabilize the target cell membrane so that engineered cargoes can be delivered while retaining very high cell viability and functionality. GenCRISPR synthetic sgRNA and Cas9 protein are then complexed into a ribonucleic protein co-delivered with GenExact ssDNA HDR templates into the cell nucleus. Press release. 

CytoReason announced an extension of its multi-year partnership with Pfizer to use CytoReason’s artificial intelligence technology for Pfizer’s drug development programs. Since launching the collaboration in 2019, Pfizer has used CytoReason's biological models in its research to enhance the understanding of the immune system as it develops innovative drugs for over 20 immune-mediated and immuno-oncology diseases. The new research agreement and investment will support the development of additional disease models and the creation of high-resolution models spanning several therapeutic areas. Press release. 

Cellares Corporation and iVexSol announced a strategic partnership to solve key challenges with viral vector manufacturing to accelerate access to life-saving therapies. By combining Cellares' automation and robotics technology with iVexSol's viral vector expertise, the partners aim to develop consistent, high-quality solutions for viral vector manufacturing to improve access to this critical reagent. Cellares' automated, closed, end-to-end cell therapy manufacturing platform, the Cell Shuttle, can be easily adjusted to different customer processing needs and supports a variety of cell therapy modalities. Press release. 

Researchers from the Lewis Katz School of Medicine at Temple University announced that a device known as the BASHIR Endovascular Catheter (THROMBOLEX) significantly reduces the size of blood clots lodged in the pulmonary arteries, leading to improvement in heart function in patients with pulmonary embolism (DOI: 10.1016/j.jcin.2022.09.011). The BASHIR catheter is made of an expandable basket with mini-infusion catheters. Once placed inside a clot, the infusion basket expands, creating new channels in the clot and increasing the surface area exposed to clot-dissolving drugs delivered through the catheters. THROMBOLEX now has FDA clearance on seven devices in the BASHIR family of catheters, all of which are currently in commercialization. Press release. 

A research network formed by Nanyang Technological University Lee Kong Chian School of Medicine and other prominent hospitals in the region has set up the Singapore Severe Asthma Registry (SSAR), the first of its kind in the country. This national registry joins the International Severe Asthma Registry as the largest international research collaboration in Singapore's respiratory medicine history. The SSAR aims to improve understanding of severe asthma, collect evidence of treatment effectiveness and safety, and identify predictors of treatment success. Press release. 

The Center for BrainHealth is excited to announce three rapid-launch research initiatives to develop improved brain systems in response to interventions. The first project will use neuroimaging data from The BrainHealth Project to glean insight into how the brain’s blood flow and connectivity change as an individual engages in brain health training. The second project uses a different machine learning approach to determine differences in the brain’s connectivity as brain health gets better. Finally, the third project seeks to create a structure and system to securely share data from The BrainHealth Project platform with other researchers. Press release. 

The U.S. Food and Drug Administration and the National Institutes of Health announced the launch of the Critical Path for Rare Neurodegenerative Diseases—a public-private partnership aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral sclerosis and other rare neurodegenerative diseases. C-Path will convene the partnership, bringing together experts in rare neurodegenerative diseases, including, but not limited to, patient communities, advocacy organizations, and private entities. Press release. 

SambaNova Systems announced the launch of its next-generation DataScale system, a fully integrated hardware-software system enabling organizations to reimagine their approach to artificial intelligence (AI). SambaNova enables the consolidation of AI sprawl into foundation models that are trained once and reused across the organization. The next generation of SambaNova DataScale offers several key enhancements: better performance, a next-generation processor, enhanced full-stack support, and customer value-based pricing. Press release. 

Eligo Bioscience and Kantonsspital St. Gallen announced their strategic alliance to develop a gene editing therapy for inflammatory cardiac diseases induced by bacterial mimicry. The collaboration builds on the foundational research published in Science (DOI: 10.1126/science.aav3487), and leverages Eligo’s proprietary technology for in vivo gene editing of the microbiome. The alliance between Eligo Bioscience and Kantonsspital St. Gallen will accelerate the development of novel therapies for inflammatory cardiac diseases by combining Kantonsspital St. Gallen’s disease and patient insights and access to key patient samples, data, and animal models, with Eligo’s unique gene-editing platform. Press release. 

