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."

On April 4, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it has expanded two additional cohorts from the Phase II SUMMIT clinical trial investigating its lead drug candidate neratinib in patients with solid tumors who have an activating EGFR or HER2 mutation (Press release, Puma Biotechnology, APR 4, 2019, View Source [SID1234534994]). The cohorts that have been expanded are (i) HER2 mutant patients with metastatic salivary gland cancer and (ii) patients with EGFR exon 18 mutation-positive lung cancer.

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The Phase II SUMMIT basket trial is an open-label, multi-center, multi-histology, international study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR, HER2 or HER4 mutations. The salivary gland cancer patients initially entered the study in the "other solid tumors with a HER2 mutation" cohort, and due to the preliminary activity seen in the trial, the Company has expanded a separate salivary gland cancer cohort pursuant to the protocol for the trial. The expanded HER2-mutant salivary gland cancer cohort and the expanded EGFR exon 18 mutant lung cancer cohort will each now enroll approximately 18 patients.

"We are pleased to expand our evaluation of neratinib in metastatic HER2 mutant salivary gland cancer and exon 18 mutated lung cancer from SUMMIT, as they both represent orphan and deadly diseases with few treatment options," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "We believe this once again demonstrates the value of the basket study approach, in particular for developing targeted therapy for rare diseases with clinically-actionable mutations. We look forward to continuing enrollment into these expanded cohorts and presenting updated trial results."

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 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 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it will host a Key Opinion Leader meeting to discuss the emerging role of biomarkers and oncolytic viruses in the treatment of cancer on Thursday, April 11, 2019 at 12 pm EDT in New York City (Press release, Oncolytics Biotech, APR 4, 2019, View Source [SID1234534997]).

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The event will feature presentations by company management and Key Opinion Leader Dirk Arnold MD, PhD, Executive Board Member of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) & Chief of Oncology at Asklepios Klinik Altona, who will discuss biomarkers, their importance in trials, their influence on large pharma and their impact in both clinical and commercial settings, as well as recent biomarker data from Oncolytics. This will be followed by a brief outline of how Oncolytics’ biomarker strategy is influencing the Company’s clinical development plan, specifically its phase 3 program in metastatic breast cancer. Dr. Arnold will be available to answer questions at the conclusion of the event.

Oncolytics’ management team will also provide an overview of the ongoing development of pelareorep, the Company’s first-in-class intravenously delivered immuno-oncolytic virus (IOV) for the treatment of solid tumors and hematological malignancies. Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus. It induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers, including metastatic breast cancer, multiple myeloma, and pancreatic cancer.

Dr. Arnold is Professor, Chief Physician, Haematology and Internal Oncology, at Asklepios Klinik Altona. He is the Chairman of the Colorectal Cancer Study Group of the Arbeitsgemeinschaft Internistische Onkologie (AIO) and is a member of the Task Force Colorectal Cancer and the Board of the Gastrointestinal Cancer Study Group of the EORTC. He is a key member of several German and other international cancer societies, including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), where he serves as a Board Member and Section Editor for Gastrointestinal Cancers of the Guideline Committee.

He previously served as Professor of Medicine at the University of Hamburg, where he held the position as Medical Director of the University Cancer Center (UCCH) until 2012. Before that, he served as Assistant Professor and Chair of the Gastrointestinal Cancer Unit at the Martin Luther University Halle-Wittenberg, Halle, Germany, where he also received his training as Medical Oncologist, and specialist in Palliative Care. From 2012 to 2015, Dr. Arnold served as Director of the Department of Medical Oncology of the Klinik für Tumorbiologie, University Freiburg. In January 2016, he joined the CUF Hospitals in Lisbon, Portugal, as Director of Oncology services.

This event is intended for institutional investors and sell-side analysts. Please RSVP in advance HERE if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com. Members of the media and the public are invited to participate via the live webcast.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.