{"id":21847,"date":"2025-01-10T14:40:28","date_gmt":"2025-01-10T14:40:28","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/?p=21847"},"modified":"2025-01-10T14:40:28","modified_gmt":"2025-01-10T14:40:28","slug":"genenta-strengthens-agreement-with-agc-biologics-to-boost-cell-therapy-manufacturing","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/biodrugs-atmp-en\/genenta-strengthens-agreement-with-agc-biologics-to-boost-cell-therapy-manufacturing\/","title":{"rendered":"Genenta Strengthens Agreement with AGC Biologics to Boost Cell Therapy Manufacturing"},"content":{"rendered":"<p><a href=\"https:\/\/www.genenta.com\/\" target=\"_blank\" rel=\"noopener\">Genenta Science<\/a> (NASDAQ: GNTA), a pioneer in immuno-oncology and a leader in cell-based therapeutics, is pleased to announce that it has strengthened its partnership with <a href=\"https:\/\/www.agcbio.com\/\" target=\"_blank\" rel=\"noopener\">AGC Biologics<\/a>, a global contract development and manufacturing organization (CDMO), by amending their Development and Master Services Agreement.<\/p>\n<p>This amendment introduces <strong>an exclusive GMP suite at the AGC Biologics Cell and Gene Center of Excellence in Milan, dedicated to the manufacturing of Genenta\u2019s cell therapy product, ensuring compliance with cGMP standards.<\/strong> This strategic move enhances Genenta\u2019s production capabilities, potentially improving efficiency and reliability in its manufacturing processes.<\/p>\n<p>The newly approved methastatic Renal Cell Cancer (mRCC) Phase 1\/2a trial began in Q4 2024, and Genenta expects to treat six patients by the end of the first half of 2025, while continuing progress with the Glioblastoma Multimforme (GBM) study. In total, <strong>Genenta projects manufacturing 27 autologous drug products in 2025.<\/strong><\/p>\n<blockquote class=\"td_pull_quote td_pull_center\"><p>Our strengthened partnership with AGC Biologics represents our unwavering commitment to patients participating in our GBM and mRCC trials. This enhanced capacity ensures that we can treat a larger number of patients and further validate our therapeutic approach, bringing us closer to our vision of transforming cancer treatment through cell-based therapies.<\/p><\/blockquote>\n<p style=\"text-align: center;\"><strong>Pierluigi Paracchi, CEO and Co-founder of Genenta Science<\/strong><\/p>\n<p>Prof. <strong>Luigi Naldini, Co-founder of Genenta<\/strong>, noted: \u201cOur recent preclinical and clinical studies underscore Temferon\u2019s unique potential to reprogram the tumor microenvironment, inhibiting myeloid cell-induced immune suppression and fostering T-cell responses. These findings provide a strong foundation for advancing therapeutic strategies targeting solid tumors and bring us closer to open up new cancer treatments.\u201d<\/p>\n<blockquote class=\"td_pull_quote td_pull_center\"><p>This approach not only enhances the potential efficacy of Temferon as a monotherapy but also suggests promising synergies when combined with various immunotherapeutic strategies, including immune checkpoint inhibitors and CAR-T cell therapies.<\/p><\/blockquote>\n<p style=\"text-align: center;\"><strong>Luigi Naldini, Co-founder of Genenta<\/strong><\/p>\n<h2>Upcoming Engagements during JPM Healthcare Week<\/h2>\n<p>Genenta will participate in <strong>Biotech Showcase 2025<\/strong>, taking place <strong>January 13\u201315, 2025, in San Francisco<\/strong> to present its innovative technology for treating solid tumors through genetically modified cell therapy. Pierluigi Paracchi will also speak at <strong>&#8220;Italy on the Move\u201d<\/strong>, a flagship biotech event organized by the Italian Ministry of Foreign Affairs and International Cooperation.<\/p>\n<p><strong>The event,<\/strong> aimed at promoting Italy\u2019s life sciences sector and fostering international investments, will <strong>be held on January 15, 2025, at INNOVIT<\/strong> \u2013 Italian Innovation and Culture Hub in San Francisco. Notable speakers include <strong>Karthic Jayaraman<\/strong>, Partner and Co-Head of Global Healthcare at TPG Capital, and <strong>Frederick Beddingfield<\/strong>, CEO of Rubedo Life Sciences.<\/p>\n<p>The event will be moderated by<strong> Audrey Greenberg<\/strong>, Co-Founder and Executive Managing Director of the Center for Breakthrough Medicines.<\/p>\n<h2>About Genenta<\/h2>\n<p>Genenta (Nasdaq: GNTA) is a clinical stage immuno-oncology company developing a proprietary hematopoietic stem cells therapy for the treatment of a variety of solid tumor cancers.<\/p>\n<p><strong>Genenta&#8217;s first in class product candidate is Temferon\u2122<\/strong>, which is designed to allow the expression of immune-therapeutic payloads within the tumor microenvironment by bone marrow derived myeloid cells and enable a durable and targeted response. Genenta <strong>has completed a Phase 1 trial for newly diagnosed Glioblastoma Multiforme<\/strong> patients with an unmethylated MGMT gene promoter, which suggests the potential reprogramming of the tumor microenvironment and inhibiting of myeloid induced tolerance, while allowing the induction of T cell responses, potentially breaking immune tolerance.<\/p>\n<p>Genenta <strong>has initiated in Q4 2024 a Phase 1\/2a metastatic Renal Cell Carcinoma<\/strong> study that will also include combination with immune checkpoint inhibitors. The treatments are designed as one-time monotherapies, but with the additional potential, when used in combination, to significantly enhance the efficacy of other approved therapeutics.<\/p>\n<h2>About AGC Biologics<\/h2>\n<p>AGC Biologics is<strong> a global CDMO based in Seattle<\/strong>, Washington, USA. The company provides pharmaceutical development and manufacturing services for protein-based biologics and cell and gene therapies.<\/p>\n<p>Has seven facilities and teams of scientists across three continents.<\/p>\n<p>They specialize in the following modalities and substances, <strong>mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.<\/strong><\/p>\n<p>The services range from process development, analytical development, cGMP manufacturing, quality control and quality assurance, and process validation.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A  new amendment of the previous agreement introduces an exclusive GMP suite at the AGC Biologics Cell and Gene Center of Excellence in Milan, dedicated to the manufacturing of Genenta\u2019s cell therapy product<\/p>\n","protected":false},"author":4,"featured_media":21856,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[769],"tags":[1087,1088],"class_list":{"0":"post-21847","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-biodrugs-atmp-en","8":"tag-agc-biologics","9":"tag-genenta-en"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - 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