{"id":16893,"date":"2022-04-05T16:55:51","date_gmt":"2022-04-05T11:25:51","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=16893"},"modified":"2022-04-05T16:55:54","modified_gmt":"2022-04-05T11:25:54","slug":"pharma-news-for-precigen-biogen-sanofi-clovis","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-precigen-biogen-sanofi-clovis","title":{"rendered":"Precigen&#8217;s PRGN-3006; Yescarta Approved as a First CAR T-cell Therapy for R\/R LBCL; Biogen &#038; Ionis\u2019 BIIB078; Nobelpharma&#8217;s HYFTOR (sirolimus topical gel) 0.2%; Cerevance Parkinson\u2019s Drug; Sanofi &#038; Regeneron\u2019s Dupixent; Clovis\u2019s Rubraca for Ovarian Cancer; Immunocore Eye Cancer Cell Therapy Approval"},"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-6a0e2cb108b94\" 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-6a0e2cb108b94\"  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-precigen-biogen-sanofi-clovis\/#FDA_Approves_Yescarta_as_a_First_CAR_T-cell_Therapy_for_Initial_Treatment_of_RR_Large_B-cell_Lymphoma\" >FDA Approves Yescarta as a First CAR T-cell Therapy for Initial Treatment of R\/R Large B-cell Lymphoma<\/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-precigen-biogen-sanofi-clovis\/#FDA_approves_Nobelpharmas_HYFTOR%E2%84%A2_sirolimus_topical_gel_02\" >FDA approves Nobelpharma&#8217;s HYFTOR&#x2122; (sirolimus topical gel) 0.2%<\/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-precigen-biogen-sanofi-clovis\/#Biogen_and_Ionis_Drug_BIIB078_Fails_in_Phase_1_Trial_for_Amyotrophic_Lateral_Sclerosis\" >Biogen and Ionis\u2019 Drug BIIB078 Fails in Phase 1 Trial for Amyotrophic Lateral Sclerosis<\/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-precigen-biogen-sanofi-clovis\/#Cerevance_preps_Pivotal_Trials_of_Parkinsons_drug_after_Phase_2_Success\" >Cerevance preps Pivotal Trials of Parkinson\u2019s drug after Phase 2 Success.<\/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-precigen-biogen-sanofi-clovis\/#FDA_Grants_Priority_Review_to_Sanofi_and_Regenerons_Dupixent_for_Eosinophilic_Esophagitis\" >FDA Grants Priority Review to Sanofi and Regeneron\u2019s Dupixent for Eosinophilic Esophagitis<\/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-precigen-biogen-sanofi-clovis\/#Covis_Plans_to_File_FDA_Approval_for_Rubraca_for_Ovarian_Cancer\" >Covis Plans to File FDA Approval for Rubraca for Ovarian Cancer<\/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-precigen-biogen-sanofi-clovis\/#Immunocore_Eye_Cancer_Cell_Therapy_Scores_European_Approval\" >Immunocore Eye Cancer Cell Therapy Scores European Approval<\/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-precigen-biogen-sanofi-clovis\/#FDA_Grants_Fast_Track_Designation_to_Precigens_Acute_Myeloid_Leukemia_Treatment_Candidate\" >FDA Grants Fast Track Designation to Precigen&#8217;s Acute Myeloid Leukemia Treatment Candidate<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-yescarta-as-a-first-car-t-cell-therapy-for-initial-treatment-of-r-r-large-b-cell-lymphoma\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Yescarta_as_a_First_CAR_T-cell_Therapy_for_Initial_Treatment_of_RR_Large_B-cell_Lymphoma\"><\/span><strong>FDA Approves Yescarta as a First CAR T-cell Therapy for Initial Treatment of R\/R Large B-cell Lymphoma<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Until now, existing CAR-T therapies have been reserved for patients with blood cancer who have tried multiple treatments. The FDA has approved <a href=\"https:\/\/www.delveinsight.com\/report-store\/yescarta-drug-insight-and-market-forecast\"><strong>Yescarta<\/strong><\/a>, a CD19-directed CAR-T therapy developed by <strong>Gilead Sciences&#8217; Kite Pharma<\/strong>, for the treatment of patients with Large B-cell Lymphoma that is refractory to one prior therapy or that relapses within <strong>12 months<\/strong> of first-line chemoimmunotherapy.