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Propanc Biopharma Initiates European Validation of its Lead Patent

On October 4, 2018 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc Biopharma" or the "Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported initiation of European (EP) validation of its lead patent in most major commercial markets in Europe (Press release, Propanc, OCT 4, 2018, View Source [SID1234529748]). EP validation is the process of converting a single granted European patent application into a national patent in one or more contracting member and extension states of the European Patent Convention.

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The Company’s lead patent, which describes a pharmaceutical composition for treating cancer, is currently undergoing validation in 14 European countries – Belgium, Czech Republic, Denmark, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Once validated, the Company will have the rights associated with a granted patent in each of these 14 European countries.

"We continue to make significant progress with the growth of our intellectual property portfolio this year. In addition to commencing validation of our lead patent in Europe, we entered national phase with another two patents and are planning to enter a third into national phase later this year," said James Nathanielsz, the Company’s Chief Executive Officer. "A strong intellectual property portfolio is a cornerstone to a biotech company and will serve to increase the value of ours. In addition to growing our IP portfolio, we also recently initiated the next phase of our POP1 drug discovery program with the University of Jaén, our research partner, to develop a backup compound to our lead product candidate, PRP, which is set to enter clinical development. We continue to build a strong foundation for our Company and its potential for future growth for our shareholders, which is most important."

FDA Grants Coordination Pharmaceuticals IND Approval for CPI-100, a Novel Antitumor Nanomedicine

On October 3, 2018 Coordination Pharmaceuticals, Inc. (CPI), a privately held and clinical-stage biopharmaceutical company focused on nanotechnology-based cancer immunotherapy, reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application to initiate a first-in-human Phase 1 clinical study of CPI-100 in patients with advanced tumors (Press release, Coordination Pharmaceuticals, OCT 3, 2018, View Source [SID1234532212]).

CPI-100 is a structurally optimal core-shell nanoparticles based on CPI’s proprietary nanoscale coordination polymer (NCP) platform technology to selectively deliver immunostimulatory chemotherapeutic combinations to tumors, providing a new approach to initiate and stimulate immune-mediated eradication of cancer cells using synergistic nanomedicines. "FDA’s timely acceptance and approval of CPI-100 IND is an important milestone for the company. We are excited about the opportunity to study the first NCP-based product in clinical trials." said Wenbin Lin, Ph.D., founder and chairman of CPI and also the James Franck Professor of Chemistry, Radiation & Cellular Oncology, and the Ludwig Center for Metastasis Research at the University of Chicago. "We expect this study will generate important insights into the safety of CPI-100 and its preliminary therapeutic efficacy in cancer patients."

Japan MHLW Grants Orphan Drug Designation to Axicabtagene Ciloleucel for Treatment of Certain Types of B-Cell Lymphoma

On October 3, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that axicabtagene ciloleucel (formerly KTE-C19) has been granted Orphan Drug designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal (thymus) large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL) and transformed follicular lymphoma (TFL), which are aggressive forms of non-Hodgkin lymphoma (NHL) (Press release, Daiichi Sankyo, OCT 3, 2018, View Source [SID1234530246]).

"Receiving Orphan Drug designation is an important step in expediting the development of axicabtagene ciloleucel in Japan and underscores the unmet needs of patients with these aggressive forms of relapsed or refractory B-cell lymphomas," said Kouichi Akahane, PhD, MBA, Executive Officer, Head of Oncology Function, R&D Division, Daiichi Sankyo. "This designation represents the third Orphan Drug designation granted for an investigational therapy in our oncology pipeline, demonstrating our commitment to transforming innovative science into value for patients. We look forward to working closely with the Japan Health Authority to bring this important cell therapy to patients in Japan as soon as possible."

The Japan MHLW Orphan Drug designation system is designed to promote research activities and support the development of orphan drugs for serious, difficult-to-treat diseases that affect fewer than 50,000 patients in Japan, and for which significant unmet medical need exists. An investigational therapy can qualify for Orphan Drug designation if there is no approved alternative treatment option or if there is high efficacy or safety compared to existing treatment options expected. Therapies receiving Orphan Drug designation qualify for several measures intended to support development including, but not limited to, guidance and subsidies for research and development activities, priority consultation for clinical development and priority review of applications.

Axicabtagene ciloleucel is a chimeric antigen receptor T cell (CAR T) therapy directed against CD19 (a cell membrane protein), which harnesses a patient’s own immune system to fight certain types of B-cell lymphoma. In January 2017, Daiichi Sankyo received exclusive development, manufacturing and commercialization rights for axicabtagene ciloleucel in Japan from California-based Kite Pharma, Inc., a Gilead company. Based on the results of a Phase 1/2 study (ZUMA-1), axicabtagene ciloleucel has been approved in the U.S. and Europe. A Phase 2 study similar to the ZUMA-1 study is currently being planned in Japan.

Onxeo to Present at the 11th Edition of the “Rencontres de la Cancérologie Française” Oncology Conference

On October 3, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology, in particular against rare or resistant cancers, reported its participation in the 11th edition of the Rencontres de la Cancérologie Française (RCFr), a major event dedicated to innovation in oncology to be held on 27 and 28 November 2018 in Paris (Press release, Onxeo, OCT 3, 2018, View Source [SID1234530186]).

This edition on the theme of "Anticipation in cancer" will be inaugurated by the French Minister of Health, Mrs Agnès Buzyn.

On this occasion, ONXEO will address a panel of experts during the session "Valorisation des projets scientifiques de technologies émergentes" (Valuation of scientific projects for emerging technologies), organized in partnership with the École polytechnique and Angels Santé.

"We are pleased to participate in this event and to have the opportunity to present to experts our lead project AsiDNA in the promising field of DNA damage response," said Olivier de Beaumont, Medical Director of Onxeo.

Session: Valuation of scientific projects for emerging technologies

Date: Tuesday, November 27, 2018

Time: 7:45 pm

Location: Chatoform’ Eurosites George V (Paris), France

181003_PR_Onxeo_RCFr18

Immunomic Therapeutics CEO to Join Panel at 18th Annual Biotech in Europe Forum

On October 3, 2018 Tomorrow, William Hearl, Ph.D., Chief Executive Officer (CEO) of Immunomic Therapeutics, Inc., will participate in a panel discussion on advanced therapeutics for oncology at the 18th Annual Biotech in Europe Forum. Dr. Hearl will discuss the potential capabilities of Immunomic’s UNiversal Intracellular Targeted Expression (UNITE) investigational technology as a comprehensive platform for precision immuno-oncology and beyond (Press release, Immunomics, OCT 3, 2018, View Source [SID1234529955]). Immunomic’s nucleic acid vaccines have the potential to use 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 at the crossroads of immunotherapies in a number of illnesses, including cancer.

Immunomic’s lysosomal targeting technology is currently being employed in a Phase II clinical trial as a cancer immunotherapy. The company is pursuing research in the early stages of three other specific oncology applications: hepatitis B and hepatocellular carcinoma, Epstein-Barr virus driven cancers, such as nasopharyngeal carcinoma, and human papilloma virus driven cancers.