On November 4, 2019 Genoscience Pharma is reported a new data from in vivo study of GNS561 alone or in combination with a PD-1 inhibitor in a transgenic mouse model of hepatocarcinoma (HCC) (Press release, GenoScience, NOV 4, 2019, View Source [SID1234550467]). In addition to good tolerance, GNS561 in combination with a PD-1 inhibitor showed significant antitumoral activity, with a 77% decrease in the macronodule counts compared to control group. This new data shows GNS561 allows PD-1 inhibitor to recover its antitumoral efficacy.

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Genoscience Pharma, a clinical-stage biotechnology company dedicated to discovering and developing anticancer treatment drugs, today announces that its poster demonstrating promising results from a combination study with a PD-1 inhibitor in a transgenic mouse model of hepatocarcinoma (HCC) was selected for presentation at the American Association for the Study of Liver Diseases (AALSD) Liver Meeting 2019 being held November 8-12, 2019 in Boston, MA.

The in vivo study was performed in a transgenic immunocompetent mouse model of HCC (ASV-B). Animals were treated by vehicle, GNS561 or PD-1 inhibitor as monotherapy or GNS561 in combination with PD-1 inhibitor. Results showed an outstanding anticancer response, with a 77% decrease of the macronodule count in the combination group compared to controls.

"We are delighted to be presenting this positive in vivo study at the AASLD Liver Meeting 2019. These results may open a new horizon in the area of immuno-oncology by enlarging indication of the use of immune checkpoint inhibitors in tumor types that are marginally sensitive to immunotherapy or for patients developing resistance to checkpoint inhibitors. We believe our results provide a strong rationale for combining our drug to a PD-1 inhibitor antibody in clinical trials with HCC patients" said Pr Eric Raymond, Chief Medical Officer at Genoscience Pharma.

"We are looking forward to assessing this combination in HCC patients, for which immunotherapy hasn’t answered the current medical need" commented Pr Philippe Halfon, president and founder of Genoscience Pharma.

Genoscience Pharma will be also presenting three additional posters at the conference. Data on the primary results of the ongoing Phase 1b assessing GNS561 in patients with primary or secondary liver cancers will be presented as well as efficacy preclinical data against intra-hepatic cholangiocarcinoma and liver fibrosis.

The details for the Company’s poster presentation are as follows:

Presenting Author: Philippe Halfon, MD, PhD.
Abstract title: GNS561, a New Oral Clinical-Stage Small Molecule Combined with a PD-1 Inhibitor Showed Remarkable Anti-Tumor Effects in a Transgenic Immunocompetent Hepatocellular Carcinoma Mouse Model (ASV-B). Poster 1993.
Presentation date and time: November 11, 2019 (presentation from 12.30 pm to 1.30 pm)

On November 2, 2019 Vaccibody AS, a clinical stage company focused on developing personalized neoepitope cancer vaccines to target solid tumors, reported that it will host its capital markets day on November 12 and is pleased to invite investors, analysts and press to presentations by the members of the company’s executive management team and by Ulrich Granzer, PhD, founder of Granzer Regulatory Consulting & Services (Press release, Vaccibody, NOV 2, 2019, View Source [SID1234550196]). Granzer has a wide range of experience in all aspects of drug development and regulatory affairs, with particular focus on bringing novel therapies to market.

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Venue: Forskningsparken, Gaustadalléen 21, 0349 Oslo. Meeting room Faros.

Date: Tuesday, 12th November 2019

Agenda:

14.00-14.10 Introduction Michael Engsig
14.10-15.00 Update on the VB N-01 study including the clinical data Agnete Fredriksen
15.00-15.45 Status of the cancer vaccine field and development of novel immunotherapies Ulrich Granzer
15.45-16.05 Company update Michael Engsig
16.05-16.30 Questions & Answers All
16.30-17.30 Mingling, snacks and drinks All

On November 2, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported new data that advance understanding of the frequency, positive predictive value and co-occurrence of genomic alterations that are targeted by newly available and investigational precision medicine therapies for thyroid cancer (Press release, Veracyte, NOV 2, 2019, View Source [SID1234550197]). The findings were enabled by Afirma Xpression Atlas analyses, which uses RNA sequencing, of Veracyte’s extensive biorepository of thyroid nodule fine needle aspiration (FNA) samples from patients undergoing evaluation for thyroid cancer. The data were presented this week during the 89th Annual Meeting of the American Thyroid Association (ATA).

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In one study, researchers assessed the frequency of ALK, BRAF, NTRK and RET fusions in nearly 48,000 consecutive patients whose thyroid nodule FNA samples were deemed indeterminate, suspicious for malignancy or malignant (Bethesda III/IV, V and VI categories, respectively) by cytopathology. The researchers found that 425 (0.89 percent) of the FNA samples harbored one of the alterations, with NTRK fusions the most common at 0.38 percent, followed by RET (0.32 percent), BRAF (0.13 percent) and ALK (0.06 percent). Additionally, RNA whole transcriptome sequencing demonstrated differences in the prevalence of these four fusions across Bethesda categories, with Bethesda V being the highest.

"NTRK fusion inhibitors have received pan-cancer FDA approval and clinical trials have included selective inhibitors of ALK, BRAF, NTRK and RET, which makes their detection in patients with thyroid cancer of interest to physicians," said Mimi I. Hu, M.D., professor at The University of Texas MD Anderson Cancer Center, who presented the findings in a poster. "As our understanding of the role of genomics in thyroid cancer advances, this information offers the potential to optimize initial treatment, predict response to treatment and prioritize selective targeted therapy should systemic treatment be needed."

