On October 13, 2022 XBiotech (NASDAQ: XBIT) reported the enrollment of the first patient in a multicenter, randomized clinical study for Natrunix in combination with trifluridine/tipiracil for the treatment of colorectal cancer (Press release, XBiotech, OCT 13, 2022, View Source [SID1234621986]). The much anticipated clinical study for XBiotech’s candidate cancer treatment is being funded by the French National Cancer Institute (INCA). The study is headed by renown oncologists Dr. François Ghiringhelli and Dr. Come Lepage, Professor in Medical Oncology and Director of the INSERM research team at the Georges-Francois Leclerc Cancer Centre, and Professor at the Department of Gastroenterology and Digestive Oncology, University Hospital Dijon, Dijon, France, respectively.

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Investigators are combining XBiotech’s Natrunix with trifluridine/tipiracil as a new candidate therapy for metastatic colorectal cancer. Subjects receiving the experimental therapy have failed earlier treatment with oxaliplatin, irinotecan, and fluoropyrimidine. Subjects are randomized to receive Natrunix plus trifluridine/tipiracil chemotherapy or placebo plus the chemotherapy. The study is designed to seamlessly proceed through Phase III development based on achievement of certain efficacy milestones in the Phase I/II portions.

Natrunix is a therapeutic monoclonal antibody discovered, manufactured, and undergoing clinical development by XBiotech. The antibody blocks the activity of substance produced by tumors and inflammatory cells that stimulates new blood vessel formation and breaks down connective tissue at the site of the tumor, allowing tumors to grow and spread. The same substance also activates blood vessels, making them sticky to enhance migration of circulating tumor cells to new sites of metastasis. Natrunix potently blocks the action of the substance, known as IL-1, which is also produced in response to chemotherapy.

Colorectal cancer is one of the most common forms of cancer in Europe and the United States, with the American Cancer Society’s estimating over 151,000 new cases and over 52,000 deaths annually in the United States alone.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

On October 13, 2022 Celdara Medical, LLC reported that the National Cancer Institute (NCI) of the National Institutes of Health (NIH) has awarded a Phase II Small Business Innovation Research (SBIR) Fast-Track grant to fund company’s ongoing development of CM-CX1, a chimeric antigen receptor (CAR) T cell therapy for the treatment of ovarian clear cell and renal cell carcinomas (Press release, Celdara Medical, OCT 13, 2022, View Source [SID1234621985]).

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Dr. Jake Reder, Co-founder and Chief Executive Officer of Celdara Medical, remarked, "We’re very grateful to the NCI for their continued support of this program. As the field begins to see the potential of CAR-T in solid tumors realized, the fundamental importance of target selection comes once again into focus. We’re working hard to bring CM-CX1 to the clinical for the benefit of patients with renal cell or ovarian clear cell carcinomas, or indeed for any patient whose tumor expresses CM-CX1’s target."

"I have been working closely with our industry and academic partners to identify ideal targets for cellular therapies and we have created something unique with CM-CX1", said Dr. Joana Murad Mabaera, Executive Director of Research at Celdara Medical and lead Principal Investigator on the study. "We have made significant progress in Phase I towards the preclinical development of CM-CX1. The Phase II funding will enable the submission of our Investigational New Drug (IND) application to bring CM-CX1 to clinic. With CM-CX1, we have an exciting opportunity to translate our promising research and make this therapeutic option accessible to patients of ovarian and renal carcinomas."

Research reported in this press release is supported by the National Cancer Institute of the National Institutes of Health under award number R44CA265424-02. The content is solely the responsibility of Celdara Medical and does not necessarily represent the official views of the National Institutes of Health.

On October 13, 2022 JSR Corporation (Representative Director, CEO: Eric Johnson, "JSR") reported that it has signed a Share Purchase Agreement to acquire the 60% of shares held by PERI Corporation ("PERI") and make JSR Electronic Materials Korea Co., Ltd. ("JEMK") a wholly owned subsidiary of JSR (Press release, JSR, OCT 13, 2022, View Source [SID1234621984]). JEMK is a joint venture between PERI and JSR, which is the sales agent/distributor of its Electronic Materials business in Korea.

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JEMK was established in 2014 and has contributed the growth and expansion of JSR’s electronic materials business in Korea. With the current progress, and full-fledged development of cutting-edge technologies at customers, including the metal oxide resist of Inpria Corporation acquired in October 2021, it becomes increasingly important for JSR to promote businesses in closer relationships with customers. Given this environment, JSR decided to make JEMK a wholly-owned subsidiary and promote greater customer satisfaction and faster service delivery through integrated group management. Going forward, JSR will collaborate with JSR Micro Korea Co., Ltd. to strengthen critical functions such as research and development.

By making JEMK a wholly owned subsidiary, JSR will further strengthen the global collaboration of its semiconductor materials business and build a system that enables solutions quickly and smoothly, which will lead to further customer and product portfolio expansion.

On October 13, 2022 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the certification of its leading in-vitro diagnostic (IVD) kit and its fully automated NeuMoDx platforms under the European Union’s new In-Vitro Diagnostic Medical Devices Regulation (IVDR) replacing the previous IVDD rules since May (Press release, Qiagen, OCT 13, 2022, View Source [SID1234621983]). The ipsogen JAK2 RGQ PCR Kit used for myeloproliferative neoplasms (MPN), a certain type of blood cancer, is now QIAGEN’s first IVD kit with IVDR CE-marking under Class C.

