{"id":18185,"date":"2022-07-26T17:19:48","date_gmt":"2022-07-26T11:49:48","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=18185"},"modified":"2022-07-26T17:43:47","modified_gmt":"2022-07-26T12:13:47","slug":"pharma-news-for-vistagen-camp4-incyte","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vistagen-camp4-incyte","title":{"rendered":"VistaGen\u2019s PH94B for Anxiety Disorder; Keytruda for Head and Neck Cancer Treatment; Bavarian Nordic\u2019s Smallpox Vaccine Imvanex; CAMP4 Raises USD 100 Million; Incyte&#8217;s WU-CART-007; Incyte\u2019s Opzelura for Vitiligo; AstraZeneca and Merck\u2019s Lynparza; Sumitomo Pharma\u2019s DSP-0390 for Brain Cancer"},"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-69f4abbb5b854\" 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-69f4abbb5b854\"  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-vistagen-camp4-incyte\/#FDA_Approves_Incytes_Opzelura_as_First_Vitiligo_Therapy\" >FDA Approves Incyte\u2019s Opzelura as First Vitiligo Therapy<\/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-vistagen-camp4-incyte\/#FDA_Grants_Fast_Track_and_Rare_Pediatric_Disease_Designations_to_WU-CART-007_in_RR_T-ALL_and_LBL\" >FDA Grants Fast Track and Rare Pediatric Disease Designations to WU-CART-007 in R\/R T-ALL and LBL<\/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-vistagen-camp4-incyte\/#VistaGen_Therapeutics_PH94B_Fails_in_the_First_of_Two_Phase_III_trials_in_Social_Anxiety_Disorder\" >VistaGen Therapeutics\u2019 PH94B Fails in the First of Two Phase III trials in Social Anxiety Disorder\u00a0<\/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-vistagen-camp4-incyte\/#Bid_to_Expand_Keytruda_Use_in_Head_and_Neck_Cancer_Therapy_Fails\" >Bid to Expand Keytruda Use in Head and Neck Cancer Therapy Fails<\/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-vistagen-camp4-incyte\/#EMA_Approves_Bavarian_Nordics_Smallpox_Vaccine_Imvanex\" >EMA Approves Bavarian Nordic\u2019s Smallpox Vaccine Imvanex<\/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-vistagen-camp4-incyte\/#CAMP4_Raises_USD_100_Million_to_Take_Lead_RNA_Drugs_into_Clinic\" >CAMP4 Raises USD 100 Million to Take Lead RNA Drugs into Clinic<\/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-vistagen-camp4-incyte\/#AstraZeneca_and_Mercks_Lynparza_Fails_Colorectal_Cancer_Trial\" >AstraZeneca and Merck\u2019s Lynparza Fails Colorectal Cancer Trial<\/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-vistagen-camp4-incyte\/#FDA_Grants_Orphan_Drug_Designation_to_DSP-0390_for_Brain_Cancer\" >FDA Grants Orphan Drug Designation to DSP-0390 for Brain Cancer<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Incytes_Opzelura_as_First_Vitiligo_Therapy\"><\/span><strong>FDA Approves Incyte\u2019s Opzelura as First Vitiligo Therapy<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The US Food and Drug Administration has approved <strong>Incyte\u2019s Opzelura<\/strong> cream 1.5% for the topical treatment of <strong>non-segmental vitiligo<\/strong> in adult and paediatric patients 12 years of age and older.<\/p>\n\n\n\n<p>With this approval, Opzelura is the first and only FDA-approved treatment for repigmentation in patients with<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/vitiligo-market\"><strong>vitiligo<\/strong><\/a>. It is also the superior topical formulation of a <a href=\"https:\/\/www.delveinsight.com\/report-store\/janus-kinase-jak-inhibitor-pipeline-insight\"><strong>Janus kinase inhibitor<\/strong><\/a> approved in the US.<\/p>\n\n\n\n<p>Vitiligo is a chronic autoimmune disease presenting a skin depigmentation caused by the loss of melanocytes, which are pigment-producing cells. Around <strong>1.5 million<\/strong> people are diagnosed with vitiligo in the US. At the same time, the total prevalence of the condition is estimated to be around<strong> 2-3 million<\/strong>, with the majority of patients, around <strong>85%<\/strong> who are suffering from non-segmental vitiligo.