Two sufferers handled with Temferon have lived three years post-surgery: © inventory.adobe.com.
Two long-term survivors handled with Temferon have lived three years post-surgery, within the TEM-LT long-term follow-up research of sufferers with newly identified glioblastoma, in response to a information launch from Genenta.
One of many sufferers had no illness development or a necessity for second line therapies following Temferon, whereas the opposite confirmed preliminary indicators of illness development that subsequently stabilized with out extra therapeutic intervention.
Each instances counsel Temferon might assist management illness development, supporting the necessity for additional analysis in bigger research, in response to the information launch.
“For the primary time, we present that hematopoietic stem cells could be engineered to durably give rise to myeloid cells that localize to the tumor and reprogram its immune atmosphere,” Professor Luigi Naldini, co-founder of Genenta Science, mentioned within the information launch. “In glioblastoma, this technique induced a pro-inflammatory shift in macrophages and the emergence of tumor-reactive T cells, providing a promising new avenue for immune engagement in opposition to one of the resistant cancers.”
On the April information cutoff, sufferers with unmethylated O6-methylguanine-DNA methyltransferase (MGMT) within the glioblastoma trial had a two-year survival fee of 29% and a median general survival of 17 months. By comparability, historic information for comparable sufferers handled with commonplace therapy had a two-year survival fee of round 14% and median general survival of 13 to fifteen months.
“We’re inspired by the constant medical indicators rising from our glioblastoma trial,” Pierluigi Paracchi, CEO of Genenta Science, mentioned within the launch. “These findings reinforce our confidence in Temferon’s differentiated mechanism and assist our dedication to advancing the platform.”
Temferon reprograms the tumor microenvironment to assist set off and maintain adaptive immune responses. It’s designed to ship immune-activating payloads instantly into the tumor microenvironment by way of bone marrow–derived myeloid cells, aiming for a sturdy and focused immune response. As well as, a research highlighting its capacity to reinforce and lengthen CAR-T exercise in preclinical fashions of stable tumors has been accepted by Science Translational Drugs, as per the discharge.
Recruitment is underway for the section 1 TEM-GU research, which goals to enroll 12 sufferers with genitourinary tumors. On this trial, Temferon is given on the identical dose beforehand proven to be protected and tolerated effectively within the dose-ranging TEM-GBM research. The trial will consider Temferon together with immune checkpoint inhibitors or tyrosine kinase inhibitors to discover potential immunologic synergy in sufferers with metastatic renal cell carcinoma. Genenta expects to reveal the protection and tolerability of Temferon on this inhabitants by the tip of the yr. Extra updates will comply with as soon as extra affected person information can be found.
TEM-GBM Trial Overview for Glioblastoma
The open-label, non-randomized section 1/2a TEM-GBM trial enrolled sufferers with newly identified supratentorial glioblastoma and an unmethylated MGMT gene promoter. Eligible contributors had undergone full or partial tumor removing, had been candidates for radiotherapy, had a Karnofsky rating of no less than 70, and a life expectancy of no less than six months. Cardiac, liver, kidney, and lung operate needed to be satisfactory, with left ventricular ejection fraction of no less than 45% and no extreme pulmonary hypertension, all confirmed inside 20 days of Temferon therapy.
Sufferers had been enrolled in considered one of eight cohorts (three sufferers every) and obtained escalating doses of Temferon alongside considered one of three conditioning regimens. Doses ranged from 0.5 million to 4 million CD34-positive cells per kilogram, with cohort-specific changes: cohorts 1 by way of 4 and 6 obtained 0.5 to three million cells/kg, cohort 5 obtained 2 million, cohort 7 obtained 3 million, and cohort 8 obtained 4 million.
The first aim was to evaluate security and tolerability within the first 90 days. Secondary objectives included medical response, progression-free survival, general survival, hematologic restoration inside 30 days, and long-term security.
References
- “Genenta pronounces long-term follow-up observations in mind tumor (GBM) research with rising survival indicators.” Information launch. Genenta. July 1, 2025. Accessed July 1, 2025.
- “The European Fee grants orphan drug designation to Temferon™ for therapy of glioma.” Information launch. Genenta Science. June 29, 2023. Accessed July 1, 2025.
For extra information on most cancers updates, analysis and schooling, don’t neglect to subscribe to CURE®’s newsletters right here.
