{"id":19345,"date":"2022-10-18T17:29:35","date_gmt":"2022-10-18T11:59:35","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=19345"},"modified":"2022-10-18T17:34:15","modified_gmt":"2022-10-18T12:04:15","slug":"pharma-news-for-tavros-mereo-odyssey","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-tavros-mereo-odyssey","title":{"rendered":"CHMP Reviews Takeda\u2019s Qdenga; FDA Sets Date for Gilead\u2019 Trodelvy Review; Odyssey&#8217;s Announces $ 168 Million Series B Financing; Tavros and Vividion Signs Agreement; Pharming Submits Leniolisib for Approval in the EU; FDA Fast Track Designation to Mereo\u2019s Alvelestat"},"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-69f6f976935e6\" 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-69f6f976935e6\"  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-tavros-mereo-odyssey\/#CHMP_Gives_Positive_Opinion_on_Takedas_Qdenga\" >CHMP Gives Positive Opinion on Takeda\u2019s Qdenga&nbsp;<\/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-tavros-mereo-odyssey\/#FDA_Sets_Feb_Review_Date_for_Gilead_Sciences_Trodelvy\" >FDA Sets Feb Review Date for Gilead Sciences\u2019 Trodelvy<\/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-tavros-mereo-odyssey\/#Odyssey_Therapeutics_Announces_Oversubscribed_USD_168_Million_Series_B_Financing\" >Odyssey Therapeutics Announces Oversubscribed USD 168 Million Series B Financing<\/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-tavros-mereo-odyssey\/#Tavros_Therapeutics_Signs_Agreement_with_Bayer_Unit_on_Targeted_Oncology_Programs\" >Tavros Therapeutics Signs Agreement with Bayer Unit on Targeted Oncology Programs<\/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-tavros-mereo-odyssey\/#Pharming_Submits_Leniolisib_for_Approval_in_the_EU\" >Pharming Submits Leniolisib for Approval in the EU<\/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-tavros-mereo-odyssey\/#FDAs_Fast_Track_Designation_to_Mereos_Alvelestat_for_Treatment_of_AATD-associated_Lung_Disease\" >FDA&#8217;s Fast Track Designation to Mereo&#8217;s Alvelestat for Treatment of AATD-associated Lung Disease<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-chmp-gives-positive-opinion-on-takeda-s-qdenga\"><span class=\"ez-toc-section\" id=\"CHMP_Gives_Positive_Opinion_on_Takedas_Qdenga\"><\/span><strong>CHMP Gives Positive Opinion on Takeda\u2019s Qdenga<\/strong>&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The European Medicines Agency\u2019s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given its approval to <strong>Takeda GmbH\u2019s Qdenga<\/strong>, a live, attenuated dengue <strong>tetravalent vaccine (TAK-003)<\/strong>. It is the first time the CHMP has reviewed a medicinal product for the EU market in a centralized procedure at the same time as a medicinal product for non-EU countries under the \u2018Eu-Medicines for all\u2019 program (EU-M4all). The EMA\u2019s approval is expected within a few months.<\/p>\n\n\n\n<p>Dengue fever, a mosquito-borne tropical disease, is prevalent in over <strong>100 countries<\/strong>, including Europe (only nine countries had experienced severe dengue epidemics pre-1970). <strong>Qdenga<\/strong>, which was approved by the <strong>BADAN POM<\/strong> in August this year for use in those aged six to 45 years old, will be used to prevent disease caused by dengue virus (DENV) serotypes 1, 2, 3, and 4 in people as young as four years old.<\/p>\n\n\n\n<p>There is already an approved <a href=\"https:\/\/www.delveinsight.com\/report-store\/dengue-fever-pipeline-insight\">dengue fever vaccine<\/a> <strong>(Sanofi\u2019s Dengvaxia)<\/strong>, but <strong>TAK-003<\/strong> has been shown to provide better protection for young children and those over 45 years old: the tetravalent vaccine was evaluated for safety and benefits in 19 clinical trials involving over <strong>27,000<\/strong> people aged 15 months to 60 years old from both endemic and non-endemic regions.<\/p>\n\n\n\n<p>The studies\u2019 findings demonstrated the prevention of fever, severe disease, and hospitalization caused by any of the four DENV serotypes. The most common side effects of any dose of <strong>Qdenga <\/strong>were injection site pain, headaches, muscle pain, and a general feeling of being ill.<\/p>\n\n\n\n<p>\u201cWe are one step closer towards the approval of a dengue vaccine that could benefit many of the millions of individuals around the world exposed to dengue. This is a major moment for the global health community, European countries and the dengue-endemic countries that participated in the EU-M4all procedure,\u201d said <strong>Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda.<\/strong> \u201cWe have been working for many years to help improve the way dengue can be prevented. Our efforts to provide a new option for dengue prevention support Takeda\u2019s overall goal to provide long-term societal value to the people we serve.\u201d<\/p>\n\n\n\n<p>Takeda will host a TAK-003 Investor Event in December 2022 to provide more information on commercial plans and regulatory updates.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Sets_Feb_Review_Date_for_Gilead_Sciences_Trodelvy\"><\/span><strong>FDA Sets Feb Review Date for Gilead Sciences\u2019 Trodelvy<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Gilead Sciences<\/strong> expects to receive a response from the FDA in February next year regarding its marketing application for <strong>Trodelvy <\/strong>in hormone receptor-positive, HER2-negative metastatic breast cancer, which the company describes as a key new indication for the drug.<\/p>\n\n\n\n<p>Based on the results of the recently reported <strong>TROPiCs-02 trial<\/strong>, the US FDA has granted <strong>Trodelvy (sacituzumab govitecan)<\/strong> priority review as a <a href=\"https:\/\/www.delveinsight.com\/report-store\/hr-positive-her2-negative-breast-cancer-market-insights\">treatment for adults with unresectable locally advanced or metastatic HR+\/HER2- breast cancer<\/a> who have progressed on endocrine-based therapy and at least two additional systemic therapies.<\/p>\n\n\n\n<p>It has set a deadline of February 23 to complete its review, which, if positive, would significantly expand the patient population eligible for Trodelvy beyond its current use in triple-negative breast cancer (TNBC) and urothelial cancer.<\/p>\n\n\n\n<p>The priority review continues <strong>Trodelvy\u2019s <\/strong>renaissance in HR+\/HER2- breast cancer, after the first <strong>TROPiCs-02<\/strong> readout at this year\u2019s <a href=\"https:\/\/www.delveinsight.com\/asco-conference-2022\">ASCO congress<\/a> revealed that the Trop2-targeting antibody-drug conjugate failed to have a significant impact on overall survival, despite meeting its primary endpoint of an improvement in progression-free survival (PFS). At the recently concluded <a href=\"https:\/\/www.delveinsight.com\/esmo-conference-2022\">ESMO meeting<\/a>, Gilead was more optimistic about the drug\u2019s prospects, noting that a trend toward improved survival with Trodelvy had now become a statistically significant improvement over the control group.<\/p>\n\n\n\n<p>\u201cTrodelvy has already changed the treatment landscape in second-line metastatic triple-negative breast cancer and pre-treated metastatic urothelial cancer, and today\u2019s news marks our third supplemental application acceptance within the last two years,\u201d said <strong>Bill Grossman, MD, Ph.D., Senior Vice President, Therapeutic Area Head, Gilead Oncology<\/strong>.<\/p>\n\n\n\n<p>There is no doubt that approval of the new indication will provide Gilead with an opportunity to accelerate sales of Trodelvy, the centerpiece of its oncology growth strategy. It made <strong>USD 305 million<\/strong> from TMBC and urothelial cancer in the first half of this year, and Gilead is hoping for significant growth as it seeks to recoup the <strong>USD 21 billion<\/strong> it paid for <strong>Trodelvy\u2019s <\/strong>original developer, <strong>Immunomedics<\/strong>, 2years ago.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Odyssey_Therapeutics_Announces_Oversubscribed_USD_168_Million_Series_B_Financing\"><\/span><strong>Odyssey Therapeutics Announces Oversubscribed USD 168 Million Series B Financing<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Odyssey Therapeutics, Inc.<\/strong>, a biotech company, has announced a <strong>USD 168 million<\/strong> Series B financing led by global venture capital firm <strong>General Catalyst<\/strong>, an active healthcare investor. The funds will be used to expand <strong>Odyssey\u2019s<\/strong> precision immunomodulator and <a href=\"https:\/\/www.delveinsight.com\/report-store\/oncology-drugs-market\">oncology medicine portfolio<\/a>.<\/p>\n\n\n\n<p>The latest funding announcement comes on the heels of the company\u2019s <strong>USD 218 million<\/strong> Series A financing in December 2021, bringing the total capital raised to <strong>USD 386 million<\/strong>, allowing Odyssey to continue its mission of developing innovative medicines for serious human diseases.