{"id":18048,"date":"2022-07-19T19:55:01","date_gmt":"2022-07-19T14:25:01","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=18048"},"modified":"2022-07-19T19:55:03","modified_gmt":"2022-07-19T14:25:03","slug":"pharma-news-for-byondis-merck-kyowa","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-byondis-merck-kyowa","title":{"rendered":"Byondis\u2019s HER2-targeting ADC trastuzumab duocarmazine; AbbVie Migraine Drug Atogepant; Gr\u00fcnenthal Acquires Bayer\u2019s Testosterone Drug Rights; Vertex Acquires ViaCyte; Merck &#038; Orion Announces Collaboration; Verve Starts Trials of Cholesterol Drug; Kyowa Kirin Drops Nourianz follow-up KW-6356; FDA Orphan Drug and Fast Track Designations to CV-01"},"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-6a19c3ac9f402\" 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-6a19c3ac9f402\"  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-byondis-merck-kyowa\/#Byondis_Files_its_HER2-Targeting_Antibody-Drug_Conjugate_ADC_Trastuzumab_Duocarmazine_in_the_US_and_Europe\" >Byondis Files its HER2-Targeting Antibody-Drug Conjugate (ADC) Trastuzumab Duocarmazine in the US and Europe<\/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-byondis-merck-kyowa\/#AbbVie_Files_Migraine_Prevention_Drug_Atogepant_in_EU\" >AbbVie Files Migraine Prevention Drug Atogepant in EU<\/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-byondis-merck-kyowa\/#Grunenthal_Acquires_Bayers_Testosterone_Drug_Rights_for_E500_Million\" >Gr\u00fcnenthal Acquires Bayer\u2019s Testosterone Drug Rights for \u20ac500 Million<\/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-byondis-merck-kyowa\/#Vertex_Acquires_ViaCyte_for_USD_320_Million\" >Vertex Acquires ViaCyte for USD 320 Million<\/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-byondis-merck-kyowa\/#Kyowa_Kirin_Drops_Nourianz_follow-up_KW-6356_for_Parkinsons\" >Kyowa Kirin Drops Nourianz follow-up KW-6356 for Parkinson\u2019s<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-byondis-merck-kyowa\/#FDA_Grants_Orphan_Drug_Fast_Track_Designations_to_CV-01_in_Recurrent_Glioblastoma\" >FDA Grants Orphan Drug, Fast Track Designations to CV-01 in Recurrent Glioblastoma<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-byondis-merck-kyowa\/#Merck_and_Orion_Announces_USD_290_Million_Collaboration_for_Prostate_Cancer_Therapy\" >Merck and Orion Announces USD 290 Million Collaboration for Prostate Cancer Therapy<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-byondis-merck-kyowa\/#Verve_Starts_Trials_of_Cholesterol_Drug_in_Test_of_Base_Editing_Technique\" >Verve Starts Trials of Cholesterol Drug in Test of Base Editing Technique<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-byondis-files-its-her2-targeting-antibody-drug-conjugate-adc-trastuzumab-duocarmazine-in-the-us-and-europe\"><span class=\"ez-toc-section\" id=\"Byondis_Files_its_HER2-Targeting_Antibody-Drug_Conjugate_ADC_Trastuzumab_Duocarmazine_in_the_US_and_Europe\"><\/span><strong>Byondis Files its HER2-Targeting Antibody-Drug Conjugate (ADC) Trastuzumab Duocarmazine in the US and Europe<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Byondis <\/strong>has filed for clearance of its <strong>HER2-targeting antibody-drug conjugate (ADC) trastuzumab<\/strong> <strong>duocarmazine<\/strong> in the United States and Europe, setting up a battle with heavyweight competitors <strong>Roche <\/strong>and <strong>AstraZeneca\/Daiichi Sankyo<\/strong> next year. The Dutch company submitted the ADC to the FDA last week, and yesterday, the company said that the EMA had formally begun its review of the <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-her2-positive-breast-cancer-market\">drug for HER2-positive, locally advanced or metastatic breast cancer<\/a> that cannot be treated surgically. Byondis believes <strong>trastuzumab duocarmazine (SYD985)<\/strong> is a &#8220;next-generation&#8221; anti-HER2 ADC with a lower toxicity profile than competitors like <strong>Roche&#8217;s Kadcyla (adotrastuzumab emtansine) and AZ\/Daiichi Sankyo&#8217;s Enhertu (trastuzumab deruxtecan).&nbsp;<\/strong><\/p>\n\n\n\n<p>This is due to the company&#8217;s <a href=\"https:\/\/www.delveinsight.com\/blog\/asco-urothelial-carcinoma-abstracts\">ADC technology platform<\/a>, which implies that the cytotoxic payload that circulates systemically after treatment is lower than that of <a href=\"https:\/\/www.delveinsight.com\/blog\/antibody-drug-conjugate-pipeline\">currently-marketed ADCs<\/a>, limiting adverse effects. The ADC is stable in the bloodstream and is internalized by cancer cells, where the payload (duocarmycin) is activated, limiting the drug&#8217;s exposure to healthy tissues. The marketing applications were filed in the US and EU based on the results of the <strong>phase III TULIP trials<\/strong>, which compared <strong>trastuzumab duocarmazine<\/strong> to the physician&#8217;s choice of therapy following at least two prior HER2-targeting treatment regimens, with an application in the US due soon.