On October 1, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that it will be presenting at the following investor, oncology and regenerative medicine conferences in October (Press release, AIVITA Biomedical, OCT 1, 2019, View Source [SID1234540000]):

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Cell & Gene Meeting on the Mesa
Company Presentation
Time: October 2, 11:00 AM PST
Location: Park Hyatt Aviara Resort Golf Club & Spa, Cognate in the Bioservices Ballroom, Carlsbad, CA

World Immunotherapy Congress
Keynote Title: Enhancing patient responses with autologous cancer stem cell vaccine in combination with checkpoint inhibitors
Time: October 16, 9:25 AM CET
Location: Congress Centre Basel, Basel, Switzerland

BIO Investor Forum
Company Presentation
Time: October 23, 10:15 AM PST
Location: Elizabethan A, The Westin St. Francis, San Francisco, CA

World Vaccine Congress
Talk Title: Autologous Cancer Stem Cell Vaccines for Solid Tumor Cancers
When: October 29, 3:45 PM CET
Location: Palau de Congressos de Catalunya, Barcelona, Spain

On October 1, 2019 Immunomic Therapeutics, Inc. reported that it has assumed sponsorship of the Investigational New Drug (IND) application for ITI-1000 from the University of Florida (UF) (Press release, Immunomic Therapeutics, OCT 1, 2019, View Source [SID1234539969]). ITI-1000 is currently being investigated in a Phase 2 ATTAC-II trial at UF and Duke. The Phase 2 protocol will remain active, the existing Principal Investigators (PIs) from UF and Duke will remain in place, and the existing relationships with the pioneers of this cancer immunotherapy, Drs. Duane Mitchell, M.D., and John Sampson, M.D., Ph.D., will stay intact.

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ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase 2 clinical trial (ATTAC-II) for the treatment of the aggressive brain tumor, Glioblastoma Multiforme (GBM). ITI-1000 is designed to target the pp65 viral antigen of Cytomegalovirus (CMV) that is expressed in GBM, but not in normal brain cells. In the ongoing ATTAC-II study (NCT02465268), some of the GBM patients’ white blood cells are removed, matured into dendritic cells and vaccinated against the pp65 viral protein, then returned to the patient. The company believes this approach may harness the body’s immune system to recognize, attack and destroy tumor cells that express CMV, which is over-expressed in GBM.

"We are very excited to lead the clinical development of ITI-1000 and assume responsibilities of the ATTAC-II study in GBM," said Dr. William Hearl, CEO of Immunomic Therapeutics. "We look forward to building upon the research momentum and exciting data generated with this program from our academic partners at Duke and the University of Florida. Our development plans will involve continuing to support the progress of the current study and potentially opening other clinical studies employing ITI-1000 in GBM. Importantly, this will add more data to our programs for GBM and supports our ongoing efforts to apply our novel UNITE platform in oncology."

About ITI-1000 and the Phase 2 (ATTAC-II) Study

ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase 2 clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was discovered using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 expressed as fusion protein with UNITE improves survival. This study will enroll up to 120 subjects at 3 clinical sites in the United States. Immunomic expects to report interim data from this study. For more information on the ATTAC-II study, please visit www.clinicaltrials.gov.

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing and MHC-II presentation to helper T-cells. 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 October 1, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that Carmen Bozic, M.D., has been appointed as the company’s Executive Vice President, Global Medicines Development and Medical Affairs. Dr. Bozic will assume the additional role of Chief Medical Officer on April 1, 2020 when Reshma Kewalramani, M.D., the company’s current Chief Medical Officer, becomes President and Chief Executive Officer of Vertex (Press release, Vertex Pharmaceuticals, OCT 1, 2019, View Source [SID1234539985]). Dr. Bozic has served as Senior Vice President and Head of Global Clinical Development since May of this year.

