On December 19, 2017 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will announce results for the fourth quarter of 2017 on Monday, February 5, 2018 (Press release, Bristol-Myers Squibb, DEC 19, 2017, View Source [SID1234522695]). During a conference call at 8:00 a.m. ET on February 5th company executives will review financial information and will address inquiries from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 866-548-4713 or international 323-794-2093, confirmation code: 4392051. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 11:00 a.m. ET on February 5, 2018 through 11:00 a.m. ET on February 19, 2018. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820 confirmation code: 4392051.

On December 18, 2017 AstraZeneca reported that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations) (Press release, AstraZeneca, DEC 18, 2017, View Source [SID1234522687]). The FDA has granted Tagrisso Priority Review status and previously granted Breakthrough Therapy Designation in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.

The submission acceptance is based on data from the Phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival (PFS) compared to current 1st-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.

On 28 September 2017, the US National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were updated to include the use of Tagrisso in the 1st-line treatment of patients with metastatic EGFRm NSCLC. The use of Tagrisso in this indication is not yet approved by the FDA.

About NSCLC

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-quarter of all cancer deaths, more than breast, prostate and colorectal cancers combined. Approximately 10-15% of patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC. These patients are particularly sensitive to treatment with currently-available EGFR-TKIs, which block the cell-signalling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to EGFR-TKI treatment leading to disease progression. Approximately half of patients develop resistance to approved EGFR-TKIs such as gefitinib and erlotinib due to the resistance mutation, EGFR T790M.Tagrisso also targets this secondary mutation that leads to disease progression. There is also a need for medicines with improved CNS efficacy, since approximately 25% of patients with EGFR-mutated NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis.

About Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have been approved in more than 60 countries, including the US, EU, Japan and China, for patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being investigated in the adjuvant setting and in combination with other treatments.

About the FLAURA trial

The FLAURA trial assessed the efficacy and safety of Tagrisso 80mg once daily vs standard-of-care EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patients with locally-advanced or metastatic EGFR-mutated NSCLC. The trial was a double-blinded, randomised trial, with 556 patients across 29 countries.

About AstraZeneca in Lung Cancer

AstraZeneca is committed to developing medicines to help every patient with lung cancer. We have two approved medicines and a growing pipeline that targets genetic changes in tumour cells and boosts the power of the immune response against cancer. Our unrelenting pursuit of science aims to deliver more breakthrough therapies with the goal of extending and improving the lives of patients across all stages of disease and lines of therapy.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

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On December 18, 2017 ONCODESIGN (Paris:ALONC) (ALONC – FR0011766229), a biopharmaceutical company specializing in precision medicine, and CYCLOPHARMA, a company developing leading molecular imaging solutions, in cooperation with Centre Georges François Leclerc (CGFL), the regional cancer research and treatment center for Burgundy, reported promising results for the Phase 1 study of the first radiotracer 1 to come out of the IMAkinib program (Press release, Oncodesign, DEC 18, 2017, View Source [SID1234522715]).

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The radiotracer, labelled with radioactive 18F-fluorine, is a molecule generated using Oncodesign’s Nanocyclix technology whose use as a companion biomarker in targeted EGFR inhibitor therapy2 is being assessed in patients with lung tumors.

The current clinical study has as its primary objective the assessment of the clinical advantages of the radiotracer using PET3, by determining its sensitivity and specificity in patients with pulmonary tumors treated with targeted anti-EGFR therapy. It is the product of cooperation between Centre Georges François Leclerc, Cyclopharma and Oncodesign as part of the Dijon-based Pharmimage cluster.

The first stage of the clinical trial, in 8 patients with EGFR mutations, has produced very encouraging results in terms of product safety, dosage and fixing on pulmonary tumors expressing mutated EGFR. These results allow the launch of the second stage of the clinical study, with the inclusion of 6 new patients with non-mutated EGFR receptors. The aim of this second stage is to demonstrate the radiotracer’s specificity.

