{"id":32981,"date":"2025-08-05T19:03:21","date_gmt":"2025-08-05T13:33:21","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=32981"},"modified":"2025-08-05T19:03:23","modified_gmt":"2025-08-05T13:33:23","slug":"pharma-news-for-anbogen-bms-clarametyx","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-anbogen-bms-clarametyx","title":{"rendered":"Anbogen\u2019s ABT-301 Cleared by FDA for Phase I\/II Colorectal Cancer Trial; Dyne\u2019s DYNE-251 Gets FDA Breakthrough Tag for Duchenne Muscular Dystrophy; BMS\u2019s BREYANZI Accepted for FDA Priority Review in MZL; Clarametyx\u2019s CMTX-101 Earns FDA Fast Track and QIDP for Infections; Anixa Begins FDA-Approved IND Transfer for Phase II Breast Cancer Vaccine Trial"},"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-6a091bdc002d4\" 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-6a091bdc002d4\"  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-anbogen-bms-clarametyx\/#Anbogen_Secures_FDA_Nod_to_Begin_Phase_III_Trial_of_ABT-301_Triplet_in_Advanced_Colorectal_Cancer\" >Anbogen Secures FDA Nod to Begin Phase I\/II Trial of ABT-301 Triplet in Advanced Colorectal Cancer<\/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-anbogen-bms-clarametyx\/#Dyne_Therapeutics_DYNE-251_Earns_FDA_Breakthrough_Therapy_Tag_for_Duchenne_Muscular_Dystrophy\" >Dyne Therapeutics\u2019 DYNE-251 Earns FDA Breakthrough Therapy Tag for Duchenne Muscular Dystrophy<\/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-anbogen-bms-clarametyx\/#FDA_Grants_Priority_Review_to_BMS_BREYANZI_for_RelapsedRefractory_Marginal_Zone_Lymphoma\" >FDA Grants Priority Review to BMS&#8217; BREYANZI for Relapsed\/Refractory Marginal Zone Lymphoma<\/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-anbogen-bms-clarametyx\/#Clarametyx_Biosciences_CMTX-101_Gets_FDA_Fast_Track_QIDP_Status_for_Infectious_Diseases\" >Clarametyx Biosciences\u2019 CMTX-101 Gets FDA Fast Track &amp; QIDP Status for Infectious Diseases<\/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-anbogen-bms-clarametyx\/#Anixa_Biosciences_Begins_FDA-Approved_IND_Transfer_for_Phase_II_Breast_Cancer_Vaccine_Trial\" >Anixa Biosciences Begins FDA-Approved IND Transfer for Phase II Breast Cancer Vaccine Trial<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-anbogen-secures-fda-nod-to-begin-phase-i-ii-trial-of-abt-301-triplet-in-advanced-colorectal-cancer\"><span class=\"ez-toc-section\" id=\"Anbogen_Secures_FDA_Nod_to_Begin_Phase_III_Trial_of_ABT-301_Triplet_in_Advanced_Colorectal_Cancer\"><\/span>Anbogen Secures FDA Nod to Begin Phase I\/II Trial of ABT-301 Triplet in Advanced Colorectal Cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Anbogen Therapeutics<\/strong> has received FDA clearance to initiate a<strong> Phase I\/II clinical trial <\/strong>of <strong>ABT-301<\/strong> in combination with <strong>tislelizumab <\/strong>and <strong>bevacizumab <\/strong>for <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-colorectal-cancer-market\">patients with <strong>metastatic colorectal cancer (mCRC)<\/strong><\/a><strong>.<\/strong> The study will enroll 66 patients with pMMR or non-MSI-H tumors\u2014types known for poor response to immunotherapies\u2014across sites in Taiwan and Australia.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are excited to advance ABT-301 into the clinic for patients with hard-to-treat mCRC,\u201d said a spokesperson from Anbogen. \u201cThe FDA\u2019s clearance highlights the strength of our preclinical and early clinical data, as well as the urgent need for novel immunotherapy combinations in this space.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>ABT-301 is an oral HDAC1\/2\/3 inhibitor shown in preclinical models to convert \u201ccold tumors\u201d into \u201chot,\u201d enhancing immune response by increasing CD8+ T cell activity, antigen presentation, and suppressing M-MDSCs. In a prior Phase I study with 23 patients, the candidate demonstrated a clean safety profile\u2014lacking common toxicities like neutropenia or cardiotoxicity seen with other HDAC inhibitors.