<\/p>\n\n\n\n<p><strong>Yescarta&#8217;s<\/strong> approval has put it ahead of <strong>Bristol Myers Squibb&#8217;s<\/strong> rival drug <strong>Breyanzi<\/strong>, which is expecting an FDA decision for the same second-line lymphoma indication by June 24. The FDA approval was based on <strong>Phase 3 Zuma-7 trial<\/strong>. According to the study, <strong>Yescarta <\/strong>reduced the risk of disease progression, death, or the need for a new therapy by <strong>60.2%<\/strong> when compared to the standard of care, which includes chemotherapy and stem cell transplant. At two years, <strong>40.5%<\/strong> of Yescarta participants were still alive and had not required additional cancer treatment or experienced cancer progression, compared to <strong>16.3%<\/strong> in the control arm.<\/p>\n\n\n\n<p>Kite will almost certainly face second-line competition from <strong>Bristol Myers&#8217; CAR-T therapy Breyanzi<\/strong>, which reduced the risk of event-free survival by <strong>65.1%<\/strong> in its own <strong>Phase 3 trial<\/strong>. <strong>Kymriah, Novartis&#8217; <\/strong>CD19-targeted CAR-T therapy, previously failed in <a href=\"https:\/\/www.delveinsight.com\/report-store\/diffuse-large-b-cell-lymphoma-pipeline-insight\">second-line Large B-cell Lymphoma (LBCL)<\/a>. Kite already has a three-year market lead with <strong>Yescarta<\/strong> over <strong>Breyanzi<\/strong>. Kite has also made significant investments in manufacturing to ensure a consistent supply and a short turnaround time. During the pandemic, the company received approval for an Amsterdam site, and it expects a Maryland facility to receive clearance and begin commercial production by mid-year. In addition, the third facility in Oceanside, California, has recently started producing engineered viral vectors for cell therapy in collaboration with an outside contractor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_approves_Nobelpharmas_HYFTOR%E2%84%A2_sirolimus_topical_gel_02\"><\/span><strong>FDA approves Nobelpharma&#8217;s HYFTOR&#x2122; (sirolimus topical gel) 0.2%<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Nobelpharma America has announced that the U.S. Food and Drug Administration (FDA) has approved <strong>HYFTOR&#x2122; (sirolimus topical gel) 0.2%<\/strong> as the first topical <a href=\"https:\/\/www.delveinsight.com\/report-store\/angiofibroma-market\">treatment therapy for facial angiofibroma<\/a> associated with Tuberous Sclerosis Complex (TSC). The therapy is approved for use in adults and children aged 6 or older. Additionally, Nobelpharma has received Orphan Drug status for HYFTOR&#x2122; for this indication.<\/p>\n\n\n\n<p>In the clinical trials, sirolimus was found to improve the size and redness of facial angiofibroma at <strong>12 weeks.<\/strong> Sirolimus is not supposed to be used in patients with a history of hypersensitivity to topical medication or other gel components.<\/p>\n\n\n\n<p>Tuberous Sclerosis Complex is a rare genetic condition affecting various parts of the body such as the skin, central nervous system, heart, kidney, lung, and other sites. As per DelveInsight, in the United States, nearly <strong>50,000 people<\/strong> are affected with Tuberous Sclerosis Complex, and about <strong>1 to 2 million<\/strong> individuals worldwide. The estimated <a href=\"https:\/\/www.delveinsight.com\/report-store\/tuberous-sclerosis-complex-epidemiology-forecast\">Tuberous Sclerosis Complex prevalence<\/a> is one in 6,000 newborns. Facial angiofibroma is observed in approximately <strong>75%-80% of TSC<\/strong> patients and results in facial skin lesions. The approval of the <strong>HYFTOR&#x2122; (sirolimus topical gel) 0.2%<\/strong> is expected to significantly improve the health outcome for the affected individuals.