Full results from the Phase 1 study are expected in the first half of 2018. Positive results would directly allow the design of a Phase 3 clinical study, with the final objective of application for Marketing Authorization.

"Measuring EGFR receptor activity in lung cancer enables early detection of tumor resistance to anti-EGFR therapies, and thus better care for patients," said Philippe Genne, founder, Chairman and CEO of Oncodesign. "In comparison with other types of companion biomarkers, using liquid or solid biopsy techniques, the advantage of a PET-based approach is that it gives clinicians an idea of the heterogeneity of the disease in the whole of the patient’s body. Together with our partners we have been pioneers in this approach."

Activating mutations for EGFR kinase are a cause of non-small cell pulmonary adenocarcinomas, which represent between 10% and 15% of lung cancers in the Caucasian population and between 30% and 50% of those in patients of Asian origin. This type of cancer affects nearly 6,000 patients in France each year, with a projection of 1.3 million patients worldwide by 2022 (up 22% in 10 years). The main treatments for this pathology include tyrosine kinase inhibitors that target EGFR, meaning that the use of a biomarker that can help clinicians in their selection of treatments is a major step forward in precision medicine.

On December 18, 2017 NanOlogy LLC, a clinical-stage pharmaceutical development company, reported the first patient has been enrolled in a clinical trial of NanoPac (nanoparticle paclitaxel) sterile suspension administered intratumorally in patients with locally advanced pancreatic adenocarcinoma (Press release, NanOlogy, DEC 18, 2017, View Source [SID1234522699]). The Phase 2a dose-rising trial will evaluate the safety and preliminary efficacy of NanoPac delivered directly into the tumor by endoscopic ultrasound-guided fine needle injection in patients who have completed current standard of care treatment prior to trial entry.

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NanoPac is part of an extensive submicron technology platform developed by NanOlogy. Gere diZerega, MD, VP of Medical Affairs, will present an overview of the platform and an update of the clinical program at Biotech Showcase, on January 8, 2018 at 3:45PM in Franciscan room D (Ballroom Level) of the Hilton San Francisco Union Square.

In 2017, an estimated 54,000 new cases of pancreatic cancer will be diagnosed in the U.S. and 43,000 people will die from the disease. Despite being relatively rare, pancreatic cancer is the third leading cause of cancer death in the USA with a survival rate of only 25% at one year and less than 10% at five years. Pancreatic cancer is so deadly because it is rarely diagnosed at an early stage while it is still local, and the disease tends to be aggressive and resistant to systemic chemotherapy. Recent advances in abdominal imaging techniques hold the promise for earlier diagnosis of pancreatic cancer and the ability to treat the disease before it spreads to other parts of the body.

"The advanced endoscopy team at Baylor College of Medicine and St Luke’s Medical Center performed the first endoscopic ultrasound-guided intratumoral injection of NanoPac for locally advanced pancreatic cancer last Friday," said Dr. Mohamed Othman, MD, Director of Advanced Endoscopy and Associate Professor of Medicine at Baylor College of Medicine in Houston, TX. "The team is hopeful that this approach may offer a more potent and less toxic alternative for patients with locally advanced disease."

"The targeted administration of submicron particle paclitaxel sterile suspension [NanoPac] by endoscopic ultrasound (EUS) represents an important step in the fight against pancreatic cancer," said Jacques Van Dam, MD, PhD, Professor of Medicine and Clinical Scholar at the University of Southern California’s Keck School of Medicine, and Principle Investigator for this multicenter trial. "Pancreatic cancer patients, their families, and their physicians recognize all too well the limitations of current therapies. Delivering NanoPac directly into the tumor may eliminate many of the toxic side effects of standard chemotherapy, while providing a higher concentration of drug directly to its intended target."