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The updated set of rules that became effective May 26, 2022, is now imposing higher and broader requirements on IVD manufacturers to receive CE-marking for their products. For example, the change includes a new risk-based classification system that ranks all IVDs from A for lowest to D for highest risk, as well as a stronger oversight by independent EU-designated organizations, so-called Notified Bodies. With its more stringent mandates, the European regulatory framework comes closer to the FDA IVD regulations in the US. The new EU regulation will ensure a higher level of protection further reinforcing patient safety. It will allow laboratories to work with high-end reagents, further increasing the quality of their results.

QIAGEN is committed to the highest standards of quality and has therefore pledged full compliance with the new rules, which apply to all manufacturers commercializing IVD medical devices on the EU market. Last year QIAGEN completed the required audit of its quality management system (QMS) through a notified body without major observation – also related to IVDR – marking a first key milestone towards the company’s IVDR compliance. Based on this result, QIAGEN will continue to submit technical documentation in order to receive certifications across the entire IVD portfolio.

With the certification of its leading IVD kit and NeuMoDx platform, the company has now reached another significant milestone in its preemptive and meticulous campaign to timely transition over 180 products that fall within the scope of IVDR. The IVD kit is now classified under Class C, according to the new regulation. The ipsogen JAK2 RGQ PCR Kit provides highly sensitive and accurate leukemia biomarker detection, supporting the evaluation of suspected MPN patients, as well as monitoring those already diagnosed. The NeuMoDx rapid, integrated PCR testing platforms for mid- and high throughput are now classified under Class A and currently offer 16 regulated assays for different infectious diseases in Europe.

"Building on our extensive regulatory experience, QIAGEN experts across our business areas are working tirelessly to ensure QIAGEN’s global quality management and products are IVDR-ready and compliant," said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. "Our customers can expect to receive certified and approved products from QIAGEN, and will profit from improved clinical performance thanks to this enhanced, sustainable and transparent regulatory framework. In addition, they will benefit from our lab-developed test capabilities of our NeuMoDx offering that will not be impacted by the new regulatory framework."

The transition period for IVDs has ended on May 26, 2022, but has been extended under certain conditions. However, European labs and clinicians supplied by QIAGEN can approach the transition with confidence, as the company has been at the forefront of developing and implementing the new regulations.

Following this significant step in the transition to new EU standards, passing the QMS audit and obtaining the product’s declaration of conformity, QIAGEN will now commence implementation of the updated labelling for these products over the coming month and will announce the release of individual products accordingly.

On October 13, 2022 Genomic Testing Cooperative, LCA (GTC) reported that its innovative artificial intelligence (AI) algorithms are now formally implemented in daily use to aid pathologists in the diagnosis and interpretation of molecular findings of genomic profiling (Press release, Genomic Testing Cooperative, OCT 13, 2022, View Source [SID1234621982]).

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GTC’s RNAnalysis algorithm is used to distinguish between 45 different diagnostic classes providing probability scores. This algorithm is complemented by a second algorithm called TraceWork. When needed, TraceWork is used to distinguish between two diagnostic entities determined by RNAnalysis to be of similar high probability score.

Results of validation of these algorithms are now published in The American Journal of Pathology, a part of Elsevier’s Journal Network (DOI:View Source).For example, independent blind testing of RNAnalysis algorithm showed correct first-choice diagnosis in 100% of acute lymphoblastic leukemia, 88% of acute myeloid leukemia, 85% of diffuse large B-cell lymphoma, 82% of colorectal cancer, 49% of lung cancer, 88% of chronic lymphocytic leukemia and 72% of follicular lymphoma. The TraceWork algorithm distinguished between lung cancer and colorectal cancer with 97.2% sensitivity and 94.5% specificity, between Hodgkin lymphoma and normal lymph node with 95.4% sensitivity and 100% specificity, between follicular lymphoma and diffuse large B-cell lymphoma with 95.9% sensitivity and 93.1% specificity, and between breast cancer and ovarian cancer with 100% sensitivity and 94.2% specificity.

"The information provided by these algorithms are used in the context of clinical and other molecular and pathologic findings and not meant to replace the need for physician’s clinical decision," said Dr. Maher Albitar, founder, chief medical officer, and chief executive officer of GTC. "We believe that transcriptomic data when combined with AI provides an efficient and effective information that can replace the need for large number immunohistochemical staining and flow cytometry testing, especially when tissue samples are scant," Dr. Albitar added.

Dr. Andre Goy, Chairman & Chief Physician Officer at John Theurer Cancer Center and Academic Chairman of Oncology at Hackensack Meridian School of Medicine, stated, "Precision diagnosis is extremely important for the practice of precision medicine. Today’s RNA and DNA profiling generates big data that requires sophisticated algorithms to decipher the clinical relevance of this data. GTC’s molecular profiling and algorithms had helped us resolve numerous diagnostically challenging cases and the results made a difference in patients management and outcome."

Dr. Aamir Ehsan, CEO/ President, Medical Director and board-certified hematopathologist and molecular geneticist of CorePath laboratories, at San Antonio, Texas, who is a collaborator and coauthor on the published work, said, "Unlike AI and imaging, transcriptomic data and AI incorporates immunohistochemistry and flow cytometry data as well as numerous additional biomarkers, but more importantly allows us to look at each biomarker individually to make the final pathologic decision. This represents major advances in the practice of pathology."

It is estimated that approximately 10% of all cancer cases are misdiagnosed and 4% of solid tumors are presented as cancer of unknown primary "CUP".