{"id":57547,"date":"2023-06-08T07:03:40","date_gmt":"2023-06-08T05:03:40","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/sar579-iph6101-receives-fda-fast-track-designation-in-the-us-for-the-treatment-of-hematological-malignancies\/"},"modified":"2023-06-08T07:03:40","modified_gmt":"2023-06-08T05:03:40","slug":"sar579-iph6101-receives-fda-fast-track-designation-in-the-us-for-the-treatment-of-hematological-malignancies","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/sar579-iph6101-receives-fda-fast-track-designation-in-the-us-for-the-treatment-of-hematological-malignancies\/","title":{"rendered":"SAR\u2019579 \/ IPH6101 Receives FDA Fast Track Designation in the US for the Treatment of Hematological Malignancies"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<b><i>SAR\u2019579, ANKET<sup>\u00ae<\/sup> platform lead asset, is a trifunctional anti-CD123 NKp46\u00d7CD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi, now under development by partner Sanofi.<\/i><\/b><\/li>\n<\/ul>\n<p>MARSEILLE, France&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/ANKET?src=hash\" target=\"_blank\" rel=\"noopener\">#ANKET<\/a>&#8211;Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (\u201c<b>Innate<\/b>\u201d or the \u201c<b>Company<\/b>\u201d) is pleased to share Sanofi\u2019s news that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SAR\u2019579 \/ IPH6101 for the treatment of hematological malignancies.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230607005831\/en\/1245155\/4\/INNATEvertnoirDS.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230607005831\/en\/1245155\/21\/INNATEvertnoirDS.jpg\"><\/a><\/p>\n<p>\nFast Track Designation is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses.<\/p>\n<p>\nSAR\u2019579, ANKET<sup>\u00ae<\/sup> platform lead asset, is a trifunctional anti-CD123 NKp46\u00d7CD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi, now under development by partner Sanofi.<\/p>\n<p>\n\u201c<i>It is promising to see SAR\u2019579 \/ IPH6101 was granted Fast Track Designation in the US for the treatment of hematological malignancies,<\/i> <i>and congratulate our partner Sanofi on this milestone<\/i>,\u201d said <b>Mondher Mahjoubi, Chief Executive Officer of Innate Pharma<\/b>. \u201c<i>In addition to the encouraging clinical data recently presented at the 2023 ASCO Annual Meeting, this FDA Fast Track Designation further validates the potential of the ANKET<sup>\u00ae<\/sup> platform to treat cancer patients with NK Cell Engagers<\/i>.\u201d<\/p>\n<p>\n<b>About ANKET<sup>\u00ae<\/sup><\/b><\/p>\n<p>\n<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.innate-pharma.com%2Fnode%2F3098%2F&amp;esheet=53416519&amp;newsitemid=20230607005831&amp;lan=en-US&amp;anchor=ANKET%26%23174%3B&amp;index=1&amp;md5=c5070a9fb27aa67b5c43f153dab53df3\" rel=\"nofollow noopener\" shape=\"rect\">ANKET<sup>\u00ae<\/sup><\/a> (<b>A<\/b>ntibody-based <b>NK<\/b> cell <b>E<\/b>ngager <b>T<\/b>herapeutics) is Innate&#8217;s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer.<\/p>\n<p>\nThis versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.<\/p>\n<p>\n<b>About the Innate-Sanofi agreements:<\/b><\/p>\n<p>\nThe Company has a research collaboration and license agreement with Sanofi to apply Innate\u2019s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.<\/p>\n<p>\nUnder the terms of the 2016 research collaboration and <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.innate-pharma.com%2Fnode%2F2150%2F&amp;esheet=53416519&amp;newsitemid=20230607005831&amp;lan=en-US&amp;anchor=license+agreement&amp;index=2&amp;md5=2668d51d14b84efdc1b470d1629d3783\" rel=\"nofollow noopener\" shape=\"rect\">license agreement<\/a>, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes IPH6101\/SAR\u2019579 (Trifunctional anti-CD123 NKp46\u00d7CD16 NK cell engager) and IPH6401\/SAR\u2019514 (Trifunctional anti-BCMA NKp46\u00d7CD16 NK cell engager). As part of the 2016 agreement, Innate Pharma will be eligible to up to \u20ac400m in development and commercial milestone payments as well as royalties on net sales.