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]).

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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."

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]).

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"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.

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]).

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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

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.

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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.

On October 3, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported it closed the previously announced underwritten public offering of common units and pre-funded units for gross proceeds of $12 million (Press release, Altimmune, OCT 3, 2018, View Source [SID1234529905]). Together with the Company’s registered direct offering announced on September 24, the Company received aggregate gross proceeds of $16.9 million.

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"We are pleased with the outcome of our fundraising efforts," said William J. Enright, President and Chief Executive Officer of Altimmune. "These proceeds strengthen our balance sheet and position us well as we continue the development of NasoVax and our other product candidates."

Altimmune intends to use the net proceeds of approximately $14.4 million from these offerings for the continued advancement of development activities for the Company’s clinical-stage product pipeline, general corporate purposes, strategic growth opportunities and repayment of the Company’s outstanding $1.5 million in aggregate principal amount of convertible notes.

Roth Capital Partners acted as sole manager for the underwritten public offering and sole placement agent for the registered direct offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.