On August 25, 2020 Proscia, a leading provider of AI-enabled digital pathology solutions, and Dutch hospital University Medical Center Utrecht (UMC Utrecht), reported that a pioneer in the adoption of routine digital pathology, are collaborating to establish a Center of Excellence to advance the use of computational pathology in clinical practice (Press release, Proscia, AUG 25, 2020, View Source [SID1234564014]). The Center of Excellence will validate the efficacy of Proscia’s AI applications and deploy them into high-throughput pathology workflows to drive quality and efficiency gains. In doing so, it will demonstrate best practices for the broader adoption of computational pathology amongst diagnostic laboratories.

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The standard of care for diagnosing diseases like cancer is the pathologist’s assessment of tissue biopsies using the microscope. This 150-year-old manual and subjective practice cannot keep pace with the rising cancer burden amid a declining pathologist population. Laboratories are quickly adopting digital pathology to successfully overcome many of these systemic challenges. They are also increasingly implementing AI to realize even more value from their digital data, driving further productivity gains and expanding the breadth of critical diagnostic information available to improve patient outcomes.

Delivering computational pathology applications for high-throughput laboratory settings requires massive amounts of data and rigorous validation to ensure that they can overcome the pre-analytical variability seen in practice. Through the collaboration, Proscia and UMC Utrecht will build one of the largest de-identified data sets for pathology research to date. The partners will also generate clinical and economic evidence demonstrating the capacity of Proscia’s AI applications to achieve their intended purposes across multiple laboratory settings.

"At UMC Utrecht, we believe that computational pathology will have an unprecedented impact on the way we diagnose and treat patients," said Paul van Diest, Head of the Department of Pathology. "We are excited to establish this Center of Excellence with Proscia, a leader in AI-enabled digital pathology, to see through our vision and ultimately improve the quality of our practice."

As one of the earliest adopters of digital pathology, UMC Utrecht will deploy Proscia’s computational pathology applications leveraging the company’s Concentriq Dx platform to highlight the impact of AI in delivering meaningful quality, efficiency, and productivity gains. CE-marked for use in primary diagnosis in Europe and available for remote use in clinical practice in the United States during the COVID-19 public health emergency, Concentriq Dx is used by leading commercial and academic laboratories to view, manage, and analyze whole slide images at an enterprise scale.

"Computational applications are poised to transform the practice of pathology; yet research alone is not enough to bring them into practice to drive this change," said Arun Ananth, Executive Vice President of Global Growth at Proscia. "We are pleased to establish a Center of Excellence with UMC Utrecht, an institution at the intersection of research and clinical practice, to go beyond validation and to highlight the value of AI-enabled digital pathology in routine diagnostic workflows."

In establishing the Center of Excellence, UMC Utrecht joins the growing list of academic and commercial laboratories with which Proscia is working to advance the use of computational pathology. In February 2020, Proscia released the results of one of the largest and most comprehensive validation studies performed in computational pathology to date, conducted in collaboration with Dermatopathology Laboratory of Central States, University of Florida, and Thomas Jefferson University Hospital, in support of the June 2019 release of its DermAI application for dermatopathology. It has also recently announced data collaborations with University of California, San Francisco and Johns Hopkins School of Medicine.

On August 25, 2020 Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported that it will host a virtual KOL meeting on Wednesday, September 16th, 2020 from 10:30 am-12 pm ET to discuss the preliminary Phase 1b efficacy and safety data for cavrotolimod, Exicure’s SNA-enabled TLR9 agonist for solid tumors (Press release, Exicure, AUG 25, 2020, View Source [SID1234564013]).

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Phase 1b Principal Investigators, Dr. Steven O’Day and Dr. Shailender Bhatia, will join Exicure’s leadership team in discussing the clinical results and progress to date.

