{"id":29017,"date":"2024-08-06T17:27:43","date_gmt":"2024-08-06T11:57:43","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=29017"},"modified":"2024-08-06T17:30:14","modified_gmt":"2024-08-06T12:00:14","slug":"pharma-news-for-adaptimmune-gsk-otsuka","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-adaptimmune-gsk-otsuka","title":{"rendered":"Tecelra by Adaptimmune: First FDA-Approved Engineered Cell Therapy for Solid Tumors; GSK&#8217;s JEMPERLI Approved for Endometrial Cancer; MBX Biosciences Secures $63.5M in Series C for PEP\u2122 Platform; FDA Stops Actinium&#8217;s Radiotherapy Blood Cancer Plans, Pushing Partnering Shift; Otsuka Acquires Jnana for Up to $1.1B, Enhancing Drug Discovery"},"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-69d0ce86068b1\" 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-69d0ce86068b1\"  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-adaptimmune-gsk-otsuka\/#Adaptimmunes_TECELRA_Becomes_First_FDA-Approved_Engineered_Cell_Therapy_for_Solid_Tumors\" >Adaptimmune\u2019s TECELRA Becomes First FDA-Approved Engineered Cell Therapy for Solid Tumors<\/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-adaptimmune-gsk-otsuka\/#GSK_Bags_Sought-after_JEMPERLI_Okay_in_Endometrial_Cancer\" >GSK Bags Sought-after JEMPERLI Okay in Endometrial Cancer&nbsp;<\/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-adaptimmune-gsk-otsuka\/#MBX_Biosciences_Raises_635_Million_in_Series_C_Financing_to_Advance_its_Precision_Endocrine_Peptide%E2%84%A2_PEP%E2%84%A2_Platform\" >MBX Biosciences Raises $63.5 Million in Series C Financing to Advance its Precision Endocrine Peptide\u2122 (PEP\u2122) Platform&nbsp;<\/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-adaptimmune-gsk-otsuka\/#FDA_Halts_Actiniums_Radiotherapy_Blood_Cancer_Plans_Prompting_a_Shift_to_Partnering\" >FDA Halts Actinium&#8217;s Radiotherapy Blood Cancer Plans, Prompting a Shift to Partnering&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-adaptimmune-gsk-otsuka\/#Otsuka_Pays_Up_to_11B_to_Buy_Jnana_Adds_Drug_Discovery_Capabilities\" >Otsuka Pays Up to $1.1B to Buy Jnana, Adds Drug Discovery Capabilities&nbsp;<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-adaptimmune-s-tecelra-becomes-first-fda-approved-engineered-cell-therapy-for-solid-tumors\"><span class=\"ez-toc-section\" id=\"Adaptimmunes_TECELRA_Becomes_First_FDA-Approved_Engineered_Cell_Therapy_for_Solid_Tumors\"><\/span>Adaptimmune\u2019s TECELRA Becomes First FDA-Approved Engineered Cell Therapy for Solid Tumors<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Adaptimmune Therapeutics announced that the FDA has approved (afamitresgene autoleucel), which will be marketed under the brand name TECELRA, for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/synovial-sarcoma-market\">treatment of unresectable or metastatic synovial sarcoma<\/a>. This marks the first engineered cell therapy for solid tumors in the U.S. and the first new therapy for synovial sarcoma in over a decade. The approval is based on the overall response rate and duration of response from the SPEARHEAD-1 trial, which showed a 43% response rate.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Adrian Rawcliffe, Adaptimmune&#8217;s Chief Executive Officer, stated, \u201cThe approval of TECELRA is a momentous step in Adaptimmune\u2019s journey to redefine the way cancer is treated and the culmination of a decade of groundbreaking R&amp;D. We are committed to advancing our robust clinical pipeline to serve more patients in need.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The SPEARHEAD-1 trial included 44 patients and demonstrated significant efficacy, with a median duration of response of 6 months. Adaptimmune plans to roll out the therapy through at least 30 treatment centers within two years. An integrated support program, AdaptimmuneAssist, will help ensure a seamless and personalized experience for patients.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Brandi Felser, CEO of the Sarcoma Foundation of America, remarked, \u201cFor decades, therapeutic options for people diagnosed with synovial sarcoma have been limited. Today, there is a renewed sense of hope for this patient community.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Sandra D\u2019Angelo, MD, from Memorial Sloan Kettering Cancer Center, added, \u201cTECELRA (afami-cel), which uses each patient\u2019s own immune cells to recognize and attack their cancer cells in a one-time infusion treatment, is significantly different than the current standards of care for advanced synovial sarcoma.