Genenta Science (NASDAQ: GNTA), a clinical-stage immuno-oncology (I/O) company developing a cell-based platform that harnesses the power of hematopoietic stem cells to deliver durable, safe treatments for solid tumors, announced who successfully dosed the first of three patients in Cohort 8 (Temferon™ at 4×10^6/kg), the final cohort of the variable-dose Phase 1 portion of the uMGMT Glioblastoma Multiforme Phase 1/2 clinical trial newly diagnosed (TEM -GBM).
THE FIRST RESULTS:
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.
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.”
Pierluigi Paracchi, CEO of Genenta, noted:
“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.”
The preliminary data generated so far, including the duration of cell presence in patients, therefore, opens up interesting possibilities for the use of Temferon in a variety of solid tumors, as also stated by Carlo Russo, CMO and Head of Development.