<\/p>\n\n\n\n<p>An over-activity of the JAK signalling pathway is thought to drive further inflammation in the progression of vitiligo.<\/p>\n\n\n\n<p>The FDA based its decision on conclusions taken from the <strong>pivotal phase 3 TRuE-V clinical trial programme<\/strong>, which evaluated the safety and efficacy of <strong>Opzelura <\/strong>versus non-medicated cream in more than <strong>600 people<\/strong> with nonsegmental vitiligo, specifically in those <strong>aged 12 years and older<\/strong>.<\/p>\n\n\n\n<p>The results showed that treatment with Opzelura significantly improved <strong>Vitiligo Area Severity Index<\/strong> scores, representing improvements in facial and complete body repigmentation at <strong>week 24 <\/strong>as compared to non-medicated cream and in an open-label extension at <strong>week 52<\/strong>.<\/p>\n\n\n\n<p>The FDA approved Opzelura in September 2021 for the topical short-term and non-continuous chronic treatment of <strong>mild-to-moderate <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/atopic-dermatitis-market\"><strong>atopic dermatitis<\/strong><\/a> in non-immuno-compromised patients of <strong>age 12 years<\/strong> and older whose disease is not controlled with topical prescription treatments, or when those treatments are not suitable.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Fast_Track_and_Rare_Pediatric_Disease_Designations_to_WU-CART-007_in_RR_T-ALL_and_LBL\"><\/span><strong>FDA Grants Fast Track and Rare Pediatric Disease Designations to WU-CART-007 in R\/R T-ALL and LBL<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA has granted fast-track and rare pediatric disease designations to the <strong>CAR T-cell therapy WU-CART-007<\/strong> for treating patients with <strong>relapsed\/refractory <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/car-t-cell-therapy-for-acute-lymphoblastic-leukemia-market\"><strong>T-cell acute lymphoblastic leukaemia<\/strong><\/a> and <strong>lymphoblastic lymphoma<\/strong>. WU-CART-007 is an allogeneic and fratricide-resistant CD7-targeted CAR T-cell therapy. The product is made to overcome the technological challenges of harnessing CAR-T cells to treat CD7-positive haematological malignancies. WU-CART-007 is under evaluation in a<strong> phase I\/II trial<\/strong> in patients with relapsed\/refractory T-ALL or LBL.<\/p>\n\n\n\n<p>Preclinical studies demonstrates that WU-CART-007 displayed high affinity and specificity for human CD7. Investigators observed potent cytotoxicity against CD7-expressing cells, including <strong>CCRF-CEM T-cell acute lymphoblastic leukaemia cells<\/strong>, primary <strong>T and NK cells<\/strong> in vitro, but not seen in <strong>CD7 cells<\/strong>, for instance, <strong>hepatocytes, astrocytes, cardiomyocytes, myeloid cells, B-cells, endothelial cells, <\/strong>and <strong>epithelial cells<\/strong>. Moreover, they did not observe cytotoxicity against hematopoietic progenitor cells in human bone marrow or cord blood.<\/p>\n\n\n\n<p>The global, open-label, first-in-human trial enrols patients with evidence of relapsed or refractory T-cell acute lymphoblastic leukaemia or T-LBL, defined by WHO classification with bone marrow blasts of at least <strong>5%<\/strong> or evidence of extramedullary disease at screening. Other critical inclusion criteria for the study include adequate renal, respiratory, hepatic, and cardiovascular function, also a life expectancy of more than <strong>12 weeks<\/strong>.<\/p>\n\n\n\n<p>The lower age limit of the trial is <strong>12 years<\/strong>, and patients between <strong>12-17 years old<\/strong> will be eligible to enrol at <strong>dose level 3 <\/strong>of the dose-escalation portion of the problem after a review of safety, efficiency and cellular pharmacokinetics and discussion with regulatory agencies.