<\/p>\n\n\n\n<p>According to GlobalData, the target patient population exceeds 370,000 across key markets annually, with an estimated commercial potential of $9 billion. Anbogen plans to leverage this milestone to attract global licensing opportunities and has initiated a Series B funding round to support continued development and commercialization.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-dyne-therapeutics-dyne-251-earns-fda-breakthrough-therapy-tag-for-duchenne-muscular-dystrophy\"><span class=\"ez-toc-section\" id=\"Dyne_Therapeutics_DYNE-251_Earns_FDA_Breakthrough_Therapy_Tag_for_Duchenne_Muscular_Dystrophy\"><\/span>Dyne Therapeutics\u2019 DYNE-251 Earns FDA Breakthrough Therapy Tag for Duchenne Muscular Dystrophy<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Dyne Therapeutics, Inc.,<\/strong> announced that the <strong>FDA <\/strong>has granted <strong>Breakthrough Therapy Designation<\/strong> to <strong><em>DYNE-251<\/em><\/strong> for <a href=\"https:\/\/www.delveinsight.com\/report-store\/duchenne-muscular-dystrophy-market\"><strong>Duchenne muscular dystrophy (DMD)<\/strong><\/a><strong> <\/strong>patients amenable to exon 51 skipping. The designation is based on promising data from the ongoing <em>DELIVER<\/em> trial, highlighting the therapy\u2019s potential to improve functional outcomes in a population with limited options.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis Breakthrough Therapy Designation is a testament to DYNE-251\u2019s potential as a next-generation treatment designed to bring meaningful improvement to individuals with DMD,\u201d said Doug Kerr, M.D., Ph.D., Chief Medical Officer at Dyne. \u201cWith sustained functional benefits seen through 18 months and near full-length dystrophin expression, we\u2019re optimistic about its long-term impact.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>With this designation, DYNE-251 now qualifies for enhanced regulatory support, including rolling submission and potential Priority Review of its future Biologics License Application (BLA). Dyne has completed enrollment in the DELIVER trial\u2019s Registrational Expansion Cohort (n=32), with data expected in late 2025 and a potential BLA submission in early 2026.<\/p>\n\n\n\n<p>Notably, DYNE-251 has also received Fast Track, Orphan Drug, and Rare Pediatric Disease designations in the U.S., along with Orphan Drug status from the EMA. Dyne continues to pursue global regulatory pathways for the therapy while advancing its parallel program, DYNE-101, which also holds Breakthrough Therapy Designation for myotonic dystrophy type 1.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-grants-priority-review-to-bms-breyanzi-for-relapsed-refractory-marginal-zone-lymphoma\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Priority_Review_to_BMS_BREYANZI_for_RelapsedRefractory_Marginal_Zone_Lymphoma\"><\/span>FDA Grants Priority Review to BMS&#8217; BREYANZI for Relapsed\/Refractory Marginal Zone Lymphoma<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Bristol Myers Squibb<\/strong> announced that the FDA accepted the <strong>supplemental Biologics License Application (sBLA) <\/strong>for <strong><em>BREYANZI<\/em><\/strong><strong> <\/strong>(lisocabtagene maraleucel; liso-cel) to treat adults with <a href=\"https:\/\/www.delveinsight.com\/report-store\/marginal-zone-lymphoma-market\"><strong>relapsed or refractory marginal zone lymphoma (MZL)<\/strong><\/a><strong> <\/strong>after at least two prior lines of systemic therapy. The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) date set for December 5, 2025.