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Navigate BioPharma Services, Inc. launches new multiplex digital PCR assay for comprehensive quantification of up to 5 different CAR-T transgenes

PRNewswire | June 02, 2023 | Read time : 05:00 min

Navigate BioPharma Services

During this year's AAPS National biotechnology conference, Navigate BioPharma Services, Inc., a Novartis subsidiary and a leading provider of innovative biomarker solutions for drug development, announced the launch of its new multiplex digital PCR assays for comprehensive quantification of multiple chimeric antigen receptor (CAR) T cells, a type of cancer immunotherapy that involves genetically modifying T cells to recognize and destroy certain cancers. These assays are based on the Qiagen QIAcuity digital PCR System, which offers a powerful yet easy-to-use digital PCR experience through its unique nanoplate system.

The new multiplex digital PCR assay enables simultaneous measurement of the number, function and persistence of CAR-T cells in clinical blood and bone marrow samples, without the need for a standard curve. It can detect as low as 0.01% of CAR-T cells among normal T cells, with a turnaround time of less than two hours. These assays can measure up to five different CAR-T cell markers in a single reaction, using specific probes for different CAR targets, to quantitate multiple CAR-domains, or combinations of commonly used therapeutic targets for CAR-T therapies. The assay can help clinicians monitor response or safety events during clinical trials to enable the development of new therapies.

"CAR-T therapy is a promising and innovative approach to treat cancer, but it requires accurate and reliable quantification of CAR-T cells for successful drug development," said Dr. Nathan Riccitelli, Associate Director of Innovative Technologies at Navigate BioPharma Services, Inc. "Our new proprietary multiplex digital PCR assay provides a comprehensive and robust solution for measuring CAR-T cells in clinical samples with high sensitivity, specificity and reproducibility."

Navigate BioPharma Services, Inc. has developed this assay for use in sponsors-led clinical trials. If interested, contact them about how this assay can be used in upcoming clinical trial studies.

Navigate Biopharma Services, Inc.

Navigate BioPharma Services, Inc., an independently operating subsidiary within the Novartis group of companies, is a leading provider of innovative biomarker and specialty bioanalytic solutions for clinical development. Over the past decade, Navigate BioPharma has built and developed its exclusive library of assays, methodologies, and biomarker solutions. Their extensive expertise offers unique, accurate, reliable, and cost-effective solutions for its customers and partners.

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prnewswire | September 01, 2023

Exacta Bioscience, a biotech company that harnesses the power of nature and its microorganisms for crop protection, and Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, today announced that Exacta is leveraging Ginkgo's end-to-end agricultural R&D services to run a fermentation optimization and scale-up program to enhance one of its crop protection products, FitoRoot®, paving the way for large-scale commercialization. FitoRoot, a biostimulant product composed of three Bacillus strains, is designed to help crops better absorb water, nutrients and strengthen their defenses against abiotic stress. This can lead to overall better crop health, improved yield and increased resistance to stress conditions such as drought or extreme temperatures. Through this partnership, Exacta will use Ginkgo's fermentation and formulation optimization services to reduce the cost of goods to make its FitoRoot technology more competitive. Accordingly, FitoRoot is currently marketed in Chile and is expected to expand to other Latin American markets, with a planned launch in 2023 by Adama Chile, who is driving biological adoption in the region. Adama Ltd is one of the world's leading crop protection companies. "We chose Ginkgo because their deep expertise in agricultural product development and optimization positions us to make one of our key crop protection products, FitoRoot, more accessible," said José Bustos, CEO at Exacta Bioscience. "We're proud of the progress Exacta has made, and this partnership marks a vital step toward accelerating our efforts to assure the quality and availability of one of our products and creating a stable and safer ecosystem." "Exacta Bioscience's emphasis on microbial solutions in crop health brings more sustainable and differentiated solutions to farmers throughout the Americas," said Magalie Guilhabert, Head of Ag Biologicals, Ginkgo Bioworks. "Together, we can continue to push the boundaries of agricultural innovation through biotechnological solutions that promote a more sustainable future for our food systems." Ginkgo's end-to-end agricultural services can help R&D teams develop more effective biological products across a variety of applications. Find out more. About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect, and respond to a wide variety of biological threats. About Exacta Bioscience Exacta Bioscience is a pioneering biotech company that uses microorganisms to create innovative bioproducts for agriculture. Their nature-inspired solutions support a future without chemical pesticides and antibiotics. With extensive knowledge of microorganisms and their effects on crops and soil, Exacta tackles modern farming challenges. Their expertise is in formulating microorganism mixtures, providing a wide range of bioproducts, specifically for crop protection. They are dedicated to delivering effective, stable, and safe crop protection and soil-enhancing products. They invite everyone to join in advancing sustainable practices for a healthier future.

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Evaxion presents promising results on EVX-B1, an AI-designed vaccine against Staphylococcus aureus

Globenewswire | August 01, 2023

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Globenewswire | August 16, 2023

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Exacta Bioscience and Ginkgo Bioworks Announce Partnership to Optimize Exacta's Crop Protection Product

prnewswire | September 01, 2023

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Evaxion presents promising results on EVX-B1, an AI-designed vaccine against Staphylococcus aureus