Steven J. O’Day, MD, is the Executive Director of the John Wayne Cancer Institute and Cancer Clinic, and Director of Providence Los Angeles Regional Research. He is the Professor of Medical Oncology, Director of Immuno-Oncology, and Director of Clinical Research at the John Wayne Cancer Institute at Providence Saint John’s Health Center. Shailender Bhatia, MD, is an Associate Professor at the University of Washington School of Medicine and an Assistant Professor of the Clinical Research Division at the Fred Hutchinson Cancer Research Center.

A live webcast will be available in the Events and Presentations section of Exicure’s website on September 16th at 10:30 am ET. An archived version will be available on the company website following the event. To RSVP for the event, please use the link here (View Source) or email [email protected].

On August 25, 2020 EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, reported that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the new drug application (NDA) for once-daily, orally-dosed tepotinib* for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping, as detected by an FDA-approved test (Press release, EMD Serono, AUG 25, 2020, View Source [SID1234564012]). Tepotinib was granted Priority Review and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which is intended to create a more efficient review process to bring safe and effective treatments to patients as early as possible.1 Priority Review is intended to accelerate evaluation of applications for drugs that could offer improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.2 Tepotinib was granted Breakthrough Therapy Designation by the FDA in September 2019 for the treatment of patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy.

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The application is based on results from the pivotal ongoing, single-arm Phase II VISION study (NCT02864992) evaluating tepotinib as monotherapy in patients with advanced NSCLC with MET exon 14 (METex14) skipping alterations prospectively assessed by liquid and/or tissue biopsy. Results demonstrate consistent response rate and durable anti-tumor activity across lines of treatment including in patients with brain metastases and in patients assessed by both liquid biopsy (LBx) and tissue biopsy (TBx). Data from the primary analysis of the VISION study were published in The New England Journal of Medicine (NEJM) on May 29, 2020 and presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program.3

"METex14 skipping alterations drive a particularly aggressive form of NSCLC in a patient population that is generally elderly, facing poor clinical prognosis and in urgent need of new therapeutic options," said Luciano Rossetti, Global Head of Research & Development for EMD Serono. "With this acceptance and review under the RTOR program, we look forward to working with FDA and to making this precision medicine available to patients in the U.S. as soon as possible."

In the US in 2020, there were approximately 228,000 new cases of lung cancer and more than 135,000 deaths from lung cancer.4 Alterations of the MET signaling pathway are found in various cancer types, including 3% to 5% of NSCLC cases, and correlate with aggressive tumor behavior and poor clinical prognosis.5-7 Patients with NSCLC harboring METex14 skipping tend to be older than those with NSCLC harboring other alterations.8 In the Phase II VISION study, the patient population is generally characterized as elderly, with a median age of 74.0 years, and as having poor clinical prognosis typical of NSCLC with METex14 skipping alterations.

In March 2020, tepotinib became the first oral MET inhibitor indicated for the treatment of advanced NSCLC harboring MET gene alterations to receive a regulatory approval globally, with the Japanese Ministry of Health, Labour and Welfare (MHLW) approval for the treatment of patients with unresectable, advanced or recurrent NSCLC with METex14 skipping alterations.

*Tepotinib is currently under clinical investigation and not yet approved in any markets outside of Japan.

About Non-Small Cell Lung Cancer
With 2 million cases diagnosed annually, lung cancer (including trachea, bronchus and lung) is the most common type of cancer worldwide and the leading cause of cancer-related death, with 1.9 million mortality cases worldwide.9 Alterations of the MET signaling pathway, including MET exon 14 (METex14) skipping alterations and MET amplifications, occur in 3% to 5% of NSCLC cases.5-7

About Tepotinib
Tepotinib is an oral MET inhibitor that is designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations. Discovered and developed in-house at Merck KGaA, Darmstadt, Germany, it has been designed to have a highly selective mechanism of action10, with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations. In March 2020, tepotinib became the first oral MET inhibitor indicated for the treatment of advanced NSCLC harboring MET gene alterations to receive a regulatory approval globally, with the Japanese Ministry of Health, Labour and Welfare (MHLW) approval for the treatment of patients with unresectable, advanced or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations whose disease progressed following platinum-based cancer therapy. Tepotinib is also being investigated in the Phase II INSIGHT 2 study in combination with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib.

