On June 5, 2024 Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the "Company"), a leader in PCR-based DNA technologies, reported that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 18/302,247, entitled "Compositions and Methods for RNA Synthesis (Press release, Applied DNA Sciences, JUN 5, 2024, https://adnas.com/apdn-us-patent-covering-fundamental-aspect-of-its-linea-ivt-platform/ [SID1234644115])."

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The resulting patent will cover the composition of the Company’s chemically modified RNA polymerase enzyme branded Linea RNAP, with expected patent protection into 2041. Linea RNAP is a core component of the Company’s Linea IVT platform that empowers mRNA manufacturers to produce better mRNA faster via a simplified mRNA production workflow with reduced or eliminated double-stranded RNA (dsRNA) contamination. Applied DNA acquired the technology underlying the Linea RNAP via its acquisition of Spindle Bio, Inc. in July 2023.

"This patent allowance, coupled with the upcoming initiation of our GMP capabilities, demonstrates our commitment to supplying GMP-grade critical starting materials for the manufacture of mRNA," said Dr. James A. Hayward, president and CEO of Applied DNA. "With approximately 450 mRNA therapies under development globally, and with a large majority of these therapies in the preclinical stage, we believe we can build significant market share via our differentiated Linea IVT platform and its numerous advantages over conventional mRNA production workflows."

About the Linea DNA and Linea IVT Platforms
The Linea DNA platform is an entirely cell-free DNA production platform founded on Applied DNA’s long-standing expertise in the large-scale enzymatic production of DNA. Capable of producing DNA in quantities ranging from milligrams to grams, the Linea DNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the Linea DNA platform is free of the adventitious DNA sequences found in other sources of DNA, is rapidly scalable, and provides for simple chemical modification of DNA constructs.

The Linea IVT platform combines DNA IVT templates manufacturing via the Linea DNA platform with a proprietary Linea RNAP to enable mRNA and sa-mRNA manufacturers to produce what Applied DNA believes to be better mRNA faster, with advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of double-stranded DNA (dsRNA) contamination; and 3) simplified mRNA production workflows.

On June 5, 2024 Nutcracker Therapeutics, Inc., a biotechnology company dedicated to developing transformative RNA therapies through its proprietary technology platform, reported a poster on NTX-472, its new preclinical drug candidate for B cell lymphoma, at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Nutcracker Therapeutics, JUN 5, 2024, View Source [SID1234644153]).

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Monoclonal antibody immunotherapies can provide an effective treatment for B cell lymphoma. However, by only targeting a single tumor antigen, such as CD19 or CD20, these treatments can place selective pressures on tumors, with cancer cells often down-regulating the expression of those specific antigens to become cold tumors, invisible to the immune system. Multispecific antibodies may be able to mitigate these effects with improved specificity to several antigens at once.

Nutcracker Therapeutics’ scientists engineered a panel of molecules simultaneously targeting CD20, CD19 and CD47 to compare them to existing monoclonal antibody immunotherapies for B cell lymphoma, including rituximab (monospecific anti-CD20) and tafasitamab (monospecific anti-CD19). Of these molecules, the team identified one which had improved tumor killing and B cell depletion in vitro, which became the NTX-472 program. Using its CodonCrackerTM software and the Nutcracker Manufacturing Unit, Nutcracker Therapeutics’ scientists then further studied NTX-472 in vivo, which showed rapid depletion of B cells with no detectable binding to red blood cells in cynomolgus monkeys.

"We’re proud to be one of the first RNA therapeutics companies to engineer a multispecific antibody," said Chief Scientific Officer Samuel Deutsch, Ph.D. "The data on NTX-472 is a testament to the capabilities of Nutcracker Therapeutics’ platform and how it enables our scientists to engineer complex molecules by the dozens, and ultimately pinpoint the best option for a viable drug candidate. We plan to further develop NTX-472 as a trispecific immunotherapy with a differentiated therapeutic and safety profile."

Previously Nutcracker Therapeutics presented preclinical data on NTX-471, an mRNA therapeutic candidate that is being developed to target CD47. Unlike the multispecific approach employed by NTX-472, NTX-471 encodes for a multivalent (octavalent) antibody to achieve high specificity via avidity for target cancer cells. During SITC (Free SITC Whitepaper) 2023, Nutcracker Therapeutics demonstrated similar cytotoxic activity of NTX-471 to existing anti-CD47 molecules, but with little-to-no binding to red blood cells. More information on NTX-471 can be found in this press release.

