Genenta Announces Long-Term Follow-Up Observations in Brain Tumor (GBM) Study with Emerging Survival Signals
Genenta Science (Nasdaq: GNTA) has reported promising long-term follow-up data from its TEM-GBM study of Temferon in glioblastoma multiforme patients. The study enrolled 38 patients, with 25 receiving Temferon. Two significant milestones were achieved with two patients surviving three years from initial surgery in the TEM-LT long-term follow-up study.
Key clinical outcomes include a 29% two-year survival rate for unmethylated MGMT patients, with median overall survival at 17 months, comparing favorably to historical cohorts showing approximately 14% two-year survival and 13-15 months median survival with standard care.
The company has also initiated the TEM-GU Phase 1 study for genitourinary tumors, targeting 12 patients with Metastatic Renal Cell Carcinoma. The trial will evaluate Temferon's combination potential with immune checkpoint inhibitors or tyrosine kinase inhibitors. Additionally, a scientific manuscript demonstrating Temferon's potential in enhancing CAR-T activity has been accepted for publication in Science Translational Medicine.
Genenta Science (Nasdaq: GNTA) ha riportato dati promettenti a lungo termine dal suo studio TEM-GBM su Temferon in pazienti con glioblastoma multiforme. Lo studio ha arruolato 38 pazienti, di cui 25 hanno ricevuto Temferon. Sono stati raggiunti due traguardi importanti con due pazienti sopravvissuti per tre anni dall'intervento chirurgico iniziale nello studio di follow-up a lungo termine TEM-LT.
I risultati clinici chiave includono un tasso di sopravvivenza a due anni del 29% per i pazienti con MGMT non metilato, con una sopravvivenza mediana complessiva di 17 mesi, risultati migliori rispetto ai dati storici che mostrano circa il 14% di sopravvivenza a due anni e una sopravvivenza mediana di 13-15 mesi con le cure standard.
La societ脿 ha inoltre avviato lo studio di fase 1 TEM-GU per tumori genito-urinari, con l'obiettivo di arruolare 12 pazienti con carcinoma renale metastatico. La sperimentazione valuter脿 il potenziale combinato di Temferon con inibitori dei checkpoint immunitari o inibitori delle tirosin-chinasi. Inoltre, un articolo scientifico che dimostra il potenziale di Temferon nel potenziare l'attivit脿 delle CAR-T 猫 stato accettato per la pubblicazione su Science Translational Medicine.
Genenta Science (Nasdaq: GNTA) ha informado datos prometedores a largo plazo de su estudio TEM-GBM sobre Temferon en pacientes con glioblastoma multiforme. El estudio incluy贸 a 38 pacientes, de los cuales 25 recibieron Temferon. Se lograron dos hitos importantes con dos pacientes que sobrevivieron tres a帽os desde la cirug铆a inicial en el estudio de seguimiento a largo plazo TEM-LT.
Los resultados cl铆nicos clave incluyen una tasa de supervivencia a dos a帽os del 29% para pacientes con MGMT no metilado, con una supervivencia global mediana de 17 meses, lo que compara favorablemente con cohortes hist贸ricas que muestran aproximadamente un 14% de supervivencia a dos a帽os y una supervivencia mediana de 13-15 meses con el tratamiento est谩ndar.
La compa帽铆a tambi茅n ha iniciado el estudio de fase 1 TEM-GU para tumores genitourinarios, con el objetivo de incluir a 12 pacientes con carcinoma renal metast谩sico. El ensayo evaluar谩 el potencial de combinaci贸n de Temferon con inhibidores de puntos de control inmunitarios o inhibidores de tirosina quinasa. Adem谩s, un manuscrito cient铆fico que demuestra el potencial de Temferon para potenciar la actividad de las CAR-T ha sido aceptado para su publicaci贸n en Science Translational Medicine.
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欤检殧 鞛勳儊 瓴瓣臣搿滊姅 氅旐嫺頇旊悩歆� 鞎婌潃 MGMT 頇橃瀽鞐愳劀 2雲� 靸濎〈鞙� 29%鞕赌 欷戩暀 鞝勳泊 靸濎〈 旮瓣皠 17臧滌洈鞚� 雮橅儉雮溂氅�, 鞚措姅 響滌 旃橂 鞁� 鞎� 14%鞚� 2雲� 靸濎〈鞙臣 13-15臧滌洈鞚� 欷戩暀 靸濎〈 旮瓣皠鞚� 氤挫澑 瓿缄卑 旖旐樃韸胳櫠� 牍勱祼頃� 鞖办垬頃� 瓴瓣臣鞛呺媹雼�.
