On October 31, 2019 Thermo Fisher Scientific reported that it will host a series of customer presentations during its corporate workshops featuring the latest clinical research data on emerging biomarkers in cancer at the Association for Molecular Pathology (AMP) 2019 annual meeting on Nov. 6 (Press release, Thermo Fisher Scientific, OCT 31, 2019, View Source [SID1234550161]). The workshops will highlight details from studies in non-small cell lung cancer, immuno-oncology and hematology, and include the introduction of Thermo Fisher’s newest next generation sequencing (NGS) assay, Oncomine Comprehensive Assay Plus.*

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As the oncology biomarker landscape continues to evolve, greater clarity is needed to understand the prevalence and proper utilization of targeted and immuno-oncology biomarkers in tumor evaluation. Drs. Alain Mita, co-director of Experimental Therapeutics, and Eric Vail, director of Molecular Pathology at Cedars Sinai, will present data on RET fusions, the value of simultaneous assessment of comprehensive molecular results and the impact of faster turnaround times.

Ilaria Alborelli, Ph.D., scientist at the Institute of Pathology, University Hospital Basel, Switzerland, will deliver preliminary results from her assessment of Oncomine Comprehensive Assay Plus, a pan-cancer assay that covers more than 500 genes and enables simultaneous analysis of both DNA and RNA from just 10 ng in a single workflow. The new assay is designed to identify all classes of somatic variants, including SNVs, CNVs, fusions and splice variants, while also measuring tumor mutation burden (TMB) and microsatellite instability (MSI) – key biomarkers for emerging immunotherapies.

Dr. Yuri Fesko, medical director for oncology for Quest Diagnostics, will provide an overview of the limitations and best practices for TMB assessment results. The workshop will also feature comparison studies from Q2 Solutions which evaluated results from Oncomine TCR-Beta assays* with other on-market panels.

The rapid adoption of NGS to effectively assess driver mutations in hematology-oncology samples is providing many advantages and efficiencies over conventional molecular testing techniques. Speakers from the University of Nebraska Medical Center and Q2 Solutions will present their assessment of how to simplify analysis of myeloid and lymphoid samples using assays from Thermo Fisher’s portfolio of Oncomine panels, including Oncomine BCR IGH assays.*

For more information on the workshops taking place at the Baltimore Convention Center (9 a.m. E.T. Nov. 6, rooms 314-315) and other activities at AMP, please stop by Thermo Fisher’s booth (#2825), or visit the website.

* For Research use only. Not for use in diagnostic procedures

On October 31, 2019 RareCyte reported an addition to the RarePlex Staining Kit product line, enabling customers to evaluate HER2 and ER expression on circulating tumor cells (CTCs) in their own laboratory (Press release, RareCyte, OCT 31, 2019, View Source [SID1234550160]). HER2 and ER are biomarkers that direct treatment recommendations for invasive breast cancer, and liquid biopsy offers a blood-based method to evaluate biomarker expression for insight into receptor status, response to treatment, and potentially therapy selection in clinical research.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The RarePlex HER2/ER CTC Panel Kit includes all the reagents necessary for immunofluorescent detection of CTCs along with HER2 and ER expression. When combined with the RareCyte platform for CTC analysis, the RarePlex HER2/ER CTC Panel Kit enables the first blood-to-result breast-specific CTC assay deployable in customer laboratories.

The HER2/ER Panel Kit was validated based on rigorous requirements set to clinical standards with guidance from CLIA and industry experts. Tad George, PhD, Sr. VP of Biology R&D at RareCyte noted "Our approach to CTC assay development and validation is centered on creating deployable products that combine the sensitivity, specificity, and precision required for multi-center trials, not only for CTC enumeration but also for classifying CTCs based on their biomarker phenotypes."

Dr. Minetta Liu, MD, Professor and Research Chair in the Department of Oncology at Mayo Clinic recently presented her work with the HER2/ER CTC Panel Kit at the Advances in Circulating Tumor Cells Conference in Corfu, Greece. "Our early work with this assay has revealed interesting patterns of HER2/ER expression that vary widely across patients. Efforts will now focus on defining thresholds for HER2 and ER positivity that are specific to CTCs. This platform will facilitate important investigations into the clinical significance of CTC heterogeneity relative to standard tissue-based definitions of HER2 positive and/or hormone receptor positive advanced breast cancer."

The HER2/ER Panel Kit is available for purchase and more information on the HER2/ER Panel Kit and the RareCyte platform is available at rarecyte.com.

RareCyte products are for research use only. Not for use in diagnostic procedures.

On October 31, 2019 The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD, ‘Breakthrough Device Designation’ for the CYTOTRON – a CE marked, whole-body therapeutic medical device (Press release, Shreis Scalene Sciences, OCT 31, 2019, View Source [SID1234550159]). "We are confident that the FDA will continue to interact with Shreis under the premises of the recent guidance (Breakthrough Devices Program), to enable the marketing submission, with the clinical datasets needed to support it," said Prof. Meena Augustus, Co-Founder CEO & CSO of Shreis. The company’s designation request stated that "The Cytotron is intended to be used to cause degeneration of uncontrolled growth of tissues. It is indicated for treating protein-linked, abnormally regenerating disorders such as neoplastic disease, by selectively targeting and enabling tissue apoptosis, allowing extended progression-free survival, with pain relief, palliation, improved quality and dignity of life. It is indicated for the treatment of solid tumors of the breast, liver, and pancreas."

