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QIAGEN gains CE-marking for in-vitro diagnostic kit and its automated testing platform NeuMoDx under new EU IVDR framework

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.

Genomic Testing Cooperative and its Co-Op Members First to Use Artificial Intelligence to Distinguish Between 45 Hematologic and Solid Neoplasms Using Targeted Transcriptome

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]).

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".

Jacobio Pharma to Collaborate with Merck on Clinical Trial of JAB-21822 in Combination with Cetuximab

On October 13, 2022 Jacobio reported it has entered into a clinical trial collaboration agreement with Merck on clinical study of combination therapy between Jacobio’s KRAS G12C inhibitor JAB-21822 and Merck’s epidermal growth factor receptor (EGFR) inhibitor Erbitux (cetuximab) (Press release, Jacobio Pharmaceuticals, OCT 13, 2022, View Source [SID1234621975]).

This clinical study aims to evaluate the efficacy of JAB-21822 in combination with cetuximab in patients with KRAS G12C-mutated colorectal cancer. Jacobio is the sponsor of the combination study, and Merck will provide cetuximab for clinical trials in China and Europe under the collaboration agreement.

"Our preclinical studies have shown that the combination of JAB-21822 and cetuximab can enhance the anti-tumor activity of JAB-21822 inhibitors in colorectal cancer tumor models, regressing tumors and delaying tumor regrowth after drug discontinuation. We look forward to new treatment options for patients through our collaboration with Merck," said Dr. WANG Yinxiang, Chairman and Chief Executive Officer of Jacobio.

About JAB-21822

JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer first-line treatment; combination therapy with SHP2 inhibitor, PD-1 monoclonal antibody and cetuximab.

About ERBITUX (cetuximab)

ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).

ERBITUX has obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.

OSE Immunotherapeutics Presents Update on BiCKI®-IL-7v and CLEC-1 Immuno-Oncology Programs at International Conferences

On October 12, 2022 OSE Immunotherapeutics SA reported that three posters have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting which will be held in person and virtually in Boston, MA, November 8 – 12 (Press release, OSE Immunotherapeutics, OCT 12, 2022, View Source [SID1234646961]). The posters will feature the latest preclinical data on the Company’s pioneering drug discovery BiCKI and Myeloid platforms and including BiCKI-IL-7 (bifunctional therapy targeting PD-1 and IL-7) and CLEC-1 (new myeloid immune checkpoint). The Company was also invited for an oral presentation at the Macrophage-directed Therapies Summit of its CLEC-1 program (Boston, October 2022).

POSTER PRESENTATION DETAILS AT THE SITC (Free SITC Whitepaper) 2022
BiCKI-IL-7v program
– Title: "IL7R TME expression correlates with immunotherapy response and is associated with Tcell stemness with decreased apoptosis" (poster #826)
Presentation date: November 11, 2022

– Title: "Anti-PD-1/IL-7v bispecific antibody promotes TCF1+ stem like T cells expansion and longlasting in vivo efficacy" (poster #1366)
Presentation date: November 11, 2022

CLEC-1 program*
– Title: "Blockade of the myeloid CLEC-1 checkpoint enhances antitumor responses and tumor antigen cross-presentation" (abstract #484)
Presentation date: November 11, 2022

ORAL PRESENTATION AT THE MACROPHAGE-DIRECTED THERAPIES SUMMIT 2022
– Title: "The C-type Lectin CLEC-1 is a Sensor of Cell Death Limiting Myeloid Cell Functions and Anti-Tumor Immunity"
Presentation date: October 4, 2022

Calidi Biotherapeutics to Present Pre-Clinical SuperNova1 (SNV1) Data at the 2022 SITC Annual Meeting

On October 12, 2022 Calidi Biotherapeutics, Inc. (Calidi), a clinical-stage biotechnology company that is pioneering allogeneic cell-based platforms to revolutionize oncolytic virus therapies, reported a poster presentation highlighting pre-clinical data from the company’s SuperNova1 (SNV1) program at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, taking place in Boston, Massachusetts and virtually, November 8-12, 2022 (Press release, Calidi Biotherapeutics, OCT 12, 2022, View Source [SID1234623229]).