Genenta Strengthens Agreement with AGC Biologics to Boost Cell Therapy Manufacturing
Genenta Science (NASDAQ: GNTA) has enhanced its partnership with AGC Biologics by securing an exclusive GMP manufacturing suite at AGC's Cell and Gene Center of Excellence in Milan. This strategic amendment aims to strengthen the production of Genenta's cell therapy products, ensuring cGMP compliance.
The company's metastatic Renal Cell Cancer (mRCC) Phase 1/2a trial, initiated in Q4 2024, aims to treat six patients by H1 2025, while the Glioblastoma Multiforme (GBM) study continues. Genenta plans to manufacture 27 autologous drug products in 2025.
Recent preclinical and clinical studies highlight Temferon's capability to reprogram the tumor microenvironment, inhibit myeloid cell-induced immune suppression, and enhance T-cell responses. The company suggests potential synergies with immunotherapeutic strategies, including immune checkpoint inhibitors and CAR-T cell therapies.
Genenta Science (NASDAQ: GNTA) ha potenziato la sua partnership con AGC Biologics assicurandosi una suite di produzione GMP esclusiva presso il Centro di Eccellenza per Cellule e Gene di AGC a Milano. Questa modifica strategica mira a rafforzare la produzione dei prodotti di terapia cellulare di Genenta, garantendo la conformità cGMP.
Il trial di fase 1/2a dell'azienda sul Cancro Renale Metastatico (mRCC), avviato nel quarto trimestre del 2024, ha come obiettivo il trattamento di sei pazienti entro il primo semestre del 2025, mentre lo studio sul Glioblastoma Multiforme (GBM) continua. Genenta prevede di produrre 27 prodotti farmaceutici autologhi nel 2025.
Recenti studi preclinici e clinici evidenziano la capacità di Temferon di riprogrammare il microambiente tumorale, inibire la soppressione immunitaria indotta dalle cellule mieloidi e migliorare le risposte delle cellule T. L'azienda suggerisce potenziali sinergie con strategie immunoterapeutiche, inclusi gli inibitori del checkpoint immunitario e le terapie con cellule CAR-T.
Genenta Science (NASDAQ: GNTA) ha mejorado su asociación con AGC Biologics al asegurar una suite de fabricación GMP exclusiva en el Centro de Excelencia de Células y Genes de AGC en Milán. Esta enmienda estratégica tiene como objetivo fortalecer la producción de los productos de terapia celular de Genenta, asegurando el cumplimiento de cGMP.
El ensayo de fase 1/2a de la compañía sobre Cáncer Renal Metastásico (mRCC), iniciado en el cuarto trimestre de 2024, busca tratar a seis pacientes para el primer semestre de 2025, mientras el estudio sobre Glioblastoma Multiforme (GBM) continúa. Genenta planea fabricar 27 productos farmacéuticos autólogos en 2025.
Los recientes estudios preclínicos y clínicos destacan la capacidad de Temferon para reprogramar el microentorno tumoral, inhibir la supresión inmune inducida por células mieloides y mejorar las respuestas de células T. La compañía sugiere sinergias potenciales con estrategias inmunoterapéuticas, incluidos los inhibidores de puntos de control inmunitario y las terapias con células CAR-T.
제넨타 사이언스 (NASDAQ: GNTA)는 AGC 바이올로직스와의 파트너십을 강화하여 밀라노 AGC의 세포 및 유전자 전문 센터에 독점 GMP 제조 시설을 확보했습니다. 이 전략적 수정은 제넨타의 세포 치료 제품 생산을 강화하고 cGMP 준수를 보장하는 것을 목표로 합니다.
회사의 전이성 신장 세포 암(mRCC) 1/2a 단계 시험은 2024년 4분기에 시작되어 2025년 상반기까지 6명의 환자를 치료하는 것을 목표로 하며, 다계층 교모세포종(GBM) 연구도 계속 진행 중입니다. 제넨타는 2025년에 27개의 자가 약물 제품을 생산할 계획입니다.
최근의 전임상 및 임상 연구는 템페론의 종양 미세환경 재프로그래밍, 과립구 세포에 의해 유도된 면역 억제를 억제하고 T세포 반응을 향상시키는 능력을 강조합니다. 회사는 면역 체크포인트 억제제 및 CAR-T 세포 치료를 포함한 면역 치료 전략과의 잠재적 시너지 효과를 제안합니다.
Genenta Science (NASDAQ: GNTA) a renforcé son partenariat avec AGC Biologics en sécurisant une suite de fabrication GMP exclusive au Centre d'Excellence Cellulaire et Génétique d'AGC à Milan. Cet amendement stratégique vise à renforcer la production des produits de thérapie cellulaire de Genenta, garantissant la conformité cGMP.
L'essai de phase 1/2a de la société sur le cancer du rein métastatique (mRCC), lancé au quatrième trimestre 2024, vise à traiter six patients d'ici le premier semestre 2025, tandis que l'étude sur le glioblastome multiforme (GBM) se poursuit. Genenta prévoit de produire 27 produits pharmaceutiques autologues en 2025.
Des études précliniques et cliniques récentes soulignent la capacité de Temferon à reprogrammer le microenvironnement tumoral, à inhiber la suppression immunitaire induite par les cellules myéloïdes et à améliorer les réponses des cellules T. La société suggère des synergies potentielles avec des stratégies immunothérapeutiques, y compris les inhibiteurs de points de contrôle immunitaire et les thérapies par cellules CAR-T.
