Coherus BioSciences to Report First Quarter Financial Results on May 9th

On April 5, 2019 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that its first quarter 2019 financial results will be released after market close on Thursday, May 9, 2019 (Press release, Coherus Biosciences, APR 5, 2019, View Source/news-releases/news-release-details/coherus-biosciences-report-first-quarter-financial-results-may" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-first-quarter-financial-results-may" rel="nofollow">View Source [SID1234535012]). Starting at 4:30 p.m. ET, Coherus’ management team will host a conference call to discuss financial results and provide a general business update.

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After releasing first quarter 2019 financial results, the company will post them on the Coherus website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information

When: Thursday, May 9, 2019 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 2969536
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

Sinovant and Roivant Launch Cytovant Sciences in Partnership with Medigene to Develop Cellular Therapies in Asia

On April 4, 2019 Sinovant Sciences and Roivant Sciences reported the launch of Cytovant Sciences, a biopharmaceutical company focused on developing and commercializing innovative cellular therapeutics in Asia. Cytovant will focus on development programs that have the potential to transform the treatment of diseases that are prevalent in Asian patients (Press release, Sinovant Sciences, APR 4, 2019, http://www.cytovant.com/d65 [SID1234557522]). Concurrent with the company’s launch, Cytovant has entered into a multi-program license and collaboration agreement with Medigene AG, a clinical stage biotechnology company focusing on the development of T cell immunotherapies.

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Medigene has granted Cytovant exclusive licenses to develop, manufacture, and commercialize Medigene’s research-stage T cell immunotherapy targeting NY-ESO-1 as well as a DC vaccine targeting WT-1 and PRAME, in Greater China, South Korea, and Japan. In addition, Cytovant and Medigene have entered into a strategic collaboration and discovery agreement for T-cell receptor (TCR) immunotherapies for two additional targets. Medigene will be responsible for the generation and delivery of the TCR constructs using its proprietary TCR discovery and isolation platform. Following this research collaboration period, Cytovant will assume sole responsibility for the development and commercialization of these TCR therapies in the relevant countries. The TCRs to be generated by Medigene will be tailored specifically to Asian patients.

Under the terms of the transaction agreements, Medigene will receive an overall upfront payment of USD 10 million as well as potential development, regulatory, and commercial milestone payments which in aggregate could total over USD 1 billion for the four products across multiple indications. Furthermore, Medigene will be eligible to receive royalty payments on net sales of the products in a low double-digit percentage in the relevant countries. Additionally, Cytovant will reimburse all R&D costs incurred by Medigene within the collaboration.

"T cell receptors are the scouts of the immune system," said Prof. Dolores Schendel, CEO/CSO of Medigene. "They help T cells recognize and destroy cancer cells. We use our sophisticated screening systems to generate tailored TCR therapies for patient populations with specific genetic characteristics. This partnership implements Medigene’s strategy to discover TCRs with various HLA specificities in order to address different populations and markets. Cytovant, with its highly experienced management and scientific team was launched by Sinovant and Roivant to achieve excellence in cell therapies and we are proud to be part of this story of delivering various TCR projects as well as our DC vaccine for development in East Asia."

"The complexities of end-to-end cell therapy manufacturing, development, and commercialization in Asia require regional focus, specialization, and knowledge," said Benjamin Zimmer, President of Roivant Health. "Roivant and Sinovant have built Cytovant precisely to address these scientific and logistical complexities. We are excited to announce this strategic alliance with Medigene, one of the leading companies in the field of T cell-based therapies, to deliver important new cellular immunotherapies to Asian patients as quickly as possible."

Dr. John Xu, a molecular immunologist by training and translational scientist, has joined Cytovant and will serve as the company’s President. Prior to joining Cytovant, Dr. Xu was President and Chief Scientific Officer of Mab-Legend Biotech, a Shanghai-based antibody discovery company. Previously, Dr. Xu also served as Chief Scientific Officer of Shanghai Benemae Pharmaceutical Corporation and as Head of the Biologics Group at GSK China. He received his B.S. in cell biology and genetics from Peking University and his Ph.D. in biochemistry and molecular biology from Harvard University.

"We are thrilled to welcome John to Cytovant," said Dr. Xinan Chen, Executive Chairman of Sinovant. "John’s deep scientific expertise and knowledge of Asia’s health priorities make him an ideal leader for the company as we prepare to rapidly scale its research and development activities. The launch of Cytovant represents an important milestone in Sinovant’s evolution as a platform for entrepreneurs like John and we look forward to building Cytovant with him."

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.