On June 5, 2024 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the launch of its new digital PCR (dPCR) Custom Assay Design Tool for copy number variation (CNV) analysis for use on its digital PCR platform QIAcuity and several other enhancements in its GeneGlobe Design and Analysis Hub, a comprehensive research platform that integrates pre-designed assays with a database of more than 10,000 biological entities including genes, miRNAs, and pathways (Press release, Qiagen, JUN 5, 2024, View Source [SID1234644137]). The new advancements aim to support customers with a wide range of assay customization options, from simple to complex and validated multiplex assays, while further improving the user experience.

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Genetic research is moving fast, and new target genes are rapidly evolving that are not covered by standard or pre-designed assays. To keep pace and close the need gap, the new digital PCR Custom Assay Design Tool has been developed as an interface on the GeneGlobe platform. It enables customers to design and order assays for use on QIAGEN’s digital PCR platform QIAcuity outside of QIAGEN’s comprehensive catalog of over 200 wet-lab validated assays for copy number variations profiling in translational cancer research. Copy number variations (CNVs) are a type of genetic variation where specific segments of the DNA are copied more or fewer times than normal in the genome, potentially affecting susceptibility to diseases and response to treatment.

"As certain copy number variations are associated with cancer, studying them can improve the understanding of how these variations can affect health and the responsiveness to treatments. It is therefore crucial for advancing precision medicine," explained Nitin Sood, Senior Vice President, Head of the Life Science Business Area at QIAGEN. "Our new digital PCR Custom Assay Design Tool in GeneGlobe provides researchers with an innovative and user-friendly tool to design customized assays for QIAcuity tailored to their specific needs, streamlining research and accelerating scientific discovery."

Additional enhancements of GeneGlobe have been launched recently or are currently in development. These include more user-friendly design pages that simplify product selection and a new tool for creating, saving and editing target gene lists, supporting researchers in creating their own panels, even collaboratively. Thanks to a software update, pathway maps from QIAGEN’s Ingenuity Pathway Analysis are now rendered faster. QIAGEN is working on improving the searchability of pathways and pathway relationships and plans to expand the interactivity of pathway diagrams, facilitating the import of selected genes into the GeneGlobe Custom Panel Design tools.

QIAGEN is building a strong pipeline for customization and plans to expand the dPCR Custom Assay Design Tool capabilities to microbial and somatic mutation assays later in 2024. When customers seek higher-order multiplexing or more complex assays, QIAGEN Genomic Services offers expert custom assay design support and assays are made available in GeneGlobe.

About GeneGlobe

QIAGEN’s proprietary research platform GeneGlobe provides researchers with easy access to an extensive range of molecular biology tools, pre-designed assays and customizable design services. The platform streamlines the process of identifying, selecting, and customizing assays, panels and pathway maps tailored to specific research needs while continuously updating its content to ensure researchers stay up to date with the latest advancements in their respective fields.

Learn more about QIAGEN’s GeneGlobe Design and Analysis Hub and the latest advancements at View Source

About QIAcuity

QIAGEN’s digital PCR platform QIAcuity uses nanoplates to disperse a sample over thousands of tiny partitions and then reads the reaction in each one simultaneously to quantify even the faintest signals from DNA and RNA. This enables specific, sensitive, and rapid detection of small copy number changes up to 5-plex.

The highly versatile QIAcuity systems integrate partitioning, thermocycling, and imaging into one workflow, cutting processing times to only two hours from six and are available in one, four and eight-plate versions. While the one-plate version processes up to 384 samples in an eight-hour shift, the eight-plate version processes up to 1,248 samples in the same time period. At the end of 2023, more than 2,000 cumulative instrument placements had been made.

On June 5, 2024 Nucleus RadioPharma, the world’s first fully integrated development, manufacturing, and supply chain organization for radiopharmaceuticals, reported the closing of a Series A extension round with new investor AstraZeneca (LSE/STO/Nasdaq: AZN) (Press release, Nucleus RadioPharma, JUN 5, 2024, View Source [SID1234644154]). AstraZeneca joins existing investors from GE Healthcare, Mayo Clinic, Eclipse Ventures, Fox Chase Cancer Center, Echo Global Granger Management Mercy Health, and the University of Missouri as Nucleus expands development, supply, and commercial manufacturing capabilities to make targeted radiotherapies and theranostics more accessible to patients globally. Concurrent with the financing, Tyrell Rivers, PhD, Executive Director of Corporate Ventures at AstraZeneca, was named to the Board of Directors.