<\/p>\n\n\n\n<p>Critical exclusion criteria include prior treatment with any <strong>anti-CD7 therapy<\/strong>; initial treatment with <strong>anti-T cell monoclonal antibodies<\/strong> other than <a href=\"https:\/\/www.delveinsight.com\/report-store\/daratumumab-emerging-insight-and-market-forecast\"><strong>daratumumab<\/strong><\/a>; failure to recover from a previous treatment; active <a href=\"https:\/\/www.delveinsight.com\/report-store\/hepatitis-b-market\"><strong>hepatitis B<\/strong><\/a> &amp; <a href=\"https:\/\/www.delveinsight.com\/report-store\/hepatitis-c-market\"><strong>hepatitis C<\/strong><\/a>, any other uncontrolled infection, or untreated HIV positive; and any severe active disease at the time of treatment, or another underlying severe morbidities that could influence study treatment.<\/p>\n\n\n\n<p>After enrollment, patients will undergo lymphodepletion with a daily dose of <strong>500 mg\/m2<\/strong> of <strong>cyclophosphamide <\/strong>and <strong>30 mg\/m2<\/strong> of <strong>fludarabine 30 mg\/m2<\/strong> on days -5 to -3. On the first day, the patients will receive an intravenous infusion of WU-CART-007.<\/p>\n\n\n\n<p>The trial&#8217;s primary endpoints include :<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Incidence of adverse effects.<\/li><li>Establishing the maximum tolerated dose.<\/li><li>Overall response rate.<\/li><li>Duration of response.<\/li><li>Progression-free survival.&nbsp;<\/li><\/ul>\n\n\n\n<p>Secondary endpoints consist of overall survival and hematopoietic stem cell transplant rate.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"VistaGen_Therapeutics_PH94B_Fails_in_the_First_of_Two_Phase_III_trials_in_Social_Anxiety_Disorder\"><\/span><strong>VistaGen Therapeutics\u2019 PH94B Fails in the First of Two Phase III trials in Social Anxiety Disorder\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Vistagen Therapeutics Inc\u2019s<\/strong> investigational drug, <strong>PH94B<\/strong>, was formulated for <strong>anxiety treatment, depression,<\/strong> and other central nervous systems<strong> (CNS) disorders<\/strong>. The previous results indicated favourable safety and tolerability profile among study participants, but the topline results fell short of the next hurdle. PH94B is made to regulate the olfactory-amygdala neural circuits of fear and anxiety, but the drug did not achieve its primary endpoint of change from baseline using the Subjective Units of Distress Scale (SUDS) when compared to placebo. The results were established from a PALISADE-1 Phase 3 clinical trial for social anxiety disorder in adults. PH94B is supposedly a tasteless, odourless, rapid-onset pherine nasal spray planned to regulate the olfactory-amygdala neural circuits of fear and anxiety.<\/p>\n\n\n\n<p>VistaGen chief executive officer Shawn Singh said: \u201cWhile the results of PALISADE-1 are not consistent with prior positive results from Phase 2 trials of PH94B in social anxiety disorder, we remain committed to transforming the treatment landscape for those living with anxiety, depression, and other central nervous system disorders. \u201cAs part of this commitment, our team will continue to pursue PH94B\u2019s potential as a new treatment option for multiple anxiety disorders \u2014 including for both <a href=\"https:\/\/www.delveinsight.com\/report-store\/acute-social-anxiety-disorder-pipeline-insight\"><strong>acute treatment for social anxiety disorder<\/strong><\/a> in our ongoing PALISADE-2 Phase 3 trial and for continued use in our ongoing <strong>Phase 2 trial <\/strong>in adjustment disorder with anxiety.<\/p>\n\n\n\n<p>PALISADE-1 clinical trial is a randomised, multi-centre, double-blind, parallel design, placebo-controlled, Phase 3 <a href=\"https:\/\/www.delveinsight.com\/report-store\/social-anxiety-disorder-market\"><strong>clinical study in adults experiencing social anxiety disorder (SAD)<\/strong><\/a>. The clinical trial was designed to evaluate the efficacy, safety, and tolerability of the acute administration of PH94B to relieve symptoms of anxiety in adult patients with SAD.