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Biomarker tests for human leukocyte antigens (HLA) type and melanoma-associated antigen A4 (MAGE-A4) tumor expression are required before treatment with TECELRA. Adaptimmune has partnered with Agilent Technologies and Thermo Fisher Scientific to provide companion diagnostic products necessary for identifying eligible patients. The treatment comes with significant safety considerations, including potential serious side effects like cytokine release syndrome (CRS) and immune effector cell\u2013associated neurotoxicity syndrome (ICANS).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-gsk-bags-sought-after-jemperli-okay-in-endometrial-cancer-nbsp\"><span class=\"ez-toc-section\" id=\"GSK_Bags_Sought-after_JEMPERLI_Okay_in_Endometrial_Cancer\"><\/span>GSK Bags Sought-after JEMPERLI Okay in Endometrial Cancer&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA has granted approval for GSK&#8217;s PD-1 inhibitor, JEMPERLI (dostarlimab), for the treatment of all adult patients with primary <a href=\"https:\/\/www.delveinsight.com\/report-store\/endometrial-cancer-market\">advanced or recurrent endometrial cancer<\/a>, marking a significant milestone in the company&#8217;s growth strategy for the drug.<\/p>\n\n\n\n<p>This approval is based on data from the RUBY trial, which demonstrated that JEMPERLI, when combined with carboplatin and paclitaxel chemotherapy, reduced the risk of death by 31% compared to chemotherapy alone over two and a half years. According to GSK, JEMPERLI is the only immuno-oncology agent to show a survival benefit in this patient group, bolstering its position against MSD&#8217;s Keytruda (pembrolizumab) in the endometrial cancer market.<\/p>\n\n\n\n<p>Previously, JEMPERLI was approved for front-line use in endometrial cancer for patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumors based on progression-free survival data from RUBY. Keytruda was also approved for first-line endometrial cancer therapy without label restrictions based on similar data. The new approval for JEMPERLI levels the playing field between the two drugs and highlights the significance of the overall survival data from RUBY Part 1 in their competition for market share.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Luke Miels, GSK&#8217;s chief commercial officer, emphasized JEMPERLI&#8217;s central role in the company&#8217;s immuno-oncology development and its potential to drive future growth beyond dMMR-driven tumors. With more than 70% of endometrial cancer tumors being mismatch repair proficient (MMRp)\/microsatellite stable (MSS), the new approval opens up the majority of the market for GSK. An EU approval for this indication is expected in the first half of 2025.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The broader label in first-line endometrial cancer is crucial for JEMPERLI&#8217;s projected annual sales to reach blockbuster status. The drug generated \u00a3188 million ($240 million) in the first half of this year, a significant increase from \u00a336 million in the same period of 2023, with peak sales projected between \u00a31 billion and \u00a32 billion.<\/p>\n\n\n\n<p>Future growth for JEMPERLI could also come from phase III trials exploring its use in rectal, lung, and head and neck cancers. This includes a new study combining JEMPERLI with GSK&#8217;s TIGIT antibody belrestotug as a first-line therapy for PDL1-high non-small cell lung cancer (NSCLC).<\/p>\n\n\n\n<p>Further developments in endometrial cancer include RUBY Part 2, which investigates the combination of JEMPERLI, chemotherapy, and GSK&#8217;s PARP inhibitor ZEJULA (niraparib). Results have shown improved progression-free survival with this triplet therapy compared to JEMPERLI and chemotherapy alone.<\/p>\n\n\n\n<p>AstraZeneca is also a competitor in this market, having received FDA approval in June for its PD-L1 inhibitor IMFINZI (durvalumab) in combination with chemotherapy for <a href=\"https:\/\/www.delveinsight.com\/report-store\/endometrial-cancer-market\">front-line endometrial cancer treatment<\/a>, restricted to dMMR tumors. The approval was based on the DUO-E study, which also tested a triple combination including AstraZeneca&#8217;s PARP inhibitor LYNPARZA (olaparib), though this was not included in the FDA&#8217;s decision.