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Genenta Secures Approval for Innovative Trial for Metastatic Renal Cell Cancer

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Genenta Science (NASDAQ: GNTA) has received approval from AIFA for a new Phase 1 clinical trial for metastatic Renal Cell Cancer (mRCC), expanding potential applications for its flagship product, Temferon™. This approval aligns with EMA standards. The company's ongoing TEM-GBM development program has completed a Phase 1 dose-ranging trial, confirming no dose-limiting toxicities across 24 patients. Temferon-derived cells remained detectable for over two years post-infusion, with treatment associated with a median survival of 16.8 months and a 25% increase in 2-year overall survival.

The new mRCC trial, targeting high-risk patients with a median overall survival of less than 2 years after multiple therapies, is expected to start in Q4 2024. Recent preclinical studies show synergy between Temferon and other immunotherapies in solid tumors. Genenta will present these developments at upcoming events, including Maxim Group's 2024 Healthcare Virtual Summit and the Society for Neuro-Oncology Annual Meeting.

Genenta Science (NASDAQ: GNTA) ha ricevuto l'approvazione dall'AIFA per un nuovo studio clinico di Fase 1 per il cancro renale metastatico (mRCC), espandendo le potenziali applicazioni per il suo prodotto di punta, Temferon™. Questa approvazione è in linea con gli standard dell'EMA. Il programma di sviluppo TEM-GBM dell'azienda ha completato uno studio di Fase 1 per la determinazione del dosaggio, confermando l'assenza di tossicità limitanti da dose in 24 pazienti. Le cellule derivate da Temferon sono rimaste rilevabili per oltre due anni dopo l'infusione, con un trattamento associato a una sopravvivenza mediana di 16,8 mesi e un aumento del 25% nella sopravvivenza globale a 2 anni.

Il nuovo studio mRCC, rivolto a pazienti ad alto rischio con una sopravvivenza globale mediana di meno di 2 anni dopo diverse terapie, dovrebbe iniziare nel quarto trimestre del 2024. Recenti studi preclinici mostrano una sinergia tra Temferon e altre immunoterapie nei tumori solidi. Genenta presenterà questi sviluppi in prossimi eventi, incluso il Healthcare Virtual Summit 2024 del Maxim Group e l'Annual Meeting della Society for Neuro-Oncology.

Genenta Science (NASDAQ: GNTA) ha obtenido la aprobación de la AIFA para un nuevo ensayo clínico de Fase 1 para el cáncer renal metastásico (mRCC), ampliando las aplicaciones potenciales de su producto insignia, Temferon™. Esta aprobación está alineada con los estándares de la EMA. El programa de desarrollo TEM-GBM de la compañía ha completado un ensayo de Fase 1 para la determinación de dosis, confirmando que no hubo toxicidades limitantes de dosis en 24 pacientes. Las células derivadas de Temferon se mantuvieron detectables durante más de dos años después de la infusión, con un tratamiento asociado a una supervivencia mediana de 16,8 meses y un aumento del 25% en la supervivencia general a 2 años.

El nuevo ensayo de mRCC, dirigido a pacientes de alto riesgo con una supervivencia global mediana de menos de 2 años después de múltiples terapias, se espera que comience en el cuarto trimestre de 2024. Estudios preclínicos recientes muestran sinergia entre Temferon y otras inmunoterapias en tumores sólidos. Genenta presentará estos desarrollos en próximos eventos, incluidos el Healthcare Virtual Summit 2024 del Maxim Group y la reunión anual de la Society for Neuro-Oncology.

Genenta Science (NASDAQ: GNTA)는 전이성 신장 세포 암(mRCC)을 위한 새로운 1상 임상 시험에 대해 AIFA의 승인을 받았습니다. 이는 Temferon™ 제품의 잠재적인 응용 분야를 확장하는 것입니다. 이 승인은 EMA 기준에 부합합니다. 회사의 TEM-GBM 개발 프로그램은 1상 용량 범위 시험을 완료하였으며, 24명의 환자에서 용량 제한 독성이 없음을 확인했습니다. Temferon 유래 세포는 주입 후 2년 이상 검출 가능했습니다. 치료는 16.8개월의 중위 생존율과 2년 전체 생존율에서 25%의 증가와 관련이 있습니다.

이번 mRCC 시험은 여러 치료 후 2년 미만의 중위 전체 생존률을 가진 고위험 환자를 대상으로 하며, 2024년 4분기에 시작될 예정입니다. 최근의 전임상 연구들은 Temferon과 다른 면역 요법 사이의 시너지를 보여주고 있습니다. Genenta는 Maxim Group의 2024 Healthcare Virtual Summit과 Neuro-Oncology 학회의 연례 회의 등에서 이러한 발전을 발표할 것입니다.

