On August 4, 2022 Thermo Fisher Scientific reported a next-generation sequencing (NGS)-based assay for research in myeloid measurable residual disease (MRD) (Press release, Thermo Fisher Scientific, AUG 4, 2022, View Source [SID1234617606]). As the first NGS-based tests to support both DNA and RNA input, the Ion Torrent Oncomine Myeloid MRD Assays (RUO)* provide a comprehensive and highly sensitive MRD assessment from blood and bone marrow samples.

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Acute myeloid leukemia (AML) is characterized by rapid disease progression and can be fatal if not treated promptly. Depending on their interventions, the number of AML patients who experience relapsed disease can be as high 78%1. Detecting remaining mutations after treatment can help identify the presence of residual disease and guide patient prognosis and further treatment decisions. This is driving a growing need for an MRD detection methods that can simultaneously track mutations across multiple genes with high sensitivity.

Current MRD detection methods do not evaluate individual mutations or can only track a very limited number at once. Thermo Fisher’s Myeloid MRD Assay has been designed to enable simultaneous testing and identification of more than 90% of common AML mutations and fusions, providing insights to guide the future of clinical applications, standards and drug development.

"MRD can help predict potential relapse in cancer patients but is not widely used for patients with AML due to lack of accurate, reproducible tests," said Luca Quagliata, global head of medical affairs at Thermo Fisher Scientific. "With the Myeloid MRD Assay, laboratories may perform comprehensive MRD analysis of mutations in myeloid samples to inform future clinical options. We are also working with the Foundation for the National Institutes of Health Biomarkers Consortium as they assess future requirements for validation and standardization of MRD as a biomarker, with the goal of improving care and advancing treatment development for patients with AML."

The Myeloid MRD Assay enables sensitive variant detection as low as 0.05% allele frequency for key DNA mutations in 33 genes and evaluation of more than 900 isoforms in 43 RNA fusion driver genes – including many targets for which there are no established assays to-date. The end-to-end workflow delivers results in as little as two days with an integrated informatics pipeline and reporting tool that can help to minimize user hands-on time and speed up time to results.

"There is a critical need for more effective disease monitoring and treatment for patients with AML who are at high risk of relapse. The MRD biomarker will be used to better understand disease progression and guide therapy decisions in the future, and as such MRD assessment is becoming an important part of cancer research today," said Bevan Tandon, MD, director of hematopathology and molecular pathology at Pathline, a leading provider of specialized pathology services. "By introducing an assay that can be evaluated as a more accurate and comprehensive way to measure residual disease, we can begin to make strides to realize the true clinical potential of MRD to improve patient outcomes."

To learn more about the Ion Torrent Oncomine Myeloid MRD Assay (RUO), please visit: www.oncomine.com/myeloid-mrd-ngs-assay

The Real-World Incidence of Relapse in Acute Myeloid Leukemia (AML): A Systematic Literature Review (SLR); Blood, Nov. 29, 2018.
*For research use only. Not for use in diagnostic procedures.

On August 4, 2022 AnHeart Therapeutics reported it will host an investigator meeting in addition to a e-poster presentation at the World Conference on Lung Cancer (WCLC) in Vienna, Austria at 11:00 am ET on Sunday, Aug. 7, 2022 (Press release, AnHeart Therapeutics, AUG 4, 2022, View Source [SID1234617605]).

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Ignatius Ou, M.D., Ph.D., Professor of Medical Oncology, University of California Irvine School of Medicine, along with members of AnHeart’s clinical development team and study investigators, will discuss the most recent clinical data of taletrectinib and the current status of the TRUST-II clinical trial for its ROS-1 inhibitor taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC).

Taletrectinib received FDA granted Breakthrough Therapy Designation (BTD) for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who are ROS1 tyrosine kinase inhibitor (TKI) treatment naïve or previously treated with crizotinib.

