On July 13, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult to treat cancers, reported that the Company will report second quarter 2022 financial results on Thursday, July, 21, 2022, after market close (Press release, Cytori Therapeutics, JUL 13, 2022, View Source [SID1234616643]). Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.

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A live webcast will be available at ir.plustherapeutics.com/events.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investor’ section. The webcast will be available on the Company’s website for 90 days following the live call.

On July 13, 2022 Triastek, Inc. ("Triastek") reported a collaboration with Eli Lilly and Company ("Lilly"), a leading global pharmaceutical company, to leverage the advantages of 3D printing technology to enable precisely targeted and programmed release of drugs in specific regions of the GI tract (Press release, Eli Lilly, JUL 13, 2022, View Source [SID1234616660]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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According to the agreement, the project will focus on the targeted release of drugs in the intestine. Triastek will focus on two aspects: Firstly, conduct an in-depth study of excipient properties and process parameters to maintain drug stability throughout the formulation development and 3D printing process, as well as during drug release. Secondly, identify a unique three-dimensional structure dosage form design, that will permit programmed release of drugs in specific parts of the intestine, with the goal of improving the bioavailability of orally administered drugs.

Triastek is a 3D printing technology platform company, and its pioneering MED technology has versatile applications in solid dosage forms development and manufacturing. With the facilitation of this collaboration by Lilly China Innovation & Partnerships, Triastek will work with Lilly to explore novel solutions to the oral delivery of drugs.

Triastek is committed to promoting the application of 3D printing technology in the pharmaceutical field. Triastek’s 1st and 2nd products (T19 and T20) have received IND clearance from the U.S. Food and Drug Administration (FDA). The company also holds 158 patent applications related to 3D printing of pharmaceuticals with comprehensive patent coverage in the world. Triastek has also established collaborations with a number of multinational pharmaceutical companies, as well as domestic pharmaceutical companies to provide technical solutions for the development of challenging formulations.

Dr. Senping Cheng, founder and CEO of Triastek, said: "the collaboration between Triastek and Lilly is a great example of applying MED technology for improving the oral delivery of drugs. We envision that the MED technology of Triastek can be used to solve the challenges in formulations leading to the development of clinically valuable products for our global partners."

On July 13, 2022 DNAnexus, Inc., a leading provider of cloud-based biomedical data analysis software serving the life sciences community, and Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported a collaboration aimed at accelerating research and reducing the time to design, validate, and commercialize new, high-quality, next-generation sequencing (NGS)-based diagnostic tests (Press release, Twist Bioscience, JUL 13, 2022, View Source [SID1234616644]). As part of the collaboration, Twist customers are able to use the integrated DNAnexus platform with Twist’s NGS Methylation Detection System and Unique Molecular Identifier (UMI) Adapter System to simplify data analysis after sequencing.

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The Twist NGS Methylation Detection System provides robust sample preparation and target enrichment solutions for identifying methylated regions in the human genome. Rare diseases, cancer, and other disorders can be identified by unique methylation patterns within samples. The NGS Methylation Detection System uses highly sensitive hybridization capture-based technology that can be integrated into diagnostic tests. This workflow can also be used to better characterize and understand the genetic mechanisms linked to specific conditions including cancer, neurodegeneration, and rare diseases. The Twist UMI Adapter System detects low-frequency variants in low-input sample sources such as cell-free DNA (cfDNA) and can be used to enable cancer research. The DNAnexus platform allows users to easily explore and analyze complex datasets in a single, scalable, cloud-based environment.

"This collaboration with DNAnexus is another example of our ongoing commitment to providing our customers with the tools they need for complete, customized, end-to-end workflows," said Emily M. Leproust, PhD, CEO and co-founder of Twist Bioscience. "Our customers can now access industry-leading computational infrastructure platforms to support their bioinformatics needs and reduce their data analysis timeline after performing a sequencing run with our NGS Methylation Detection and UMI Adapter Systems."

Today, DNAnexus has more than 12,000 users across 48 countries and works with the largest and most innovative pharmaceutical companies, diagnostic laboratories, and academic medical centers around the world, along with the UK Biobank and the FDA. The platform provides a comprehensive cloud environment that supports the entire diagnostic development and production cycle from R&D through to deployment of the validated test. The environment was designed to meet the most rigorous standards for quality, security, privacy, and safety.

"Twist’s proprietary synthetic DNA tools continue to be used to advance research and precision medicine and to change the way diagnostics are developed," said John Ellithorpe, PhD, President of DNAnexus. "With the integrated DNAnexus platform, Twist customers can now reduce the complex data analysis bottleneck, which we believe will offer significant time savings and cost advantages."

On July 13, 2022 miR Scientific, LLC reported the miR Sentinel Prostate Cancer Test is now commercially available in the United States, Puerto Rico and select international markets (Press release, miR Scientific, JUL 13, 2022, View Source [SID1234616661]). miR Sentinel is a novel, urine-based, molecular test that analyzes small non-coding RNA using a proprietary biostatistical algorithm. The miR Sentinel Test assesses the risk of aggressive prostate cancer and is intended to aid in the clinical management of men >45 years of age at risk for prostate cancer.

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The results of a recent clinical study performed at multiple sites within the US and Puerto Rico were presented at the 2022 American Urological Association’s Annual Meeting. In the study cohort of ~1100 men, the miR Sentinel Test was shown to identify molecular evidence of prostate cancer in at-risk men with 98.5% sensitivity and distinguish clinically non-significant (nominally No Pathological Evidence of Prostate Cancer and Grade Group 1), from clinically significant prostate cancer (nominally Grade Groups 2-5) with a prognostic sensitivity of 83% 2.

