Prima BioMed Ltd, a biotechnology company, focuses on the development of immunotherapeutic products for the treatment of various types of cancer. IMP321 Clinical Development The company’s lead program is the development of IMP321 (a recombinant protein in clinical trials for the treatment of cancer) in partnership with Eddingpharm for China, including Macau and Hong Kong, and Taiwan. As part consideration for the collaboration agreement with Eddingpharm, GMP grade IMP321 material has been manufactured in preparation for two clinical trials, such as one termed AIPAC in metastatic breast cancer in conjunction with chemotherapy and the second in combination with an undisclosed immune checkpoint inhibitor. The trials are expected to commence in late 2015 or in 2016. IMP731 Clinical Development In January 2015, the company announced a single digit million USD milestone payment by GlaxoSmithKline (GSK) for the development of GSK2831781 in first time in human clinical trials. The company’s subsidiary, Immutep SA (Immutep), licensed IMP731 to GSK for the development of depleting antibodies that target lymphocyte activation gene 3 (LAG-3). The technology has potential application foremost in autoimmunity. IMP701 Clinical Development IMP701 is an antagonist antibody targeting the LAG-3 molecule and has applications for the treatment of cancer. It works to block the negative signal that cancer cells could give cytotoxic T cells to stop them from responding to the cancer. In 2012, Immutep licensed the IMP701 technology to Costim Pharmaceuticals. In 2014, Costim Pharmaceuticals was acquired by Novartis. Novartis have been conducting pre-clinical development of IMP701 and a Phase I started in August 2015. CVac Clinical Development for the Treatment of Ovarian Cancer Patients in Remission The company had obtained orphan indication designation in both the United States and Europe. Fast Track designation was also granted in the United States in May 2014. After completing a strategic review of the assets of the company after acquiring Immutep, a decision was made to consolidate the data collected in the CVac clinical trial program and to seek a development partner to continue the programs. Intellectual Property The Immutep patent portfolio is extensive with 11 families at the time of the acquisition in December 2014. Five patent families are licensed from Merck Serono and cover the background LAG-3 intellectual property. One family is licensed from a Paris University and another family is jointly owned with the Institut national de la santé et de la recherche médicale in Paris and is licensed to GSK. The remaining families are owned by Immutep and two new provisional applications have been filed since the acquisition of Immutep. The portfolio provides protection for the use of IMP321 and the licensed assets. CVac is protected in the major markets and various other countries by one patent family licensed from the Burnet Institute in Melbourne, Australia. The patents provide claims for producing dendritic cells treated with mannan fusion protein and reinjecting the treated cells back into patients. CVac is a registered trademark in Australia, the United States, Europe, New Zealand, China, and the UAE. Immutep is a registered trademark in France. The company owns both of these trademarks in these jurisdictions. Significant Events In December 2015, Prima BioMed Ltd. announced important progress in its collaboration with NEC Corporation and Yamaguchi University. In this collaboration, first announced in May 2015, Prima's IMP321 Antigen Presenting Cell activator (APC) is being combined with a therapeutic vaccine for different carcinoma types that was developed at Yamaguchi. Regulatory Authorities The company’s ongoing research and development activities, production, and marketing of its pharmaceutical product is subject to regulation by various governmental authorities, including in Australia, principally the Therapeutics Goods Administration; in the United States, principally the Food and Drug Administration (FDA); and in Europe, principally the European Medicines Agency. The company, and any manufacturers of its products, is required to comply with applicable FDA manufacturing requirements contained in the FDA’s GMP regulations.
prima biomed ltd
(PRR:Australian Stock Exchange Ltd)
95 Pitt Street
Sydney, NSW 2000
Phone: 61 2 8315 7003
Fax: 61 2 8569 1880www.primabiomed.com.au
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