<\/p>\n\n\n\n<p>The physician\u2019s choice of therapy included <strong>Seagen&#8217;s oral HER2 drug Tykerb (lapatinib)<\/strong> plus <strong>Roche&#8217;s chemotherapeutic drug Xeloda (capecitabine)<\/strong> or <a href=\"https:\/\/www.delveinsight.com\/report-store\/trastuzumab-biosimilars-insight\"><strong>Roche&#8217;s HER2 therapy Herceptin (trastuzumab)<\/strong><\/a> plus one of <strong>Xeloda, vinorelbine, or eribulin.<\/strong> The FDA has assigned trastuzumab duocarmazine a typical 10-month review duration in the United States. Byondis has teamed with <strong>German pharmaceutical company Meda<\/strong>c to commercialize the drug in Europe.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"AbbVie_Files_Migraine_Prevention_Drug_Atogepant_in_EU\"><\/span><strong>AbbVie Files Migraine Prevention Drug Atogepant in EU<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>AbbVie <\/strong>has submitted its oral <strong>CGRP inhibitor atogepan<\/strong>t for the prevention of both episodic and chronic migraine in the EU, attempting to catch up with <strong>Pfizer\/BioHaven<\/strong> and their recently authorized <strong>Vydura <\/strong>drug. The EMA file for atogepant covers <a href=\"https:\/\/www.delveinsight.com\/report-store\/migraine-market\">migraine prevention<\/a> in people who experience at least four migraine days per month &#8211; the same indication that was approved for <strong>Vydura (rimegepant) <\/strong>in April as the first oral medication for migraine prevention.<\/p>\n\n\n\n<p>In the United States, <strong>Atogepant <\/strong>was licensed as <strong>Qulipta <\/strong>last September for migraine prevention. In contrast, Vydura<strong> <\/strong>is marketed as <strong>Nurtec ODT<\/strong> and was cleared for acute migraine therapy in early 2020 and for prevention in May 2021. AbbVie sells another oral <strong>CGRP called Ubrelvy (ubrogepant)<\/strong> for acute <a href=\"https:\/\/www.delveinsight.com\/report-store\/migraine-pipeline-insight\">migraine treatment<\/a>, which produced roughly <strong>USD 552 million<\/strong> last year, but hasn&#8217;t yet published Qulipta&#8217;s quarterly sales performance. Meanwhile, <strong>Biohaven <\/strong>reported Nurtec ODT sales of <strong>USD 462 million<\/strong> in 2021, prompting <strong>Pfizer <\/strong>to pay <strong>USD 500 million<\/strong> upfront for the drug&#8217;s rights outside the US in November.<\/p>\n\n\n\n<p>Last month, the drugmaker revealed new evidence with atogepant in the prevention of chronic migraine &#8211; defined by the FDA as at least 15 migraine days per month for at least three months &#8211; that AbbVie suggests could help it differentiate atogepant from its competitor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Grunenthal_Acquires_Bayers_Testosterone_Drug_Rights_for_E500_Million\"><\/span><strong>Gr\u00fcnenthal Acquires Bayer\u2019s Testosterone Drug Rights for \u20ac500 Million<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Gr\u00fcnenthal <\/strong>is paying up to <strong>\u20ac500 million<\/strong> for rights to <strong>Nebido (testosterone undecanoate)<\/strong>, sold in around <strong>80 countries<\/strong> worldwide for a testosterone deficiency, and made <strong>\u20ac117 million<\/strong> last year.<\/p>\n\n\n\n<p>The legacy product now lies outside <strong>Bayer\u2019s <\/strong>core areas of oncology, cardiology, ophthalmology, hematology, radiopharmaceuticals, and women\u2019s health, and the funds raised from the sale will support the \u201congoing transformation of Bayer\u2019s pharmaceutical business to focus on the key areas of the future medical innovation,\u201d said the company.<\/p>\n\n\n\n<p>Fellow German group Gr\u00fcnenthal is a pharma company focused mainly on pain products, although its portfolio also includes other specialty medicines such as <strong>Nexium <\/strong>for gastrointestinal disorders.<\/p>\n\n\n\n<p>It has a history of buying mature brands from other pharmaceutical companies, for instance paying <strong>$300 million<\/strong> for rights to <strong>AstraZeneca\u2019s <\/strong>migraine therapy <strong>Zomig <\/strong>in a similar deal five years ago.