About VISION
VISION is Phase II, pivotal, multi-center, multi-cohort, single-arm, open-label study investigating tepotinib as a monotherapy for advanced (locally advanced or metastatic) non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping alterations or MET amplification identified by liquid or tissue biopsy. The primary outcome measure is objective response as assessed by independent review committee (IRC) and according to Response Evaluation Criteria in Solid Tumors (RECIST). Secondary outcome measures include objective response, duration of response, objective disease control, progression free survival, overall survival and other measures. The trial is ongoing and continuing to enroll patients.

References

US Food and Drug Administration. Real-Time Oncology Review Pilot Program. View Source Accessed August 2020.
US Food and Drug Administration. Priority Review. View Source Accessed August 2020.
Paik PK et al. Tepotinib in non–small-cell lung cancer with MET exon 14 skipping mutations. N Engl J Med 2020 May 29; [e-pub]. (View Source)
American Cancer Society. Key Statistics for Lung Cancer. American Cancer Society. Atlanta, Ga. 2020. Accessed at View Source August 2020.
Reungwetwattana T, et al. Lung Cancer 2017;103:27-37.
Mo HN, et al. Chronic Dis Transl Med 2017;3(3):148-153.
Lutterbach B, et al. Cancer Res 2007;67:2081-8.
Schrock AB et al. J Thorac Oncol 2016;11(9):1493-1502.
Global Burden of Disease Cancer Collaboration. JAMA Oncol. 2019;5:1749–1768
Bladt F, et al. Clin Cancer Res 2013;19:2941-2951.
All Merck KGaA, Darmstadt, Germany press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to www.emdgroup.com/subscribe to register for your online subscription of this service as our geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

On August 25, 2020 Kintara Therapeutics, Inc. ("Kintara" or the "Company") (Nasdaq: KTRA) reported that it has closed its previously announced private placement with investors providing for the sale and issuance of 2,185 shares of its Series C Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share priced at-the-market under the rules of the Nasdaq Stock Market (Press release, Kintara Therapeutics, AUG 25, 2020, View Source [SID1234564011]). The Preferred Stock is convertible into shares of the Company’s common stock at a conversion price of $1.214 per share. The closing resulted in gross proceeds to the Company of approximately $2.2 million, which is in addition to the $19.6 million of gross proceeds previously announced in connection with the initial closing of the private placement. The Preferred Stock accrues dividends as previously announced.

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The Company intends to use the net proceeds from the offering to fund the previously announced registration study for VAL-083 in newly diagnosed and recurrent GBM, the 15-patient REM-001 confirmatory lead-in study intended to continue seamlessly into a full Phase 3 pivotal study for CMBC, and for working capital. Also, as previously disclosed, the GBM trial will be executed through the Company’s partnership with Global Coalition for Adaptive Research (GCAR) through the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study, an adaptive clinical trial platform in GBM.

The shares of Preferred Stock described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and, along with the common shares issuable upon their exercise or payable as dividends pursuant to the Preferred Stock, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

On August 25, 2020 Shenzhen Yuce Biological reported that completed a $43 million Series C round led by Yuanzhi Science & Technology Medical for its clinical testing of cancer immunotherapies (Press release, Shenzhen Yuce Biotechnology, AUG 25, 2020, View Source [SID1234564010]). Yuce Bio has developed a new antigen detection and identification platform, a professional database for cancer immunology based on bioinformatics, and a large real-world research database of tumor immunodiagnosis. As part of its program, Yuce has developed YuceOne Plus, the first in vitro diagnostic reagent that uses gene testing to evaluate the effectiveness of an immunotherapy drug regimen.

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