In another study, researchers evaluated the positive predictive value of the NTRK, RET, BRAF and ALK fusions in 58 patients with indeterminate thyroid nodules (Bethesda III/IV categories) from Veracyte’s biorepository for whom surgical pathology diagnoses were available. They found that NTRK and RET fusions were associated with malignancy in 28 of 30 nodules, while risk of malignancy was lower among nodules with ALK (67 percent) or BRAF (75 percent). In a third study, researchers found that when using RNA sequencing data on a large sample of nearly 48,000 thyroid nodule FNA samples (Bethesda categories III-VI), they identified 263 co-occurrences of gene fusions and variants that were previously considered "mutually exclusive."

"The findings from these three studies underscore the power of our extensive biorepository of thyroid nodule FNA samples and our optimized RNA sequencing platform to advance understanding of the genomic underpinnings of thyroid cancer and to better capture the biology of thyroid lesions," said Richard T. Kloos, M.D., senior medical director, endocrinology, at Veracyte. "As precision medicine therapies that target specific gene alterations emerge, understanding individual patients’ genomic profiles becomes increasingly important to physicians. Our Afirma Xpression Atlas provides this information at the same time as initial diagnosis with the Afirma Genomic Sequencing Classifier, or GSC, to help inform treatment decisions."

Also during the ATA meeting, Veracyte unveiled its new Afirma patient report, which in addition to identifying patients with benign or suspicious-for-cancer nodules among those deemed indeterminate by cytopathology, based on Afirma GSC results, now provides individualized and actionable variant and fusion information on each patient. This information includes: risk of malignancy, associated neoplasm type, relative risk of lymph node metastasis and extrathyroidal extension; availability of FDA-approved therapy; and genetic counseling and germline testing considerations. This information is also provided for patients with cytopathology results that are suspicious for malignancy or malignant (Bethesda V and VI).

About Afirma

The Afirma Genomic Sequencing Classifier (GSC) and Xpression Atlas provide physicians with a comprehensive solution for a complex landscape in thyroid nodule diagnosis. The Afirma GSC was developed with RNA whole-transcriptome sequencing and machine learning and helps identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to help patients avoid unnecessary diagnostic thyroid surgery. The Afirma Xpression Atlas provides physicians with genomic alteration content from the same fine needle aspiration samples that are used in Afirma GSC testing and may help physicians decide with greater confidence on the surgical or therapeutic pathway for their patients. The Afirma Xpression Atlas includes 761 DNA variants and 130 RNA fusion partners in over 500 genes that are associated with thyroid cancer.

On November 1, 2019 OPKO Health, Inc. (NASDAQ: OPK) reported its operating and financial results for the three months ended September 30, 2019, as well as provide guidance on expected revenues and operating expenses for the third quarter 2019, after the close of the U.S. financial markets on Tuesday, November 5, 2019 (Press release, Opko Health, NOV 1, 2019, View Source [SID1234550185]).

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OPKO’s senior management will provide a business update and discuss its financial results in a live conference call and audio webcast beginning at 4:30 p.m. Eastern time on Tuesday, November 5, 2019.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time on Tuesday, November 5, 2019. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN: 866-634-2258
INTERNATIONAL DIAL-IN: 330-863-3454
PASSCODE: 7270239
WEBCAST: OPKO 3Q19 Results Conference Call
For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 7270239. The replay can be accessed for a period of time on OPKO’s website at OPKO 3Q19 Results Conference Call.

On November 1, 2019 Biodesix, Inc., reported that it has completed acquisition of Oncimmune’s laboratory and incidental pulmonary nodule (IPN) malignancy test in the United States, further extending the company’s blood-based lung cancer diagnostic portfolio (Press release, Biodesix, NOV 1, 2019, View Source [SID1234550186]). The United Kingdom-based company’s U.S. commercial and lab operations, including a Clinical Laboratory Improvement Amendments (CLIA) lab in DeSoto, Kansas, today transitioned to Biodesix. The Kansas lab is the sole U.S. provider of the EarlyCDT Lung test.

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"Biodesix is a leader in the development and delivery of blood-based diagnostic solutions for lung cancer. The completion of the acquisition of Oncimmune in the U.S. is emblematic of our continued growth in providing support across the continuum of patient lung care," said David Brunel, CEO of Biodesix. "Oncimmune shares this commitment, and we are proud to continue our partnership. We are both dedicated to robust science and quality, while putting the individual patient experience first."

Biodesix will offer complementary tests that help empower physicians to stratify patients into distinct nodule management pathways. The EarlyCDT Lung test helps physicians determine if an incidental pulmonary nodule (IPN) is potentially cancerous, while the Nodify XL2TM Test is used to help physicians identify those IPNs with a very low risk of cancer. In addition to lung nodule management, the EarlyCDT Lung test may have future utility in lung cancer screening. Results from Early detection of Cancer of the Lung Scotland (ECLS), a randomized controlled study of 12,209 people at high risk of developing cancer, were presented at the International Association for the Study of Lung Cancer’s (IASLC) 2019 World Conference on Lung Cancer in Barcelona.

"We are delighted to be working with Biodesix, a company with a successful track record of commercializing clinical diagnostic lung tests in the U.S. and that is dedicated to improving patient management and outcomes. In the near term, EarlyCDT Lung is a very synergistic addition to the Nodify XL2 test in helping physicians manage IPNs. Longer term, the addition of a screening indication for EarlyCDT Lung in the U.S. will fully realize the value of the test and will ultimately save lives through earlier detection of lung cancer," said Adam M. Hill, M.D., Ph.D., CEO of Oncimmune.