<\/p>\n<div class=\"bwpagebreakafter\"><\/div>\n<p>\nAnother <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.innate-pharma.com%2Fnode%2F3178%2F&amp;esheet=53416519&amp;newsitemid=20230607005831&amp;lan=en-US&amp;anchor=license+agreement&amp;index=3&amp;md5=6bb582eb5fc037f3d971ef7b0c55101d\" rel=\"nofollow noopener\" shape=\"rect\">license agreement<\/a> was entered in December 2022, which includes IPH62 and 2 options.<\/p>\n<p>\n<b>About Innate Pharma<\/b><\/p>\n<p>\nInnate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET<sup>\u00ae<\/sup> (<b>A<\/b>ntibody-based <b>NK<\/b> cell <b>E<\/b>ngager <b>T<\/b>herapeutics) proprietary platform.<\/p>\n<p>\nInnate\u2019s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET<sup>\u00ae<\/sup> multi-specific NK cell engagers to address multiple tumor types.<\/p>\n<p>\nInnate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.<\/p>\n<p>\nHeadquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.<\/p>\n<p>\nLearn more about Innate Pharma at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.innate-pharma.com%2F&amp;esheet=53416519&amp;newsitemid=20230607005831&amp;lan=en-US&amp;anchor=www.innate-pharma.com&amp;index=4&amp;md5=66121d291700bb11cc784c1bb0fd8a75\" rel=\"nofollow noopener\" shape=\"rect\">www.innate-pharma.com<\/a> and follow us on <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2FInnatePharma&amp;esheet=53416519&amp;newsitemid=20230607005831&amp;lan=en-US&amp;anchor=Twitter&amp;index=5&amp;md5=f5afbbc9945ddd5e2227c4d87a56388a\" rel=\"nofollow noopener\" shape=\"rect\">Twitter<\/a> and <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Finnate-pharma%2F&amp;esheet=53416519&amp;newsitemid=20230607005831&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=6&amp;md5=32791a8143f2fedc1400b2498921e733\" rel=\"nofollow noopener\" shape=\"rect\">LinkedIn<\/a>.<\/p>\n<p>\n<b>Information about Innate Pharma shares<\/b><\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl\">\n<tr>\n<td class=\"bwvertalignt bwpadl0 bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignl bwcellpmargin\">\n<b>ISIN code<\/b><\/p>\n<\/td>\n<td colspan=\"1\" rowspan=\"1\"><\/td>\n<td colspan=\"1\" rowspan=\"1\"><\/td>\n<td colspan=\"1\" rowspan=\"1\"><\/td>\n<td class=\"bwvertalignt bwpadl0 bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\nFR0010331421<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0 bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignl bwcellpmargin\">\n<b>Ticker code<\/b><\/p>\n<\/td>\n<td colspan=\"1\" rowspan=\"1\"><\/td>\n<td colspan=\"1\" rowspan=\"1\"><\/td>\n<td colspan=\"1\" rowspan=\"1\"><\/td>\n<td class=\"bwvertalignt bwpadl0 bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\nEuronext: IPH Nasdaq: IPHA<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0 bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignl bwcellpmargin\">\n<b>LEI<\/b><\/p>\n<\/td>\n<td colspan=\"1\" rowspan=\"1\"><\/td>\n<td colspan=\"1\" rowspan=\"1\"><\/td>\n<td colspan=\"1\" rowspan=\"1\"><\/td>\n<td class=\"bwvertalignt bwpadl0 bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n9695002Y8420ZB8HJE29<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n<b>Disclaimer on forward-looking information and risk factors<\/b><\/p>\n<p>\nThis press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including \u201cbelieve,\u201d \u201cpotential,\u201d \u201cexpect\u201d and \u201cwill\u201d and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company\u2019s commercialization efforts and the Company\u2019s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties which could cause the