<\/p>\n\n\n\n<p>Gr\u00fcnenthal will purchase cash upfront, with the final figure dependent on any closing adjustments. It will also take ownership of a contract business in the United States, where <strong>Endo Pharmaceuticals<\/strong> licenses <strong>Nebido <\/strong>from Bayer and sells it under the brand name, <strong>Aveed<\/strong>.<\/p>\n\n\n\n<p>The two companies said that the transaction is expected to close by the end of 2022, subject to approval by the competition authorities.<\/p>\n\n\n\n<p>The divestment comes as Bayer is engaged in a push to become a top ten oncology company by 2030. <a href=\"https:\/\/www.delveinsight.com\/report-store\/prostate-cancer-market-insight\"><strong>Prostate cancer<\/strong><\/a> treatment Nubeqa drives its ambition, recently tipped to become a <strong>\u20ac3 billion seller<\/strong>.<\/p>\n\n\n\n<p>The group faces competition from big-selling pharma products <strong>Eylea <\/strong>for ophthalmic diseases and <strong>anticoagulant Xarelto <\/strong>in the coming years. It is pivoting to growth areas to ride out that revenue loss.<\/p>\n\n\n\n<p>Nubeqa is one of three drugs the company hopes to help weather that impact on revenues, along with recently-approved <a href=\"https:\/\/www.delveinsight.com\/report-store\/diabetic-kidney-disease-dkd-market\"><strong>diabetic kidney disease<\/strong><\/a> <strong>therapy Kerendia <\/strong>and <strong>elinzanetant <\/strong>for <strong>menopausal symptoms<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Vertex_Acquires_ViaCyte_for_USD_320_Million\"><\/span><strong>Vertex Acquires ViaCyte for USD 320 Million<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Vertex Pharmaceuticals<\/strong> recently announced that it would acquire <strong>ViaCyte<\/strong>, a private cellular therapy company, for <strong>$320 million<\/strong>. Vertex\u2019s acquisition of ViaCyte gives it access to complementary technologies to pursue novel stem cell-derived cell replacement therapies as a functional treatment cure for <a href=\"https:\/\/www.delveinsight.com\/report-store\/type-1-diabetes-market\"><strong>type 1 diabetes<\/strong><\/a>.<\/p>\n\n\n\n<p>Vertex is currently engaged in clinical trials for <strong>VX-880<\/strong>, an investigational allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy for T1D. According to a company press release, it has seen promising safety and efficacy results from its ongoing Phase I\/II study.<\/p>\n\n\n\n<p>Vertex\u2019s acquisition of ViaCyte grants them complementary assets to accelerate the development of VX-880. These include additional human stem cell lines, intellectual property around stem cell differentiation, and good manufacturing practice manufacturing facilities for cell-based therapies.<\/p>\n\n\n\n<p>\u201cVX-880 has successfully showed clinical proof of concept in type 1 diabetes, and the procurement of ViaCyte will advance our goal of transforming, if not curing <a href=\"https:\/\/www.delveinsight.com\/report-store\/type-1-diabetes-pipeline-insight\"><strong>type 1 diabetes<\/strong><\/a> by expanding our capabilities and bringing additional tools, technologies, and assets to our current stem cell-based programs,\u201d added Reshma Kewalramani, president and CEO, Vertex.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Kyowa_Kirin_Drops_Nourianz_follow-up_KW-6356_for_Parkinsons\"><\/span><strong>Kyowa Kirin Drops Nourianz follow-up KW-6356 for Parkinson\u2019s<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Kyowa Kirin has announced that it had dropped the development of its <a href=\"https:\/\/www.delveinsight.com\/report-store\/parkinsons-disease-pipeline-insights\">Parkinson\u2019s disease therapeutics<\/a> candidate, KW-6356, despite positive proof-of-concept results in a mid-stage trial. KW-6356 is a drug of the adenosine A2A receptor antagonist class, and in the phase 2 data, the drug has depicted promising results as monotherapy and, in a combo, to <a href=\"https:\/\/www.delveinsight.com\/report-store\/parkinsons-disease-market-size-analysis-treatment\"><strong>treat Parkinson&#8217;s disease<\/strong><\/a>. Kyowa Kirin started the development of KW-6356 as a follow-up to Nourianz (istradefylline), the Kyowa\u2019s first-gen adenosine A2 agonist. The USFDA approved Nourianzby in 2019. KW-6356 has a higher affinity and selectivity for adenosine A2A receptors, and upon approval from the regulatory authorities, the therapy is expected to cover a wider group of Parkinson\u2019s patients than Nourianz.