Genenta Science (NASDAQ: GNTA) a reçu l'approbation de l'AIFA pour un nouvel essai clinique de Phase 1 pour le cancer des cellules rénales métastatiques (mRCC), élargissant les applications potentielles pour son produit phare, Temferon™. Cette approbation est conforme aux normes de l'EMA. Le programme de développement TEM-GBM de l'entreprise a achevé un essai de Phase 1 de dosage, confirmant l'absence de toxicités limitantes de dose chez 24 patients. Les cellules dérivées de Temferon sont restées détectables pendant plus de deux ans après l'infusion, le traitement étant associé à une survie médiane de 16,8 mois et à une augmentation de 25 % de la survie globale à 2 ans.

Le nouvel essai mRCC, ciblant des patients à haut risque avec une survie globale médiane de moins de 2 ans après plusieurs thérapies, devrait commencer au quatrième trimestre 2024. Des études précliniques récentes montrent une synergie entre Temferon et d'autres immunothérapies dans les tumeurs solides. Genenta présentera ces développements lors des événements à venir, y compris le Healthcare Virtual Summit 2024 du Maxim Group et la réunion annuelle de la Society for Neuro-Oncology.

Genenta Science (NASDAQ: GNTA) hat die Genehmigung von der AIFA für eine neue klinische Studie der Phase 1 für metastasierenden Nierenzellkrebs (mRCC) erhalten, was die potenziellen Anwendungen seines Flaggschiffprodukts Temferon™ erweitert. Diese Genehmigung entspricht den Standards der EMA. Das laufende TEM-GBM-Entwicklungsprogramm des Unternehmens hat eine Phase-1-Dosierungsstudie abgeschlossen, die keine dosislimitierenden Toxizitäten bei 24 Patienten bestätigte. Temferon-abgeleitete Zellen waren über zwei Jahre nach der Infusion nachweisbar, wobei die Behandlung mit einer medianen Überlebensdauer von 16,8 Monaten und einem Anstieg von 25% in der 2-Jahres-Gesamtüberlebensrate in Verbindung steht.

Die neue mRCC-Studie, die auf hochrisikobehaftete Patienten mit einer mittleren Gesamtüberlebenszeit von weniger als 2 Jahren nach mehreren Therapien abzielt, wird voraussichtlich im 4. Quartal 2024 beginnen. Neueste präklinische Studien zeigen Synergien zwischen Temferon und anderen Immuntherapien bei soliden Tumoren. Genenta wird diese Entwicklungen bei bevorstehenden Veranstaltungen vorstellen, darunter der Healthcare Virtual Summit 2024 der Maxim Group und das jährliche Treffen der Society for Neuro-Oncology.

Positive
  • Approval for new Phase 1 clinical trial in metastatic Renal Cell Cancer, expanding Temferon's potential applications
  • Successful completion of Phase 1 dose-ranging trial for Glioblastoma Multiforme with no dose-limiting toxicities
  • Temferon-derived cells detectable for over two years post-infusion in GBM patients
  • 25% increase in 2-year overall survival for GBM patients treated with Temferon
  • Preclinical studies show synergy between Temferon and other immunotherapies in solid tumors
Negative
  • None.

Insights

This approval for a new Phase 1 trial in metastatic Renal Cell Cancer (mRCC) is a significant milestone for Genenta Science. It demonstrates the potential versatility of their Temferon™ platform beyond Glioblastoma Multiforme (GBM). Key points:

  • Expansion into mRCC, a high-need indication with treatment options for late-stage patients
  • Leverages promising results from GBM studies, where Temferon showed a 25% increase in 2-year overall survival
  • Preclinical data suggests synergy with other immunotherapies, potentially opening doors for combination treatments
  • Trial commencement in Q4 2024 targets a population with <2 years median survival after multiple therapies

This development could significantly impact Genenta's market position if Temferon demonstrates efficacy in mRCC, potentially leading to expanded indications and increased investor interest.

The expansion of Temferon™ into metastatic Renal Cell Cancer (mRCC) is a strategic move that could address a critical unmet need. Several aspects are noteworthy:

  • mRCC has a poor prognosis, with 25% of newly diagnosed patients presenting with metastatic disease
  • Temferon's mechanism of action, delivering IFNα to reprogram the tumor microenvironment, has shown promise in urinary tract tumors
  • The completed Phase 1 GBM trial demonstrated a favorable safety profile and encouraging survival data
  • Long-term persistence of Temferon-derived cells (>2 years) suggests potential for durable treatment effects

If successful, this approach could offer a novel treatment modality for mRCC patients who have exhausted other options, potentially improving survival outcomes and quality of life. The synergy with other immunotherapies also opens up possibilities for combination strategies, which could be a game-changer in solid tumor treatment.