company&#8217;s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (\u201cFacteurs de Risque&#8221;) section of the Universal Registration Document filed with the French Financial Markets Authority (\u201cAMF\u201d), which is available on the AMF website <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.amf-france.org&amp;esheet=53416519&amp;newsitemid=20230607005831&amp;lan=en-US&amp;anchor=http%3A%2F%2Fwww.amf-france.org&amp;index=7&amp;md5=36a59a2b6b28e25b63fba5db618c60a3\" rel=\"nofollow noopener\" shape=\"rect\">http:\/\/www.amf-france.org<\/a> or on Innate Pharma\u2019s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (\u201cSEC\u201d), including the Company\u2019s Annual Report on Form 20-F for the year ended December 31, 2022, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.<\/p>\n<div class=\"bwpagebreakafter\"><\/div>\n<p>\nThis press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b><span class=\"bwuline\">Investors<\/span><\/b><br \/><b>Innate Pharma<\/b><br \/>Henry Wheeler<br \/>\n<br \/>Tel.: +33 (0)4 84 90 32 88<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#x74;&#x6f;&#58;&#72;&#101;&#110;ry&#46;w&#x68;&#x65;&#x65;&#x6c;&#x65;&#x72;&#64;&#105;&#110;&#110;&#97;te-&#x70;&#x68;&#x61;&#x72;&#x6d;&#x61;&#46;&#102;&#114;\" rel=\"nofollow noopener\" shape=\"rect\">&#x48;&#x65;&#110;&#114;&#121;&#46;&#x77;&#x68;&#x65;&#101;&#108;er&#x40;&#x69;&#x6e;&#110;&#97;t&#x65;&#x2d;&#x70;&#104;&#97;&#114;m&#x61;&#x2e;&#x66;&#114;<\/a><\/p>\n<p>\n<b><span class=\"bwuline\">Media Relations<\/span><\/b><br \/><b>NewCap<\/b><br \/>Arthur Rouill\u00e9<br \/>\n<br \/>Tel.: +33 (0)1 44 71 00 15<br \/>\n<br \/><a target=\"_blank\" href=\"mai&#108;&#116;&#111;&#x3a;&#x69;&#x6e;&#x6e;&#x61;&#x74;e&#64;n&#101;&#119;&#99;&#97;&#x70;&#x2e;&#x65;&#x75;\" rel=\"nofollow noopener\" shape=\"rect\">i&#110;&#x6e;&#x61;t&#101;&#x40;&#x6e;e&#119;&#99;&#x61;&#x70;&#46;&#101;&#x75;<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>SAR\u2019579, ANKET\u00ae platform lead asset, is a trifunctional anti-CD123 NKp46\u00d7CD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi, now under development by partner Sanofi. MARSEILLE, France&#8211;(BUSINESS WIRE)&#8211;#ANKET&#8211;Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (\u201cInnate\u201d or the \u201cCompany\u201d) is pleased to share Sanofi\u2019s news that the U.S. Food and Drug &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/sar579-iph6101-receives-fda-fast-track-designation-in-the-us-for-the-treatment-of-hematological-malignancies\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-57547","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>SAR\u2019579 \/ IPH6101 Receives FDA Fast Track Designation in the US for the Treatment of Hematological Malignancies - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/sar579-iph6101-receives-fda-fast-track-designation-in-the-us-for-the-treatment-of-hematological-malignancies\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"SAR\u2019579 \/ IPH6101 Receives FDA Fast Track Designation in the US for the Treatment of Hematological Malignancies - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"SAR\u2019579, ANKET\u00ae platform lead asset, is a trifunctional anti-CD123 NKp46\u00d7CD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi, now under development by partner Sanofi. MARSEILLE, France&#8211;(BUSINESS WIRE)&#8211;#ANKET&#8211;Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (\u201cInnate\u201d or the \u201cCompany\u201d) is pleased to share Sanofi\u2019s news that the U.S. Food and Drug ... 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MARSEILLE, France&#8211;(BUSINESS WIRE)&#8211;#ANKET&#8211;Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (\u201cInnate\u201d or the \u201cCompany\u201d) is pleased to share Sanofi\u2019s news that the U.S. Food and Drug ... 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