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Theranostics combines diagnostics and therapeutics for personalized cancer treatment using radiotracers that selectively bind to specific cancer cells. A low-dose radiotracer helps visualize tumors, guiding targeted therapy, while a higher-dose radiotracer delivers potent radiation to kill cancer cells with minimal damage to healthy tissues. This precision approach reduces side effects compared to traditional treatments and shows promise in treating metastatic cancers like neuroendocrine tumors, prostate cancer, and lymphoma.

"Theranostic radiopharmaceuticals represent a new hope for millions of people with limited treatment alternatives," said Nucleus RadioPharma CEO Charles S. Conroy. "These drugs, designed for precise targeting, are demonstrating remarkable effectiveness while upholding an exceptional safety record. The funding expands the accessibility and impact of these life-saving treatments, paving the way for large-scale production and instilling optimism in those with limited options."

Dr. Tyrell Rivers is Executive Director of Corporate Ventures at AstraZeneca, where he is responsible for creating and executing innovative, value-enhancing business strategies. Prior to assuming this role in 2014, he worked at MedImmune Ventures, specializing in life science investing. Earlier in his career, Dr. Rivers held various positions at Merck & Co., where he led technical support for commercial vaccines and directed global business initiatives for accessing key technologies for research and development. He is a Board member of ADC Therapeutics, Cellectis, Cerapedics, and Quell Therapeutics. Dr. Rivers holds his B.S. in Chemical Engineering from the Massachusetts Institute of Technology, a Ph.D. in Chemical Engineering from the University of Texas at Austin, and an M.B.A. from the New York University Stern School of Business.

With more than 20 years of supporting business initiatives in the investment and life science sectors, Dr. Rivers brings extensive experience in aiding company growth, directing corporate strategy, and establishing financially sound businesses.

Conroy added: "The support of AstraZeneca and Tyrell on the board has ignited our excitement as this funding will facilitate the expansion of our development, supply, and commercial manufacturing capabilities, ultimately enhancing global accessibility to targeted radiotherapies and theranostics for patients worldwide."

Radiopharmaceuticals offer precise cancer treatment, but the intricate supply chain, akin to managing a rapidly melting ice cube, demands precise timing due to the perishable nature of radioactive materials, consequently restricting patient access. Nucleus RadioPharma is at the forefront of addressing these challenges by enhancing manufacturing and supply chain efficiency, to broaden the accessibility of radiopharmaceuticals as a promising frontier in oncology.

On June 5, 2024 ArriVent BioPharma, Inc., ("ArriVent") a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported that the Company has entered into a collaboration agreement with Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Alphamab"), a wholly owned subsidiary of Alphamab Oncology, to discover, develop and commercialize novel antibody drug conjugates ("ADCs") for the treatment of cancers (Press release, ArriVent Biopharma, JUN 5, 2024, View Source [SID1234644117]).

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"This exciting collaboration strengthens and complements our pipeline with the potential to add multiple innovative new ADC programs and exemplifies our strategic model of identifying and developing potential first-and best-in-class product candidates from across the globe," said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "We look forward to complementing the research and discovery capabilities of Alphamab with our global drug development and commercialization expertise to address the unmet needs of cancer patients."

"ArriVent shares our passion for developing differentiated, clinically valuable, and globally competitive new drugs," said Ting Xu, Ph.D., Founder, Chairman, and CEO of Alphamab Oncology. "This collaboration, based on Alphamab’s proprietary and clinically validated glycan-conjugation platform, combined with ArriVent’s deep knowledge in oncology and extensive development experience, provides us with the opportunity to work together to deliver important new oncology therapeutics to patients."

Under the agreement, both companies will leverage Alphamab’s proprietary linker-payload platform and glycan-conjugation technology to identify novel ADCs for oncology indications. The agreement gives ArriVent exclusive rights to develop and commercialize ADCs globally, except greater China, which includes outside of mainland China, Hong Kong, Macau and Taiwan where Alphamab retains the right to develop and commercialize the ADCs.

The terms of the agreement include combined upfront and potential milestone payments to Alphamab of up to $615.5 million in aggregate for the potential programs, based on the achievement of certain regulatory, development, and sales milestones. In addition, Alphamab is entitled to receive tiered sales royalties from ArriVent for each ADC product.