Genenta Demonstrated Reprogramming of the Tumor Microenvironment in GBM Patients, Paving the Way for Innovative Treatments of Solid Tumors

Based on Preliminary Data from Ongoing Dose Ranging Stage of the Phase 1/2 Clinical Trial

MILAN, Italy and NEW YORK, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Genenta Science (NASDAQ: GNTA), a clinical-stage immuno-oncology (I/O) company developing a cell-based platform harnessing the power of hematopoietic stem cells to provide durable and safe treatments for solid tumors, today announced that:

We have successfully dosed the first of three patients in Cohort 8 (Temferon at 4x10^6/kg), the last cohort of the Phase 1 dose-ranging part of the Phase 1/2 clinical trial in newly diagnosed uMGMT Glioblastoma Multiforme (TEM-GBM) patients. The second patient has been enrolled and the treatment is planned.

• Thus far, the preliminary data indicate no dose-limiting toxicities related to Temferon have been detected in any of 22 treated patients.
• Temferon-derived differentiated cells were evident within the peripheral blood 14 days after infusion and were still detectable at more than 24 months.
• As of December 2023, preliminary data in uMGMT patients, the most aggressive form of GBM, show a 2-year Overall Survival (OS) of 25%; the historically reported data observed in uMGMT and methilated patients undergoing current standard of care is approximately 14% to 18%, respectively.
• We expect reporting top line Phase 1 dose-ranging data by the end of 2Q24.

Dr. Luigi Naldini, co-founder of Genenta and Director at the San Raffaele - Telethon Institute for Gene Therapy, stated, “Several techniques, including RNA single-cell analysis, suggest that Temferon can reprogram the Tumor Microenvironment (TME) in patients similarly to what we had demonstrated in preclinical models and activate the immune cell infiltration towards mounting immune responses against the tumor.”

“We had a patient who, albeit anecdotal, survived for over three years with Temferon and second line treatment, with a stable tumor during that period,” reported Carlo Russo, CMO and Head of Development. “We believe our preliminary data generated so far, including the duration of the cell presence in the patients, combined with our pre-clinical data showing the agnostic efficacy, open up intriguing possibilities for the use of Temferon in a variety of solid tumors.”

“The absence of limiting toxicity observed so far suggests the ability of our technology to prevent systemic toxicity in humans commonly associated with powerful anti-tumor proteins,” noted Pierluigi Paracchi, CEO of Genenta.