Glioblastoma study achieves milestone with successful dose escalation, setting stage for Phase 2

MILAN and NEW YORK, Oct. 02, 2024 (GLOBE NEWSWIRE) -- Genenta Science (NASDAQ: GNTA), a pioneer in immuno-oncology and a leader in cell-based therapeutics, is pleased to announce that the Agenzia Italiana del Farmaco (AIFA) has approved a new Phase 1 clinical trial for metastatic Renal Cell Cancer (mRCC), marking a significant expansion of the potential applications for Genenta’s flagship product, Temferon™. This approval by AIFA is in line with the standards that are harmonized across European regulatory frameworks established by the European Medicines Agency (EMA).

From the CEO's Desk: Pierluigi Paracchi, CEO and Co-founder of Genenta, stated: “This approval to initiate a Phase 1 trial in metastatic renal cell carcinoma marks another significant milestone for Genenta, leverages the encouraging results from treating Glioblastoma Multiforme (GBM), and underscores our platform’s potential versatility and effectiveness in other solid tumor indications. We believe Temferon will offer a new experimental treatment to patients with late-stage mRCC, a patient population with no currently available treatment options. The insights gained from our uMGMT Glioblastoma Multiforme (TEM-GBM) studies continue to inform and enhance our understanding, demonstrating Temferon's potential to reprogram the tumor microenvironment and activate the immune system across diverse oncology landscapes.”

Clinical Progress: Genenta's ongoing TEM-GBM development program is progressing having completed a Phase 1 dose-ranging trial that confirmed the absence of dose-limiting toxicities across 24 patients. Temferon-derived cells remained detectable in the peripheral blood for over two years post-infusion. The treatment has been associated with a median survival of 16.8 months, showing a 25% increase in the 2 years overall survival, setting the stage for our decision to advance to Phase 2 of the study.

Metastatic disease is evident in 25% of newly diagnosed patients with mRCC. The newly approved mRCC trial, expected to commence in Q4 2024, targets a high-risk patient population whose median overall survival is currently less than 2 years after multiple lines of therapy. IFNα, the therapeutic payload delivered by Temferon, has demonstrated benefits across a range of solid tumors, including those involving the urinary tract. This trial aims to leverage similar immune response mechanisms against renal cell cancer.

Preclinical Update: Prof. Luigi Naldini, Co-founder of Genenta, noted: “Our recent preclinical studies demonstrate synergy between Temferon and other immunotherapy treatments, specifically in the context of solid tumors. This innovative approach leverages Temferon's ability to reprogram the tumor microenvironment, fostering a cell-mediated immune response. These findings are pivotal as they lay the groundwork for new therapeutic strategies that could significantly improve outcomes for patients with solid tumors.”

Upcoming Engagements: Genenta will showcase these developments at several upcoming events, including Maxim Group’s 2024 Healthcare Virtual Summit (October 15-17) and at the Society for Neuro-Oncology (SNO) Annual Meeting (November 21-24, Houston, Texas).

About Genenta and Temferon
Genenta (www.genenta.com) is a clinical-stage biotechnology company engaged in the development of a proprietary hematopoietic stem cell therapy for the treatment of a variety of solid tumor cancers. Temferon™ is based on ex-vivo gene transfer into autologous Tie2+ hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs). Temferon is currently under investigation in a clinical trial for newly diagnosed Glioblastoma Multiforme patients with an unmethylated MGMT gene promoter (uMGMT-GBM) and expects to commence a Phase 1 clinical trial for metastatic Renal Cell Carcinoma (mRCC). Temferon is designed to reach solid tumors, induce a durable immune response not restricted to pre-selected tumor antigens nor type, and avoid systemic toxicity, which are some of the main unresolved challenges in immuno-oncology.

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.

Genenta Media
Tiziana Pollio, Mobile: +39 348 23 15 143
Email: tiziana.pollio@genenta.com


FAQ

What new clinical trial has Genenta (GNTA) received approval for?

Genenta (GNTA) has received approval from AIFA for a new Phase 1 clinical trial for metastatic Renal Cell Cancer (mRCC), expanding the potential applications of its flagship product, Temferon™.

When is Genenta (GNTA) expected to start the new mRCC trial?

Genenta (GNTA) is expected to start the new metastatic Renal Cell Cancer (mRCC) trial in Q4 2024.

What were the results of Genenta's (GNTA) Phase 1 dose-ranging trial for Glioblastoma Multiforme?

Genenta's (GNTA) Phase 1 dose-ranging trial for Glioblastoma Multiforme confirmed no dose-limiting toxicities across 24 patients, with Temferon-derived cells remaining detectable for over two years post-infusion and treatment associated with a median survival of 16.8 months.

What improvement in survival did Genenta (GNTA) report for Glioblastoma Multiforme patients treated with Temferon?

Genenta (GNTA) reported a 25% increase in 2-year overall survival for Glioblastoma Multiforme patients treated with Temferon.

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