CELL AND GENE THERAPY

Sphere Fluidics Closes a $40 Million Funding Round Led by Sofinnova Partners and Redmile Group

Sphere Fluidics | October 29, 2021

Sphere Fluidics, a company that has developed and is commercialising single cell analysis systems underpinned by its proprietary picodroplet technology, announced today that it has closed a $40 million investment round. The round was led by Sofinnova Partner and Redmile Group investing on equal terms.

Sphere Fluidics will use the funding to enable the expansion of the Company’s international sales activities in key markets and improving its support for customers. Furthermore, it will expand its product research and development programs, including novel applications for its proprietary Cyto-Mine® Single Cell Analysis System.

The Cyto-Mine is an automated cost-effective platform which integrates single cell screening, sorting, dispensing, imaging, and clone verification and has been purchased by an international customer base including global pharmaceutical companies, biotech, CDMOs, and leading research institutions. The platform can process millions of samples per day, assessing and isolating rare or valuable cell variants or biological products, to simplify and improve throughput across antibody discovery, cell line development and single cell diagnostics. The funds raised will support ongoing commercialization, broadening the technology’s adoption into new, innovative research areas such as cell therapy, synthetic biology and genome editing, in addition to ongoing enhancements of the platform’s capabilities and performance. In conjunction with the financing, Sofinnova’s Tom Burt and Redmile Group’s Rob Faulkner will join the Board.

This is a transformational investment from two of the most respected specialist investment funds in the industry and a recognition of the untapped potential of the pioneering product and market development carried out by the Company to date.

Andrew Mackintosh, Chairman of Sphere Fluidics 
 

Frank Craig, CEO, Sphere Fluidics, commented: “This funding round is not only testament to the potential of Sphere Fluidics’ single cell analysis technology, but also to the expertise of our team. The investment will underpin our growth strategy, enabling us to expand both our product range and our support to new and existing customers, globally.

Tom Burt, Partner, Sofinnova Partners, commented: “We remain impressed by Cyto-Mine’s high-throughput, ease-of-use and accessible cost. In the growing markets of monoclonal antibody discovery, cell line development and cell therapy, we see a significant need for such an affordable and reliable single cell analysis system as Cyto-Mine, capable of performing multiple assays on tens of millions of individual cells per run.”

Spotlight

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MEDICAL

Pancreatic Cancer Cells Harness Normal Tissue Turnover to Build Protective Barriers

