Clinical Trials
3
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2014
Terminated
3
100.0%
No approval data available
- A first-in-human phase 1 trial of Temferon, a gene therapy using patients' own engineered blood stem cells, met its safety primary endpoint in 24 patients with newly diagnosed, treatment-resistant glioblastoma. - The therapy reprograms the immunosuppressive tumor microenvironment by delivering interferon-α locally via tumor-infiltrating macrophages, avoiding the severe systemic toxicity that previously limited this cytokine's use. - Median overall survival reached 16.7 months in patients with unmethylated MGMT promoter, a population with among the worst prognosis, and two patients achieved late partial responses more than a year after treatment. - The study provides clinical proof-of-concept for a 'living drug' platform that could be applied to other solid tumors, with optimized versions already in development for ovarian cancer.
- Genenta Science's TEM-GBM study shows 44% of glioblastoma patients achieved 18-month survival with Temferon therapy, compared to 38% in the previous data cut. - The trial maintains a 29% two-year survival rate and 17-month median overall survival, substantially outperforming historical standard-of-care outcomes of 14% and 13-15 months respectively. - One patient has reached three years of survival without requiring additional therapeutic interventions, representing a notable milestone in this aggressive brain cancer. - Preliminary immune findings suggest bone marrow-derived myeloid cells successfully deliver therapeutic payloads within the tumor microenvironment as intended.
- Genenta Science S.p.A. stock experienced a dramatic 284% surge following the announcement of a strategic collaboration with Anemocyte to enhance off-the-shelf lentiviral vector plasmid DNA production capabilities. - The partnership positions Genenta as a key player in the gene therapy manufacturing sector, with the company maintaining strong financial fundamentals including $22M in total assets and over $19M in working capital. - Trading activity showed extreme volatility with the stock reaching an intraday high of $9.97 before settling at $4.99, reflecting significant investor interest and institutional involvement in the biotechnology company. - The collaboration is expected to extend Genenta's technological capabilities in producing high-quality lentiviral vectors, a critical component for advancing gene therapy treatments.
- Genenta Science and Anemocyte announced an expanded strategic partnership focused on off-the-shelf lentiviral vector plasmid DNA technology platform development and commercialization. - The collaboration leverages Genenta's clinically validated LVV plasmid DNA technology, originally developed from foundational research by co-founder Professor Luigi Naldini. - ANEMOCYTE will enhance its client offerings by providing reliable, top-quality materials from R&D to GMP grade across preclinical to commercial stages. - The partnership builds on an existing successful collaboration between the two companies in plasmid DNA manufacturing and production services.
- Two patients with newly diagnosed glioblastoma multiforme have survived three years from initial surgery in Genenta's TEM-GBM trial, with one showing no disease progression and the other achieving disease stabilization without additional therapy. - The phase 1/2a trial demonstrated a 29% two-year survival rate and 17-month median overall survival in unmethylated MGMT patients, compared to historical rates of 14% and 13-15 months respectively. - Temferon represents a first-in-class hematopoietic stem cell therapy that reprograms the tumor microenvironment by delivering interferon-alpha directly to tumors through engineered myeloid cells. - Genenta has initiated the TEM-GU phase 1 study to evaluate Temferon in genitourinary cancers, with plans to demonstrate safety in metastatic renal cell carcinoma by year-end.
- Genenta Science has formed a strategic collaboration with Italian biotech manufacturing organization Anemocyte to produce critical starting materials for cell-based cancer therapies. - The partnership encompasses the establishment of cell banks and manufacturing of plasmids for viral vector production, supporting Genenta's immuno-oncology clinical trials. - Anemocyte's expertise in plasmid DNA production has enabled high-quality therapeutic product manufacturing, confirming its role as a reliable partner for Genenta's advancement. - The collaboration facilitates progress in Genenta's ongoing Phase 1/2a metastatic renal cell carcinoma study and supports the development of Temferon™, their first-in-class hematopoietic stem cell therapy.
• Genenta Science strengthens its partnership with AGC Biologics to enhance cell therapy manufacturing capabilities. • An exclusive GMP suite in Milan will be dedicated to producing Genenta's cell therapy product, ensuring cGMP compliance. • Genenta's Phase 1/2a trial for metastatic Renal Cell Cancer (mRCC) began in Q4 2024, with plans to treat six patients by mid-2025. • The enhanced capacity supports ongoing Glioblastoma Multiforme (GBM) studies and aims to validate Genenta's therapeutic approach.
• Genenta Science has received AIFA approval for a Phase 1 clinical trial of Temferon™ in metastatic Renal Cell Cancer (mRCC). • The mRCC trial, set to begin in Q4 2024, will target high-risk patients with limited survival after multiple therapies. • Prior Phase 1 trial of Temferon™ in Glioblastoma Multiforme (GBM) showed a 25% increase in 2-year overall survival. • Preclinical data indicates Temferon™ demonstrates synergy with other immunotherapies in solid tumors, enhancing its potential.
