{"id":11573,"date":"2018-11-30T10:37:19","date_gmt":"2018-11-30T09:37:19","guid":{"rendered":"https:\/\/www.hollandbio.nl\/?p=11573"},"modified":"2018-12-03T10:50:51","modified_gmt":"2018-12-03T09:50:51","slug":"fda-clears-editas-crispr-study-in-humans","status":"publish","type":"post","link":"https:\/\/www.hollandbio.nl\/en\/nieuws\/fda-clears-editas-crispr-study-in-humans\/","title":{"rendered":"Editas receives FDA approval for CRISPR study in patients"},"content":{"rendered":"

Editas Medicine, a leading genome editing company, announced the U.S. Food and Drug Administration (FDA) has accepted the Company\u2019s Investigational New Drug (IND) application for EDIT-101, an experimental CRISPR genome editing medicine being investigated for the treatment of Leber Congenital Amaurosis type 10 (LCA10).<\/p>\n

\u201cThe FDA\u2019s acceptance of our IND for EDIT-101 is a significant moment in the field of genome editing, and importantly, a critical milestone for patients, as we are now one step closer to a treatment for LCA10,\u201d said Katrine Bosley, President and Chief Executive Officer, Editas Medicine. \u201cThis moment is a truly exciting one for us, and we look forward to embarking on our next chapter as a clinical stage company, harnessing the power of CRISPR technology to transform the lives of people with serious diseases around the world.\u201d<\/p>\n

With the IND acceptance, Editas Medicine has earned a $25 million milestone payment from Allergan as part of the alliance between the companies to discover and develop experimental ocular medicines targeting serious, vision-threatening diseases. Editas Medicine and its partner, Allergan Pharmaceuticals International Limited (Allergan), a wholly-owned subsidiary of Allergan plc, expect to enroll 10 to 20 patients in a Phase 1\/2 open label, dose escalation study to evaluate the safety, tolerability, and efficacy of EDIT-101.<\/p>\n

The Editas Medicine-Allergan Alliance<\/strong>
\nIn March 2017, Editas Medicine and Allergan Pharmaceuticals International Limited (Allergan) entered a strategic alliance and option agreement under which Allergan received exclusive access and the option to license up to five of Editas Medicine\u2019s genome editing programs for ocular diseases, including EDIT-101.\u00a0Under the terms of the agreement, Allergan is responsible for development and commercialization of optioned products, subject to Editas Medicine\u2019s option to co-develop and share equally in the profits and losses of two optioned products in the United States.\u00a0In August 2018, Allergan exercised its option to develop and commercialize EDIT-101 globally for the treatment of LCA10. Additionally, Editas Medicine exercised its option to co-develop and share equally in the profits and losses from EDIT-101 in the United States. Editas Medicine is also eligible to receive development and commercial milestones, as well as royalty payments on a per-program basis.\u00a0The agreement covers a range of first-in-class ocular programs targeting serious, vision-threatening diseases based on Editas Medicine\u2019s unparalleled CRISPR genome editing platform, including CRISPR\/Cas9 and CRISPR\/Cpf1 (also known as Cas12a).<\/p>\n

Source: Editas Medicine<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Editas Medicine, a leading genome editing company, announced the U.S. Food and Drug Administration (FDA) has accepted the Company\u2019s Investigational New Drug (IND) application for EDIT-101, an experimental CRISPR genome editing medicine being investigated for the treatment of Leber Congenital Amaurosis type 10 (LCA10). \u201cThe FDA\u2019s acceptance of our IND for EDIT-101 is a significant […]<\/p>\n","protected":false},"author":6,"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-11573","post","type-post","status-publish","format-standard","hentry","category-gezondheid"],"acf":[],"yoast_head":"\nEditas receives FDA approval for CRISPR study in patients - 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\/fda-clears-editas-crispr-study-in-humans\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Editas receives FDA approval for CRISPR study in patients - hollandbio\" \/>\n<meta property=\"og:description\" content=\"Editas Medicine, a leading genome editing company, announced the U.S. Food and Drug Administration (FDA) has accepted the Company\u2019s Investigational New Drug (IND) application for EDIT-101, an experimental CRISPR genome editing medicine being investigated for the treatment of Leber Congenital Amaurosis type 10 (LCA10). \u201cThe FDA\u2019s acceptance of our IND for EDIT-101 is a significant […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.hollandbio.nl\/en\/nieuws\/fda-clears-editas-crispr-study-in-humans\/\" \/>\n<meta property=\"og:site_name\" content=\"hollandbio\" \/>\n<meta property=\"article:published_time\" content=\"2018-11-30T09:37:19+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2018-12-03T09:50:51+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\\\/fda-clears-editas-crispr-study-in-humans\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/nieuws\\\/fda-clears-editas-crispr-study-in-humans\\\/\"},\"author\":{\"name\":\"hollandbio\",\"@id\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/#\\\/schema\\\/person\\\/833d6a25b39946e61c6101af1fa96fbb\"},\"headline\":\"Editas receives FDA approval for CRISPR study in patients\",\"datePublished\":\"2018-11-30T09:37:19+00:00\",\"dateModified\":\"2018-12-03T09:50:51+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/nieuws\\\/fda-clears-editas-crispr-study-in-humans\\\/\"},\"wordCount\":398,\"publisher\":{\"@id\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/#organization\"},\"articleSection\":[\"Gezondheid\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/nieuws\\\/fda-clears-editas-crispr-study-in-humans\\\/\",\"url\":\"https:\\\/\\\/www.hollandbio.nl\\\/en\\\/nieuws\\\/fda-clears-editas-crispr-study-in-humans\\\/\",\"name\":\"Editas receives FDA approval for CRISPR study in patients - 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