Genenta and Anemocyte announce a collaboration for the manufacturing of starting materials for cutting-edge cell-based therapies
Genenta Science (GNTA) has announced a strategic collaboration with Anemocyte, an Italian Biotech Manufacturing Organization (BMO), for the production of critical starting materials for cell-based therapies. The partnership involves the successful establishment of Cell Banks and manufacturing of Plasmids for viral vector production. Anemocyte's expertise has been crucial in supporting Genenta's clinical trials progression through high-quality manufacturing processes. The collaboration highlights the synergy between Genenta's immuno-oncology platform and Anemocyte's manufacturing capabilities, with Genenta being notably recognized as the first Italian company listed on Nasdaq.
Genenta Science (GNTA) ha annunciato una collaborazione strategica con Anemocyte, un'organizzazione italiana di produzione biotecnologica (BMO), per la produzione di materiali di partenza fondamentali per terapie cellulari. La partnership prevede l'istituzione di Banche Cellulari e la produzione di Plasmidi per la creazione di vettori virali. L'esperienza di Anemocyte è stata determinante nel supportare l'avanzamento degli studi clinici di Genenta attraverso processi produttivi di alta qualità. Questa collaborazione mette in luce la sinergia tra la piattaforma di immuno-oncologia di Genenta e le capacità produttive di Anemocyte, con Genenta riconosciuta come la prima azienda italiana quotata al Nasdaq.
Genenta Science (GNTA) ha anunciado una colaboración estratégica con Anemocyte, una Organización Italiana de Manufactura Biotecnológica (BMO), para la producción de materiales iniciales críticos para terapias basadas en células. La alianza incluye el establecimiento exitoso de Bancos de Células y la fabricación de Plásmidos para la producción de vectores virales. La experiencia de Anemocyte ha sido fundamental para apoyar el avance de los ensayos clínicos de Genenta mediante procesos de fabricación de alta calidad. Esta colaboración destaca la sinergia entre la plataforma de inmunooncología de Genenta y las capacidades de manufactura de Anemocyte, siendo Genenta reconocida como la primera empresa italiana en cotizar en Nasdaq.
Genenta Science (GNTA)는 세포 기반 치료제의 핵심 시작 물질 생산을 위해 이탈리아의 바이오테크 제조 조직(BMO)인 Anemocyte와 전략적 협력을 발표했습니다. 이번 파트너십은 세포 은행 구축과 바이러스 벡터 생산을 위한 플라스미드 제조의 성공적인 확립을 포함합니다. Anemocyte의 전문성은 고품질 제조 과정을 통해 Genenta의 임상 시험 진행을 지원하는 데 중요한 역할을 했습니다. 이 협력은 Genenta의 면역항암 플랫폼과 Anemocyte의 제조 역량 간의 시너지를 강조하며, Genenta는 나스닥에 상장된 최초의 이탈리아 기업으로 주목받고 있습니다.
Genenta Science (GNTA) a annoncé une collaboration stratégique avec Anemocyte, une organisation italienne de fabrication biotechnologique (BMO), pour la production de matériaux de départ essentiels aux thérapies cellulaires. Ce partenariat comprend la mise en place réussie de banques cellulaires et la fabrication de plasmides pour la production de vecteurs viraux. L'expertise d'Anemocyte a été cruciale pour soutenir l'avancement des essais cliniques de Genenta grâce à des processus de fabrication de haute qualité. Cette collaboration met en avant la synergie entre la plateforme d'immuno-oncologie de Genenta et les capacités de fabrication d'Anemocyte, Genenta étant reconnue comme la première entreprise italienne cotée au Nasdaq.
Genenta Science (GNTA) hat eine strategische Zusammenarbeit mit Anemocyte, einer italienischen Biotech-Fertigungsorganisation (BMO), für die Produktion wichtiger Ausgangsmaterialien für zellbasierte Therapien bekannt gegeben. Die Partnerschaft umfasst die erfolgreiche Einrichtung von Zellbanken und die Herstellung von Plasmiden zur viralen Vektorproduktion. Die Expertise von Anemocyte war entscheidend, um Genentas klinische Studien durch hochwertige Herstellungsprozesse zu unterstützen. Die Zusammenarbeit unterstreicht die Synergie zwischen Genentas Immunonkologie-Plattform und den Fertigungskapazitäten von Anemocyte, wobei Genenta als erstes italienisches Unternehmen an der Nasdaq gelistet ist.
- Strategic partnership with Anemocyte enhances manufacturing capabilities for critical starting materials
- Successful production of Cell Banks and Plasmids confirms manufacturing quality
- Cost-effective and reliable partnership established for future clinical trials
- None.
Insights
Genenta's manufacturing partnership with Anemocyte establishes critical cell banks and plasmids for advancing their immuno-oncology pipeline through clinical development.
This collaboration between Genenta Science and Anemocyte represents a significant operational milestone in Genenta's development pathway. The successful production of cell banks and plasmids for viral vector manufacturing addresses one of the most critical challenges in cell and gene therapy development.
