{"id":17522,"date":"2020-07-07T16:20:48","date_gmt":"2020-07-07T14:20:48","guid":{"rendered":"https:\/\/www.hollandbio.nl\/?p=17522"},"modified":"2020-07-07T16:53:07","modified_gmt":"2020-07-07T14:53:07","slug":"isa-pharmaceuticals-receives-us-orphan-drug-designation-for-isa101b-in-hpv16-positive-cervical-cancer","status":"publish","type":"post","link":"https:\/\/www.hollandbio.nl\/en\/nieuws\/isa-pharmaceuticals-receives-us-orphan-drug-designation-for-isa101b-in-hpv16-positive-cervical-cancer\/","title":{"rendered":"ISA Pharmaceuticals receives US Orphan-Drug Designation for ISA101b in HPV16-positive Cervical Cancer"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">ISA Pharmaceuticals B.V., a clinical-stage company dedicated to developing rationally designed immunotherapeutics for oncology and infectious disease, today announced that it received Orphan Drug Designation from the Food and Drug Administration (FDA) in the USA for its lead product ISA101b for treatment of Human Papilloma Virus type 16 (HPV16)-positive cervical cancer.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">According to the latest statistics of the Centers for Disease Control and Prevention, HPV causes more than 34,000 cases of cancer in the United States each year. <a href=\"https:\/\/www.cdc.gov\/cancer\/cervical\/\">Cervical cancer<\/a>&nbsp;is the most common HPV-associated cancer in women, with HPV16 being responsible for approximately 50% of&nbsp;cases. HPV16-positive cervical cancer is the number 2 cause of cancer for women in the age 15-44 in the US. At 1% annually, rates of cervical cancer have been dropping only marginally due to prevention through screening and prophylactic vaccination. There is an important medical need for disease modifying therapies to treat women with this terrible disease. For 2020, SEER databases project 13,800 new cases and 4,290 women dying from cervical cancer in the US.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ISA101b is a clinical-stage immunotherapy targeting HPV16-induced diseases such as cervical and oropharyngeal cancer. It induces specific immune responses to the oncogenic E6 and E7 proteins of HPV16 and is based on ISA\u2019s proprietary Synthetic Long Peptide (SLP\u00ae) technology.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cWe are pleased to have Orphan Drug Designation for our ISA101b program targeting HPV16-positive cervical cancers,\u201d said Kees Melief, Chief Scientific Officer of ISA Pharmaceuticals. \u201cOur mission is to unleash the power of the patient\u2019s own immune system to eradicate their cancer while maintaining optimal quality of life. We believe the best and most logical way to do this is through the use of SLPs. The metastatic form of cervical cancer has a particularly high unmet medical need with 5 year survival rates not going beyond 17%. The Orphan Drug Designation for ISA101b recognizes the urgent need for more efficacious treatment options for patients suffering from metastatic HPV16-positive cervical cancer.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Source: ISA Pharmaceuticals (<a href=\"https:\/\/www.isa-pharma.com\/isa-pharmaceuticals-receives-us-orphan-drug-designation-for-isa101b-in-hpv16-positive-cervical-cancer\/\">Press release<\/a>)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ISA Pharmaceuticals B.V., a clinical-stage company dedicated to developing rationally designed immunotherapeutics for oncology and infectious disease, today announced that it received Orphan Drug Designation from the Food and Drug Administration (FDA) in the USA for its lead product ISA101b for treatment of Human Papilloma Virus type 16 (HPV16)-positive cervical cancer. According to the latest [&hellip;]<\/p>\n","protected":false},"author":16,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[],"class_list":["post-17522","post","type-post","status-publish","format-standard","hentry","category-gezondheid"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISA Pharmaceuticals receives US Orphan-Drug Designation for ISA101b in HPV16-positive Cervical Cancer - hollandbio<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.hollandbio.nl\/en\/nieuws\/isa-pharmaceuticals-receives-us-orphan-drug-designation-for-isa101b-in-hpv16-positive-cervical-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISA Pharmaceuticals receives US Orphan-Drug Designation for ISA101b in HPV16-positive Cervical Cancer - hollandbio\" \/>\n<meta property=\"og:description\" content=\"ISA Pharmaceuticals B.V., a clinical-stage company dedicated to developing rationally designed immunotherapeutics for oncology and infectious disease, today announced that it received Orphan Drug Designation from the Food and Drug Administration (FDA) in the USA for its lead product ISA101b for treatment of Human Papilloma Virus type 16 (HPV16)-positive cervical cancer. According to the latest [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.hollandbio.nl\/en\/nieuws\/isa-pharmaceuticals-receives-us-orphan-drug-designation-for-isa101b-in-hpv16-positive-cervical-cancer\/\" \/>\n<meta property=\"og:site_name\" content=\"hollandbio\" \/>\n<meta property=\"article:published_time\" content=\"2020-07-07T14:20:48+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-07-07T14:53:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.hollandbio.nl\/wp-content\/uploads\/2025\/01\/hb-opengraph_illu.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"675\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"HollandBIO\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@hollandbio\" \/>\n<meta name=\"twitter:site\" content=\"@hollandbio\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"HollandBIO\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/nieuws\\\/isa-pharmaceuticals-receives-us-orphan-drug-designation-for-isa101b-in-hpv16-positive-cervical-cancer\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/nieuws\\\/isa-pharmaceuticals-receives-us-orphan-drug-designation-for-isa101b-in-hpv16-positive-cervical-cancer\\\/\"},\"author\":{\"name\":\"HollandBIO\",\"@id\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/#\\\/schema\\\/person\\\/48824449f08e494bb7ea02e1ff5dd6ea\"},\"headline\":\"ISA Pharmaceuticals receives US Orphan-Drug Designation for ISA101b in HPV16-positive Cervical Cancer\",\"datePublished\":\"2020-07-07T14:20:48+00:00\",\"dateModified\":\"2020-07-07T14:53:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/nieuws\\\/isa-pharmaceuticals-receives-us-orphan-drug-designation-for-isa101b-in-hpv16-positive-cervical-cancer\\\/\"},\"wordCount\":344,\"publisher\":{\"@id\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/#organization\"},\"articleSection\":[\"Gezondheid\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/nieuws\\\/isa-pharmaceuticals-receives-us-orphan-drug-designation-for-isa101b-in-hpv16-positive-cervical-cancer\\\/\",\"url\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/nieuws\\\/isa-pharmaceuticals-receives-us-orphan-drug-designation-for-isa101b-in-hpv16-positive-cervical-cancer\\\/\",\"name\":\"ISA Pharmaceuticals receives US Orphan-Drug Designation for ISA101b in HPV16-positive Cervical Cancer - 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