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Biocartis and Merck to Collaborate on New Liquid Biopsy Technology for RAS Biomarker Testing

Biocartis, an innovative molecular diagnostics company, recently announced that Biocartis has signed a collaboration agreement with Merck KGaA (Merck) for the development and commercialization of a new liquid biopsy RAS biomarker test for patients with metastatic colorectal cancer (mCRC). The test will be developed on Biocartis’ innovative, fully automated molecular diagnostics system, Idylla™, which is designed to offer accurate and reliable molecular information from virtually any biological sample in virtually any setting. The new test aims to support clinical practice in performing integrated liquid biopsy RAS biomarker tests, independently of the laboratories’ volume of testing or level of expertise.

Quest Diagnostics Introduces Dako’s PD-L1 Companion Diagnostic for KEYTRUDA, Merck’s Anti-PD-1 Therapy for Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 with Disease Progression On or After Platinum-Containing Chemotherapy

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced that it will provide clinical laboratory testing using the PD-L1 IHC 22C3 PharmDx™ immunohistochemistry companion diagnostic.

Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) with Pembrolizumab Presented at AACR Annual Meeting and Published in the New England Journal of Medicine

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new data from KEYNOTE-001, a Phase 1b study evaluating pembrolizumab, the company’s investigational anti-PD-1 therapy, in naïve and previously-treated patients with advanced non-small cell lung cancer (NSCLC). In a new analysis of 313 patients from a validation data set for tumour PD-L1 expression, overall-response rate (ORR) was 45.4 percent (95% CI, 33.5-57.3) in patients with greater than or equal to (>=) 50 percent of tumour cells positive for PD-L1 expression (n=73). In the other PD-L1 subgroups, ORR was 16.5 percent (95% CI, 9.9-25.1) in patients with 1-49 percent tumour cells positive (n=103) and 10.7 percent (95% CI, 2.3-28.2) in patients with less than1 percent tumour cells positive (n=28) for PD-L1 expression. In the total study population, ORR was 19.4 percent (95% CI, 16.0-23.2) (n=495), which was consistent with data previously presented from this study. These data from KEYNOTE-001 will be presented today by Dr. Edward Garon, Jonsson Comprehensive Cancer Center, University of California, Los Angeles at the American Association for Cancer Research (AACR) Annual Meeting (abstract #CT104), were part of the AACR press program, and were also published today in the New England Journal of Medicine.

Sysmex Inostics and Merck Serono Announce First RAS Testing Center Implementing Sysmex Inostics’ Blood-based OncoBEAM Testing in Spain: Important Milestone for mCRC Patients

Sysmex Inostics, a subsidiary of Sysmex Corporation, recently announced the first RAS biomarker testing site offering their (Sysmex Inostics) blood-based OncoBEAM™ tests in Spain. Aside from Sysmex Inostics’ US-based CLIA certified laboratory, the Vall d’Hebron Institute of Oncology located in Barcelona, Spain, will be the first of numerous medical centers globally to use OncoBEAM™ assays for patients with metastatic colorectal cancers (mCRC) once CE Mark is received. This marks an important milestone in Sysmex Inostics’ collaboration with Merck’s biopharmaceutical business, Merck Serono, for the development and commercialization of a RAS biomarker testing kit for patients with mCRC, which was signed at a ceremony coinciding with the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, U.S in June 2014.

EMD Serono Establishes Immuno-Oncology Research and Early Development Platform to Advance Innovation in Cancer Therapies

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, recently announced its commitment to the field of cancer immunotherapy by creating a fully dedicated immuno-oncology innovation platform integrating research, early development and biomarker strategies. In addition to the company’s existing oncology platform, this new immuno-oncology platform will focus on developing therapies that leverage the immune system’s natural ability to fight tumors, and work in combination with existing and future therapies.

“We are pleased to announce our commitment to immuno-oncology, recognizing that the complexity of cancer requires diverse approaches that will enable alternative therapeutic interventions,” said Bernhard Kirschbaum, Head of Global Research and Early Development at Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “In order to spur research and early development in this specialized area, we have created an innovative environment where researchers and clinicians work side-by-side to advance potential new cancer immunotherapies.”

The new immuno-oncology platform includes three innovation clusters, each of which is focused on discovery research and the advancement of molecules into the clinic through proof of confidence:

  • Therapeutic cancer vaccines: targeting tumor antigens to elicit a tumor-specific immune response
  • Cancer stem cells: targeting cancer stem cells to prevent or reduce tumor formation and inhibit metastases
  • Immunotolerance: eliminating or circumventing inhibitory mechanisms in the immune system that prevent cancer cells from being recognized and attacked by the body

To ensure a broad immuno-oncology research and early development platform, EMD Serono has assembled an in-house team of preeminent researchers and clinicians who will focus resources and technologies to build a portfolio of investigational immunotherapies, while collaborating with premier academia, research and industry organizations to complement internal capabilities.

The current immuno-oncology portfolio comprises therapeutic candidates in early clinical development and a robust pipeline of pre-clinical molecules. Leading therapeutic concepts in the clinic are:

  • A monoclonal antibody targeting PD-L1 (programmed cell death ligand) expressed by various tumors, currently in Phase I in solid tumors
  • NHS-IL12, a cancer immunotherapy targeting IL-12 to the necrotic regions of tumors, sponsored by the United States National Cancer Institute (NCI), currently in Phase I in solid tumors
  • NHS-IL2, targeting IL-2 to the necrotic regions of tumors, completed Phase I and currently preparing for Phase II in solid tumors

“Our goal is to develop leading immunotherapies that work in combination with other therapeutic modalities, understanding that attacking multiple cancer targets simultaneously increases the possibility of therapeutic success,” said Helen Sabzevari, Head of Immuno-Oncology, Global Research and Early Development at Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “We are committed to delivering on the promise of immuno-oncology by combining creative thinking with strong research and clinical excellence, and, more importantly, by keeping patient needs at the heart of our efforts.”

Source: EMD Serono