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Biogen_and_Ionis_Drug_BIIB078_Fails_in_Phase_1_Trial_for_Amyotrophic_Lateral_Sclerosis\"><\/span><strong>Biogen and Ionis\u2019 Drug BIIB078 Fails in Phase 1 Trial for Amyotrophic Lateral Sclerosis<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In one of the latest clinical updates, Biogen and Ionis Pharmaceuticals have announced the failure of their potential drug <strong>BIIB078 (IONIS-C9Rx)<\/strong> for Amyotrophic Lateral Sclerosis (ALS). BIIB078 is an investigational antisense oligonucleotide for the treatment of <strong>C9orf72-associated Amyotrophic Lateral Sclerosis<\/strong>.&nbsp;<\/p>\n\n\n\n<p>In the phase I clinical-stage, <strong>BIIB078 <\/strong>was evaluated in a randomized, placebo-controlled, dose-escalating trial to assess the efficacy of the therapy administered intrathecally to adults (n=106). The therapy was unable to meet any secondary efficacy endpoints and failed to show clinical benefit. Further, Biogen has announced to discontinue the clinical program.<\/p>\n\n\n\n<p>Amyotrophic Lateral Sclerosis, commonly known as Lou Gehrig&#8217;s disease, is a group of rare neurological diseases that mainly involve the nerve cells (neurons). <strong>C9orf72-associated ALS <\/strong>is a complex genetic form of ALS. As per DelveInsight, the <a href=\"https:\/\/www.delveinsight.com\/report-store\/amyotrophic-lateral-sclerosis-epidemiology-forecast\">Amyotrophic Lateral Sclerosis prevalent population<\/a> in the seven major markets was found to be <strong>71,600+<\/strong> in <strong>2020 <\/strong>and is expected to grow during the forecast period.&nbsp; Furthermore, the diagnosed prevalent cases of ALS in the United States were <strong>18,800+<\/strong> in <strong>2020<\/strong>. As of now, there is no cure and proven treatment for ALS. However, pharma and biotech companies are vigorously exploring the ALS treatment landscape. Biogen is also actively working in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/amyotrophic-lateral-sclerosis-als-market\">Amyotrophic Lateral Sclerosis Therapeutics Market<\/a> with several investigational drugs in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/amyotrophic-lateral-sclerosis-als-pipeline-insight\">ALS pipeline<\/a> such as tofersen, BIIB105, and BIIB100.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Cerevance_preps_Pivotal_Trials_of_Parkinsons_drug_after_Phase_2_Success\"><\/span><strong>Cerevance preps Pivotal Trials of Parkinson\u2019s drug after Phase 2 Success<\/strong>.<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Cerevance<\/strong>, a clinical-stage drug discovery and development company focused on <a href=\"https:\/\/www.delveinsight.com\/blog\/central-nervous-system\"><strong>central nervous system diseases<\/strong><\/a>, has announced the successful completion of its<strong> Phase II <\/strong>clinical trial of <strong>CVN424<\/strong>, the company\u2019s first-in-class, once-a-day, an orally-delivered compound in development to treat <strong>Parkinson\u2019s disease<\/strong>. Apart from safety objectives, the drug achieved a compelling, dose-dependent reduction of \u201c<strong>OFF-time,<\/strong>\u201d which refers to time periods of the day when Parkinson disease&#8217; symptoms recur despite medication.&nbsp;<\/p>\n\n\n\n<p>CVN424 was evaluated in a double-blind, randomized, placebo-controlled multicenter <strong>Phase II<\/strong> study at two dose levels in Parkinson\u2019s disease patients with motor fluctuations. Approximately <strong>135 subjects<\/strong> with Parkinson\u2019s disease were enrolled on a stable dosage of <strong>levodopa <\/strong>and other <a href=\"https:\/\/www.delveinsight.com\/report-store\/parkinsons-disease-pipeline-insights\">Parkinson\u2019s therapies<\/a> but with at least two hours or more per day of average OFF time. Following the baseline safety &amp; efficacy assessments, subjects were randomized to receive once-daily doses of low-dose CVN424, high-dose CVN424, or a matching placebo for four weeks.