{"id":410117,"date":"2021-01-07T06:33:08","date_gmt":"2021-01-07T11:33:08","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=410117"},"modified":"2021-01-07T06:33:08","modified_gmt":"2021-01-07T11:33:08","slug":"affimed-announces-pipeline-and-business-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/affimed-announces-pipeline-and-business-update\/","title":{"rendered":"Affimed Announces Pipeline and Business Update"},"content":{"rendered":"<div class=\"mw_release\">\n<ul>\n<li>Continued progress for AFM13 and AFM24 clinical studies<\/li>\n<li>Strengthened cash position provides anticipated runway into the first half of 2023<\/li>\n<\/ul>\n<p>\n        <strong>Heidelberg, Germany, January 7, 2021 \u2013<\/strong> Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced an update on its pipeline and business.<\/p>\n<p>\u201cAffimed ended 2020 with significant momentum across all major programs and a strong balance sheet that provides cash runway into the first half of 2023,\u201d commented CEO Adi Hoess. \u201cWith three innate cell engagers in clinical development and multiple active collaborations, Affimed is positioned for numerous catalysts in 2021 and beyond.\u201d<\/p>\n<p>\n        <strong>Clinical Stage Program Updates<\/strong>\n      <\/p>\n<p>\n        <strong>AFM13 (CD30\/CD16A ICE\u00ae)<\/strong>\n      <\/p>\n<ul>\n<li>AFM13-202, a Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T-cell lymphoma (pTCL), remains ahead of schedule and Affimed expects to complete the interim data analysis during the first half of 2021. <\/li>\n<li>The first dose cohort of AFM13-104, an investigator sponsored Phase 1 study at The University of Texas MD Anderson Cancer Center evaluating the tolerability and efficacy of AFM13 preloaded cord blood-derived NK cells (cbNK) followed by weekly AFM13 monotherapy in patients with refractory CD30 expressing lymphomas, is ongoing. <\/li>\n<\/ul>\n<p>\n        <strong>AFM24 (EGFR\/CD16A ICE\u00ae)<\/strong>\n      <\/p>\n<ul>\n<li>AFM24-101, a Phase 1\/2a clinical trial of AFM24, the EGFR\/CD16A targeted ICE\u00ae for treatment of patients with EGFR-expressing solid tumors, has completed dose cohort 3 (80 mg per patient) without showing dose limiting side effects and patients are currently being enrolled and treated in dose cohort 4 (160 mg per patient). <\/li>\n<li>Affimed and NKMax America completed a pre-IND meeting with the U.S. Food and Drug Administration in December 2020. \u00a0The companies plan to submit an IND in the first half of 2021 for a Phase1\/2a study to investigate different dose levels of AFM24 in combination with NKMax America`s autologous NK cell product SNK01 in patients with EGFR expressing solid tumors.<\/li>\n<\/ul>\n<p>\n        <strong>Other Business Updates<\/strong>\n      <\/p>\n<ul>\n<li>As of December 31, 2020, Affimed\u2019s preliminary unaudited cash and cash equivalents were approximately \u20ac147 million. Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents will support operations into the first half of 2023.<\/li>\n<\/ul>\n<p>\n        <strong>About Affimed N.V.<\/strong>\n      <\/p>\n<p>Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer. Affimed\u2019s fit-for-purpose ROCK\u00ae platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed\/refractory peripheral T cell lymphoma and into a Phase 1\/2a dose escalation\/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, please visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=oujJgG6ioIy2ITjmonSsytb6BJzOgbfdumPJods6j1B-YBotK8FWeBYkIVE-beCj2PlfxruOVtEetNR3glfxag==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>www.affimed.com<\/u><\/a>.<\/p>\n<p>\n        <strong>FORWARD-LOOKING STATEMENTS<\/strong>\n      <\/p>\n<p>\u00a0This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cgoal,\u201d \u201cintend,\u201d \u201clook forward to,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cshould,\u201d \u201cwill,\u201d \u201cwould\u201d and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of our ICE\u00ae molecules, the value of our ROCK\u00ae platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading \u201cRisk Factors\u201d in Affimed\u2019s filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.