NYU Langone Health | April 05, 2022

In the presence of pancreatic tumors, certain immune cells break down structural proteins into molecules that trigger the building of dense tissue, a known barrier to therapy, a new study finds. Led by researchers from NYU Grossman School of Medicine, the study revolves around the dense protein meshwork that supports organs and helps to rebuild damaged tissue. Collagen protein fibers, the major component of the mesh, are continually broken down and replaced to maintain tensile strength, and as part of the wound healing process. Past studies have shown that immune cells called macrophages contribute to a process called desmoplasia, which is caused by the abnormal turnover and excessive deposition of collagen that insulates pancreatic cancers. In this environment, macrophages are also known to engulf and break down collagen through the action of a protein called the mannose receptor (MRC1). Publishing online April 4 in the Proceedings of the National Academies of Sciences, the current study found that the degraded collagen increased the amount of arginine, an amino acid that is used by the enzyme nitric oxide synthase (iNOS) to produce compounds called reactive nitrogen species (RNS). This, in turn, caused neighboring, supportive stellate cells to build collagen-based meshes around tumors, say the study authors. Pancreatic cancer is the third leading cause of cancer-related deaths in the United States, with a five-year survival rate of 10%. Pancreatic cancer remains difficult to treat in large part due to the extensive network of fibrotic tissue around tumors. This network not only blocks access by therapies, but also promotes aggressive growth. For the current study, experiments showed that macrophages grown in dishes of nutrients (cultures), and converted into their cancer-tolerant setting (M2), broke down far more collagen than macrophages that attack cancer cells (M1). Further, the team confirmed with a series of tests that M2 macrophages have higher levels of enzymes that generate RNS, such as iNOS. To confirm these findings in live mice, the team implanted stellate cells that were either "pre-fed" with collage, or maintained in an unfed state, into the flanks of the study animals along with pancreatic cancer cells. The team observed a 100 percent increase in the density of intra-tumoral collagen fibers in tumors derived from cancer cells co-implanted with stellate cells pre-treated with collagen. Importantly, the study showed for the first time that macrophages near pancreatic cancer cells, not only take in and break down more collagen as part of scavenging for proteins that feed abnormal growth, but also are changed by the scavenging, such that their energy processing system (metabolism) is rewired and signals for fibrotic buildup. Our team uncovered a mechanism that connects collagen turnover to the building of a treatment-resistant environment around pancreatic tumors, As this dense environment is a major reason why pancreatic cancer is so deadly, a better understanding of links between protein scavenging and the building of protective barriers will be needed to improve the treatment of this devastating malignancy." Bar-Sagi. Kimmelman has financial interests in Vescor Therapeutics, and is listed on patents pertaining to KRAS-regulated metabolic pathways, redox control pathways in pancreatic cancer, targeting GOT1 as a therapeutic approach, and the autophagy control of iron metabolism. Kimmelman is on the scientific advisory board for Rafael/Cornerstone Pharmaceuticals, and consults for Deciphera and Abbvie. Bar-Sagi is on the Scientific Advisory Board of Rafael/Cornerstone Pharmaceuticals and Samumed LLC, and is also on the board of the Pancreatic Cancer Action Network. These relationships are being managed in keeping with the policies of NYU Langone Health.

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Illumina Introduces New Pan-Cancer Companion Diagnostic to Match Patients with Rare Genetic Mutations to Targeted Therapy

Illumina | May 27, 2022

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight™ Oncology (TSO) Comprehensive (EU) test. This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. The CDx pan-cancer indication will allow identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2 or NTRK3, and may benefit from targeted therapy with Bayer's VITRAKVI® (larotrectinib), in accordance with the approved therapeutic labeling. TSO Comprehensive (EU) is a comprehensive genomic profiling (CGP) test which combines less prevalent biomarkers with more prevalent ones in the same test, using a single biopsy specimen. This helps maximize the chances of identifying an actionable alteration so that patients can be treated with a targeted therapy or enrolled into a clinical trial based on their unique tumor genomic profile. The addition of this first CDx claim specific to NTRK gene fusions, a rare but highly actionable biomarker, helps provide patients harboring this genetic alteration with an opportunity to benefit from larotrectinib, a genomically matched treatment. This CDx claim, developed in partnership with Bayer, is the first of a series under development, building upon Illumina's broad portfolio of oncology partnerships with industry leaders to advance cancer diagnostics and precision medicine, We continue to focus on unlocking the potential of new biomarkers to identify those most likely to benefit from precision medicines so that no patient is left behind—we don't want anyone to miss the opportunity to have their biomarker detected and gain access to a potentially life-saving therapy." Paula Dowdy, Senior Vice President and General Manager of Illumina for Europe, the Middle East, and Africa. Across most solid cancer tumor types, NTRK gene fusions can have a rare prevalence of 0.1-3% and can be challenging to detect as these genes fuse with many different partners, many of them previously unknown. Most CDx tests are specific to one type of cancer, but the NTRK claim is pan-cancer, enabling TSO Comprehensive (EU) to target multiple solid tumor types and a broad range of known and novel gene fusion partners across all three NTRK genes. This helps maximize the chances of finding actionable information from each patient's biopsy, to inform treatment with larotrectinib. Since it launched four years ago, VITRAKVI has demonstrated high response rates and highly durable responses in adults and children with TRK fusion cancer, The CE marking of Illumina's TSO Comprehensive (EU) assay inclusive of NTRK gene fusion detection for VITRAKVI is an important advance in enabling precision oncology for patients in Europe. Assays that enable precision oncology through comprehensive genomic testing are crucial for informing optimal treatment plans and help to ensure the best possible outcomes for cancer patients. We look forward to continuing to collaborate with Illumina to ensure that more patients are evaluated comprehensively inclusive of NTRK gene fusions." Christine Roth, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Bayer's Oncology Strategic Business Unit. The performance of TSO Comprehensive (EU) with NTRK fu­sions was assessed by analytical and clinical validation studies. 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Professor Richard Kennedy, Global VP of Biomarker Development & Medical Director, Almac Diagnostic Services. Illumina has a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive (EU) following appropriate regulatory approvals. These CDx claims will help unlock groundbreaking targeted therapies and immunotherapies to make a difference in the lives of cancer patients. As Illumina continues to expand its broad portfolio of oncology partnerships with industry leaders, the company aims to advance cancer diagnostics and precision medicine. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. About Illumina Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.

