{"id":15164,"date":"2022-01-04T17:38:39","date_gmt":"2022-01-04T12:08:39","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=15164"},"modified":"2022-01-06T09:23:59","modified_gmt":"2022-01-06T03:53:59","slug":"pharma-news-for-accutar-bio-thera-nykode-elusys","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-accutar-bio-thera-nykode-elusys","title":{"rendered":"Accutar&#8217;s Phase I clinical trial for AC0176; Bio-Thera&#8217;s cancer drug, BAT6005; Nykode&#8217;s Covid-19 vaccine trial; Heat Biologics acquires Elusys"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a0e2a900620b\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a0e2a900620b\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-accutar-bio-thera-nykode-elusys\/#FDA_approves_IND_application_of_Accutar_for_a_prostate_cancer_treatment_trial\" >FDA approves IND application of Accutar for a prostate cancer treatment trial<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-accutar-bio-thera-nykode-elusys\/#Bio-Thera_Solutions_begins_dosing_in_Phase_I_trial_of_cancer_drug\" >Bio-Thera Solutions begins dosing in Phase I trial of cancer drug<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-accutar-bio-thera-nykode-elusys\/#Nykode_doses_first_participant_in_Phase_III_Covid-19_vaccine_trial\" >Nykode doses first participant in Phase I\/II Covid-19 vaccine trial<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-accutar-bio-thera-nykode-elusys\/#Heat_Biologics_to_acquire_Elusys_Therapeutics\" >Heat Biologics to acquire Elusys Therapeutics<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-ind-application-of-accutar-for-a-prostate-cancer-treatment-trial\"><span class=\"ez-toc-section\" id=\"FDA_approves_IND_application_of_Accutar_for_a_prostate_cancer_treatment_trial\"><\/span><strong>FDA approves IND application of Accutar for a prostate cancer treatment trial<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The US Food and Drug Administration (FDA) has granted Accutar Biotechnology\u2019s Investigational New Drug (IND) application for Phase I clinical trial of AC0176 for treating <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-castration-resistant-prostate-cancer-mcrpc-market\">metastatic castration-resistant prostate cancer (mCRPC)<\/a>.<\/p>\n\n\n\n<p>An investigational orally bioavailable, chimeric degrader molecule, AC0176, is designed to aim and degrade androgen receptor (AR) for <a href=\"https:\/\/www.delveinsight.com\/report-store\/prostate-cancer-epidemiology-forecast\">prostate cancer treatment<\/a>.  AR is a hormone-regulated transcription factor, which plays a prominent role in the initiation and progression of prostate cancer.<\/p>\n\n\n\n<p>Accutar stated that AC0176 showed selective and robust degradation of AR protein with broad coverage of AR mutants and favorable pharmacological properties in the preclinical studies. In the Phase 1 study, AC0176\u2019s pharmacokinetics, preliminary anti-tumor activity, safety, and tolerability will be assessed to treat <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-castration-resistant-prostate-cancer-mcrpc-epidemiology-forecast\">mCRPC patients<\/a>.<\/p>\n\n\n\n<p>Accutar Biotechnology CEO Jie Fan said that the IND clearance for AC0176 is another vital validation. After their AC0682 entered the clinic, their AI platform can bolster and progress the discovery of potentially differentiated clinical candidates quickly, incredibly complex compounds such as chimeric degraders.<\/p>\n\n\n\n<p>The IND clearance for AC0176 is also critical towards delivering a potential <a href=\"https:\/\/www.delveinsight.com\/report-store\/prostate-cancer-market\">new treatment for prostate cancer<\/a> based on a differentiated mechanism of action from second-generation nonsteroidal AR antagonists, which are the current standard of care for this patient population.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Bio-Thera_Solutions_begins_dosing_in_Phase_I_trial_of_cancer_drug\"><\/span><strong>Bio-Thera Solutions begins dosing in Phase I trial of cancer drug<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>China-based commercial-stage pharmaceutical firm Bio-Thera Solutions has initiated dosing in Phase I clinical trial of BAT6005, a <a href=\"https:\/\/www.delveinsight.com\/report-store\/tigit-inhibitors-pipeline-insight\">monoclonal antibody to target TIGIT in cancer <\/a>patients.<\/p>\n\n\n\n<p>The trial will assess the pharmacokinetics and safety of BAT6005, which was discovered using the firm\u2019s fully synthetic human antibody discovery platform, called IDEAL that stands for Intelligent Design and Engineered Antibody Libraries. BAT6005 has normal IgG1 ADCC function.