Temferon Yields Positive Survival Rates in TEM-GBM Trial Update

An update from the ongoing TEM-GBM trial (NCT03866109) shows that key survival metrics remain consistent in patients with glioblastoma multiforme (GBM) who have an unmethylated MGMT (uMGMT) gene promoter and are treated with Temferon, an experimental gene therapy.^1,2

Of the total patients, 44% have reached 18-month survival compared with the 38% reported in April. The 2-year survival rate continues to be 29%, and the median overall survival (OS) remains at 17 months, both consistent with prior findings. Historically, cohorts of patients with uMGMT treated with standard of care typically show a 2-year survival rate of approximately 14% and a median OS of 13 to 15 months. 

In this study, 1 patient has reached 3-year survival following the administration of Temferon 39 months after initial surgery. The patient did not receive additional therapeutic interventions or second-line treatments during this period. At the follow-up visit at the 3-year mark, the patient showed disease progression and underwent a second surgery. The patient has continued protocol-scheduled assessments and has completed the 3.5-year follow-up visit within the long-term surveillance study. Additionally, this patient is the second in the study who has not required further therapeutic interventions during the reported follow-up.

Utilizing the TEM-GBM study as the first clinical setting for evaluation, the platform has provided preliminary immunological data regarding Temferon's interaction within the tumor microenvironment. These findings demonstrate the capacity of bone marrow–derived myeloid cells to localize at the tumor site and effect in situ delivery of immunotherapeutic payloads, consistent with the platform's proposed mechanism of action. Although these are exploratory observations requiring validation in subsequent controlled trials, they are instrumental in informing the continuous development of Temferon, including the exploration of combination therapeutic strategies and the refinement of the cell-based delivery system.

In 2023, the FDA granted orphan drug designation to Temferon for the treatment of patients with GBM. 

As of the November 21, 2025, data cutoff date, 25 patients have been treated with Temferon. These data are compared with the previously disclosed April 15, 2025, cutoff, published on July 1, 2025.³

About the TEM-GBM Trial

The TEM-GBM trial is a nonrandomized, open-label, phase 1/2a dose-escalation study across 3 locations in Italy. Patients are treated with a single injection of Temferon. Part A of the study will evaluate the safety and tolerability of 5 escalating doses of Temferon and 3 different conditioning regimens in up to 27 patients, following first-line treatment.²

The estimated completion date of the study is December 9, 2025.

Patient inclusion criteria include but are not limited to patients having undergone complete or partial tumor resection, being eligible for radiotherapy, and having a life expectancy of at least 6 months at screening. 

Patient exclusion criteria include but are not limited to using other investigational agents or procedures within 4 weeks prior to study enrollment; having a known hypersensitivity to carmustine, busulfan, thiotepa, lenograstim, or plerixafor; having previous allogenic bone marrow transplantation or kidney or liver transplant; and having clinical evidence of persistent raised intracranial pressure following surgical resection. 

“We are encouraged by the consistent clinical signals emerging from our glioblastoma trial,” Pierluigi Paracchi, CEO of Genenta Science, said in a news release from July 1, 2025.³ “These findings reinforce our confidence in Temferon’s differentiated mechanism and support our commitment to advancing the platform.” 

REFERENCES

1. Genenta reports long-term survival trends and immune findings in brain tumor (GBM) trial. News release. Genenta Science. November 24, 2025. Accessed November 25, 2025. https://tinyurl.com/4uu3vztb 

2. A study evaluating Temferon in patients with glioblastoma & unmethylated MGMT (TEM-GBM). ClinicalTrials.gov. Updated January 6, 2025. Accessed November 26, 2025. https://clinicaltrials.gov/study/NCT03866109 

3. Genenta announces long-term follow-up observations in brain tumor (GBM) study with emerging survival signals. News release. Genenta Science. July 1, 2025. Accessed November 26, 2025. https://tinyurl.com/mu4v3n7p