<\/p>\n\n\n\n<p>Additionally, VistaGen has two other drug candidates in its central nervous system pipeline, <strong>PH10 <\/strong>and <strong>AV-101<\/strong>, as <a href=\"https:\/\/www.delveinsight.com\/report-store\/generalized-anxiety-disorder-pipeline-insight\"><strong>potential treatments for anxiety<\/strong><\/a>, depression and other central nervous system disorders.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Bid_to_Expand_Keytruda_Use_in_Head_and_Neck_Cancer_Therapy_Fails\"><\/span><strong>Bid to Expand Keytruda Use in Head and Neck Cancer Therapy Fails<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The very recent immunotherapies have provided cancer treatment for many types. The transformation in <a href=\"https:\/\/www.delveinsight.com\/blog\/oncological-drugs-to-be-launch-in-2022\"><strong>cancer treatment<\/strong><\/a> is very hopeful for some cases, but they do sometimes tend to fail or have an impact \u2013 as Merck &amp; Co has experienced in a study of Keytruda in head and neck cancer. The PD-1 inhibitor failed in <strong>Phase 3 KEYNOTE-412 trial <\/strong>in<strong> 780 newly-diagnosed <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/head-and-neck-squamous-cell-carcinoma-epidemiology-forecast\"><strong>patients with head and neck squamous cell carcinoma (HNSCC)<\/strong><\/a><strong>,<\/strong> a notoriously hard-to-treat form of cancer. The clinical trial study compared Keytruda (pembrolizumab) given with cisplatin and radiotherapy \u2013 followed by maintenance therapy with Keytruda for around a year \u2013 to placebo plus cisplatin and radiotherapy and placebo during the maintenance phase.<\/p>\n\n\n\n<p>The results indicative for the primary endpoint of the study was even-free survival, but there was no statistically significant difference between the groups on this measure, even though patients on the<strong> PD-1 therapy <\/strong>did slightly better. Keytruda- a blockbuster drug has been approved <strong>since 2016 <\/strong>as a second-line option after chemotherapy for patients with more advanced disease, i.e. recurrent or relapsed Head and neck squamous cell carcinomas that have metastasised to other parts of the body.<\/p>\n\n\n\n<p>The study results of KEYNOTE-412 rushes Merck\u2019s hopes of extending Keytruda\u2019s indications in HNSCC to non-metastatic disease in an all-comer population, regardless of <strong>PD-L1 status<\/strong>. Currently, the only another <a href=\"https:\/\/www.delveinsight.com\/report-store\/recurrent-head-and-neck-cancer-squamous-cell-carcinoma-pipeline-insight\"><strong>immunotherapy approved to treat HNSCC<\/strong><\/a> is Bristol-Myers Squibb\u2019s Opdivo (nivolumab), which can be used as a second-line option after chemotherapy.<\/p>\n\n\n\n<p>Merck says it is committed to \u201cinvestigating Keytruda-based regimens for this debilitating type of cancer in earlier stages of disease.\u201d<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"EMA_Approves_Bavarian_Nordics_Smallpox_Vaccine_Imvanex\"><\/span><strong>EMA Approves Bavarian Nordic\u2019s Smallpox Vaccine Imvanex<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The European Medicines Agency has expanded the permitted indications for <strong>Bavarian Nordic&#8217;s<\/strong> smallpox vaccine <strong>Imvanex <\/strong>for monkeypox, which has now infected tens of thousands of individuals in dozens of countries around the world. <strong>Imvanex <\/strong>has been approved in the EU since 2013 for smallpox, a virus related to <a href=\"https:\/\/www.delveinsight.com\/report-store\/monkeypox-market\">monkeypox<\/a>, and should not be approved to protect adults from monkeypox disease, according to the CHMP. Two years after calling COVID-19 a &#8220;public health emergency of international concern,&#8221; the World Health Organization (WHO) has officially declared monkeypox a &#8220;public health emergency of international concern.