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."

On May 28, 2019 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that the Company’s management team will participate in the following upcoming investor conferences (Press release, Karyopharm, MAY 28, 2019, View Source [SID1234536601]):

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The Jefferies 2019 Global Healthcare Conference on Wednesday, June 5, 2019, and will present at 3:00 p.m. ET.

The JMP Securities 2019 Life Sciences Conference on Wednesday, June 19, 2019, and will present at 11:30 a.m. ET.
A live webcast of the presentations can be accessed on the "Events & Presentations" page in the Investors section of the Company’s website, View Source A replay of each webcast will be archived on the Company’s website for 90 days following the presentation.

On May 28, 2019 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported that it has been awarded Chinese Patent No. ZL201080019566.9 entitled, DEVICES AND METHODS OF CELL CAPTURE AND ANALYSIS (Press release, Biocept, MAY 28, 2019, View Source [SID1234536618]). The issued patent covers methods and devices for the capture of rare cells of interest, including CTCs that are shed into the blood stream by solid tumors where an antibody, or mixture of antibodies, and a microchannel are used for cell capture, detection, and analysis. The patent encompasses the use of any biological sample type of interest and is the 33rd patent issued to Biocept that is core to its liquid biopsy technology and commercial testing platforms.

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"The granting of this patent further expands Biocept’s international footprint for capturing and analyzing rare cells from biological fluids, such as blood, bone marrow, cerebral spinal fluid (CSF), and tissue, to assess the status of patients with cancer," said Lyle Arnold, Ph.D., Chief Scientific Officer at Biocept. "This technology interfaces well with Biocept’s other patented liquid biopsy technologies that include a blood collect tube and circulating tumor DNA (ctDNA) analysis, which are intended to aid physicians in the treatment of their patients with cancer."

"Obtaining this new patent provides additional intellectual property coverage for the unique and novel features of our Target Selector platform, featuring our antibody cocktail and microchannel capture technologies for CTCs and other rare cells of interest," said Michael Nall, Biocept’s President and CEO. "We believe that the issuance of additional patents around the world leverages our investment in our cutting-edge liquid biopsy technologies and expands the opportunity for Biocept to generate revenue in territories outside the U.S."

On May 28, 2019 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported it will participate in the Jefferies 2019 Global Healthcare Conference on Wednesday, June 5, 2019, in New York City (Press release, Medtronic, MAY 28, 2019, View Source;p=RssLanding&cat=news&id=2399814 [SID1234536602]).

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Mike Coyle, executive vice president and president of Medtronic’s Cardiac and Vascular group (CVG), will answer questions about the company beginning at 11:00 a.m. EDT (10:00 a.m. CDT).

A live audio webcast of the session will be available on June 5, 2019, by clicking on the Investors Events link at View Source An archived audio file will be available for replay on the same webpage later in the day.

On May 28, 2019 Alphamab Oncology, a leading biopharmaceutical company dedicated to global development of innovative biologics for cancer therapy, reported that it has completed a US$60 million Series B financing led by Hudson Bay Capital Management LP and participated by new investors including entrepreneur Adrian Cheng (Press release, Alphamab, MAY 28, 2019, View Source [SID1234536619]). Existing institutional investors including China Venture Capital Fund (CVC), PAG, and Advantech Capital also participated. Proceeds from the financing round will be used for developing the pipeline, commissioning a new R&D and manufacturing site, accelerating the clinical development of clinical stage assets, and preparing for commercial launch of KN035 (Envafolimab).

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Alphamab Oncology is well positioned to develop next-generation multi-functional biologics therapy for cancer treatment based on its extensive expertise in protein engineering and proprietary platforms including Bispecific and Mix-mAb Platforms as well as rich experience in single domain antibodies. The company has also assembled highly experienced management and technical teams with experiences covering the entire R&D process of innovative biologic drugs.

The new round comes on the heel of its strong US$130 million Series A financing in November 2018 – one of the largest in China’s biotechnology industry in recent years. Since then, Alphamab Oncology has advanced several drug candidates in its pipeline and formed new partnerships for its leading assets:

KN035 (Envafolimab), the world’s leading subcutaneous injection of PD-L1 antibody, entered phase II and phase III clinical trials for multiple indications.
KN046, the world’s first PD-L1/CTLA-4 bispecific antibody, has undergone phase I clinical trials in Australia and China which has demonstrated promising early clinical results, and is undergoing phase II clinical trials for multiple indications in China. Additionally, Alphamab Oncology reached a partnership with HEC Research Institute and TOT Biopharm to develop innovative combination therapies involving KN046.
KN026, an anti-HER2 bispecific antibody, is starting phase II clinical trial in China.
Immunomodulator KN019 is undergoing phase II clinical trial in China.
"Since the founding of the company, we have been working hard to break new grounds. We have been focusing on the development of key platforms and proprietary innovative drug candidates, and consistently executing our long-term strategy, focusing on global development for innovative biological dugs. We are striving to transform cancer into a controllable and treatable disease and to improve quality of life of cancer patients," said Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology. "We are very grateful to these prestigious investors for their enthusiasm and confidence in Alphamab Oncology. We look forward to working with our stakeholders to accelerate the new generation of multi-functional biological therapeutics, and to fulfill our vision to be globally competitive."

Sander Gerber, Chief Executive Officer and Chief Investment Officer of Hudson Bay Capital Management LP, added, "We are pleased to support Alphamab Oncology in its mission of creating effective, high quality and affordable biotherapeutics for cancer treatment. Hudson Bay’s investment in Alphamab Oncology underscores our confidence in the company’s ability to be a next-generation leader in the development and commercialization of innovative biological oncology drugs globally. We look forward to helping Alphamab Oncology advance its strong product pipeline to drive significant value for the business over time."

Mr. Shaojing Ma, Managing Director of China Venture Capital Fund (CVC) commented: "Alphamab Oncology leads the new-generation innovative biopharmaceutical industry in China. As a Series A shareholder, China Venture Capital Fund is excited to witness that, within one year, the Company has achieved rapid progress in R&D and clinical development, and various data has proven the tremendous growth potential of its products; with a more robust product pipeline, the Company has demonstrated its capability to maintain world-leading R&D of innovative drugs. Therefore, we are also actively participating in this Series B funding. We expect that after entering the capital market in the future, Alphamab Oncology will gain more opportunities for international development and stands out as an excellent representative of innovative Chinese biopharmaceutical companies to the world."

Adrian Cheng commented: "Technological innovation can be a powerful tool in improving the human condition. I believe that advances in biotechnology and pharmaceuticals will be crucial in changing our lives for the better, and I am delighted to see China taking its place at the forefront of medical innovation. Alphamab Oncology boasts world-class capabilities in ground-breaking research and development and they’re very strong in team execution. We are pleased to be a contributor to Alphamab Oncology’s growth as it becomes the world’s leading research and development company for tumor-targeted drugs."