Genenta Science (NASDAQ: GNTA) hat seine Partnerschaft mit AGC Biologics durch die Sicherung eines exklusiven GMP-Fertigungsbereichs im AGC-Zentrum für Zell- und Gentherapie in Mailand verbessert. Diese strategische Änderung zielt darauf ab, die Produktion der Zelltherapieprodukte von Genenta zu stärken und die Einhaltung von cGMP sicherzustellen.
Die Phase-1/2a-Studie des Unternehmens über metastasierenden Nierenzellkrebs (mRCC), die im vierten Quartal 2024 begonnen wurde, zielt darauf ab, bis zum ersten Halbjahr 2025 sechs Patienten zu behandeln, während die Studie über Glioblastom multiforme (GBM) weiterhin läuft. Genenta plant, 27 autologe Arzneimittelprodukte im Jahr 2025 herzustellen.
Neueste präklinische und klinische Studien heben die Fähigkeit von Temferon hervor, das Tumormikroumfeld neu zu programmieren, die durch myeloide Zellen induzierte Immunsuppression zu hemmen und die T-Zell-Antworten zu verbessern. Das Unternehmen schlägt potenzielle Synergien mit immuntherapeutischen Strategien vor, einschließlich Immun-Checkpoint-Inhibitoren und CAR-T-Zelltherapien.
- Secured exclusive GMP manufacturing suite at AGC Biologics facility
- Planned production of 27 autologous drug products in 2025
- Phase 1/2a trial for mRCC on track with 6 patients targeted for H1 2025
- Positive preclinical and clinical data showing Temferon's potential in combination therapies
- None.
Insights
The strengthened partnership with AGC Biologics marks a critical manufacturing milestone for Genenta's cell therapy production capabilities. The exclusive GMP suite dedication is particularly significant as it addresses one of the key challenges in cell therapy manufacturing - consistent quality and scalability. The projected manufacturing of 27 autologous drug products in 2025 represents a substantial production commitment that requires robust infrastructure.
The dedicated manufacturing suite will likely reduce batch-to-batch variability and cross-contamination risks, while potentially decreasing production turnaround times. This enhanced control over the manufacturing process is important for maintaining product quality and meeting clinical trial timelines for both the mRCC and GBM studies. The ability to treat six patients by H1 2025 in the mRCC trial demonstrates a clear operational trajectory.
The dual-program advancement in both metastatic Renal Cell Cancer and Glioblastoma Multiforme represents a strategic approach to solid tumor treatment. The preclinical and clinical findings regarding Temferon's ability to reprogram the tumor microenvironment are particularly noteworthy. The potential synergies with immune checkpoint inhibitors and CAR-T cell therapies suggest a versatile therapeutic platform that could address multiple treatment modalities.
For investors, the key value proposition lies in Temferon's demonstrated ability to inhibit myeloid cell-induced immune suppression while promoting T-cell responses. This dual mechanism of action differentiates it from conventional monotherapies and positions it well in the competitive cell therapy landscape. The planned treatment of multiple patients across two challenging indications in 2025 will provide important efficacy data points.
Sharing Insights at the 'Italy on the Move' Event and Engaging Investors at Biotech Showcase During JPM Healthcare Week in San Francisco
MILAN and NEW YORK, Jan. 09, 2025 (GLOBE NEWSWIRE) -- Genenta Science (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 AGC Biologics, a global contract development and manufacturing organization (CDMO), by amending their Development and Master Services Agreement. This amendment introduces an exclusive GMP suite at the AGC Biologics Cell and Gene Center of Excellence in Milan, dedicated to the manufacturing of Genenta’s cell therapy product, ensuring compliance with cGMP standards. This strategic move enhances Genenta’s production capabilities, potentially improving efficiency and reliability in its manufacturing processes.
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, Genenta projects manufacturing 27 autologous drug products in 2025.
"Our strengthened partnership with AGC Biologics represents our unwavering commitment to patients participating in our GBM and mRCC trials," said Pierluigi Paracchi, CEO and Co-founder of Genenta. "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."
Prof. Luigi Naldini, Co-founder of Genenta, noted: "Our recent preclinical and clinical studies underscore Temferon’s unique potential to reprogram the tumor microenvironment, inhibiting myeloid cell-induced immune suppression and fostering T-cell responses. 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. These findings provide a strong foundation for advancing therapeutic strategies targeting solid tumors and bring us closer to open up new cancer treatments."
Upcoming Engagements during JPM Healthcare Week: Genenta will participate in Biotech Showcase 2025, taking place January 13–15, 2025, in San Francisco to present its innovative technology for treating solid tumors through genetically modified cell therapy. Pierluigi Paracchi will also speak at "Italy on the Move”, a flagship biotech event organized by the Italian Ministry of Foreign Affairs and International Cooperation. The event, aimed at promoting Italy’s life sciences sector and fostering international investments, will be held on January 15, 2025, at INNOVIT – Italian Innovation and Culture Hub in San Francisco. Notable speakers include Karthic Jayaraman, Partner and Co-Head of Global Healthcare at TPG Capital, and Frederick Beddingfield, CEO of Rubedo Life Sciences. The event will be moderated by Audrey Greenberg, Co-Founder and Executive Managing Director of the Center for Breakthrough Medicines.
About Genenta
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. Genenta's 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 a 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 combination with immune checkpoint inhibitors. Our 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 completion and timing of its ongoing clinical trial for newly diagnosed GBM patients with uMGMT-GBM, its expected 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
FAQ
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