&#8221;<\/p>\n\n\n\n<p>Since the virus&#8217;s first appearance two months ago, there have been over <strong>16,000<\/strong> cases reported from <strong>75 <\/strong>countries, with more than two-thirds detected in Europe, a size of outbreak never before seen with the virus. After analyzing data from many animal studies that indicated protection against the monkeypox virus in nonhuman primates inoculated with Imvanex, the EMA&#8217;s human medicines committee, the CHMP, recommended approval of the <a href=\"https:\/\/www.delveinsight.com\/blog\/monkeypox-outbreak\">monkeypox vaccine<\/a> on last Friday.&nbsp;<\/p>\n\n\n\n<p>In June, the company announced that it had received orders for <strong>1.5 million<\/strong> doses of the injection from an unidentified European country, with delivery set to begin in the fourth quarter. It had previously secured supply deals with the US and Canada &#8211; where the vaccine is known as Jynneos &#8211; for around <strong>7 million<\/strong> doses, with approximately <strong>1 million<\/strong> doses anticipated to be delivered this year.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CAMP4_Raises_USD_100_Million_to_Take_Lead_RNA_Drugs_into_Clinic\"><\/span><strong>CAMP4 Raises USD 100 Million to Take Lead RNA Drugs into Clinic<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>CAMP4 Therapeutics<\/strong> is prepared to begin the first clinical study of a drug targeting regulatory RNA (regRNA) molecules, which can be used to fine-tune gene expression, with a <strong>USD 100 million<\/strong> second-round financing. CAMP4 believes that antisense oligonucleotide (ASO) treatments targeting these regRNA regions have the ability to increase protein production from any disease-associated gene, thereby addressing hereditary diseases &#8220;at their core.&#8221; The newest fundraising round, led by Enavate Sciences and including new investors Gaingels, an unidentified managed care organization, and existing backers, will give the company the funds it needs to push two of its &#8216;RNA actuator&#8217; candidates into clinical testing. The first will be a chemical meant to treat <a href=\"https:\/\/www.delveinsight.com\/report-store\/dravet-syndrome-market\">Dravet syndrome<\/a>, a rare form of persistent epilepsy that can cause dozens of seizures each month and for which there are few effective medicines &#8211; and none that address the fundamental cause of the disease.<\/p>\n\n\n\n<p>Dravet syndrome is caused in around <strong>80%<\/strong> of cases by abnormalities in a gene coding for a sodium channel &#8211; SCN1A &#8211; which is necessary for the proper functioning of neurons in the brain. CAMP4&#8217;s medication intends to upregulate SCN1A function to eliminate seizures, and human trials are set to begin in mid-2023.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"AstraZeneca_and_Mercks_Lynparza_Fails_Colorectal_Cancer_Trial\"><\/span><strong>AstraZeneca and Merck\u2019s Lynparza Fails Colorectal Cancer Trial<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In one of the latest failures in the clinical drug development segment, Merck has announced that it has stopped the Phase III LYNK-003 trial evaluating PARP inhibitor Lynparza. Lynparza is being studied in <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-colorectal-cancer-epidemiology-forecast\"><strong>patients with unresectable or metastatic colorectal cancer<\/strong><\/a> who have not progressed following first-line induction. Lynparza is an immuno-oncology drug and co-developed &amp; co-commercialized by Merck in association with oncology pharma giant AstraZeneca. The decision was based on the recommendation of an independent Data Monitoring Committee following the review of data at an interim analysis.\u00a0<\/p>\n\n\n\n<p>In the Phase III LYNK-003 study, Lynparza is being evaluated in 309 patients with unresectable or metastatic colorectal cancer. No new safety signals were observed with Lynparza in patients. Merck has further stated that it will convey the decision to stop a study of Lynparza to the patients and study investigators.