<\/p>\n\n\n\n<p>CVN424 showed a 1.3 hour improvement in OFF-time at the high dose as compared to placebo at four weeks. This was accompanied by a rise in ON-time without <strong>Troublesome Dyskinesia,<\/strong> without a meaningful worsening of ON-Time with Troublesome Dyskinesia. Efficacy enhanced at four weeks in comparison with two weeks, and <strong>daytime sleepiness<\/strong> as measured by the <strong>Epworth Sleepiness Scale<\/strong> was reduced compared to placebo, differentiating it from most Parkinson\u2019s disease drugs used as adjuncts to levodopa. At the lower dose, CVN424 also showed a meaningful improvement in OFF-time and ON-time without Troublesome Dyskinesia compared to placebo. The most prevailing adverse effects were vomiting, nausea, and headache, occurring in two subjects each at the higher dose. All other adverse reactions appeared in one issue or less.<\/p>\n\n\n\n<p>Cerevance intends to pursue additional <strong>Phase II\/III<\/strong> clinical studies with CVN424 to build a clear pathway to regulatory approval of the drug for the <strong>adjunctive therapy<\/strong>. The company will assess the drug\u2019s promise as a stand-alone treatment for recently diagnosed patients not yet treated with levodopa.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Priority_Review_to_Sanofi_and_Regenerons_Dupixent_for_Eosinophilic_Esophagitis\"><\/span><strong>FDA Grants Priority Review to Sanofi and Regeneron\u2019s Dupixent for Eosinophilic Esophagitis<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The <strong>Food and Drug Administration<\/strong> has granted <strong>Breakthrough Therapy<\/strong> designation to <a href=\"https:\/\/www.delveinsight.com\/blog\/dupixent-market\"><strong>Dupixent<\/strong><\/a><strong> <\/strong>to treat patients <strong>12 years<\/strong> and older suffering with <strong>Eosinophilic Esophagitis (EoE)<\/strong>. The identification for this investigational use is based on positive results from <strong>Part A<\/strong> of a <strong>Phase III<\/strong> trial in patients with eosinophilic esophagitis.<\/p>\n\n\n\n<p>There are currently no FDA-approved <a href=\"https:\/\/www.delveinsight.com\/report-store\/eosinophilic-esophagitis-pipeline-insight\">medicines for Eosinophilic Esophagitis<\/a>, a chronic and <strong>progressive type II inflammatory disease<\/strong> that breaks the esophagus and prevents it from functioning correctly. Over time, excessive type II inflammation causes scarring and narrowing of the esophagus, making it difficult to swallow. If left untreated, eosinophilic esophagitis can affect a patient\u2019s ability to eat and cause food to become stuck after being destroyed (food impaction), leading to a medical emergency.<\/p>\n\n\n\n<p>In the <strong>United States<\/strong>, there are around <strong>160,000 patients<\/strong> with Eosinophilic Esophagitis who are currently being treated with different unapproved therapies or diet modifications. Of these patients, around <strong>50,000<\/strong> have failed multiple treatments.<\/p>\n\n\n\n<p><strong>Sanofi <\/strong>along with <strong>Regeneron <\/strong>previously reported positive results from Part A of the pivotal <strong>Phase III trial<\/strong> assessing Dupixent in patients 12 years and older suffering with EoE. Part A of the double-blind, randomized, placebo-controlled trial of <strong>81 patients <\/strong>met both of its co-primary endpoints and all critical secondary endpoints. Patients who are treated on a weekly basis with <strong>Dupixent 300 mg<\/strong> over a 24-week treatment period have experienced a reduction in symptoms, esophageal inflammation, and abnormal endoscopic findings in the esophagus.