<\/p>\n\n\n\n<p>Kyowa Kirin cited the &#8220;global regulatory landscape, development hurdles, and timelines for potential market entry&#8221; as the key factor that makes an additional investment into the therapeutics development of KW-6356 as untenable and unsustainable. Kyowa further stated in the press release stated that clinical factors are not the issue for the decision and the therapy was potentially effective in relieving motor and non-motor symptoms. In August 2018, Kyowa Kirin, armed with positive proof-of-concept data, said it would continue to pursue development on its own.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Orphan_Drug_Fast_Track_Designations_to_CV-01_in_Recurrent_Glioblastoma\"><\/span><strong>FDA Grants Orphan Drug, Fast Track Designations to CV-01 in Recurrent Glioblastoma<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The U.S. Food and Drug Administration (FDA) has granted both Orphan Drug and Fast Track Designations to Alpheus Medical&#8217;s CV-01 delivery of sonodynamic therapy (SDT) as a potential treatment for <a href=\"https:\/\/www.delveinsight.com\/report-store\/glioblastoma-epidemiology-forecast\"><strong>patients with recurrent Glioblastoma<\/strong><\/a>. Alpheus Medical&#8217;s proprietary, investigational SDT is a noninvasive drug-device combination that targets cancer cells throughout the entire hemisphere using low-intensity, diffuse ultrasound. The sonodynamic therapy is administered in an outpatient setting and does not require imaging.&nbsp;<\/p>\n\n\n\n<p>Currently, Northwell Health&#8217;s North Shore University Hospital in Long Island, New York, is enrolling patients for a first-in-human, phase 1 clinical trial evaluating the safety, optimal dosage, and efficacy of the sonodynamic <a href=\"https:\/\/www.delveinsight.com\/report-store\/high-grade-glioma-pipeline-insight\"><strong>therapy platform for recurrent high-grade glioma<\/strong><\/a>. The trial is expected to enroll up to 33 patients.<\/p>\n\n\n\n<p>Glioblastoma is one of the most common primary brain cancer and accounts for nearly 57% of all gliomas and 48% of all primary <a href=\"https:\/\/www.delveinsight.com\/report-store\/central-nervous-system-lymphoma-market\"><strong>malignant central nervous system (CNS) tumors<\/strong><\/a>. Currently, there are only a few effective options in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/glioblastoma-market\"><strong>Glioblastoma Therapeutics Market<\/strong><\/a>. Alpheus Medical\u2019s CV-01 is expected to change the landscape of high-grade glioma and the patient outcome.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Merck_and_Orion_Announces_USD_290_Million_Collaboration_for_Prostate_Cancer_Therapy\"><\/span><strong>Merck and Orion Announces USD 290 Million Collaboration for Prostate Cancer Therapy<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Merck <\/strong>and <strong>Orion <\/strong>announced global collaboration for the development and commercialization of Orion\u2019s <strong>investigational candidate ODM-208<\/strong> which is an investigational steroid synthesis inhibitor for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-castration-resistant-prostate-cancer-mcrpc-market\"><strong>Metastatic Castration-Resistant Prostate Cancer<\/strong><\/a>. The drug targets cytochrome P450 11A1 (CYP11A1), an enzyme important in steroid production. ODM-208 is supposedly an oral, non-steroidal, selective inhibitor of the CYP11A1 enzyme currently being evaluated in <strong>Phase 2 clinical trial<\/strong> for <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-castration-resistant-prostate-cancer-pipeline-insight\">Metastatic Castration-Resistant Prostate Cancer treatment<\/a>. By inhibiting <strong>CYP11A1 enzyme activity, <\/strong>ODM-208 is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/blog\/tag\/merck\">Merck<\/a> will make an upfront payment to Orion of about <strong>USD 290 million<\/strong>, which will be expensed by Merck in the <strong>third quarter of 2022<\/strong> and included in non-GAAP results. Orion will be solely responsible for manufacturing the clinical and commercial supply of ODM-208. In addition, the contract provides both parties with an option to convert the initial co-development and co-commercialization agreement into a global exclusive license to Merck. Orion would be eligible to receive milestone payments associated with progress in the development and commercialization of ODM-208 and tiered double-digit royalties on sales if the product is approved. The total amount potentially accrued from multiple regulatory and sales milestone events represents a substantial opportunity for Orion.