On January 24, 2023 As part of a global, multiyear agreement, Thermo Fisher Scientific reported it is working with AstraZeneca to develop a solid tissue and blood-based companion diagnostic (CDx) test for Tagrisso (osimertinib) (Press release, Thermo Fisher Scientific, JAN 24, 2023, View Source [SID1234626525]). The CDx will help identify patients with non-small cell lung cancer (NSCLC) who may be eligible for treatment with Tagrisso by identifying tumors that exhibit epidermal growth factor receptor (EGFR) alterations including exon 21 L858R mutations, exon 19 deletions or T790M mutations.

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The collaboration will leverage the Oncomine Dx Express Test* on the Genexus Dx System*, a fully-integrated next-generation sequencing (NGS) platform featuring an automated specimen-to-report workflow that economically delivers results in as little as 24 hours to bring test results to clinicians and patients faster. NGS-based CDx testing offers the ability to detect multiple biomarkers from a single test, helping to match patients with an appropriate targeted therapy more quickly. The need for faster diagnostic turnaround times was reinforced by research presented at ASCO (Free ASCO Whitepaper) 2022 that found patients with advanced stage NSCLC had better outcomes, including survival rates, when molecular testing results were available early enough to inform initial treatment decisions.

"As part of our ongoing partnership with AstraZeneca, today’s announcement will help bring targeted oncology treatments to more patients in need of new care options," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "By leveraging the Genexus Dx System’s unprecedented turnaround time, we can help ensure molecular testing results are more readily available to inform vital treatment decisions."

Tagrisso is currently approved in numerous countries and regions around the world for the following indications: the treatment of patients with locally advanced or metastatic EGFR T790M mutation positive NSCLC; the first-line treatment of patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations; and, the adjuvant treatment after tumor resection in patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

On January 24, 2023 Capstan Therapeutics, Inc., a biotechnology company dedicated to advancing in vivo reprogramming of cells through targeted lipid nanoparticles, reported that Capstan management will participate in the upcoming SVB Securities 2023 Global Biopharma Conference, being held virtually between January 31-February 2 and February 13-16, 2023 (Press release, Capstan Therapeutics, JAN 24, 2023, View Source [SID1234626524]).

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Capstan will participate in the private company exhibition taking place between January 31-February 2, 2023.

On January 24, 2023 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported that the Compensation Committee of the Company’s Board of Directors granted ten new employees options to purchase a total of 44,300 shares of the Company’s common stock at an exercise price per share of $22.02, which was the closing price on January 23, 2023, and restricted stock units to acquire a total of 22,150 shares of the Company’s common stock (Press release, Arcus Biosciences, JAN 24, 2023, View Source [SID1234626523]). The equity awards were granted pursuant to the Company’s 2020 Inducement Plan, which was approved by the Company’s Board of Directors in January 2020 pursuant to the "inducement exception" under NYSE Listed Company Manual Rule 303A.08.

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On January 24, 2023 ATUM, a global specialist and industry leader in bioengineering solutions, reported the signing of a full licensing agreement for the Leap-In Transposase technology with Codiak BioSciences, a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics, a new class of medicines (Press release, ATUM, JAN 24, 2023, View Source [SID1234626522]).

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Under the terms of the agreement, ATUM will provide Codiak access to its Leap-In Transposase technology to generate mammalian cells expressing exosomes engineered to deliver therapeutic payloads. The Leap-In technology is an integrated solution combining proprietary re-coding algorithms, unique genetic vector elements as well as a transposon-based mechanism for efficient insertion of genetically stable elements into the genome.

Scott Estes, Ph.D., VP of Cell Line Development at Codiak, said, "Through years of rigorous research and clinical validation we have created a platform for engineering and manufacturing therapeutic exosomes with various payloads on the surface or inside the lumen. We believe ATUM’s transposase technology has the potential to effectively synergize with Codiak’s engEx Platform to further enhance loading these vesicles, making them more potent and reducing cost of goods."

Claes Gustafsson, Ph.D., Chief Commercial Officer and Co-Founder at ATUM, commented, "Exosomes are bio vesicles that have the potential to fundamentally change drug delivery. We are proud and excited to license the Leap-In Transposase technology to Codiak for the engineering of cell lines that enables rapid and robust production of exosomes."

On January 24, 2023 bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) reported publication of "Detection of early-stage lung cancer in sputum using automated flow cytometry and machine learning" detailing results of the Company’s clinical trial for its non-invasive diagnostic CyPath Lung in Respiratory Research, one of the leading peer-reviewed open access journals in the field of respiratory medicine (Press release, BioAffinity Technologies, JAN 24, 2023, View Source [SID1234626521]).

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CyPath Lung showed 92% sensitivity and 87% specificity in high-risk patients who had nodules smaller than 20 millimeters or no nodules in the lung, with an area under the ROC curve of 94%. Overall, the test resulted in specificity of 88% and sensitivity of 82%, similar to far more invasive procedures currently used to diagnose lung cancer. More than half of those in the cancer cohort had early Stage I or II lung cancer. CyPath Lung detected multiple forms of cancer including adenocarcinoma, squamous cell carcinoma and small cell lung cancer.

"The fact that CyPath Lung can accurately predict lung cancer at an early stage in patients with small nodules is particularly important. Findings of lesions between six and 20 millimeters as a result of lung cancer screening can lead to unnecessary invasive procedures or a ‘watchful waiting’ period for patients," said Vivienne Rebel, MD, PhD, bioAffinity Chief Medical and Science Officer and Executive Vice President. "Our test is intended for use with patients who display these indeterminant nodules to increase the accuracy of lung cancer screening and provide certainty for patients and their physicians."

"CyPath Lung uses an automated flow-based approach combined with machine learning that can be put into routine lab use without requiring expert evaluation of samples or being subject to operator bias," said Madeleine Lemieux, PhD, who is first author and led development of the automated analysis used in CyPath Lung. "The entire sample is rapidly analyzed which ensures maximal sensitivity. The automated, numerical analysis captures complex interactions between lung cancer and the micro-environment to reliably predict the presence of lung cancer that would not be possible for even expert individuals to do from visual flow data."

Before working with bioAffinity Technologies, Dr. Lemieux was a computational biologist at the Dana Farber Institute and Harvard Medical School. She has contributed to more than 40 publications leveraging data from high-throughput platforms. Dr. Lemieux and Dr. Rebel began their successful collaboration during their doctoral studies.

CyPath Lung uses flow cytometry, a method able to interrogate individual cells in a fraction of a second, and automated analysis to identify parameters in sputum that are indicative of cancer. Unlike genomic or other molecular markers used in liquid biopsies, bioAffinity’s CyPath technology does not collect genetic material for evaluation. Instead, CyPath Lung analyzes the lung micro-environment and identifies whole cell populations that indicate cancer is present in the lung.