<\/p>\n\n\n\n<p>Part A of the trial also showed safety results consistent with the known safety profile of <a href=\"https:\/\/www.delveinsight.com\/report-store\/dupilumab-emerging-insight-and-market-forecast\">Dupixent in its approved indications<\/a>. The eosinophilic esophagitis trial is ongoing, with additional patients enrolling in <strong>Part B<\/strong> and patients continuing in a 28-week extended active treatment period (<strong>Part C<\/strong>) after completing either <strong>Part A<\/strong> or<strong> Part B<\/strong>.<\/p>\n\n\n\n<p><strong>Breakthrough Therapy<\/strong> designation is expected to accelerate the development &amp; review of drugs in the U.S. that target life-threatening diseases. Drugs qualifying for this designation must show preliminary clinical results that the drug may substantially improve clinically significant endpoints over available therapies or placebo if there are no available therapies. In 2017, Dupixent was granted <strong>Orphan Drug designation<\/strong> for the possible treatment of Eosinophilic Esophagitis. This is given to investigational medicines intended to treat rare diseases that affect less than around<strong> 200,000<\/strong> people in the United States. Dupixent&#8217;s potential use in eosinophilic esophagitis is currently under clinical development, and no regulatory authority has evaluated its safety and efficacy for this indication.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Covis_Plans_to_File_FDA_Approval_for_Rubraca_for_Ovarian_Cancer\"><\/span><strong>Covis Plans to File FDA Approval for Rubraca for Ovarian Cancer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Clovis intends to apply for FDA approval in the second quarter based on a positive readout. The anticipated FDA approval, will likely place <strong>Clovis&#8217;s Rubraca<\/strong>, a drug used for <a href=\"https:\/\/www.delveinsight.com\/report-store\/epithelial-ovarian-cancer-pipeline-insight\"><strong>Epithelial Ovarian Cancer treatment<\/strong><\/a><strong> <\/strong>alongside its competitor drugs from <strong>GlaxoSmithKline<\/strong> and <strong>AstraZeneca<\/strong>. Rubraca inhibited tumor development in all patients with BRCA mutations and HRD positive malignancies, as well as those with tumors that did not exhibit homologous recombination deficiencies (HRD).&nbsp;<\/p>\n\n\n\n<p>Nonetheless, given the new Rubraca data comes two years after FDA approvals for <strong>GSK&#8217;s Zejula<\/strong> and <strong>AstraZeneca<\/strong>, as well as <a href=\"https:\/\/www.delveinsight.com\/report-store\/lynparza-api-insights\"><strong>Merck&#8217;s Lynparza<\/strong><\/a> in the first-line maintenance scenario, however, the Clovis drug&#8217;s market potential remains unknown. Moreover, Rubraca&#8217;s findings look competitive against <strong>Zejula<\/strong>, the only PARP inhibitor with a broad, all-comers nod in first-line maintenance. The drug &#8220;exceeded&#8221; the company&#8217;s expectations in the <strong>Phase 3 Athena-Mono trial<\/strong>, according to the company, as Rubraca monotherapy reduced the risk of progression or death from<a href=\"https:\/\/www.delveinsight.com\/report-store\/ovarian-cancer-market\"> Ovarian Cancer<\/a> by <strong>48%<\/strong> compared to placebo in all patients independent of tumor biomarker status.&nbsp;<\/p>\n\n\n\n<p>Patients who took the drug witnessed <strong>no disease progression for 20.2 months<\/strong>, compared to <strong>9.2 months<\/strong> for those who took a placebo. Rubraca lowered that risk by <strong>35%<\/strong> in individuals without HRD in an exploratory subgroup study.<strong> Athena-Combo<\/strong>, the other phase of the Athena clinical programme, is investigating whether adding <strong>Bristol Myers Squibb&#8217;s PD-1 inhibitor Opdivo<\/strong> might further improve upon Rubraca monotherapy. The readout from that comparison has been pushed back into the first quarter of next year due to a slower-than-expected increase in disease progression or mortality occurrences. Clovis feels it has another opportunity to increase its market share in first-line maintenance.