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis FDA acceptance brings us one step closer to potentially standardizing CAR T cell therapy as a treatment option for MZL,\u201d said Rosanna Ricafort, Vice President and Senior Global Program Lead, Hematology and Cell Therapy, Bristol Myers Squibb. \u201cMany MZL patients experience multiple relapses, and BREYANZI offers hope for lasting responses in this difficult-to-treat population.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The submission is supported by data from the MZL cohort of the <em>TRANSCEND FL<\/em> study, a Phase II, open-label, multicenter, single-arm trial. Results, presented at the 2025 International Conference on Malignant Lymphoma (ICML), showed that <em>BREYANZI<\/em> achieved durable response rates with a consistent and manageable safety profile in patients with heavily pretreated MZL.<\/p>\n\n\n\n<p>If approved, <em>BREYANZI<\/em> would become the first and only CAR T cell therapy indicated for MZL, addressing a critical unmet need. The FDA recently removed the Risk Evaluation and Mitigation Strategy (REMS) requirement and approved streamlined patient monitoring protocols for <em>BREYANZI<\/em>, improving accessibility while maintaining safety standards.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clarametyx-biosciences-cmtx-101-gets-fda-fast-track-amp-qidp-status-for-infectious-diseases\"><span class=\"ez-toc-section\" id=\"Clarametyx_Biosciences_CMTX-101_Gets_FDA_Fast_Track_QIDP_Status_for_Infectious_Diseases\"><\/span>Clarametyx Biosciences\u2019 CMTX-101 Gets FDA Fast Track &amp; QIDP Status for Infectious Diseases<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Clarametyx Biosciences <\/strong>announced that the <strong>FDA<\/strong> has granted both <strong>Fast Track and Qualified Infectious Disease Product (QIDP) designations<\/strong> for its lead candidate, <strong>CMTX-101, <\/strong>for the treatment of<strong> chronic bacterial pulmonary infections <\/strong>in <a href=\"https:\/\/www.delveinsight.com\/report-store\/cystic-fibrosis-market\">people with<strong> cystic fibrosis (CF)<\/strong><\/a>. The designations aim to expedite the development and review of therapies for serious infections and provide additional regulatory benefits, including five years of extended market exclusivity.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe receipt of both Fast Track and QIDP designations underscores CMTX-101\u2019s potential as an innovative therapy for chronic respiratory conditions,\u201d said David V. Richards, CEO of Clarametyx. \u201cWith expanded support from our investors, we\u2019re well positioned to advance both our therapeutic and vaccine pipelines, including reaching full enrollment in our lead trial by year-end.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The ongoing phase Ib\/IIa trial of CMTX-101 in CF patients is evaluating safety, pharmacokinetics, immunogenicity, and reductions in Pseudomonas aeruginosa burden. A positive interim analysis announced in June 2025 met the criteria to progress, triggering expansion of the study\u2019s next phase and trial site network.<\/p>\n\n\n\n<p>To support its development programs, Clarametyx also announced the closing of an upsized second tranche of Series A funding from existing investors. The funding will accelerate clinical progress of CMTX-101 and further the company\u2019s vaccine program, which is targeting an IND submission by 2027.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-anixa-biosciences-begins-fda-approved-ind-transfer-for-phase-ii-breast-cancer-vaccine-trial\"><span class=\"ez-toc-section\" id=\"Anixa_Biosciences_Begins_FDA-Approved_IND_Transfer_for_Phase_II_Breast_Cancer_Vaccine_Trial\"><\/span>Anixa Biosciences Begins FDA-Approved IND Transfer for Phase II Breast Cancer Vaccine Trial<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Anixa Biosciences<\/strong>, in collaboration with the<strong> Cleveland Clinic<\/strong>, initiated the transfer of the Investigational <strong>New Drug (IND) application<\/strong> for its <a href=\"https:\/\/www.delveinsight.com\/report-store\/breast-cancer-market\"><strong>breast cancer vaccine<\/strong><\/a>. With the Phase I trial now completed and enrollment closed, Anixa is assuming full sponsorship to advance the program into a Phase II clinical study. The IND, originally held by Cleveland Clinic, is being transitioned to Anixa to support the next phase of clinical development.