RhoVac announces that all patients completed the follow-up phase of the clinical phase I / II study

On April 2, 2019 RhoVac AB ("RhoVac") reported that all prostate cancer patients who participated in the clinical phase I / II study with RhoVac’s drug candidate RV001, have completed their 9- and 12-month’s follow-ups (Press release, RhoVac, APR 4, 2019, View Source [SID1234555932]). This marks the completion of the clinical phase I / II study for the participating patients.

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RhoVac’s clinical phase I / II study was conducted during the period of Q1 2017 to Q1 2019. The 22 patients recruited for this study had been diagnosed with prostate cancer and been treated with prostatectomy. Blood samples were drawn before, during and after the study to analyze the product-mediated immune response to the treatments. The results, reported in August 2018, showed a significant immune response in 86% of patients. The patients also participated in 3-, 6-, 9- and 12-month’s follow-ups to study the duration of the immune response. This follow-up phase is now completed as all 22 patients have had their final follow-up visit at the clinical site.

The last samples from the 9- and 12-month’s follow-up phase have now been sent to the University of Tübingen for immunological analysis. RhoVac expects to report these results mid-2019.

CEO Anders Ljungqvist comments:

– The company’s first clinical study, RhoVac-001, is now completed and only analyzes and final reporting of the follow-up phase remain. I am proud that RhoVac has completed this study within the set timeframe. A result we have largely achieved thanks to the highly dedicated patients who have participated in the study. This combined with an outstanding collaboration with Copenhagen Prostate Cancer Center at University Hospital, Copenhagen; Phase I unit Zelo at Bispebjerg and Frederiksberg Hospital, DanTrials ApS and T-cell Monitoring Group, the Department of Immunology at the University of Tübingen, Germany have all ensured that we have been able to communicate conclusive results according to time frame. Thank you very much to all the participants.

Quest Diagnostics To Release First Quarter 2019 Financial Results On April 23

On April 4, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report first quarter 2019 results on Tuesday, April 23, 2019, before the market opens (Press release, Quest Diagnostics, APR 4, 2019, View Source [SID1234535027]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-480-3547 for domestic callers or 203-369-1551 for international callers, no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on April 23, 2019 until midnight Eastern Time on May 7, 2019.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

CStone Pharmaceuticals presented poster of pre-clinical result for CS1003 at AACR

On April 4, 2019 CStone Pharmaceuticals ("CStone"; HKEX:2616) reported a poster of pre-clinical data of CS1003 at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, CStone Pharmaceauticals, APR 4, 2019, View Source [SID1234535024]).

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CS1003 is a humanized IgG4 PD-1 monoclonal antibody designed to block the interaction of PD-1 with its ligands PD-L1 and PD-L2 for the immunotherapy of multiple tumor types. In contrast with other PD-1 antibodies, CS1003 recognizes both human and murine PD-1, providing a unique competitive advantage during efficacy testing in syngeneic mouse tumor models.

According to the pre-clinical result presented for the first time, CS1003 can specifically bind to human, mouse and cynomolgus monkey PD-1 and block the binding of PD-1 to PD-L1 and PD-L2; as a result, CS1003 promotes the proliferation and cytokine release of CD4+ T cells in vitro, and inhibites tumor progression in both CloudmanS91 mouse melanoma syngeneic model and MC38-huPD-L1 colon cancer engrafted in hu-PD-1 knock-in mouse model in vivo. The pharmacokinetic (PK) study in cynomolgus monkeys following single intravenous administration showed the exposure of CS1003 increased proportionally with dose levels and the PK properties were linear over 2-18 mg/kg. CS1003 demonstrated a favorable safety profile with the highest non-severely toxic dose (HNSTD) at 100 mg/kg.

CStone is currently conducting a Phase I clinical trial in China and Australia, and received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (‘FDA’) for CS1003 in October 2018.

"CS1003 is a differentiated anti-PD-1 monoclonal antibody which allows us to quickly evaluate efficacy for combination therapies in animal models at the preclinical stage, and better predict the safety and efficacy of clinical trials," CStone Chief Science Officer Dr. Jon Wang noted. "As one of CStone’s immune-oncology backbone drug candidates, we will leverage this unique advantage to explore and develop combination therapies with CS1003 for various solid tumors and hematological malignancies, with the aim of providing better treatment options to patients in China and globally. "

Clinical Status of CS1003

CStone is currently conducting a Phase I clinical trial in Australia to assess the safety and anti-tumor effects of CS1003 as a monotherapy in patients with advanced solid tumors. CStone received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for CS1003 in October 2018 and will extend the Phase I study to the United States.