Globenewswire | August 01, 2023

Evaxion Biotech A/S a clinical-stage biotechnology company specializing in the discovery and development of AI-powered immunotherapies, presents promising results of EVX-B1 at the Staphylococcal Diseases Gordon Research Conference in New Hampshire, USA. “I am excited to present the impressive results of EVX-B1 at the Gordon Research Conference. The demonstration of full disease protection and complete bacterial clearance marks a significant advancement in the fight against this widespread and often antibiotic-resistant pathogen. With the many previous unsuccessful attempts to develop an effective S. aureus vaccine, EVX-B1 instills renewed hope in the battle against the bacteria,” said Steven Projan, PhD, Scientific Advisor to Evaxion and poster presenter. EVX-B1 has been designed using Evaxion’s proprietary AI technology for vaccine target discovery. The AI technology has enabled the identification of novel S. aureus antigens, paving the way for the development of a vaccine with potential for broad protection against clinically relevant strains. EVX-B1 induces strong immune responses, both cellular and humoral, that translate to a high level of protection in preclinical models for skin infection and sepsis. Importantly, EVX-B1 prevents both the development of disease and effectively eliminates the infection itself. In a 12-month immunogenicity study, EVX-B1 induced high and long-lasting antibody titers. A booster immunization substantially increased the immune response, protecting against S. aureus infection. The EVX-B1 vaccine candidate is ready for non-clinical development, CMC, and subsequent clinical testing. “The remarkable performance of EVX-B1 in state-of-the-art animal models is a testament to our innovative approach and the power of computational target discovery. We are excited about the potential impact this vaccine could have in preventing S. aureus infections, which have long posed significant challenges to global health and where antibiotic resistance is developing fast,” said Birgitte Rønø, Chief Scientific Officer at Evaxion. The poster entitled “EVX-B1: An AI-designed vaccine against Staphylococcus aureus, demonstrating full disease protection and complete bacterial clearance” is presented at the Staphylococcal Diseases Gordon Research Conference in New Hampshire, USA, taking place from 30th of July to 4th of August this year (https://www.grc.org/staphylococcal-diseases-conference/2023/). About S. aureus infections The S. aureus bacteria are usually harmless but can cause serious infections, leading to sepsis or death. S. aureus is causing severe hospital-acquired infections. Antibiotic-resistant S. aureus, particularly Methicillin-resistant S. aureus (MSRA) infections, are of critical concern and remain a prevention priority. According to the CDC, nearly 120,000 bloodstream infections with 20,000 associated deaths were reported in 2019 (https://www.cdc.gov/mmwr/volumes/68/wr/mm6809e1.htm). The estimated annual economic impact of MRSA on US hospitals alone is $3.2-4.2 billion. About EDEN Our proprietary EDEN platform rapidly identifies novel, highly protective antigens for the use in pathogen-specific prophylactic vaccines against bacteria. Within EDEN, our proprietary algorithms allow us to predict and identify those antigens we believe will trigger a robust, protective immune response against almost any bacterial infectious disease. The input to the AI models is a feature transformation of the protein data set, in which several global and sequence-resolved properties are extracted. These structural and functional features have been selected for their relevance in protein chemistry, immunology, protein structure and ability to guide the network in discriminating protective versus non-protective antigens. About Evaxion   Evaxion Biotech A/S is a pioneering company developing AI-powered immunotherapies. Evaxion’s proprietary and scalable AI technologies decode the human immune system to discover and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Evaxion has a broad pipeline of candidates, including three personalized cancer immunotherapies. It is located in Hørsholm, Denmark, listed on the Nasdaq New York stock exchange.

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Graf Acquisition Corp. IV and NKGen Biotech, Inc. Announce Effectiveness of Form S-4 for Proposed Business Combination

Globenewswire | August 16, 2023

Graf Acquisition Corp. IV and NKGen Biotech, Inc. on August 14, 2023 announced that Graf’s registration statement on Form S-4 relating to the previously announced business combination (the “Business Combination”) with NKGen, has been declared effective by the U.S. Securities and Exchange Commission (the “SEC”). Graf also commenced mailing the definitive proxy statement/prospectus on August 14, 2023, which was included in the Registration Statement, relating to the special meeting of its stockholders to be held in connection with the Business Combination (the “Special Meeting”) to stockholders of record as of the close of business on August 7, 2023 (the “Record Date”). The Special Meeting will be held virtually at 10:00 a.m., New York City time, on August 30, 2023 at https://www.cstproxy.com/grafiv/​sm2023. Graf’s stockholders of record as of the Record Date are entitled to vote at the Special Meeting. In connection with the Special Meeting, Graf’s stockholders who wish to exercise their redemption rights must do so no later than 5:00 p.m., New York City time, on August 28, 2023 by following the procedures specified in the definitive proxy statement/prospectus for the Special Meeting. In addition, Graf announced on August 14, 2023 that it intends to voluntarily transfer the listing of its shares of common stock and public warrants to The Nasdaq Stock Market LLC (“Nasdaq”) from the New York Stock Exchange (the “NYSE”) following the completion of the Business Combination. In connection with the closing of the Business Combination, Graf will change its name to “NKGen Biotech, Inc.” and NKGen will change its name to “NKGen Operating Biotech, Inc.” The common stock and public warrants of the post-combination company are expected to commence trading on Nasdaq the day after the closing of the Business Combination under the symbols “NKGN” and “NKGNW,” respectively. Graf’s units, common stock and public warrants will continue to trade on the NYSE until the transfer is complete. The decision to list on Nasdaq was made in consideration of the Business Combination and enables the post-combination company to be listed alongside the other innovative biotechnology companies that are also listed on Nasdaq. At the closing of the Business Combination, Graf will delist its units, shares of common stock and public warrants from the NYSE. The Nasdaq listing and NYSE delisting are subject to the closing of the Business Combination and fulfillment of all Nasdaq listing requirements and NYSE delisting procedures. About Graf Acquisition Corp. IV Graf is a blank-check company incorporated as a Delaware corporation and formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with one or more businesses. About NKGen Biotech, Inc. NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapies. NKGen is headquartered in Santa Ana, California, USA.

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