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Immunocore_Eye_Cancer_Cell_Therapy_Scores_European_Approval\"><\/span><strong>Immunocore Eye Cancer Cell Therapy Scores European Approval<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In one of the latest clinical development in<a href=\"https:\/\/www.delveinsight.com\/report-store\/tcr-therapy-market\"> <strong>TCR therapy domain<\/strong><\/a>, <strong>Immunocore Holdings plc<\/strong> received the <strong>European Commission (EC)<\/strong> approval for <strong>Kimmtrak (tebentafusp)<\/strong> for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). Kimmtrak is a novel bispecific protein that combines a <strong>soluble T cell receptor<\/strong> with an <strong>anti-CD3 immune-effector function<\/strong>. It is the first therapy to show a survival benefit in patients with unresectable or<a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-uveal-melanoma-mum-epidemiology-forecast\"> Metastatic Uveal Melanoma<\/a>.<\/p>\n\n\n\n<p>Uveal melanoma is a rare and aggressive kind of melanoma that affects the eye. Although it is the most common primary intraocular malignancy in adults, detection is rare, and up to <strong>50%<\/strong> of persons with uveal melanoma develop metastatic disease. However, the development of Kimmtrak signifies a paradigm change in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/uveal-melanoma-epidemiology-forecast\">treatment of unresectable or metastatic uveal melanoma<\/a>.<\/p>\n\n\n\n<p>The EC approval comes after the <strong>Committee for Medicinal Products for Human Use<\/strong> (CHMP) issued a favorable opinion in February 2022. The CHMP recommendation for Kimmtrak is based on the findings of <strong>Immunocore&#8217;s Phase 3 IMCgp100-202 <\/strong>clinical study, which were published in the <strong>New England Journal of Medicine<\/strong> on <strong>September 23, 2021<\/strong>. The data for the biggest <strong>Phase 3 trial<\/strong> ever conducted in mUM, revealed that Kimmtrak provided an unparalleled median OS benefit as a first-line therapy. In the intent-to-treat population, the <strong>OS Hazard Ratio (HR)<\/strong> recommended Kimmtrak, <strong>HR=0.51<\/strong>, over the investigator&#8217;s treatment choice (<strong>82%<\/strong> pembrolizumab; <strong>13%<\/strong> ipilimumab; <strong>6%<\/strong> dacarbazine). Treatment-related side events were tolerable and consistent with the suggested mechanism of action in the randomized <strong>Phase 3 Kimmtrak (tebentafusp)<\/strong> <strong>study<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Fast_Track_Designation_to_Precigens_Acute_Myeloid_Leukemia_Treatment_Candidate\"><\/span><strong>FDA Grants Fast Track Designation to Precigen&#8217;s Acute Myeloid Leukemia Treatment Candidate<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA has granted <strong>PRGN-3006<\/strong> UltraCAR-T Fast track designation for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/relapsed-refractory-acute-myeloid-leukemia-r-r-aml-pipeline-insight\">treatment of patients with relapsed or refractory Acute Myeloid Leukemia (R\/R AML)<\/a>. The FDA previously designated the multigenic autologous chimeric antigen receptor (CAR)-T cell agent as an orphan drug for the treatment of R\/R Acute Myeloid Leukemia. <strong>PRGN-3006<\/strong> is currently being tested in a single-center, nonrandomized, investigator-initiated <strong>Phase 1\/1b study<\/strong>. Patients with R\/R Acute Myeloid Leukemia and those with high-risk Myelodysplastic Syndrome are both included in the study.