&nbsp;<\/p>\n\n\n\n<p>Bio-Thera Solutions SVP Dr. Jin-Chen Yu said that TIGIT is an immune-oncology drug target of tremendous interest. Preclinical data generated in support of the BAT6005 IND is very promising. BAT6005 is one of various IO assets entering Phase 1 studies and transitioning Bio-Thera\u2019s innovative IO pipeline from a preclinical pipeline to a clinical pipeline. They plan to look for combinations of BAT6005 with BAT1308, their <a href=\"https:\/\/www.delveinsight.com\/report-store\/anti-cd279-pd-1-antibody-pipeline-insight\">novel PD-1 antibody<\/a>, for treating several ranges of cancers.<\/p>\n\n\n\n<p>The multicentre, open-label, dose-escalation Phase I trial to assess the safety and tolerability aspects of BAT6005 as a single agent. This trial anticipates the enrollment of patients suffering from <a href=\"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-janssen-silver-therapeutics-sanofi-regeneron\">advanced solid tumors<\/a>. The trial\u2019s primary aim comprises ascertaining maximum tolerated dose, preliminary anti-tumor activity, and pharmacokinetics.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Nykode_doses_first_participant_in_Phase_III_Covid-19_vaccine_trial\"><\/span><strong>Nykode doses first participant in Phase I\/II Covid-19 vaccine trial<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Nykode Therapeutics has dosed the first participant in Phase I\/II VB-D-01 clinical trial of its <a href=\"https:\/\/www.delveinsight.com\/report-store\/covid-19-therapeutic-pipeline-vaccines\">T cell-specific Covid-19 vaccine candidate<\/a> in unvaccinated individuals.<\/p>\n\n\n\n<p>The shot can potentially prime T cells, thereby eliciting a wide-ranging immune response against present and future viral variants. The open-label, two-arm dose-escalation, and dose-expansion trial is designed to evaluate the safety, reactogenicity, and immunogenicity of both the T cell-specific\/VB10.2210 and the RBD\/VB10.2129 vaccine candidates in healthy subjects.<\/p>\n\n\n\n<p>The Research Council of Norway supports the trial being carried out in Norway at the Oslo University Hospital and the Haukeland University Hospital, Bergen. In the dose-escalation portion, three dose levels of both the vaccines will be searched, while the dose-expansion segment will evaluate a selected dose. Furthermore, single and two doses of both vaccines will be assessed in the dose-escalation phase.<\/p>\n\n\n\n<p>The VB10.2210 vaccine encodes a mixture of conserved and immuno-dominant T cell epitope hotspots covering various <a href=\"https:\/\/www.delveinsight.com\/blog\/monoclonal-antibody-therapy\">antigens of the SARS-CoV-2 virus<\/a>. It encodes 96 immunogenic T cell epitopes of eight viral proteins, including Spike. According to preliminary analysis, no epitopes outside the Spike were impacted by the Omicron variant of the SARS-CoV-2 virus.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Heat_Biologics_to_acquire_Elusys_Therapeutics\"><\/span><strong>Heat Biologics to acquire Elusys Therapeutics<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Heat Biologics, Inc., a clinical-stage biopharmaceutical company zeroed in on developing first-in-class therapies for modulation of the immune system, has executed a definitive merger agreement to buy Elusys Therapeutics, a commercial-stage biodefense company, and the manufacturer of ANTHIM\u00ae (obiltoxaximab) Injection, according to which Elusys will merge into a wholly-owned subsidiary of Heat. The acquisition is anticipated to close during the first quarter of 2022 and is subject to customary closing conditions. ANTHIM is approved for use in the U.S. and Canada and Europe, and the United Kingdom under the brand name Obiltoxaximab SFL.<\/p>\n\n\n\n<p>The strategic acquisition of Elusys is planned to improve Heat\u2019s immunotherapy portfolio and further position Heat to take a vital role in the biodefense space. The addition of ANTHIM, together with Heat\u2019s previously announced RapidVax\u00ae platform designed for targeting emerging biological threats, would tremendously expand the company\u2019s infectious disease product portfolio. To date, Elusys has been awarded over USD 350 million in research and development contracts and procurement orders from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR), the National Institute of Allergy and Infectious Disease (NIAID), and the Department of Defense (DOD).