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-mbx-biosciences-raises-63-5-million-in-series-c-financing-to-advance-its-precision-endocrine-peptide-pep-platform-nbsp\"><span class=\"ez-toc-section\" id=\"MBX_Biosciences_Raises_635_Million_in_Series_C_Financing_to_Advance_its_Precision_Endocrine_Peptide%E2%84%A2_PEP%E2%84%A2_Platform\"><\/span>MBX Biosciences Raises $63.5 Million in Series C Financing to Advance its Precision Endocrine Peptide\u2122 (PEP\u2122) Platform&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>MBX Biosciences, Inc., has successfully closed a <strong>$63.5 million<\/strong> Series C financing round. This funding round was led by Deep Track Capital and included new investors Driehaus Capital Management and T. Rowe Price Associates, Inc., as well as existing investors Frazier Life Sciences, OrbiMed, and Wellington Management. This influx of capital is expected to support the company&#8217;s research and development efforts through 2026, covering critical milestones and data read-outs.<\/p>\n\n\n\n<p>The new funding will accelerate MBX\u2019s clinical programs, including a Phase II trial of MBX 2109, a parathyroid hormone peptide prodrug aimed at <a href=\"https:\/\/www.delveinsight.com\/report-store\/hypoparathyroidism-market\">treating hypoparathyroidism<\/a>. Topline results from this trial are anticipated in the third quarter of 2025. Additionally, MBX 1416, a candidate for post-bariatric hypoglycemia, is currently undergoing a Phase I single and multiple ascending dose trial, with topline data expected in late 2024. The company is also advancing its portfolio in obesity and metabolic diseases, including MBX 4291, a long-acting GLP-1\/GIP receptor co-agonist prodrug currently in IND-enabling studies.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Gerard Smith, M.D., Managing Director at Deep Track Capital, expressed enthusiasm about MBX\u2019s innovative approach and their ability to transform scientific discoveries into effective therapies. The Series C financing underscores the confidence investors have in MBX\u2019s team and their groundbreaking work in the endocrine and metabolic drug space.<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-halts-actinium-s-radiotherapy-blood-cancer-plans-prompting-a-shift-to-partnering-nbsp\"><span class=\"ez-toc-section\" id=\"FDA_Halts_Actiniums_Radiotherapy_Blood_Cancer_Plans_Prompting_a_Shift_to_Partnering\"><\/span>FDA Halts Actinium&#8217;s Radiotherapy Blood Cancer Plans, Prompting a Shift to Partnering&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Actinium Pharmaceuticals has faced a major hurdle with the FDA rejecting its application for approval of Iomab-B, a targeted radiotherapy for <a href=\"https:\/\/www.delveinsight.com\/report-store\/acute-myeloid-leukemia-aml-market\">acute myeloid leukemia<\/a>. The setback comes despite promising results from the Phase III SIERRA trial, which showed Iomab-B achieving a higher rate of complete remission compared to standard care. However, the FDA has requested an additional head-to-head randomized trial specifically designed to demonstrate a survival benefit, which Actinium had not anticipated.<\/p>\n\n\n\n<p>The SIERRA trial showed a median overall survival (OS) of 6.4 months for patients receiving Iomab-B versus 3.2 months for those in the control group. Despite this, the analysis was complicated by a significant portion of control patients crossing over to the Iomab-B group, leading to a request for further validation without such crossovers. This additional trial will be necessary to meet the FDA\u2019s requirements for approval.<\/p>\n\n\n\n<p>In light of the FDA&#8217;s demands, Actinium has decided to seek a partner for Iomab-B rather than advancing it independently. The company will now shift its focus to other development programs, including Actimab-A, Iomab-ACT, and several preclinical candidates. This decision has sharply impacted Actinium\u2019s stock, which fell 69% in premarket trading. The company, ending March with $84 million in cash, will need to navigate these challenges while exploring new opportunities in its pipeline.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-otsuka-pays-up-to-1-1b-to-buy-jnana-adds-drug-discovery-capabilities-nbsp\"><span class=\"ez-toc-section\" id=\"Otsuka_Pays_Up_to_11B_to_Buy_Jnana_Adds_Drug_Discovery_Capabilities\"><\/span>Otsuka Pays Up to $1.1B to Buy Jnana, Adds Drug Discovery Capabilities&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Otsuka Pharmaceutical Co., Ltd. has entered into a definitive agreement to acquire Jnana Therapeutics Inc. for up to $1.125 billion. The deal involves an initial payment of $800 million to Jnana&#8217;s shareholders, with an additional $325 million contingent upon achieving development and regulatory milestones. The acquisition is expected to be completed by the third quarter of fiscal 2024, pending customary closing conditions.