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Genenta Science (Nasdaq : GNTA) a publi茅 des donn茅es prometteuses 脿 long terme issues de son 茅tude TEM-GBM sur Temferon chez des patients atteints de glioblastome multiforme. L'茅tude a inclus 38 patients, dont 25 ont re莽u Temferon. Deux 茅tapes importantes ont 茅t茅 franchies avec deux patients survivant trois ans apr猫s la chirurgie initiale dans l'茅tude de suivi 脿 long terme TEM-LT.
Les r茅sultats cliniques cl茅s montrent un taux de survie 脿 deux ans de 29% chez les patients avec MGMT non m茅thyl茅, avec une survie globale m茅diane de 17 mois, ce qui est favorable par rapport aux cohortes historiques affichant environ 14% de survie 脿 deux ans et une survie m茅diane de 13 脿 15 mois sous traitement standard.
La soci茅t茅 a 茅galement lanc茅 l'茅tude de phase 1 TEM-GU pour les tumeurs g茅nito-urinaires, visant 12 patients atteints de carcinome r茅nal m茅tastatique. L'essai 茅valuera le potentiel de Temferon en combinaison avec des inhibiteurs de points de contr么le immunitaire ou des inhibiteurs de tyrosine kinase. De plus, un manuscrit scientifique d茅montrant le potentiel de Temferon 脿 renforcer l'activit茅 des CAR-T a 茅t茅 accept茅 pour publication dans Science Translational Medicine.
Genenta Science (Nasdaq: GNTA) hat vielversprechende Langzeitdaten aus der TEM-GBM-Studie mit Temferon bei Patienten mit Glioblastom gemeldet. Die Studie umfasste 38 Patienten, von denen 25 Temferon erhielten. Zwei bedeutende Meilensteine wurden erreicht, indem zwei Patienten drei Jahre nach der Erstoperation im Langzeit-Follow-up der TEM-LT-Studie 眉berlebten.
Wichtige klinische Ergebnisse umfassen eine 29%ige Zweijahres眉berlebensrate bei Patienten mit unmethyliertem MGMT und eine medianes Gesamt眉berleben von 17 Monaten, was im Vergleich zu historischen Kohorten, die etwa 14% Zweijahres眉berleben und 13-15 Monate medianes 脺berleben unter Standardtherapie zeigten, g眉nstig ist.
Das Unternehmen hat zudem die Phase-1-Studie TEM-GU f眉r genitourin盲re Tumoren gestartet, mit dem Ziel, 12 Patienten mit metastasiertem Nierenzellkarzinom einzuschlie脽en. Die Studie wird das Kombinationspotenzial von Temferon mit Immun-Checkpoint-Inhibitoren oder Tyrosinkinase-Inhibitoren untersuchen. Zus盲tzlich wurde ein wissenschaftliches Manuskript, das das Potenzial von Temferon zur Steigerung der CAR-T-Aktivit盲t zeigt, zur Ver枚ffentlichung in Science Translational Medicine angenommen.
- None.
- Small patient sample size with only 25 patients receiving Temferon
- Clinical trial data remains subject to adjustment pending site audits
- Product candidate not yet approved by FDA or any regulatory authority
Insights
Genenta's GBM trial shows promising survival signals with 29% 2-year survival rate versus 14% historical standard, suggesting Temferon's potential efficacy.
Genenta's long-term follow-up data for their Temferon treatment in glioblastoma multiforme (GBM) patients reveals some encouraging signals. Two patients have survived three years post-surgery, with one showing no disease progression and requiring no second-line therapies, while the other exhibited initial progression that later stabilized without additional intervention. These cases suggest Temferon may potentially control disease progression, though larger studies are needed for confirmation.
The most significant data point is the
Genenta is now expanding Temferon's application to genitourinary tumors, particularly Metastatic Renal Cell Carcinoma, with a Phase 1 study actively recruiting. The fixed dose being used (4 million modified cells per kg) has already demonstrated safety in the GBM trials, which reduces certain development risks. The combination approach with checkpoint inhibitors or tyrosine kinase inhibitors is a logical strategy to potentially enhance efficacy.