<\/p>\n\n\n\n<p>Through ongoing, multi-year partnerships with the U.S. government, Elusys has been supplying ANTHIM to the U.S. Strategic National Stockpile (SNS)\u2014the government\u2019s repository of critical medical supplies for biowarfare preparedness. Following the closing of this acquisition, Elusys will continue to operate as a wholly-owned subsidiary of Heat. Under the terms of the merger agreement with Elusys, Heat will buy all outstanding shares of Elusys. No stock or warrants will be issued to the acquisition, and Elusys has no outstanding debt.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA approves IND application of Accutar for a prostate cancer treatment trial The US Food and Drug Administration (FDA) has granted Accutar Biotechnology\u2019s Investigational New Drug (IND) application for Phase I clinical trial of AC0176 for treating metastatic castration-resistant prostate cancer (mCRPC). An investigational orally bioavailable, chimeric degrader molecule, AC0176, is designed to aim and [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":15166,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[137,10830,15648,18946,18962,420,639,498,18935,18907],"industry":[17225],"therapeutic_areas":[17227,17231,17557,17228,17243],"class_list":["post-15164","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-cancer","tag-covid-19","tag-covid-19-vaccines","tag-mcrpc","tag-metastatic-castration-resistant-prostate-cancer","tag-news","tag-pharma-news","tag-prostate-cancer","tag-tigit","tag-tigit-inhibitors","industry-pharmaceutical","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-infectious-diseases","therapeutic_areas-male-health","therapeutic_areas-oncology","therapeutic_areas-respiratory-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Accutar&#039;s AC0176; Bio-Thera Cancer Drug; Nykode&#039;s Covid-19 Trial<\/title>\n<meta name=\"description\" content=\"Accutar&#039;s AC0176 clinical trial; Bio-Thera begins clinical trial of BAT6005; Nykode Covid-19 trial; Heat Biologics acquires Elusys\" \/>\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.delveinsight.com\/blog\/pharma-news-for-accutar-bio-thera-nykode-elusys\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Accutar&#039;s AC0176; Bio-Thera Cancer Drug; Nykode&#039;s Covid-19 Trial\" \/>\n<meta property=\"og:description\" content=\"Accutar&#039;s AC0176 clinical trial; Bio-Thera begins clinical trial of BAT6005; 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href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">COVID-19<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Covid-19 vaccines<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">mCRPC<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">metastatic castration-resistant prostate cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Prostate Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">TIGIT<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">TIGIT Inhibitors<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Cancer<\/span>","<span class=\"advgb-post-tax-term\">COVID-19<\/span>","<span class=\"advgb-post-tax-term\">Covid-19 vaccines<\/span>","<span class=\"advgb-post-tax-term\">mCRPC<\/span>","<span class=\"advgb-post-tax-term\">metastatic castration-resistant prostate cancer<\/span>","<span class=\"advgb-post-tax-term\">news<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>","<span class=\"advgb-post-tax-term\">Prostate Cancer<\/span>","<span class=\"advgb-post-tax-term\">TIGIT<\/span>","<span class=\"advgb-post-tax-term\">TIGIT Inhibitors<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 4 years ago","modified":"Updated 4 years ago"},"absolute_dates":{"created":"Posted on Jan 4, 2022","modified":"Updated on Jan 6, 2022"},"absolute_dates_time":{"created":"Posted on Jan 4, 2022 5:38 pm","modified":"Updated on Jan 6, 2022 9:23 am"},"featured_img_caption":"pharma-news-for-accutar-bio-thera-nykode-heat-biologics-elusys","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/15164","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=15164"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/15164\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/15166"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=15164"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=15164"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=15164"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=15164"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=15164"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}