Temferon™: Clinical Development

TEM-GBM Study — Glioblastoma Multiforme (Phase 1/2a)

The lead clinical program evaluated Temferon in newly diagnosed Glioblastoma Multiforme (GBM) patients harboring an unmethylated MGMT gene promoter (uMGMT-GBM) — a population with particularly poor prognosis and limited response to standard-of-care therapies.

A total of 25 patients were enrolled in the TEM-GBM study and received Temferon. Phase 1 dose escalation was completed across multiple cohorts with no dose-limiting toxicities observed. As of the November 2025 data cut, key survival metrics remain consistent with prior observations:

• Median overall survival (mOS): 17 months
• Two-year survival rate: 29% (vs. approximately 14% in historical uMGMT standard-of-care cohorts)
• 18-month survival rate: 44%

Two patients have been enrolled in the TEM-LT long-term follow-up study, both surviving three years from the time of initial surgery. 

Preliminary findings indicate that bone marrow-derived myeloid cells are capable of reaching the tumor site and delivering immunotherapeutic payloads in situ, consistent with the intended mechanism of Temferon. Evidence of TME reprogramming, inhibition of myeloid-induced immune tolerance, and induction of T cell responses have been observed, suggesting the potential to break immune tolerance in this historically refractory setting. A scientific manuscript demonstrating Temferon's potential to enhance and prolong CAR-T cell activity in preclinical murine models of solid tumors has been published in Science Translational Medicine.

These observations are exploratory in nature and subject to confirmation in larger controlled studies.