NanOlogy has a broad clinical development program underway for NanoPac sterile suspension, including clinical trials in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. In addition, NanOlogy and affiliate DFB Soria are progressing clinical trials for Soria-developed SOR007 (nanoparticle paclitaxel) ointment in cutaneous metastases and actinic keratosis. Clinical trials for NanoDoce (nanoparticle docetaxel) are planned in 2018 pending IND approval. An inhaled version of NanoPac has shown evidence of tumor reduction in a preclinical lung cancer study after PK studies demonstrated retention of drug in lung tissues for more than 14 days following nebulized inhalation and no abnormalities within the trachea or lung upon gross and histologic exam.

Starting with the world’s most prescribed systemic chemotherapeutic agents, the patented NanOlogy submicron particle production technology reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into patented, stable, naked submicron particles with exponentially increased surface area and unique geometry. Unlike conventional nanoparticles, which use coating or carrier agents for stability, NanoPac and NanoDoce particles are stable in their naked form and suspended prior to use without such agents for local delivery to the site of disease.

On December 18 2017 Galera Therapeutics, Inc. reported positive results from its Phase 2b clinical trial for its lead drug candidate, GC4419 for severe oral mucositis (SOM) in patients with head and neck cancer receiving chemoradiation (Press release, Galera Therapeutics, DEC 18, 2017, View Source [SID1234522697]). In the intent-to-treat population, the 90 milligram (mg) dose of GC4419 met its primary endpoint, demonstrating a highly significant (p=0.024), clinically meaningful and dose-dependent reduction in the duration of SOM as defined by the World Health Organization as Grade 3 or 4. In the pre-specified secondary endpoints, GC4419 demonstrated a consistent effect across all efficacy measures.

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"We are excited by these results and believe these are robust data in this patient population. Up to 70 percent of patients with head and neck cancer receiving radiotherapy experience severe oral mucositis, and GC4419 has the potential to become an important treatment in a therapeutic area that has not seen meaningful innovation," said J. Mel Sorensen, M.D., Galera Therapeutics, President and Chief Executive Officer. "The results of this trial validate the superoxide dismutase mimetic mechanism of action of GC4419, demonstrating its role in reducing the side effects of radiation therapy. We look forward to discussing the results of this trial and our next steps with the FDA."

The 223-patient, double blind, randomized, placebo-controlled trial treated patients with head and neck cancer with either 30 mg or 90 mg of GC4419 or placebo by infusion on the days they received their radiation treatment. Patients were randomized to one of the three treatment groups (1:1:1) and the trial recruited patients in both the United States and Canada. The primary outcome measure was the duration of SOM experienced by patients scheduled to receive seven weeks of radiation therapy plus cisplatin.

GC4419 was well tolerated and the frequency of treatment-related side effects was comparable across all treatment arms in the trial.

"Oral mucositis is a common and debilitating side effect of chemoradiation to treat head and neck cancer. Oral mucositis can severely and negatively impact quality of life, treatment outcomes and recovery, as many patients are unable to eat or drink for several weeks," said Carryn Anderson, M.D., Head and Neck Radiation Oncologist, University of Iowa. "New treatment options are urgently needed to reduce or eliminate this problem, and the Phase 2b data on GC4419 suggests a new approach to mitigate oral mucositis in patients with head and neck cancer by preventing the damaging effects of radiation in normal tissue."

About Oral Mucositis

In the United States, more than 50 percent of patients with cancer receive radiotherapy at some time in their treatment. In patients with head and neck cancer, radiotherapy is a mainstay of treatment and approximately 70 percent of patients receiving chemoradiotherapy develop severe oral mucositis as defined by the World Health Organization as Grade 3 or 4, which is the most debilitating side effect of the radiotherapy. Oral mucositis can also adversely affect cancer treatment outcomes. In addition, patients with severe OM suffer significant pain, may be unable to eat solid food or even drink liquids, and may develop serious infections. Further, the costs of managing these side effects are substantial, particularly when hospitalization and/or surgical placement of PEG tubes to maintain nutrition and hydration are required. Importantly, severe OM may result in interruptions in radiotherapy, which can compromise the otherwise good prognosis for tumor control in many of these patients. There is currently no drug approved to prevent or treat severe OM in patients with head and neck cancer.