\u00a0<\/p>\n\n\n\n<p>Merck and AstraZeneca are also assessing the potential of Lynparza as both a monotherapy and in new combinations for other cancer types, including <a href=\"https:\/\/www.delveinsight.com\/report-store\/ovarian-cancer-market\"><strong>ovarian cancer<\/strong><\/a>, <a href=\"https:\/\/www.delveinsight.com\/report-store\/her2-positive-breast-cancer-market\"><strong>breast cancer<\/strong><\/a> and <a href=\"https:\/\/www.delveinsight.com\/report-store\/pancreatic-cancer-market\"><strong>pancreatic cancer<\/strong><\/a>.<\/p>\n\n\n\n<p>At the pre-specified interim analysis for progression-free survival, the efficacy of Lynparza as a monotherapy and in combination with bevacizumab relative to control met the criteria for futility. Both experimental arms will be discontinued.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Orphan_Drug_Designation_to_DSP-0390_for_Brain_Cancer\"><\/span><strong>FDA Grants Orphan Drug Designation to DSP-0390 for Brain Cancer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In the latest development in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/brain-cancer-market\"><strong>Brain Cancer therapeutics market<\/strong><\/a>, the Food and Drug Administration (FDA) has granted Orphan Drug Designation to Sumitomo Pharma Oncology\u2019s DSP-0390 for Brain Cancer treatment.<\/p>\n\n\n\n<p>DSP-0390 is an investigational emopamil-binding protein (EBP) inhibitor for treating brain cancer. DSP-0390 mediates de novo cholesterol synthesis for cell membrane structure and signalling, enabling aberrant growth of tumors. The therapy is being studied in a Phase 1 clinical trial in patients with recurrent, high-grade glioma, which is being conducted in the United States and Japan. DSP-0390 has shown cytotoxic activity against <a href=\"https:\/\/www.delveinsight.com\/report-store\/glioblastoma-market\"><strong>Glioblastoma<\/strong><\/a>, <a href=\"https:\/\/www.delveinsight.com\/report-store\/colorectal-cancer-crc-market\"><strong>colorectal cancer<\/strong><\/a>, and <a href=\"https:\/\/www.delveinsight.com\/report-store\/triple-negative-breast-cancer-tnbc-pipeline-insight\"><strong>triple-negative breast cancer in vitro<\/strong><\/a>.\u00a0<\/p>\n\n\n\n<p>Earlier, SMP Oncology\u2019s TP-3654 also received Orphan Drug Designations.\u00a0 It is the second therapy that has received Orphan Drug Designations recently.\u00a0 TP-3654 is a proprietary investigational oral inhibitor of PIM kinases for <a href=\"https:\/\/www.delveinsight.com\/report-store\/myelofibrosis-pipeline-insight\"><strong>treating myelofibrosis<\/strong><\/a>.\u00a0<\/p>\n\n\n\n<p>Brain cancer also referred to as brain tumors, leads to the abnormal growth of cells in the brain and is malignant. Further investigation and the development of the novel therapies like DSP-0390 are expected to improve the overall treatment scenario in the coming years.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Approves Incyte\u2019s Opzelura as First Vitiligo Therapy The US Food and Drug Administration has approved Incyte\u2019s Opzelura cream 1.5% for the topical treatment of non-segmental vitiligo in adult and paediatric patients 12 years of age and older. With this approval, Opzelura is the first and only FDA-approved treatment for repigmentation in patients with vitiligo. [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":18187,"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":[17],"tags":[19573,627,7478,1954,174,16668,19575,288,19576,19572,17259,19577,19574,911,17528],"industry":[17225],"therapeutic_areas":[17237,17245,17228],"class_list":["post-18185","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-acute-lymphoblastic-leukaemia","tag-anxiety","tag-atopic-dermatitis","tag-brain-cancer","tag-colorectal-cancer","tag-dravet-syndrome","tag-head-and-neck-squamous-cell-carcinoma-hnscc","tag-hepatitis","tag-hnscc","tag-janus-kinase-inhibitor","tag-leukaemia","tag-monkeypox-vaccine","tag-social-anxiety-disorder","tag-vitiligo","tag-vitiligo-therapies","industry-pharmaceutical","therapeutic_areas-dermatology","therapeutic_areas-neurology","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- 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