Beckman Coulter Life Sciences announced that it acquired ValitaCell. Headquartered in Dublin, Ireland, ValitaCell creates analytical technologies and products for the biopharmaceutical industry to reduce new therapeutics' cost and time to market. Compared to other industry IgG quantification assays, the ValitaTiter product outperforms in speed and ease of use while offering numerous advantages over other long and tedious techniques, like ELISA and HPLC. Press release. 

The University of Texas MD Anderson Cancer Center and Radiopharm Theranostics announced the launch of Radiopharm Ventures, a joint venture created to develop novel radiopharmaceutical therapeutic products for cancer. Radiopharm Ventures brings together MD Anderson’s innovative and proprietary technologies in antigen discovery and molecular imaging with Radiopharm’s expertise in developing radiopharmaceutical products. Radiopharmaceuticals are designed to deliver small doses of radiation to specifically targeted cells for either therapeutic or diagnostic purposes. The joint venture will focus initially on developing at least four medicinal products based on MD Anderson's intellectual property. Press release. 

XuanZhu BioPharm and Chemical.AI jointly announced a collaboration focusing on cancer, metabolism, digestion, and other fields to develop new drugs with proprietary intellectual property rights. The two companies will focus on Chemcal.AI’s product, ChemAIRS, an AI-assisted retrosynthesis platform and chemical synthesis route design system based on AI+ big data. ChemAIRS can learn from in-house laboratory data and provide feasible and cost-effective routes accordingly, a crucial part of the lab digitalization process. In addition, Chemical.AI will release the latest ChemAIRS version to improve the algorithm by delivering more accurate predicted pathways, faster computing time, and editable reaction conditions. Press release. 

Within3 announced the Within3 Insights Management Platform that simplifies the development of tailored market mapping. Dashboards bring prefiltered treatment patterns and locations of healthcare professional influence and identify influential healthcare professionals for engagement. Deploying the platform’s asynchronous communication and enhanced collaborative capabilities alone will see typical efficiencies of an 80% reduction in travel and related expenses, 50% honoraria cost savings, and up to twice the level of engagement and stakeholder participation. The Insights Management Platform also provides access to Within3’s industry-leading analytics and customer success teams, optimizing the value of insights. Press release. 

BioIVT acquired XenoTech, a company specializing in potential drug candidate testing. This transaction demonstrates BioIVT’s continuing commitment to providing its biopharmaceutical customers with a comprehensive portfolio of research models and services. XenoTech’s product lines include best-in-class microsomes and complement BioIVT’s portfolio of hepatocytes and other hepatic products. In addition, XenoTech’s expertise combines BioIVT’s strengths in drug transporter research, B-CLEAR disposition studies, and long-term HEPATOPAC models. Press release. 

Lunaphore and Nucleai announced a collaboration to accelerate the discovery of novel biomarkers and drug targets using the latest spatial imaging and machine learning technologies. The partnership will utilize Lunaphore’s innovative COMET platform for hyperplex staining and imaging with Nucleai’s cutting-edge AI spatial models to derive new insights from tissue biopsies, including novel drug targets, mechanisms of action, and biomarkers to advance the field of precision medicine. The combined solutions will provide laboratories with an integrated end-to-end spatial biology workflow from automated hyperplex sequential immunofluorescence staining and imaging to AI-enabled state-of-the-art image processing and data analytics. As part of the partnership, the companies also plan to develop predictive and prognostic spatial biomarker assays. Press release.  

Integral Molecular was accepted into the U.S. Food & Drug Administration (FDA)’s Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This program was created to expand the drug development tool types listed in the 21st Century Cures legislation. Integral Molecular’s Membrane Proteome Array for antibody specificity and safety profiling intends to address in vitro testing recommendations to assess the unintended binding of monoclonal antibodies that can result in safety and toxicity issues. This technology is designed to be compatible with numerous biotherapeutic modalities, including monoclonal antibodies, bispecifics, and CAR-T therapeutics. The FDA has posted a statement on this letter of intent acceptance to the ISTAND Pilot Program. Press release. 

AcuraBio, formerly Luina Bio, has been acquired by biotech investor Dr. Glenn Haifer and Ampersand Capital Partners, a global healthcare private equity firm. AcuraBio is a globally focused organization bringing innovative therapeutics to market for customers in the biotech, pharmaceutical, and animal health industries while providing recombinant proteins, vaccines, and complex live biotherapeutic products. As part of the rebranding, AcuraBio plans to increase production facility capacity and actively evaluate expansion into new service offerings and technological capabilities. Press release. 

