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European Medicines Agency Accepts Marketing Authorisation Application for Prestige BioPharma’s Trastuzumab Biosimilar HD201 for Review

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.

Autolus Therapeutics to Participate in Upcoming Investor Conferences in June

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]):

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.

Axial Biotherapeutics to Participate in Upcoming Conferences in June

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]):

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

Bio-Techne’s New Exosome-Based Liquid Biopsies Helping To Advance Personalized Care In Lung Cancer Diagnostics

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.

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."

Sermonix Receives FDA Fast Track Designation for Investigational Drug Lasofoxifene

On May 28, 2019 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development of female-specific oncology products, reported that its lead investigational drug, lasofoxifene, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) (Press release, Sermonix Pharmaceuticals, MAY 28, 2019, View Source [SID1234536622]). Sermonix is currently engaged in a Phase 2 clinical study of lasofoxifene in estrogen receptor-positive (ER+) metastatic breast cancer.

Fast Track designation allows companies to "get important new drugs to the patient earlier," according to the FDA. It is designed to facilitate the development of and expedite the review of drugs that treat serious conditions and fill an unmet medical need. The Fast Track designation will allow Sermonix more frequent interactions with the FDA during Phase 2 and for the potential to obtain breakthrough designation and priority review of a New Drug Application.

"Lasofoxifene’s Fast Track designation highlights the significant unmet medical needs of women who have estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation," said Sermonix Chief Executive Officer Dr. David Portman. "Fast Track will allow us to more quickly complete our development program and, if successful, make lasofoxifene available to patients sooner."

Sermonix’s open-label, randomized, multi-center Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study will assess the activity of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation. ESR1 mutations are commonly found in women with ER+ metastatic breast cancer progressing after prior endocrine treatment and confer poorer prognosis. A liquid biopsy test will be utilized to identify women for inclusion in the ELAINE study.

"We are very encouraged to receive Fast Track designation, a recognition of lasofoxifene’s potential promise as a precision medicine for women with ER+ metastatic breast cancer," said Sermonix Chairman Dr. Anthony Wild.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized SERM, lasofoxifene, if approved, could play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.