On May 29, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) reported that the Company will participate in two investor conferences in June (Press release, Valeant, MAY 29, 2019, View Source [SID1234536630]).

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Paul S. Herendeen, executive vice president and chief financial officer, Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, and William Woodfield, vice president and treasurer, are scheduled to participate at the Barclays High Yield Bond & Syndicated Loan Conference in Colorado Springs, Colo., on June 6, 2019 at 10:50 a.m. MDT (12:50 p.m. EDT).

Joseph C. Papa, chairman and chief executive officer, Sam Eldessouky, senior vice president and corporate controller, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the BMO Prescription for Success Healthcare Conference in New York on June 25, 2019 at 10:00 a.m. EDT.

Live webcasts and audio archives of the presentations will be available on the Investor Relations page of the Bausch Health Companies Inc. web site at: View Source

On May 28, 2019 Prestige BioPharma (herein, Prestige) reported that European Medicines Agency (EMA) has validated and accepted for review the Marketing Authorization Application (MAA) for its trastuzumab biosimilar HD201 (Tuznue) on 23 May 2019 (Press release, Prestige BioPharma, MAY 28, 2019, View Source [SID1234593981]).

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HD201 is Prestige’s lead development candidate biosimilar to Herceptin (trastuzumab), which is indicated for the treatment of adult patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Accordingly, if authorized by the EMA, HD201 (Prestige) would take part in the race along with Herzuma (Celltrion), Kanjinti (Amgen), Ontruzant (Samsung Bioepis), and Trazimera (Pfizer) to seize the EU market as one of the comparable biosimilars, which is currently dominated by Herceptin (Roche).

Furthermore, the positive top-line results from the Phase I / Phase III global clinical trial of HD201 confirm that HD201 is exceptionally biosimilar to Herceptin in terms of clinical response and PK, in addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials.

Dr Lisa S. Park, Chief Executive Officer of Prestige, commented: "We are very pleased that EMA has initiated the review of the HD201 Marketing Authorisation Application. It is a major step in our endeavor to become a global player focussing on biosimilars and innovative biologics. Our development approach has proven to be highly efficient with regard to trial performance, demonstrating exceptional similarity, and dossier filing."

HD201 will be Prestige’s first biosimilar to receive a positive Committee for Medicinal Products for Human Use (CHMP) opinion for marketing authorization from the EMA. Based on this achievement, Prestige will continue to move forward with other 8 biosimilars and innovative biologics in its portfolio, which are currently at different stages of development, from nonclinical development to advanced clinical stages.

On May 28, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that management will participate in the following investor conferences in June (Press release, Autolus, MAY 28, 2019, View Source [SID1234550816]):

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Dr. Christian Itin, chairman and chief executive officer, will present at the Jefferies 2019 Healthcare Conference in New York on Wednesday, June 5 at 2:30 p.m. ET and will host one-on-one meetings with attendees. A live webcast of the presentation will be available on the investor relations section of Autolus’ website at View Source An archived replay will be available on the company’s website for a period of 90 days after the conference.
Andrew Oakley, chief financial officer, and Christopher Vann, chief operating officer, will participate in the Goldman Sachs 40th Annual Global Healthcare Conference in Rancho Palos Verdes, Calif., hosting one-on-one meetings on Tuesday, June 11, 2019.

On May 28, 2019 Axial Biotherapeutics, a biotechnology company dedicated to building a unique class of gut-targeted programs for neurodegenerative diseases and neurodevelopmental disorders, reported that the company will participate in the following conferences in June (Press release, Axial Biotech, MAY 28, 2019, View Source [SID1234537218]):

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BIO International Convention 2019 on Monday, June 3, 2019 at 3:00 p.m. ET in Philadelphia, PA
Panel Presentation: What’s Next: The Landscape of Innovation in 2019 and Beyond
Session ID: 537703
CNS Targets and Translational Strategies on Wednesday, June 19, 2019 at 8:05 a.m. ET in
Boston, MA
Presentation: Harnessing the Gut-Brain Axis to Discover Novel CNS Therapeutics
JMP Securities Life Sciences Conference on Thursday, June 20, 2019 at 11:30 a.m. ET in New
York, NY

On May 28, 2019 Bio-Techne reported the publication of a recent validation study demonstrating that the proprietary exosome-based liquid biopsy tests from Bio-Techne’s Exosome Diagnostics brand may be used to assess the mutational status of the Epidermal Growth Factor Receptor (EGFR) gene in patients with non-small cell lung cancer (NSCLC) (Press release, Bio-Techne, MAY 28, 2019, View Source [SID1234536927]). The data from this study will be available to discuss at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from May 31 to June 4 in Chicago, IL.

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NSCLC is the most common type of lung cancer. Approximately 10-40% of patients with NSCLC have mutations within the EGFR gene. Several treatment options for NSCLC use drugs targeting cells with EGFR mutations; however, over half of these patients develop resistance during treatment due to the emergence of a resistance mutation in the gene. It is critical that tumor mutations be monitored during therapy of NSCLC patients, given the aggressive nature of this lung cancer, and to ensure that patients receive the most effective treatment option.

The study published in Oncotarget describes Bio-Techne’s proprietary technique to co-isolate exosomal RNA/DNA and cell-free tumor DNA in a single step, followed by a qPCR-based assay to detect 29 different types of mutations in EGFR, including EGFR T790M.

Highlights of the data include:

The extended EGFR panel achieved a sensitivity of 92% (L858R) and 95% (T790M) both at 100% specificity, and 86% sensitivity for exon 19 indels at 94% specificity in patients with M1b extra-thoracic disease.
Including the challenging patients with intrathoracic (M0/M1a) disease resulted in a sensitivity of 90% (L858R), 83% (T790M) and 73% for exon 19 indels.
"This a game-changer for liquid biopsies," stated Steven Silverman, VP and General Manager of Bio-Techne’s Exosome Diagnostics brand. "The results from this validation study shows not only that our proprietary technique increases the performance of liquid biopsy mutation assays, but it can also be used to measure changes on the RNA transcriptome. In addition, we can enrich for exosomes derived from specific tissues using surface markers, making it possible to profile the RNA transcriptome from those tissue-specific cells in the biofluids."