Details of the e-poster presentation at WCLC 2022:

Abstract Title: TRUST-II: A Global Phase II Study for Taletrectinib in ROS1-fusion Positive Lung Cancer and Other Solid Tumors
Session: EP08.02 – Metastatic Non-small Cell Lung Cancer – Molecular Targeted Treatments
Final Program #: EP08.02-118
Author: Misako Nagasaka, M.D. Ph.D., University of California Irvine, School of Medicine

E-posters will be displayed on both days of the conference from August 7-8, 2022, 09:45 – 18:00. For more information, visit: View Source

The e-poster, as with other selected presentations regarding developments in AnHeart’s business given by management at certain investor and medical conferences, can be found on the company’s website, www.anhearttherapeutics.com, under Publications.

On August 4, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that the American Gastroenterological Association (AGA) recently published a best practice advice article stating that the TissueCypher Barrett’s Esophagus test may be beneficial for risk-stratification of patients with non-dysplastic Barrett’s esophagus (BE) (Press release, Castle Biosciences, AUG 4, 2022, View Source [SID1234617604]). TissueCypher is Castle’s test for patients with BE that is designed to predict progression to high-grade dysplasia (HGD) and/or esophageal adenocarcinoma (EAC), a form of esophageal cancer. The best practice advice article from the AGA, titled "AGA Clinical Practice Update on New Technology and Innovation for Surveillance and Screening in Barrett’s Esophagus: Expert Review," was recently published online in Clinical Gastroenterology and Hepatology and can be viewed here.

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"TissueCypher uses artificial intelligence to provide clinicians with critical information about a patient’s risk of developing HGD or EAC beyond what is possible through traditional pathology review," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "TissueCypher is designed to identify patients diagnosed with Barrett’s esophagus who may progress to HGD or EAC at a rate five to ten times higher than the current standard of care.1 This type of personalized risk-stratification information can potentially save lives when patients at high-risk of progression are identified early and provided with risk-appropriate treatments."

"Current approaches for risk stratification of patients with BE, both in community practice and academic clinical settings, are limited to subjective systems that have failed to stem the rapid rise in the incidence of EAC over the last few decades," said Robert Cook, Ph.D., senior vice president of research and development at Castle Biosciences. "TissueCypher can be a game-changing innovation in this clinical area through its ability to identify patients at risk of progression to HGD and EAC, who are often missed due to reliance on traditional histopathology and clinical variables, and also predict future progression to esophageal cancer, two, three or even five years post endoscopy. Based on the published clinical data, the AGA agreed that TissueCypher may be beneficial as part of an improved care pathway for managing patients with BE."

AGA Clinical Practice Update

AGA’s clinical practice updates present the current state-of-the-art guidance and include a combination of evidence-based information, and when not available, best consensus opinion concerning the management of gastrointestinal (GI) diseases.2 AGA’s latest update on BE was an expert review commissioned jointly by the AGA Institute Clinical Practice Updates Committee, the AGA Center for GI Innovation and Technology and the AGA Governing Board. It includes a number of Best Practice Advice statements (BPAs) intended to provide practical advice on the management of BE based on expert opinion and a review of existing literature.

The potential risk-stratification benefit of TissueCypher in the management of patients with BE is included in BPA 9 in the recent update: "Tissue systems pathology-based prediction assay may be utilized for risk-stratification of patients with non-dysplastic BE."

Several clinical studies were cited as evidence in the BPA.3-6 These studies provide further support for the overall accuracy and strong, independent predictive ability of TissueCypher in risk-stratifying patients for progression to esophageal cancer, by identifying both high-risk patients who may be missed by the current standard of care as well as low risk patients who may be able to avoid unnecessary treatments.

About TissueCypher Barrett’s Esophagus Test

The TissueCypher Barrett’s Esophagus test is Castle’s precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). The TissueCypher Barrett’s Esophagus test is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (NDBE), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by nine peer-reviewed publications of BE progressor patients with leading clinical centers around the world. The test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022.