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Dr. Rajah Vijay Kumar D.Sc., Inventor of the Cytotron and Shreis’ technology partner, at Scalene Cybernetics Ltd (SCL), and the Scalene Center for Advanced Research & Development (S-CARD), located in Bengaluru, India, said, "The clinical trial with this non-invasive, tissue engineering platform technology called Quantum Magnetic Resonance Therapy (QMRT) could eventually help to establish the Cytotron as an integral adjunct to existing standards of care in the cancer armamentarium."(Cytotron Publication, 2016)

"We are very encouraged by the breakthrough designation that will expedite review of an Investigational Device Exemption and future marketing application by the FDA, " said Rayol John Augustus Ph.D., Founder-President and COO of SSS-LLC. The diligent support of Dr. R.V. Kumar D.Sc., the dedicated efforts of Emergo by UL based in Austin, Texas, the Shreis’ regulatory team, the staff of SCL and S-CARD, helped ensure a favorable decision by the FDA.

Shreis, while actively pursuing collaborations for clinical trials in the current proposed indications for use, intend to also submit a request for Breakthrough designation in other solid tumors such as adult and pediatric brain tumors, lung cancer, and other life-limiting diseases.

On October 31, 2019 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that it will release its third quarter 2019 financial results and provide a corporate update on Thursday, November 7, 2019, after the close of the U.S. financial markets (Press release, Arena Pharmaceuticals, OCT 31, 2019, View Source [SID1234550158]). The Company will host a conference call and live webcast to discuss the results with the investment community the same day at 4:30 PM EST.

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Conference Call & Webcast Information
When: Thursday, November 7, 2019, at 4:30 PM EST
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 2598434

Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of Arena’s website. A replay of the conference call will be archived under the investor relations section of Arena’s website for 30 days after the call.

On October 31, 2019 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, reported a regulatory and clinical update on IDE196 following receipt of meeting minutes from an End‑of‑Phase 1 (EOP1) meeting with the FDA (Press release, Ideaya Biosciences, OCT 31, 2019, View Source [SID1234550157]). IDE196 is being evaluated for the treatment of MUM and other solid tumors harboring activating GNAQ or GNA11 (GNAQ/11) mutations in its ongoing Phase 1/2 clinical trial entitled "Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions" (ClinicalTrials.gov Identifier: NCT03947385).

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"Following FDA feedback from the EOP1 meeting, we plan to initiate the Phase 2 single-arm, potentially registration-enabling clinical trial of IDE196 monotherapy. This arm of our clinical trial will target enrollment of 60 evaluable MUM patients with blinded independent central review (BICR)‑determined overall response rate (ORR) as the primary endpoint," said Bao Truong, Vice President, Head of Regulatory Affairs at IDEAYA Biosciences. "We look forward to the continued clinical advancement of IDE196 in MUM and in our broader tissue-type agnostic basket trial to treat other solid tumors that harbor activating GNAQ/11 mutations, including in cutaneous melanoma and colorectal cancer," said Julie Hambleton, M.D., Chief Medical Officer and Senior Vice President at IDEAYA Biosciences.

Regulatory and Clinical Program Highlights for IDE196:

FDA EOP1 meeting minutes indicate that the proposed single-arm Phase 2 IDE196 clinical trial may be adequate to support a new drug application (NDA) seeking Accelerated Approval of IDE196 monotherapy for the treatment of MUM
Phase 2 dose selection, and the single-arm, potentially registration‑enabling Phase 2 part of the Phase 1/2 clinical trial is anticipated to be initiated in Q4 2019
This Phase 2 clinical trial will target enrollment of 60 evaluable MUM patients with the primary endpoint of overall response rate (ORR) as determined by blinded independent central review (BICR), supported by BICR‑determined duration of response (DOR) as a secondary endpoint
The 13-week GLP-compliant toxicology studies in 2 species is scheduled to initiate in November 2019, in support of FDA requirement that results of these studies be submitted prior to enrollment of more than approximately 50 patients in the investigational arm of the clinical trial that will support a marketing application
An immediate release tablet formulation for IDE196 is on-track for introduction in the clinic in Q1 2020, as a potential registration and commercial formulation
Interim data for GNAQ/11 Phase 1/2 basket trial expected in Q2/Q3 2020
Confirmed Complete Response observed at month 31 in one patient previously reported with confirmed Partial Response in the ongoing IDE196 monotherapy clinical trial conducted by Novartis (ClinicalTrials.gov Identifier: NCT02601378)
"We are grateful for the regulatory feedback from the FDA on our single-arm trial design, providing an opportunity for a potential Accelerated Approval path for IDE196 monotherapy in MUM, a high unmet medical need and a solid tumor indication where there are no FDA approved therapies. We are also encouraged to see continued progress in our tissue-type agnostic GNAQ/11 Phase 1/2 basket trial to treat solid tumor patients beyond MUM," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.