<\/p>\n\n\n\n<p>All Series A investors are participating in the Series B financing, as are new investors <strong>Fidelity Management &amp; Research Company and T. GreatPoint Ventures, Catalio Capital Management, Walleye Capital, Alexandria Venture Investments, and The Healthcare Innovation Investment Fund LLC<\/strong> are among the investors.<\/p>\n\n\n\n<p>\u201cOdyssey is pioneering next generation therapeutics by marrying a powerful drug discovery engine integrating machine learning, biology, and medicinal and structural chemistry with an exceptional leadership team of proven drug developers. We are pleased to partner with General Catalyst and our world-class syndicate of investors and believe the interest in our immunology and oncology pipeline and capabilities further validates our approach to therapeutic development,\u201d said <strong>Gary D. Glick, Ph.D., Founder and Chief Executive Officer of Odyssey Therapeutics<\/strong>. \u201cWe have made tremendous strides since our launch in 2021, and we value the support as we advance multiple candidates into IND-enabling studies in 2023.\u201d<\/p>\n\n\n\n<p>The \u2018drug hunting engine\u2019 of the company works by combining \u201cboth established and newly emerging drug discovery technologies to tackle immunology and oncology targets with the greatest clinical and commercial potential.\u201d This includes targets that were previously thought to be \u201cundruggable.\u201d<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tavros_Therapeutics_Signs_Agreement_with_Bayer_Unit_on_Targeted_Oncology_Programs\"><\/span><strong>Tavros Therapeutics Signs Agreement with Bayer Unit on Targeted Oncology Programs<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On October 12, 2022, Tavros Therapeutics and Vividion Therapeutics announced a strategic collaboration agreement to discover or target four oncology targets across an initial five-year term. Both players will come up with a uniqure set of expertise to achieve the desired goals. As per the update, Tavros will receive $17.5 million in a cash upfront payment from Vividion. Upon attaining the prespecified preclinical, clinical development, and commercial milestones, Tavros is eligible to receive up to $430.5 million in potential future payments. Moreover, Tavros will get a low-single-digit royalty on sales of specific potential programs. Vividion has options to pursue up to five additional targets with up to $482 million in potential additional future payments.<\/p>\n\n\n\n<p>Vividion Therapeutics is a leading biopharmaceutical company and a wholly owned and independently operated subsidiary of Bayer AG. Vividion utilizes novel discovery technologies to unlock high-value, traditionally undruggable targets with precision therapeutics for devastating cancers and <a href=\"https:\/\/www.delveinsight.com\/blog\/upcoming-drugs-for-autoimmune-diseases\"><strong>immune disorders<\/strong><\/a>. Based in Durham (North Carolina), Tavros Therapeutics, through its precision oncology platform, is working on the new frontier of targeted therapies exploiting tumors\u2019 genetic vulnerabilities. As per the agreement, Tavros utilizes functional and computational genomics technologies to uncover unique vulnerabilities within tumors, discover novel targets and biomarkers in areas of high unmet clinical need, and identify novel clinical positioning strategies for existing molecules.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Pharming_Submits_Leniolisib_for_Approval_in_the_EU\"><\/span><strong>Pharming Submits Leniolisib for Approval in the EU<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On Oct. 11, 2022, Pharming Group N.V. announced that it had submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for leniolisib. Pharming\u2019s Leniolisib is an oral, selective phosphoinositide 3-kinase delta (PI3K\u03b4) inhibitor designed to treat activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency in adults and adolescents 12 years or older.&nbsp;<\/p>\n\n\n\n<p>Earlier in August 2022, EMA\u2019s Committee for Medicinal Products for Human Use (CHMP) granted permission to accelerate the assessment for the leniolisib MAA. Under accelerated assessment, the review timeframe decreases from 210 days to 150 days. As per the updates from Pharming, the marketing authorization for leniolisib in the EEA is anticipated in H1 2023. To date, leniolisib has been well tolerated during both the Phase 1 first-in-human trial in healthy subjects and the Phase II\/III registration-enabling study.<\/p>\n\n\n\n<p>Activated Phosphoinositide 3-kinase \u03b4 syndrome (APDS) is a recently recognized rare primary immunodeficiency disease.