<\/p>\n\n\n\n<p>Worldwide, <a href=\"https:\/\/www.delveinsight.com\/report-store\/prostate-cancer-pipeline-insight\">Prostate cancer<\/a> is the second most common cancer in people assigned male at birth, with an estimated<strong> 1.4 million patients <\/strong>diagnosed worldwide in <strong>2020. <\/strong>Approximately 10-20% of patients with advanced prostate cancer are estimated to develop CRPC within five years, and at least 84% of these patients may develop <a href=\"https:\/\/www.delveinsight.com\/blog\/metastatic-castration-sensitive-prostate-cancer-market\">metastases at the time of CRPC diagnosis<\/a>. Patients with advanced prostate cancer have a particularly poor prognosis, and the five-year survival rate remains low.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Verve_Starts_Trials_of_Cholesterol_Drug_in_Test_of_Base_Editing_Technique\"><\/span><strong>Verve Starts Trials of Cholesterol Drug in Test of Base Editing Technique<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Verve Therapeutics<\/strong> has initiated dosing patients in a <strong>Phase 1b trial<\/strong> of its<strong> in vivo gene-editing drug<\/strong> for <a href=\"https:\/\/www.delveinsight.com\/blog\/tag\/cholesterol\"><strong>high cholesterol<\/strong><\/a>, made to permanently switch off the <a href=\"https:\/\/www.delveinsight.com\/report-store\/pcsk9-inhibitors-psck9i-market\"><strong>PCSK9 gene<\/strong><\/a> with a one-shot treatment. The clinical trial, namely heart-1 study, is enrolling patients with an inherited form of very high cholesterol \u2013 <a href=\"https:\/\/www.delveinsight.com\/blog\/tag\/heterozygous-familial-hypercholesterolemia\"><strong>heterozygous familial hypercholesterolaemia (HeFH)<\/strong><\/a> \u2013 that predisposes them to the early development of heart disease. The first subject is administered with the dose of<strong> VERVE-101<\/strong>, the first test in humans of an experimental CRISPR\/Cas9 genome editing technique known as base editing. Via base editing, drugs replace a single nucleotide in the DNA strand with another without making double-strand breaks (DSBs) in the gene.<\/p>\n\n\n\n<p>The clinical trial<strong> heart-1 <\/strong>will enroll <strong>40 adults<\/strong> with HeFH and established <a href=\"https:\/\/www.delveinsight.com\/blog\/cardiovascular-disease-landscape\">atherosclerotic cardiovascular disease<\/a>, initially in New Zealand, although the plan is to expand the study to include investigation sites in the UK and US later this year, subject to regulatory consent. It will look at the effects of VERVE-101 on levels of PCSK9 and<strong> LDL cholesterol <\/strong>(LDC-c) in the blood, with the first data expected next year.<\/p>\n\n\n\n<p>After the development process, VERVE-101 could provide a one-off alternative to a lengthening list of PCSK9 inhibitors that have to be dosed chronically. The first antibodies to reach the market were <strong>Amgen\u2019s Repatha (evolocumab)<\/strong> and <strong>Sanofi\/Regeneron\u2019s Praluent (alirocumab)<\/strong> \u2013 which were launched several years ago . Verve\u2019s trial could add another candidate into the mix, but for now, the attention is on establishing base editing as a therapeutic strategy.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Byondis Files its HER2-Targeting Antibody-Drug Conjugate (ADC) Trastuzumab Duocarmazine in the US and Europe Byondis has filed for clearance of its HER2-targeting antibody-drug conjugate (ADC) trastuzumab duocarmazine in the United States and Europe, setting up a battle with heavyweight competitors Roche and AstraZeneca\/Daiichi Sankyo next year. The Dutch company submitted the ADC to the FDA [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":18050,"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":[127,137,841,927,2867,812,1787,19549,19551,19550,1193,1826,498,13055,17722],"industry":[17225],"therapeutic_areas":[17240,17245,17228],"class_list":["post-18048","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-breast-cancer","tag-cancer","tag-cancer-research","tag-cancer-treatment","tag-cholesterol","tag-diabetes","tag-glioblastoma","tag-glioblastoma-therapeutics","tag-heterozygous-familial-hypercholesterolaemia","tag-high-grade-glioma","tag-migraine","tag-parkinsons-disease","tag-prostate-cancer","tag-prostate-cancer-market","tag-type-1-diabetes","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-neurology","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- 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