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Vertex also announced the appointment of Nia Tatsis, Ph.D., currently Vertex’s Senior Vice President, Global Regulatory Affairs, as Senior Vice President, Chief Regulatory Officer, effective immediately.

"The addition of Carmen and Nia to Vertex’s executive team further strengthens our leadership ranks as we work towards completing our CF journey and bringing new therapies into the clinic in a variety of new disease areas," said Jeffrey Leiden, M.D., Ph.D., Chairman, President and Chief Executive Officer of Vertex.

Dr. Bozic received her M.D. and completed her residency in Internal medicine at McGill University in Montreal, Canada, and then completed a fellowship in Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital in Boston. Since joining Vertex, she has been leading Clinical Development of the company’s cystic fibrosis and alpha-1 antitrypsin deficiency programs, as well as leading Clinical Operations across the pipeline, among other areas. Prior to joining Vertex, Dr. Bozic spent more than 20 years at Biogen, including as Senior Vice President, Global Development. During her tenure at Biogen, she led multiple functions, including Global Clinical Development, Safety, Preclinical Safety, Regulatory, Clinical Operations and Biometrics.

"I am thrilled to take on the leadership of Vertex’s talented Global Medicines Development and Medical Affairs team at such an exciting time for the company," said Dr. Bozic. "Vertex advanced its cystic fibrosis portfolio through the clinic with unprecedented speed and purpose, and now has seven potential therapies in the clinic with the opportunity to transform the treatment of patients with other serious diseases."

Dr. Tatsis received her Ph.D. in Cell and Molecular Biology from the University of Vermont and holds a B.S. in Biology from Temple University. She was a Post-Doctoral Fellow at the Wistar Institute and has held positions of increasing responsibility at pharmaceutical companies including Sanofi, Pfizer, and Wyeth prior to joining Vertex in 2017. Most recently, she was Vice President, Head of Global Regulatory Affairs of the Sanofi Genzyme Business Unit focused on Immunology, Rare Diseases, Multiple Sclerosis and Oncology.

"Vertex is a company that is relentlessly focused on scientific innovation and bringing transformative advances in medicine to patients with serious diseases," said Dr. Tatsis. "We have an outstanding regulatory team and I am honored to lead them in this role as we work to deliver on our mission and strategy."

On October 1, 2019 Immunicom, Inc., a medical technology company reported that has been awarded FDA Breakthrough Device Designation for its non-pharmaceutical solution for treating stage IV metastatic cancer, gained an additional $1.85 million towards its Series B investment round on September 9th (Press release, Immunicom, OCT 1, 2019, View Source [SID1234540001]). This increases Immunicom’s overall capital raised to $21.85 million.

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Immunicom has also hired Raju Chauhan as Vice President of Program Management to provide guidance and oversight to both internal and customer facing initiatives. "We are very fortunate to add Raju to Immunicom’s growing team," said Amir Jafri, the company’s Founder and CEO. "With Raju on our team we will be more proficient in achieving our fast-paced global business deals and groundbreaking research goals to accelerate bringing Immunopheresis to the world."

Raju has over 30 years of experience working in the technology development and managing teams across the globe with a proven record of creating and delivering, innovative, cost-effective solutions for mission-critical business problems. He has been an integral part of managing projects for several fortune 50 companies as well as healthcare space. At Cardinal Health, Raju managed teams spread across several locations in USA. Raju has also managed and worked with many different teams in several countries including Canada, China, India, and Ukraine. Raju has worked in many different industries including Medical Device Manufacturers, Healthcare, Oil and Gas, Software, Telecommunications, Food and Beverages, Airlines, Credit Bureaus, Background Checks, Real Estate, Professional Services and Utilities.

Raju received his Master of Computer Science degree from Mississippi State University.

On October 1, 2019 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that it will hold its third-quarter 2019 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Tuesday, Oct. 29 (Press release, Merck & Co, OCT 1, 2019, View Source [SID1234539970]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 5635157. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 5635157. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.