<\/p>\n\n\n\n<p>Jnana Therapeutics is renowned for its RAPID chemoproteomics platform, which is designed to discover drugs for challenging targets that are difficult to address with traditional methods. The platform has enabled Jnana to identify innovative compounds and pursue drug discovery for rare diseases and autoimmune conditions. Notably, Jnana has developed JNT-517, an allosteric small molecule inhibitor that shows promise as a first-in-class oral <a href=\"https:\/\/www.delveinsight.com\/report-store\/phenylketonuria-pku-market\">treatment for phenylketonuria<\/a>. This compound has demonstrated effectiveness and safety in early-stage clinical trials, potentially benefiting a large segment of the PKU population that currently lacks effective treatment options.<\/p>\n\n\n\n<p>In addition to its work in PKU, Jnana is focusing on autoimmune diseases, targeting challenging proteins such as interferon regulatory factor 3 (IRF3), a key transcription factor involved in the production of interferon.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Otsuka&#8217;s President and Representative Director, Makoto Inoue, highlighted the strategic value of the acquisition: \u201cI am gratified that Otsuka has entered into an agreement with Jnana. The addition of Jnana&#8217;s drug discovery technology and small molecule pipeline in PKU and autoimmune diseases will strengthen our R&amp;D in the Boston area of the U.S., one of the most important bioclusters in the world, and in a combined form will have a synergistic effect on Otsuka Pharmaceutical&#8217;s global expansion.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Joanne Kotz, Ph.D., CEO and co-founder of Jnana Therapeutics, expressed enthusiasm about the merger: \u201cThis transaction acknowledges our achievements with the RAPID platform and JNT-517 for PKU. We look forward to advancing JNT-517 into a registrational study in 2025 and further developing our pipeline of oral medicines for autoimmune diseases with Otsuka.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Following the acquisition, Jnana will continue its operations in Boston as a wholly owned subsidiary of Otsuka. The deal is subject to approval by Jnana\u2019s shareholders and compliance with U.S. antitrust regulations.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Adaptimmune\u2019s TECELRA Becomes First FDA-Approved Engineered Cell Therapy for Solid Tumors Adaptimmune Therapeutics announced that the FDA has approved (afamitresgene autoleucel), which will be marketed under the brand name TECELRA, for the treatment of unresectable or metastatic synovial sarcoma. This marks the first engineered cell therapy for solid tumors in the U.S. and the first [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":29018,"comment_status":"closed","ping_status":"closed","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":[18089,20331,704,17786,349,420,639,18821,5789,16905],"industry":[17225],"therapeutic_areas":[17240,17228],"class_list":["post-29017","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-acute-myeloid-leukemia","tag-endometrial-cancer","tag-fda","tag-hypoparathyroidism","tag-latest-pharma-news","tag-news","tag-pharma-news","tag-phenylketonuria","tag-recent-pharma-news","tag-synovial-sarcoma","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-oncology"],"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>Pharma News | Adaptimmune, GSK, Otsuka<\/title>\n<meta name=\"description\" content=\"Adaptimmune&#039;s Tecelra, GSK&#039;s JEMPERLI, MBX&#039;s $63.5M Financing, FDA Halts Actinium, Otsuka Acquires Jnana for $1.1B\" \/>\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-adaptimmune-gsk-otsuka\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Adaptimmune, GSK, Otsuka\" \/>\n<meta property=\"og:description\" content=\"Adaptimmune&#039;s Tecelra, GSK&#039;s JEMPERLI, MBX&#039;s $63.5M Financing, FDA Halts Actinium, Otsuka Acquires Jnana for $1.1B\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-adaptimmune-gsk-otsuka\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2024-08-06T11:57:43+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-08-06T12:00:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/08\/06171837\/pharma-news-for-Adaptimmune-GSK-Otsuka.png\" \/>\n\t<meta property=\"og:image:width\" content=\"772\" \/>\n\t<meta property=\"og:image:height\" content=\"482\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Jatin Vimal\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta 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