Temferon's mechanism of action鈥攔eprogramming the tumor microenvironment to promote immune responses鈥攔epresents an innovative approach to cancer immunotherapy. The acceptance of their research for publication in Science Translational Medicine lends scientific credibility to their platform technology. The ability to engineer hematopoietic stem cells to generate tumor-localizing myeloid cells that induce pro-inflammatory shifts and T-cell responses offers a differentiated approach to tackling immunosuppressive tumor microenvironments.
Genitourinary Tumor Study Ongoing with Active Screening and Enrollment
MILAN and NEW YORK, July 01, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology, today announced that a total of 38 patients were enrolled in newly diagnosed glioblastoma multiforme (TEM-GBM) study, with 25 patients receiving Temferon. Two patients have been enrolled in the TEM-LT long-term follow-up study, surviving three years from the time of 1st听蝉耻谤驳别谤测. One of these long-term survivors has not experienced disease progression following Temferon administration and has not required any second-line therapies. The other showed initial signs of disease progression that subsequently stabilized without additional therapeutic intervention. Both these cases suggest possible Temferon-mediated control of disease progression, which warrants further investigation in larger studies.
As of the April data cutoff, the survival rate at two years in the GBM trial for unmethylated MGMT (uMGMT) patients remained consistent at
In parallel, the TEM-GU Phase 1 study鈥攄esigned to enroll 12 patients with genitourinary tumors鈥攈as begun recruitment. In this trial, Temferon is administered at a fixed dose of 4 million genetically modified cells per kilogram of body weight鈥攁 level previously shown to be safe and well tolerated in the TEM-GBM dose-ranging study. Genenta aims to demonstrate the safety and tolerability of Temferon in patients with Metastatic Renal Cell Carcinoma by year-end. The study is designed to evaluate Temferon in combination with immune checkpoint inhibitors or tyrosine kinase inhibitors to assess the potential for immunologic synergy in this patient population. Further clinical updates will be shared once sufficient patient experience has been gained to support meaningful interpretation.
Temferon's mechanism of action is based on the reprogramming of the tumor microenvironment, which promotes the activation and durability of adaptive immune responses. A scientific manuscript demonstrating Temferon鈥檚 potential to enhance and prolong the durability of CAR-T activity in preclinical murine models of solid tumors has been accepted for publication in Science Translational Medicine.
鈥�For the first time, we show that hematopoietic stem cells can be engineered to durably give rise to myeloid cells that localize to the tumor and reprogram its immune environment. In glioblastoma, this strategy induced a pro-inflammatory shift in macrophages and the emergence of tumor-reactive T cells, offering a promising new avenue for immune engagement against one of the most resistant cancers,鈥� said prof. Luigi Naldini, co-founder of Genenta Science.
鈥�We are encouraged by the consistent clinical signals emerging from our glioblastoma trial,鈥� said Pierluigi Paracchi, CEO of Genenta Science. 鈥淭hese findings reinforce our confidence in Temferon鈥檚 differentiated mechanism and support our commitment to advancing the platform.鈥�
About Genenta Science
Genenta Science (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鈥檚 first in class product candidate is Temferon鈩�, 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.听Genenta has completed the Phase 1 trial for newly diagnosed Glioblastoma Multiforme (GBM) 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 a Phase 1/2a metastatic Renal Cell Carcinoma study that will also include a combination with immune checkpoint inhibitors.听Genenta鈥檚 treatments are designed as听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 鈥渇orward-looking statements,鈥� 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 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渃ontemplate,鈥� 鈥渃ould,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渋ntend,鈥� 鈥渟eek,鈥� 鈥渕ay,鈥� 鈥渕ight,鈥� 鈥減lan,鈥� 鈥減otential,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥渟uggest,鈥� 鈥渢arget,鈥� 鈥渁im,鈥� 鈥渟hould,鈥� "will,鈥� 鈥渨ould,鈥� 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鈥檚 current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the funding provided by the recently acquired Mandatory Convertible Bond, the completion and timing of Genenta's ongoing Phase 1/2a clinical trial for newly diagnosed GBM patients with uMGMT-GBM, its clinical trial for metastatic RCC or any related studies, as well as Genenta鈥檚 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 鈥淩isk Factors鈥� in Genenta's Annual Report on Form 20-F for the year ended December 31, 2024 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鈩� is an investigational product candidate for which the effectiveness and safety have not been established. In addition, Temferon鈩� is not approved for use in any jurisdiction.
Genenta Science Media
Tiziana Pollio, Mobile: +39 348 23 15 143
E-mail:听[email protected]
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