<\/p>\n\n\n\n<p><strong>PRGN-3006<\/strong> study is currently recruiting patients for a dose-escalation phase to determine the maximum-tolerated dose (MTD) of CAR T cells. The study&#8217;s coprimary endpoints are the number of patients who experience dose-limiting toxicities (DLTs) and the number of patients who experience treatment-related adverse events. The study&#8217;s secondary endpoints include disease progression in Acute Myeloid Leukemia patients, disease response in <a href=\"https:\/\/www.delveinsight.com\/report-store\/myelodysplastic-syndrome-pipeline-insight\">Myelodysplastic Syndrome patients<\/a>, absolute lymphocyte count, and the number of<strong> PRGN-3006<\/strong> T cells present in patients treated with the agent.<\/p>\n\n\n\n<p>Patients must have R\/R AML or high-risk MDS, an absolute lymphocyte count of <strong>0.2 k\/L<\/strong>, a Karnofsky performance score of <strong>60%<\/strong>, and a life expectancy of at least <strong>12 weeks<\/strong> to be eligible for the study. Patients must also have sufficient levels of serum bilirubin, alanine and aspartate aminotransferase, and ejection fraction. Those who have had an allogeneic stem cell transplant must be at least <strong>3 months<\/strong> post-transplant before participating in the study.<\/p>\n\n\n\n<p>The fast track designation will aid in the timely development of this program, and the company is looking forward to working even more closely with the FDA to potentially bring this new and highly differentiated overnight UltraCAR-T therapy to patients.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Approves Yescarta as a First CAR T-cell Therapy for Initial Treatment of R\/R Large B-cell Lymphoma Until now, existing CAR-T therapies have been reserved for patients with blood cancer who have tried multiple treatments. The FDA has approved Yescarta, a CD19-directed CAR-T therapy developed by Gilead Sciences&#8217; Kite Pharma, for the treatment of patients [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":16896,"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":[18089,74,19218,158,17001,349,667,18088,420,444,639,19219,19220],"industry":[17225],"therapeutic_areas":[17229,17240,17239,17238,17233,17241,17245,17228,17234],"class_list":["post-16893","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-acute-myeloid-leukemia","tag-amyotrophic-lateral-sclerosis","tag-angiofibroma","tag-central-nervous-system","tag-eosinophilic-esophagitis","tag-latest-pharma-news","tag-lymphoma","tag-myelodysplastic-syndromes","tag-news","tag-ovarian-cancer","tag-pharma-news","tag-tuberous-sclerosis-complex","tag-uveal-melanoma","industry-pharmaceutical","therapeutic_areas-central-nervous-system","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-gastroenterology","therapeutic_areas-genetic-disorders","therapeutic_areas-hematological-disorders","therapeutic_areas-musculoskeletal","therapeutic_areas-neurology","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 and Updates | Precigen, Biogen, Cerevance, Sanofi, Clovis<\/title>\n<meta name=\"description\" content=\"Precigen&#039;s PRGN-3006; Biogen &amp; Ionis\u2019 BIIB078; Nobelpharma&#039;s HYFTOR; Cerevance&#039;s CVN424; Sanofi &amp; Regeneron\u2019s Dupixent; Clovis\u2019s Rubraca\" \/>\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-precigen-biogen-sanofi-clovis\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News and Updates | Precigen, Biogen, Cerevance, Sanofi, Clovis\" \/>\n<meta property=\"og:description\" content=\"Precigen&#039;s PRGN-3006; Biogen &amp; Ionis\u2019 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href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Acute Myeloid Leukemia<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">amyotrophic lateral sclerosis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Angiofibroma<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Central nervous system<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Eosinophilic Esophagitis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Latest pharma 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