In the advanced therapy medicinal product (ATMP) space, manufacturing isn't merely supportive—it's central to product development and regulatory approval. Cell banks ensure consistent cellular starting materials across production batches, while high-quality plasmids are essential DNA templates for the viral vectors that deliver genetic modifications. Both components are scrutinized heavily by regulators.
The CMO's statement that "further manufacturing steps confirmed our expectations" suggests successful technical validation of these materials in their production process—a substantial de-risking event. For cell therapy companies, manufacturing consistency is often as challenging as clinical efficacy itself.
Anemocyte's characterization as a "top-quality, cost-effective, and reliable partner" signals Genenta has secured capabilities that balance quality with economic sustainability, critical for small biotech companies with limited runways. The reference to supporting "further progress in the next phase of trials" indicates this partnership enables Genenta to advance its clinical development program.
While the announcement lacks specifics about which therapeutic candidates will directly benefit or the exact timeline impact, establishing robust manufacturing infrastructure is foundational for any cell therapy company progressing toward later-stage development and potential commercialization.
Anemocyte established Cell Banks and Plasmids for Viral Vector Production
MILAN and NEW YORK, May 07, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology and a leader in cell-based therapeutics, today announced a collaboration with Anemocyte, a leading Biotech Manufacturing Organization (BMO) based in Italy. This strategic partnership marks a major milestone, encompassing the successful production of critical starting materials, including the establishment of Cell Banks and the manufacturing of Plasmids for viral vector production.
This collaboration represents a pivotal step in the advancement of immuno-oncology therapies, highlighting the powerful synergy between Genenta's innovative platform and Anemocyte's proven expertise in the production of high-quality starting materials.
"Thanks to Anemocyte, Genenta has achieved significant milestones in the progression of its clinical trials. The expertise and knowledge of Anemocyte’s team have been instrumental throughout the entire manufacturing process of these critical starting materials," stated Carlo Russo, M.D., Chief Medical Officer & Head of Development of Genenta Science. "Further manufacturing steps confirmed our expectations with Anemocyte’s plasmid DNA in the production of high-quality therapeutic products. Such results confirmed the role of Anemocyte as a top-quality, cost-effective, and reliable partner."
"Genenta's status as the first Italian company listed on Nasdaq is a testament to its innovation and leadership in the immuno-oncology space. We are immensely proud of this collaboration with Genenta supporting its pioneering product and technology, facilitating further progress in the next phase of trials," expressed Marco Ferrari, CEO of Anemocyte. "Genenta symbolizes the concerted efforts of the Italian industry and academia to accelerate advancements in the Cell and Gene therapeutic field. Moreover, this collaboration confirms the direction Anemocyte has taken as future steps which have been built around pillars of flexibility, quality, and sustainability."
About Anemocyte:
Anemocyte is a Biotech Manufacturing Organization (BMO) based in Italy, offering comprehensive development and manufacturing services and providing innovative solutions from R&D to GMP. Specialized in the development and production of pDNA and mRNA, Anemocyte brings over 25 years of expertise in manufacturing innovative therapies and related starting materials.
For more information, visit www.anemocyte.com.
About Genenta
Genenta (Nasdaq: GNTA) is a clinical-stage immuno-oncology company developing a proprietary hematopoietic stem cell therapy for the treatment of a variety of solid tumor cancers. Genenta first-in-class product candidate is Temferon™, 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 has completed the Phase 1 trial for newly diagnosed Glioblastoma Multiforme 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. Genenta has initiated in Q4 2024 a Phase 1/2a metastatic Renal Cell Carcinoma study that will also include a combination with immune checkpoint inhibitors. Genenta’s 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.
Forward-Looking Statements
Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Genenta’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the funding to be provided by the Mandatory Convertible Bond, the completion and timing of Genenta's ongoing clinical trial for newly diagnosed GBM patients with uMGMT-GBM, its clinical trial for metastatic RCC or any related studies, as well as Genenta’s ability to fund its research and development plans. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Genenta's Annual Report on Form 20-F for the year ended December 31, 2023 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of the date of this announcement, and Genenta undertakes no duty to update such information except as required under applicable law. This press release discusses product candidates that are under preclinical or clinical evaluation and that have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. Until finalized in a clinical study report, clinical trial data presented herein remain subject to adjustment as a result of clinical site audits and other review processes. No representation is made as to the safety or effectiveness of these product candidates or the use for which such product candidates are being studied. Temferon™ is an investigational product candidate for which the effectiveness and safety have not been established. In addition, Temferon™ is not approved for use in any jurisdiction.
Genenta Media
Tiziana Pollio, Mobile: +39 348 23 15 143
Email: tiziana.pollio@genenta.com
Anemocyte Media
Telephone +39 0299372311
Email: media@anemocyte.com
www.anemocyte.com
FAQ
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