CS1003 was approved in June 2018 by the China National Medical Product Administration (NMPA) to start clinical research, and a Phase I bridging clinical study was initiated in November 2018 for patients to start clinical research with advanced solid tumors and lymphomas.

Adhera Therapeutics Appoints Nancy Phelan as Chief Executive Officer

On April 4, 2019 Adhera Therapeutics, Inc. (OTCQB: ATRX), a specialty pharmaceutical company leveraging technology to commercialize unique therapies and improve patient outcomes, reported that its Board of Directors has appointed Nancy R. Phelan to serve as Chief Executive Officer of the Company (Press release, Marina Biotech, APR 4, 2019, View Source [SID1234535015]). Ms. Phelan has served as a member of the Board of Directors since October 2018.

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"I am excited to assume the role of Chief Executive Officer of Adhera Therapeutics," Ms. Phelan said. "Adhera has been focused on its sales efforts for its first commercial product – PRESTALIA – for the past three fiscal quarters, and I look forward to growing the patient-centric success that Adhera has achieved. I want to express gratitude to my colleagues on the Board for this opportunity and I look forward to working collaboratively to grow the company, expand sales and increase shareholder value."

"I am pleased to welcome Nancy as the new CEO of Adhera Therapeutics," Uli Hacksell, Ph.D., the Chairman of the Board of Directors of Adhera, said. "Given her deep experience commercializing pharmaceutical products, and the successes that she has enjoyed in her career, and having gotten to know Nancy over the past several months on the Adhera Board, I am confident that she will be an effective leader of the company."

Ms. Phelan is an accomplished senior executive and thought leader with over 20 years’ success in the healthcare and biotech industries. She is a passionate and compassionate leader of high performing teams with deep expertise in designing effective customer marketing strategies and building commercial capabilities that drive performance. For the past several years, Ms. Phelan has served as a Board member and/or advisor to various entities and organizations involved in the health care and technology sectors. Previously, she held roles of increasing responsibility for Bristol-Myers Squibb Company (BMS) and Wyeth, including Head of Worldwide Commercial Operations for BMS and Executive Director in Commercial Development for Wyeth. Ms. Phelan received a BA with Honors from Franklin & Marshall College and completed coursework in Villanova University’s MBA program.

In connection with the appointment of Ms. Phelan as Chief Executive Officer of Adhera, Robert C. Moscato, Jr. resigned from such position, as well as from his position as a member of the Board of Directors, effective immediately.

"We would like to thank Rob for his service to Adhera during a critical time in the company’s development as it launched its commercial efforts for Prestalia and completed a strategic reorganization, and we wish him well as he pursues other ventures," Dr. Hacksell said.

RedHill Biopharma to Present at Three Conferences in April

On April 4, 2019 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on gastrointestinal diseases, reported that the Company will present at three conferences in April (Press release, RedHill Biopharma, APR 4, 2019, View Source [SID1234535014]):

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H.C. Wainwright Global Life Sciences Conference
Date: Tuesday, April 9, 2019, 11:30 a.m. GMT
Content: Corporate overview
Speaker: Guy Goldberg, chief business officer
Location: JW Marriott Grosvenor House, London, Spencer Suite
Live Webcast: View Source
The webcast will be available via replay for 30 days on the Company’s website.

BioCentury’s Future Leaders in the Biotech Industry Conference
Date: Friday, April 12, 2019, 9:00 a.m. EDT
Content: Corporate overview
Speaker: Dror Ben-Asher, chief executive officer
Location: Millennium Broadway Hotel & Conference Center, New York

World Orphan Drug Congress USA 2019
Date: Friday, April 12, 2019, 3:10 p.m. EDT
Content: YELIVA (opaganib) for cholangiocarcinoma and RHB-204 for pulmonary nontuberculous mycobacteria (NTM) infections
Speaker: Patricia Anderson, vice president regulatory affairs
Location: Gaylord National Harbor Hotel, Oxon Hill, MD