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.

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

On April 4, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported agreement with Memorial Sloan Kettering Cancer Center (MSK) for the conduct of an investigator-sponsored clinical trial of SELLAS’ Wilms tumor-1 (WT1)-targeting peptide immunotherapeutic agent, galinpepimut-S (GPS), in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab, in patients with malignant pleural mesothelioma (MPM) (Press release, Sellas Life Sciences, APR 4, 2019, View Source [SID1234535011]). The Phase 1 open-label clinical study will enroll patients with MPM who harbor relapsed or refractory disease after having received frontline standard of care multimodality therapy with study drug provided by both SELLAS and Bristol-Myers Squibb. The principal investigator for the study will be Dr. Marjorie G. Zauderer, MD, Co-Director, Mesothelioma Program, Team Lead, Thoracic Disease Management Team, and Assistant Attending Physician in the Division of Thoracic Oncology, Department of Medicine at MSK.

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The purpose of the trial is to determine if the administration of GPS in combination with nivolumab has the potential to demonstrate antitumor immune responses and meaningful clinical activity in the presence of macroscopic disease in MPM patients. The study will also investigate the tolerability of the combination, evaluate the immunogenicity of the two agents administered together, by CD4+ and CD8+ T-lymphocytes (both peripherally and at the tumor site), and gauge the degree of clinical benefit by assessment of the overall response rate with the combination in comparison with that reported with nivolumab alone in historical comparable patient populations. In a randomized, controlled, blinded Phase 2 clinical trial in MPM patients completed in 2017, GPS monotherapy, given as maintenance after first line tumor-debulking multimodality treatment, demonstrated meaningful clinical activity with median survival of 22.8 months vs. 18.3 months in the control group (N=41) and with associated sustained immune responses (both CD4+ and CD8+) against the WT1 antigen while adverse events were mainly comprised of low grade reactions at the site of the injection.

"SELLAS is excited to embark upon this trial, as we look to expand the utility of GPS in combination with PD-1 inhibitors, and specifically nivolumab. The nivolumab/GPS immunotherapy combination is well positioned to exploit the unique features of each of these two agents through potential synergistic immune-based mechanisms of antitumor action. If positive, this clinical effort will allow us to consider advancing the clinical development of the combination of GPS and nivolumab in relapsed or refractory MPM as a potentially promising approach to treat patients with this recalcitrant thoracic malignancy," stated Dr. Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

"The rationale for this innovative clinical effort is based upon the presumed immunobiologic and pharmacodynamic synergy between the two investigational agents. We hypothesize that the negative influence of tumor microenvironment factors on the immune response is mitigated by nivolumab, thus providing the opportunity for the patients’ own immune cells to invade and destroy cancerous growth deposits specifically sensitized against WT1 by GPS. WT1 is both a densely and frequently expressed tumor-associated antigen in MPM, and we believe it represents the optimal target for directly immunizing, vaccine-type therapies such as GPS against this tumor type," commented Dr. Nicholas J. Sarlis, MD, PhD, Chief Medical Officer and Executive Vice President of SELLAS.

Data from a Phase 1 open-label clinical study of patients with WT1+ ovarian cancer in second or greater remission suggested clinical activity for the combination of GPS plus nivolumab, with a progression-free survival (PFS) rate of 70% at one year among patients who received at least three doses of GPS in combination with nivolumab (7/10), while historical 1-year PFS rates with best standard treatment do not exceed 50% in this disease setting.

GPS is also currently being studied in combination with Merck’s anti-PD-1 therapy, pembrolizumab, in patients with measurable tumor burden in the context of a Phase 1/2 open-label, non-comparative, multicenter, multi-arm ‘basket’-type clinical study in five indications.

On April 4, 2019 Immunomic Therapeutics, Inc. reported that it will participate at the World Vaccine Congress Washington being held in Washington, D.C. April 14-17, 2019 (Press release, Immunomic Therapeutics, APR 4, 2019, View Source [SID1234535010]). Teri Heiland, Ph.D., Immunomic’s Senior Vice President of Research and Development, will participate in a panel entitled "Strategies to enhance vaccine acceptance in future generations."
In addition to its panel participation, Immunomic has been nominated for the World Vaccine Congress Vaccine Industry Excellence (ViE) Award for Best New Vaccine Technology/Platform. The winner of the award is expected to be announced during the conference.

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The World Vaccine Congress Washington is a multi-faceted conference experience with over 300 industry leading speaker, 10 conferences, 8 workshops, 100+ exhibitors providing the most exciting vaccine event on the planet.

Panel details are as follows:

Title: Strategies to enhance vaccine acceptance in future generations
Panel Category: Vaccine Safety
Panel Date and Time: Tuesday, April 16, 2019 9:40 AM
Location: Renaissance Washington DC Downtown Hotel, Washington D.C.

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On April 4, 2019 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that senior management will present corporate updates at two upcoming investor conferences in April (Press release, GlycoMimetics, APR 4, 2019, View Source [SID1234535009]). Details are as follows:

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HC WAINWRIGHT GLOBAL LIFE SCIENCES CONFERENCE
Who: Chief Financial Officer Brian Hahn
When: Tuesday, April 9 at 2:10 p.m. (GMT)
Where: London, UK

18TH ANNUAL NEEDHAM HEALTHCARE CONFERENCE
Who: Chief Executive Officer Rachel King
When: Wednesday, April 10 at 3:30 p.m. (ET)
Where: New York, NY

To access the live webcast and subsequent archived recordings for each of these presentations, please visit the GlycoMimetics website at www.glycomimetics.com.