"We believe that the miR Sentinel Test offers patients and providers a non-invasive means of accurately assessing a man’s prostate cancer risk, which could potentially reduce unnecessary biopsies and biopsy-related complications in men with low-risk of clinically significant prostate cancer, while prioritizing diagnostic and treatment resources to those men that potentially harbor clinically significant prostate cancer," said Sam Salman, Chairman and CEO of miR Scientific. "This aligns with miR Scientific’s vision to revolutionize prostate cancer disease management by improving accessibility and accuracy of the tools used to assess each man’s personal risk of aggressive disease."

In a subset analysis of men from this cohort where the findings of TRUS and MRI-guided biopsies disagreed on the presence of prostate cancer, the miR Sentinel Test was able to correctly identify 99% (71/72) of men found positive by either biopsy type while identifying all but 4 of 234 cases where prostate cancer was found by either TRUS or MRI resulting in a false negative rate of 1.7%. Additionally, 87% of men with PSA levels <3 found to have pathologic grade group 2 through 5 upon biopsy were identified by the miR Sentinel Test as having molecular evidence of intermediate or high risk of aggressive disease2. These findings suggest that the miR Sentinel Test may represent a significant improvement over the current standards of care and other tools being used to detect and classify prostate cancer.

"Accurate assessment of a man’s individual risk related to prostate cancer is one of the cornerstones of appropriate patient management. The miR Sentinel Test has the potential to provide a significant improvement over the current tools that are available to physicians," said Laurence Klotz, MD, FRCSC, CM, miR Scientific’s Chief Medical Officer, Professor of Surgery and Chair of Prostate Cancer Research, University of Toronto Sunnybrook. "The implementation of such an innovation into practice could have a dramatic impact on outcomes through appropriately guiding the need for further diagnostic workup in men with elevated risk of significant cancer and guiding treatment in those subsequently diagnosed."

The current version of the miR Sentinel Test represents a refined and clinically validated assessment developed for commercialization based on our comprehensive miR Sentinel PCC4 assay, which received FDA Breakthrough Device Designation in third quarter 2020 and the original three-test proof of concept, published in the Journal of Urology1 in September 2020.

Additional information on the miR Sentinel Prostate Cancer Test as well as information on how to access the test can be found by visiting miRSentinel.com or calling 855-55CALLMIR from the United States or +1 (855) 552-2556.

On July 13, 2022 Anumana, Inc., an AI-driven health technology company and portfolio company of nference, reported that it has launched a multi-year strategic collaboration with Novartis Pharmaceuticals Corporation ("Novartis") to deploy a series of artificial intelligence (AI)-powered software solutions that will detect hidden cardiovascular conditions (Press release, Novartis, JUL 13, 2022, View Source [SID1234616678]). The collaboration will drive development and delivery of electrocardiogram (ECG) AI algorithms to help physicians accelerate detection and intervention for patients with previously undetected life-threatening heart disease. The ECG AI algorithm is still in development and not yet FDA authorized for commercial clinical use.

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The collaboration will support Anumana’s efforts to implement AI-enabled diagnostic software that can detect signals from ECGs that humans cannot interpret. The collaboration will initially focus on cardiovascular diseases. Working with its expert partners from Mayo Clinic, Anumana will deploy novel solutions that use AI to analyze an ECG, a widely available, painless test that records the heart’s electrical signals to identify undiagnosed left ventricular dysfunction, or a weak heart pump, which can lead to heart failure. The AI will also screen for atherosclerotic cardiovascular disease, which can lead to heart attack and stroke. In addition, an evidence-based, digital point-of-care solution will be developed to guide in optimizing guideline-directed medical therapies with the aim to lower risk for potentially avoidable hospitalizations and cardiovascular death.

"Anumana technology is designed to help physicians identify patients who are at maximum risk of heart failure, long before they develop symptoms," said Murali Aravamudan, CEO of Anumana. "Bringing together premier global organizations will allow us to expand access to best-in-class, AI-powered digital tools to benefit patients through earlier detection and intervention, when and where health care providers need it most."

"Many heart diseases develop for years before signs and symptoms appear, but the first event may be life threatening," said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic and Chair of Anumana’s Mayo Clinic Board of Advisors. "AI enables us to uncover hidden signals our bodies transmit to detect otherwise occult heart diseases, potentially years before symptoms appear. This collaboration has the potential to transform the use of an ubiquitous inexpensive test, the ECG, with the aim of democratizing disease detection and helping medical care teams to proactively manage heart disease ahead of time and prevent some clinical events from ever happening."

"Cardiovascular disease is a widespread and multifactorial disease and, in order to mitigate its impact, we must look beyond therapeutic innovation and reimagine how we approach cardiovascular care," said Victor Bulto, President, Novartis Innovative Medicines US. "Novartis is proud to collaborate with Anumana on innovative and data-driven solutions to better predict the risk of life-threatening heart disease, further driving forward our commitment to improving patient experiences and population health outcomes in this patient population."

The Mayo Clinic Cardiology team, led by Dr. Friedman, pioneered the application of AI in cardiology and developed several algorithms based on millions of ECGs, including a low ejection fraction algorithm that received FDA Breakthrough Device Designation in 2019 and Emergency Use Authorization for COVID-19 in 2020. Further validating the technology, a recent study presented by Mayo Clinic used a modified version of Anumana’s 12-lead ECG algorithm to detect left ventricular dysfunction with single-lead ECGs in smartwatches. These algorithms are licensed to Anumana for development of clinical solutions and have been validated by over 30 peer-reviewed publications, including a first of its kind prospective clinical impact study on low ventricular ejection fraction that was published in Nature Medicine in 2021. These software solutions are currently in development with each algorithm as a candidate for marketing authorization through an FDA DeNovo request.