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INDUSTRIAL IMPACT

Element Biosciences Becomes the Newest Member of 10x Genomics’ Compatible Partner Program (CPP) Across Multiple Single Cell Applications

Element Biosciences, Inc. | March 01, 2022

Element Biosciences, Inc., developer of a new and disruptive DNA sequencing platform, announced a partnership with 10x Genomics, a life sciences leader focused on mastering biology to advance human health, that demonstrates the seamless integration of the Element AVITI™ System and 10x Genomics’ single cell technologies. 10x Genomics’ Chromium Single Cell and Visium Spatial platforms enable researchers to examine biology at true resolution, combining hardware, chemistry, and software to give single cell and spatial views of biology at a scale and efficiency that is unprecedented. The combination of the AVITI System’s performance, cost, and flexibility with 10x Genomics’ leading single cell assays provides customers more access and choice for their biological research. “We are excited about the partnership we’ve established with 10x Genomics and our new status as a validated CPP member. As one of the most exciting new areas in NGS, we believe this will help bring 10x Genomics’ and Element Biosciences’ customers together for our combined performance and cost advantages in single cell and spatial analysis.” Shawn Levy, Senior Vice President of Applications and Scientific Affairs, Element Biosciences “At 10x Genomics, part of our commitment to supporting our customers with single cell and spatial analysis is ensuring they have access to advanced sequencing solutions through rigorous validation,” said Brad Crutchfield, Chief Commercial Officer, 10x Genomics. “We are excited to certify Element through our Compatible Partner Program and provide our customers with more ways to adopt single cell and spatial analysis to enhance their research and fuel scientific discoveries.” About 10x Genomics 10x Genomics is a life science technology company building products to interrogate, understand and master biology to advance human health. The company's integrated solutions include instruments, consumables and software for analyzing biological systems at a resolution and scale that matches the complexity of biology. 10x Genomics products have been adopted by researchers around the world including in all of the top 100 global research institutions as ranked by Nature in 2020 based on publications and all of the top 20 global pharmaceutical companies by 2020 research and development spend, and have been cited in over 3,300 research papers on discoveries ranging from oncology to immunology and neuroscience. The company's patent portfolio comprises more than 1,300 issued patents and patent applications. About Element Biosciences, Inc. Element Biosciences is a multi-disciplinary life science company currently focused on developing disruptive DNA sequencing technology for research and diagnostic markets. Through innovating every fundamental element of a sequencing system, Element will empower customers with affordable high-quality data and an improved user experience, which in turn will accelerate scientific discoveries and broaden the use of genomic medicine.