&nbsp; It is estimated that APDS affects approximately 1 to 2 people per million. Variants in either of two genes, PIK3CD or PIK3R1, lead to the development of APDS. These two genes regulate the maturation of white blood cells. Pharming\u2019s Leniolisib is a small-molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K with immunomodulating. Leniolisib inhibits the production of phosphatidylinositol-3-4-5-trisphosphate (PIP3). PIP3 is an important cellular messenger activating AKT (via PDK1) and regulates many cell functions such as proliferation, differentiation, cytokine production, cell survival, angiogenesis, and metabolism.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDAs_Fast_Track_Designation_to_Mereos_Alvelestat_for_Treatment_of_AATD-associated_Lung_Disease\"><\/span><strong>FDA&#8217;s Fast Track Designation to Mereo&#8217;s Alvelestat for Treatment of AATD-associated Lung Disease<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On October 17, 2022, Mereo BioPharma Group announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for its investigational oral neutrophil elastase inhibitor, alvelestat (MPH-966). Earlier, in May 2022, Mereo reported positive top-line safety and efficacy data from the ASTRAEUS Phase 2 study of alvelestat in severe <a href=\"https:\/\/www.delveinsight.com\/report-store\/alpha-1-antitrypsin-deficiency-a1atd-market\"><strong>Alpha-1 Antitrypsin Deficiency (A1ATD)<\/strong><\/a>-associated <a href=\"https:\/\/www.delveinsight.com\/report-store\/emphysema-market\"><strong>emphysema<\/strong><\/a>. The Company plans to provide a further update on the program on October 31, 2022.<\/p>\n\n\n\n<p>Mereo is looking forward to having an End-of-Phase 2 meeting with the FDA to discuss the design of a registration-enabling study for alvelestat as a <a href=\"https:\/\/www.delveinsight.com\/report-store\/alpha-1-antitrypsin-deficiency-aatd-pipeline-insight\"><strong>treatment for AATD-associated lung disease<\/strong><\/a>, including the potential opportunity for an accelerated approval pathway, around the end of the year.<br>AATD is a rare genetic disease that results in a deficiency of the alpha-1 antitrypsin protein, which protects the lungs against damaging enzymes that the body releases during inflammation. As per the estimates, about 50,000 people in North America and 60,000 in Europe are affected with severe AATD. AATD can lead to pulmonary emphysema, a progressive, life-threatening lung disease. To improve the <a href=\"https:\/\/www.delveinsight.com\/report-store\/alpha-antitrypsin-deficiency-aatd-market-size-analysis\"><strong>AATD treatment<\/strong><\/a> scenario globally, several key companies are actively working in the therapeutics market.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>CHMP Gives Positive Opinion on Takeda\u2019s Qdenga&nbsp; The European Medicines Agency\u2019s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given its approval to Takeda GmbH\u2019s Qdenga, a live, attenuated dengue tetravalent vaccine (TAK-003). It is the first time the CHMP has reviewed a medicinal product for the EU market in a centralized procedure [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":19353,"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":[16950,19831,71,19832,127,622,19414,230,19830,349,420,639],"industry":[17225],"therapeutic_areas":[17231,17228,17234],"class_list":["post-19345","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-aatd","tag-activated-phosphoinositide-3-kinase--syndrome","tag-alpha-1-antitrypsin-deficiency","tag-apds","tag-breast-cancer","tag-dengue","tag-dengue-fever","tag-emphysema","tag-her2-negative-metastatic-breast-cancer","tag-latest-pharma-news","tag-news","tag-pharma-news","industry-pharmaceutical","therapeutic_areas-infectious-diseases","therapeutic_areas-oncology","therapeutic_areas-rare-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>Pharma News Updates | Takeda, Gilead, Odyssey, Tavros, Vividion, Mereo<\/title>\n<meta name=\"description\" content=\"Takeda\u2019s Qdenga; Gilead\u2019 Trodelvy Review; Odyssey&#039;s Series B Financing; Pharming&#039;s Leniolisib; Mereo\u2019s Alvelestat; Tavros and Vividion&#039;s\" \/>\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-tavros-mereo-odyssey\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News Updates | Takeda, Gilead, Odyssey, Tavros, Vividion, Mereo\" \/>\n<meta property=\"og:description\" content=\"Takeda\u2019s Qdenga; Gilead\u2019 Trodelvy Review; Odyssey&#039;s Series 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