On August 4, 2022 invoX Pharma Limited ("invoX"), a wholly owned subsidiary of Sino Biopharmaceutical Limited ("Sino Biopharm") (HKEX 1177 HK), focused on research and development (R&D) and business development activities outside of China, and F-star Therapeutics, Inc. ("F-star") (NASDAQ:FSTX), a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, reported that invoX has extended the expiration of its previously announced tender offer for all of the issued and outstanding shares of F-star common stock for a price of $7.12 per share (Press release, InvoX Pharma, AUG 4, 2022, View Source [SID1234617603]). The tender offer is now scheduled to expire at 05:00 p.m., Eastern Time, on September 19, 2022, unless it is further extended. The tender offer was previously scheduled to expire at one minute after 11:59 P.M., Eastern time, on August 3, 2022.

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The tender offer is being extended in order to allow additional time for the satisfaction of the regulatory conditions to the offer. The depositary for the tender offer has advised invoX that as of the previous expiration time there were validly tendered and not withdrawn a total of approximately 13,026,582 shares of F-star common stock, and approximately 2,704,867 shares of F-star common stock tendered pursuant to a notice of guaranteed delivery.

All terms and conditions of the tender offer remain unchanged during the extension period. F-star shareholders who have already tendered their shares do not have to re-tender their shares or take any other action as a result of the extension. Complete terms and conditions of the tender offer are set forth in the Offer to Purchase, Letter of Transmittal and other related materials, which have been filed by invoX with the Securities and Exchange Commission ("SEC") on July 7, 2022, as amended. In addition, F-star filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC on July 7, 2022, as amended, which includes, among other things, the recommendation of F-star’s board of directors that F-star stockholders tender all of their shares in the tender offer.

The Information Agent for the tender offer is Innisfree M&A Incorporated. The Depositary and Paying Agent for the tender offer is Computershare Trust Company, N.A. For all questions relating to the tender offer, please call the Information Agent, Innisfree M&A Incorporated toll-free at (888) 750-5830; banks and brokers may call collect at (212) 750-5833.

Advisors

PJT Partners is acting as financial advisor to invoX, and Morgan Stanley & Co. LLC is acting as financial advisor to F-star. Shearman & Sterling LLP is serving as legal counsel to invoX and Sino Biopharm and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to F-star.

On August 4, 2022 Mevion Medical Systems, the leading provider of compact proton therapy systems for use in radiation treatment for cancer patients, reported that the accelerator for the MEVION S250i Proton Therapy System was delivered on July 28, 2022, to Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology in Wuhan, China (Press release, Mevion Medical Systems, AUG 4, 2022, View Source [SID1234617602]). This milestone commences the system installation at Tongji Hospital’s proton therapy center, the first of its kind in Central China.

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The system at Tongji Hospital features Mevion’s industry leading HYPERSCAN Pencil Beam Scanning (PBS) technology and Adaptive Aperture pMLC. This powerful duo provides faster and more precise targeted dose delivery to tumors thus, minimizing the damage to surrounding healthy tissue and organs at risk. The system also integrates a diagnostic quality CT imaging system and a surface tracking system for high precision patient positioning and intra-fraction motion management.

Founded in 1900, Tongji Hospital currently treats over 6 million patients annually. It has developed into one of the world’s largest and most powerful oncology medical teaching and research facilities, and the recently opened Optics Valley Tongji Children’s Hospital is located on the same campus as the new proton therapy center. In addition to the Mevion system, the new proton therapy center will also be equipped with a cutting-edge whole-body PET/CT imaging system. Tongji Hospital has also built a second proton vault, making it China’s first proton center applying the One Plus One multi-system installation approach. This approach gives cancer centers the flexibility to add a second system in the future to correspond to the growth of patient volume and clinical expertise. By doing a staged installation approach, financial burdens are significantly reduced at the start of the clinical proton therapy program, and the risk of technology obsolescence is mitigated greatly.

"Mevion is excited to start the system installation at world-class Tongji Hospital, and we look forward to a continued partnership that will give patients in Central China much-needed access to proton therapy," said Tina Yu, Ph.D., chief executive officer and president of Mevion. "We are proud of our technology that provides advanced cancer treatment to patients and allows hospitals to expand their proton therapy program at their own pace."

*Mevion is actively seeking regulatory approval from the National Medical Products Administration (NMPA) in China.