The University of Texas MD Anderson Cancer Center and Virogin Biotech announced a strategic collaboration to accelerate the development of investigational treatments—including oncolytic viruses and immunotherapies—for patients with advanced cancers. The five-year partnership will support the clinical development of Virogin’s therapies with multiple clinical trials in various cancer types to evaluate the safety and clinical benefit of these therapies and to identify prognostic biomarkers of response. Virogin’s viral therapies are engineered to eliminate tumor cells and stimulate innate and adaptive anti-tumor immune responses. Press release. 

Strata Oncology announced integrating discrete genomic data from its StrataNGS next-generation sequencing-based tumor profiling with the University of Wisconsin Carbone Cancer Center and UW Health Epic genomics module. The integration will streamline workflows for physicians by creating an easily-accessible and user-friendly database, allowing them to quickly identify the optimal therapy for each cancer patient. This integration will also enable the institution to expand its research and understanding of cancer. Press release. 

Benchling launched the industry’s first complete set of capabilities for designing, modeling, and studying natural and chemically modified RNA in a single solution. This new RNA solution is the first purpose-built offering to help R&D organizations accelerate the delivery of drug candidates. It features an RNA-aware registry with visualization tools for oligo and mRNA design and is the only tool with support for chemical modification of mRNA sequences. As a result, RNA biologists and chemists can collaborate more efficiently, standardize their work across teams, and develop drug candidates faster. Press release. 

Sharecare announced the evolution of Smart Omix by Sharecare, a proprietary digital clinical research solution that enables real-world data collection and digital biomarker creation through mobile research studies. The web-based Smart Omix platform is a no-code solution that allows researchers to design, launch, manage, and analyze clinical studies through an easily accessible, self-service interface. Studies can be launched through the Smart Omix by Sharecare companion app, where researchers can collect rich real-world data via smartphone. The platform also supports individuals using their devices to self-report and visualize their data, observe health metrics, and inform their care teams about their health status. Press release. 

Polyplus continues to build out its mRNA support portfolio by launching in vivo-jetRNA+ transfection reagent for in vivo mRNA delivery using a preformed liposome. The new in vivo-jetRNA+ transfection reagent is an efficient, stable, and safe delivery system leading to 100% mRNA encapsulation for comparable lipid nanoparticle delivery. Applications include prophylactic vaccines, mRNA therapeutics (cancer therapy, rare disease, etc.), and gene editing. It can target multiple organs via systemic injection routes in various models without limiting the liver. Press release. 

BGI's Thalassemia Gene Detection Kit has recently obtained CE-IVDD approval. The kit is developed based on the combinatorial probe-anchor synthesis sequencing method, a next-generation sequencing technology, to detect α-thalassemia and β-thalassemia mutations qualitatively. Peripheral blood samples will be used for genetic screening of the general population and diagnosis of abnormal hemoglobinopathy. It was estimated that 5-7% of the world's population carries a mutated gene affecting the production or function of the hemoglobin molecule. Over 330,000 affected infants are born annually (83% sickle cell disorders, 17% thalassaemias). Press release. 

The National Institutes of Health launched a $3 million Connecting the Community for Maternal Health Challenge competition to encourage US community-based and advocacy organizations to conduct maternal health research. The challenge is part of the White House Blueprint for Addressing the Maternal Health Crisis. The three-phase challenge is open to non-academic, 501(c)(3) organizations based in the United States, including advocacy, community, and faith-based organizations. Research ideas must align with the goals of the IMPROVE initiative, which aims to reduce preventable causes of maternal death and improve maternal health before, during, and after delivery. Press release. 

Mayo Clinic, Hibiscus BioVentures, and Innoforce launched Mayflower BioVentures. This academic and industry relationship will establish independent cell and gene therapy companies to advance the development of Mayo Clinic technologies through preclinical and early feasibility studies. With a shared interest in identifying treatments and preventing disease, Mayflower aims to develop new cures for severe and complex conditions through cell and gene therapies. The Mayflower management team brings together clinical leaders from Mayo Clinic with operational and investment experience from Hibiscus to move scientific discoveries from the lab bench to patients' bedsides. Press release.