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are pleased with the progress and preliminary findings from our Phase I clinical trial, which show that the vaccine is well tolerated, with more than 70% of patients tested to date exhibiting protocol-defined immune responses,\u201d said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. \u201cThe IND transfer represents a major step in advancing to a Phase II trial under our sponsorship.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>To support the IND transfer and regulatory planning, Anixa has engaged Advyzom, a regulatory consulting firm with expertise in FDA interactions, to serve as its U.S. regulatory agent. This strategic collaboration ensures streamlined coordination as Anixa prepares to initiate the next trial phase.<\/p>\n\n\n\n<p>The breast cancer vaccine, developed with the Cleveland Clinic, targets \u03b1-lactalbumin\u2014an antigen typically expressed in lactating breast tissue but also present in many breast cancers. By generating an immune response against this protein, the vaccine holds promise for both therapeutic and preventive applications in patients with \u03b1-lactalbumin\u2013expressing tumors.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Anbogen Secures FDA Nod to Begin Phase I\/II Trial of ABT-301 Triplet in Advanced Colorectal Cancer Anbogen Therapeutics has received FDA clearance to initiate a Phase I\/II clinical trial of ABT-301 in combination with tislelizumab and bevacizumab for patients with metastatic colorectal cancer (mCRC). The study will enroll 66 patients with pMMR or non-MSI-H tumors\u2014types [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":32982,"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":[17126],"tags":[127,19791,3878,195,6347,6346,17788,16882,204,1796,218,12860,12862,17916,704,349,18832,19000,20734,18999,19001,21630,420,639],"industry":[17225],"therapeutic_areas":[17238,17228,17243],"class_list":["post-32981","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-others","tag-breast-cancer","tag-breast-cancer-diagnostics","tag-breast-cancer-treatment","tag-cystic-fibrosis","tag-cystic-fibrosis-drug-market","tag-cystic-fibrosis-drugs","tag-cystic-fibrosis-pipeline","tag-cystic-fibrosis-treatment","tag-delveinsight","tag-duchenne-muscular-dystrophy","tag-duchenne-muscular-dystrophy-dmd","tag-duchenne-muscular-dystrophy-market","tag-duchenne-muscular-dystrophy-pipeline","tag-duchenne-muscular-dystrophy-treatment","tag-fda","tag-latest-pharma-news","tag-marginal-zone-lymphoma","tag-metastatic-colorectal-cancer","tag-metastatic-colorectal-cancer-crc","tag-metastatic-colorectal-cancer-market","tag-metastatic-colorectal-cancer-therapies","tag-metastatic-colorectal-cancer-treatment","tag-news","tag-pharma-news","industry-pharmaceutical","therapeutic_areas-genetic-disorders","therapeutic_areas-oncology","therapeutic_areas-respiratory-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 | Anbogen, BMS, Clarametyx<\/title>\n<meta name=\"description\" content=\"Anbogen\u2019s ABT-301; Dyne Therapeutics\u2019 DYNE-251; Bristol Myers Squibb\u2019s BREYANZI; Clarametyx&#039;s CMTX-101; Anixa\u2019s Breast Cancer Vaccine\" \/>\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-anbogen-bms-clarametyx\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Anbogen, BMS, Clarametyx\" \/>\n<meta property=\"og:description\" content=\"Anbogen\u2019s ABT-301; Dyne Therapeutics\u2019 DYNE-251; Bristol Myers Squibb\u2019s BREYANZI; Clarametyx&#039;s CMTX-101; Anixa\u2019s Breast 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