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MEDICAL

Dover To Acquire Manufacturer Of Flow-Measurement Devices For Biopharma And Semiconductor Production Applications

Dover | May 11, 2022

Dover (NYSE: DOV) announced today that it has entered into a definitive agreement to acquire Malema Engineering Corporation ("Malema"), a designer and manufacturer of high-precision, mission-critical flow-measurement and control instruments serving customers in the biopharmaceutical, semiconductor, and industrial sectors. Malema will become part of the PSG business unit within Dover's Pumps & Process Solutions segment. Malema's products will expand Dover's biopharma single-use production offering, which already includes Quattroflow pumps, CPC connectors, and em-tec flowmeters. Based in Boca Raton, FL, and with facilities in San Jose, CA, Singapore, South Korea, and India, Malema expects to generate approximately $40-45 million in revenue during the full year 2022 and has a robust growth outlook. Over the past four decades, Malema has cultivated a loyal base of blue-chip customers, OEMs, and end-users with substantial aftermarket and recurring revenue streams. Malema's first-of-its-kind single-use flow sensor using Coriolis technology offers superior flow-measurement performance and accuracy versus alternative technologies, reducing the potential for measurement error and eliminating the need for calibration in time-sensitive and contamination-intolerant environments. We see a tremendous long-term growth opportunity in the bioprocessing industry driven by a strong and growing pipeline of effective novel biologic drugs, biosimilars, protein therapies, non-COVID mRNA vaccines, as well as budding cell & gene therapies. Additionally, the growing adoption of more efficient single-use production processes supports a robust outlook for our offerings of single-use components to end-customers. We believe that pairing Malema's technology with our existing portfolio of single-use pumps for biopharma processing will greatly enhance the accuracy and value proposition of our solutions to our customers. PSG's President, Karl Buscher. We are methodically building out our biopharma platform through proactive capacity additions, new product development, and opportunistic acquisitions of highly-attractive niche component technologies, Malema represents a strategic and highly-complementary flow-control and sensing technology and further strengthens our sensor portfolio with new proprietary technology. In addition to attractive biopharma applications, we expect strong growth in the semiconductor space on the capacity expansion and re-shoring tailwinds." Richard J. Tobin, President and Chief Executive Officer of Dover. The purchase price is comprised of $225 million in cash at closing, subject to customary purchase price adjustments, and up to $50 million in contingent consideration dependent on the achievement of certain financial objectives over a two-year period. The transaction is expected to close in the second quarter and is subject to the satisfaction of customary closing conditions, including applicable regulatory approvals. About Dover: Dover is a diversified global manufacturer and solutions provider with annual revenue of approximately $8 billion. We deliver innovative equipment and components, consumable supplies, aftermarket parts, software and digital solutions, and support services through five operating segments: Engineered Products, Clean Energy & Fueling, Imaging & Identification, Pumps & Process Solutions, and Climate & Sustainability Technologies. Dover combines global scale with operational agility to lead the markets we serve. Recognized for our entrepreneurial approach for over 65 years, our team of over 25,000 employees takes an ownership mindset, collaborating with customers to redefine what's possible. Headquartered in Downers Grove, Illinois, Dover trades on the New York Stock Exchange under "DOV." About PSG: PSG is a global pump solution expert and leading manufacturer of pumps, systems, and related flow-control technology for the safe and efficient transfer of critical and valuable fluids and materials. Headquartered in Oakbrook Terrace, IL, PSG is comprised of several world-class brands, including Abaque®, All-Flo®, Almatec®, Blackmer®, Ebsray®, em-tec®, Griswold®, Hydro Systems™, Mouvex®, Neptune™, Quantex™, Quattroflow®, and Wilden®. PSG products are manufactured in three continents – North America, Europe, and Asia – in state-of-the-art facilities that practice lean manufacturing and are ISO-certified. PSG is part of the Pumps & Process Solutions segment of Dover Corporation.

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Spotlight

In this video, see how the innovative and flexible design features of the SpectraDrop™ Micro-volume Microplate enables accelerated sample preparation time and increased laboratory productivity of DNA, RNA, and protein samples as low as 2 μL. The SpectraDrop™ Micro-Volume Microplate assures uniform and reproducible analysis and integrates seamlessly with the StakMax® Microplate Handling System for greater research capacity.

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