<\/p>\n<p>\n        <strong>Investor Relations Contact<\/strong>\n      <\/p>\n<p>Alexander Fudukidis<br \/>Head of Investor Relations<br \/>E-Mail: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=IfNGpN-jfoAmrv_pSVWIsqZWYttFCicOsK536zw13foKikpkQPm2qm-0EtjaEDKB4FDWazxNPTprV9A3fFJM7Ey3gyYIHurFANaDLwN5ZQ8=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>a.fudukidis@affimed.com<\/u><\/a><br \/>Tel.: +1 (917) 436-8102<\/p>\n<p>\n        <strong>Media Contact<\/strong>\n      <\/p>\n<p>Mary Beth Sandin <br \/>Head of Marketing and Communications<br \/>E-Mail: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=lYJQS3LSD_orHglha1REVMC0NehI-HjDVAQODWxETUe7kSh-QKHGP-yYAwlMgCH-uPruPefdY4Wl5g4ITjkWZQ9T9vT6C3Mw7cxrCxMB-Ig=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>m.sandin@affimed.com<\/u><\/a><\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMDQ0OTQxMyM0MDA4NDgyNDAjMjAwMzczNA==\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml-eu.globenewswire.com\/release\/track\/1ad9095d-fa22-4e62-a9d6-c83947756906\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Continued progress for AFM13 and AFM24 clinical studies Strengthened cash position provides anticipated runway into the first half of 2023 Heidelberg, Germany, January 7, 2021 \u2013 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced an update on its pipeline and business. \u201cAffimed ended 2020 with significant momentum across all major programs and a strong balance sheet that provides cash runway into the first half of 2023,\u201d commented CEO Adi Hoess. \u201cWith three innate cell engagers in clinical development and multiple active collaborations, Affimed is positioned for numerous catalysts in 2021 and beyond.\u201d Clinical Stage Program Updates AFM13 (CD30\/CD16A ICE\u00ae) AFM13-202, a Phase 2 registration-directed study of AFM13 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/affimed-announces-pipeline-and-business-update\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Affimed Announces Pipeline and Business Update&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-410117","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Affimed Announces Pipeline and Business Update - Market Newsdesk<\/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.marketnewsdesk.com\/index.php\/affimed-announces-pipeline-and-business-update\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Affimed Announces Pipeline and Business Update - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Continued progress for AFM13 and AFM24 clinical studies Strengthened cash position provides anticipated runway into the first half of 2023 Heidelberg, Germany, January 7, 2021 \u2013 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced an update on its pipeline and business. \u201cAffimed ended 2020 with significant momentum across all major programs and a strong balance sheet that provides cash runway into the first half of 2023,\u201d commented CEO Adi Hoess. \u201cWith three innate cell engagers in clinical development and multiple active collaborations, Affimed is positioned for numerous catalysts in 2021 and beyond.\u201d Clinical Stage Program Updates AFM13 (CD30\/CD16A ICE\u00ae) AFM13-202, a Phase 2 registration-directed study of AFM13 &hellip; Continue reading &quot;Affimed Announces Pipeline and Business Update&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/affimed-announces-pipeline-and-business-update\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-01-07T11:33:08+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMDQ0OTQxMyM0MDA4NDgyNDAjMjAwMzczNA==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/affimed-announces-pipeline-and-business-update\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/affimed-announces-pipeline-and-business-update\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Affimed Announces Pipeline and Business Update\",\"datePublished\":\"2021-01-07T11:33:08+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/affimed-announces-pipeline-and-business-update\\\/\"},\"wordCount\":734,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/affimed-announces-pipeline-and-business-update\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=MTAwMDQ0OTQxMyM0MDA4NDgyNDAjMjAwMzczNA==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/affimed-announces-pipeline-and-business-update\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/affimed-announces-pipeline-and-business-update\\\/\",\"name\":\"Affimed Announces Pipeline and Business Update - 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