Workflow
Temferon™
icon
Search documents
Genenta Reports Long-Term Survival Trends and Immune Findings in Brain Tumor (GBM) Trial
Globenewswire· 2025-11-24 09:00
Core Insights - Genenta Science has provided an update on its TEM-GBM study for newly diagnosed glioblastoma multiforme (GBM) patients with an unmethylated MGMT gene promoter, reporting that 25 patients have been treated with Temferon as of November 21, 2025 [1][2] Group 1: Clinical Study Results - Key survival metrics for TEM-GBM patients show that 44% of patients have reached 18-month survival, an increase from 38% reported in April 2025 [7] - The two-year survival rate remains at 29%, and the median overall survival is consistent at 17 months, compared to historical cohorts of uMGMT patients treated with standard care, which typically show a two-year survival rate of approximately 14% and median overall survival of 13-15 months [7] - The study includes a patient who has reached three years of survival following Temferon administration, marking a significant milestone in the study [7] Group 2: Mechanism and Observations - The GBM study provides early observations on Temferon's behavior within the tumor microenvironment, indicating that bone-marrow-derived myeloid cells can deliver immunotherapeutic payloads at the tumor site, aligning with the platform's intended design [3] - These preliminary findings are exploratory and will inform the broader development of Temferon, including potential combination approaches and the evolution of the underlying cell-based delivery technology [3] Group 3: Financial Position - Following a registered direct offering on October 27, the company reported approximately $30 million in cash and short-term investments as of November 1, 2025 [4] Group 4: Company Overview - Genenta Science is a clinical-stage immuno-oncology company developing a proprietary hematopoietic stem cell therapy for various solid tumor cancers, with Temferon as its first-in-class product candidate [5] - The company has completed a Phase 1 trial for newly diagnosed GBM patients with an unmethylated MGMT gene promoter, suggesting potential reprogramming of the tumor microenvironment and induction of T cell responses [5] - Genenta has also initiated a Phase 1/2a study for metastatic Renal Cell Carcinoma, which will include combinations with immune checkpoint inhibitors [5]
Genenta Announces Pricing of $15.0 Million Registered Direct Offering of American Depositary Shares
Globenewswire· 2025-10-27 00:30
Core Viewpoint - Genenta Science has entered into a securities purchase agreement to sell 4,285,715 American Depositary Shares (ADSs) at $3.50 per ADS, aiming for gross proceeds of approximately $15.0 million before expenses [1][2]. Group 1: Offering Details - The offering involves the sale of securities solely by Genenta, with no warrants or derivative securities issued [1]. - Maxim Group LLC is the lead placement agent, while Rodman & Renshaw LLC acts as the co-placement agent for the offering [2]. - The expected closing date for the offering is around October 28, 2025, pending customary closing conditions [2]. Group 2: Use of Proceeds - Genenta plans to utilize the net proceeds from the offering for working capital and general corporate purposes [2]. Group 3: Company Overview - Genenta Science is a clinical-stage immuno-oncology company focused on developing proprietary hematopoietic stem cell therapies for solid tumor cancers [5]. - The company's lead product candidate, Temferon™, aims to express immune-therapeutic payloads within the tumor microenvironment, potentially enhancing immune responses [5]. - Genenta has completed a Phase 1 trial for newly diagnosed Glioblastoma Multiforme (GBM) patients and has initiated a Phase 1/2a study for metastatic Renal Cell Carcinoma, which will include combinations with immune checkpoint inhibitors [5].
Genenta and Anemocyte Announce Strategic Partnership to Advance Off-The-Shelf LVV Plasmid DNA Production
Globenewswire· 2025-10-24 08:00
Core Insights - Genenta Science and ANEMOCYTE have announced a strategic collaboration focusing on off-the-shelf lentiviral vector (LVV) Plasmid DNA technology, expanding their existing partnership in plasmid DNA production [1][2][3] - The collaboration aims to enhance ANEMOCYTE's offerings by utilizing Genenta's established LVV Plasmid DNA technology, which is based on foundational research by Professor Luigi Naldini [2][3] - This partnership is expected to support the development of advanced therapy programs across the life sciences industry, ensuring clients have access to reliable and scalable solutions [3] Company Overview - Genenta Science is a clinical-stage immuno-oncology company developing a proprietary hematopoietic stem cell therapy for solid tumor cancers, with its lead product candidate being Temferon™ [5] - Temferon™ is designed to express immune-therapeutic payloads within the tumor microenvironment, potentially enhancing T cell responses and breaking immune tolerance [5] - ANEMOCYTE is a Biotech Manufacturing Organization based in Italy, specializing in the development and manufacturing of pDNA and mRNA, with over 25 years of expertise in innovative therapies [4]
Genenta and Anemocyte Announce Strategic Partnership to Advance Off-The-Shelf LVV Plasmid DNA Production
Globenewswire· 2025-10-24 08:00
Core Insights - Genenta Science and ANEMOCYTE have announced a strategic collaboration focusing on off-the-shelf lentiviral vector (LVV) Plasmid DNA technology, expanding their existing partnership in plasmid DNA production [1][3] - The collaboration aims to leverage Genenta's established LVV Plasmid DNA technology, enhancing ANEMOCYTE's offerings to clients by providing high-quality materials from R&D to GMP grade [2][3] - This partnership signifies a commitment to supporting the life science industry with innovative solutions, ensuring clients have access to a reliable platform for advanced therapy programs [3] Company Profiles - Genenta Science is a clinical-stage immuno-oncology company developing a proprietary hematopoietic stem cell therapy for various solid tumor cancers, with its first-in-class product candidate, Temferon™, designed to express immune-therapeutic payloads within the tumor microenvironment [5] - ANEMOCYTE is a Biotech Manufacturing Organization based in Italy, specializing in the development and manufacturing of pDNA and mRNA, with over 25 years of expertise in innovative therapies [4]
Genenta Announces Long-Term Follow-Up Observations in Brain Tumor (GBM) Study with Emerging Survival Signals
Globenewswire· 2025-07-01 09:00
Core Insights - Genenta Science is conducting ongoing clinical trials for its immuno-oncology product, Temferon, focusing on glioblastoma multiforme and genitourinary tumors [1][3][6] Group 1: Glioblastoma Multiforme Study - A total of 38 patients have been enrolled in the glioblastoma multiforme study, with 25 patients receiving Temferon [1] - The two-year survival rate for unmethylated MGMT (uMGMT) patients in the GBM trial is 29%, with a median overall survival of 17 months, compared to historical cohorts showing a 14% survival rate and a median overall survival of 13 to 15 months [2] - Two patients have been enrolled in a long-term follow-up study, with one showing no disease progression and the other stabilizing after initial progression, indicating potential efficacy of Temferon [1] Group 2: Genitourinary Tumor Study - The TEM-GU Phase 1 study has begun recruitment, aiming to enroll 12 patients with genitourinary tumors, administering Temferon at a fixed dose of 4 million genetically modified cells per kilogram [3] - The study will evaluate the safety and tolerability of Temferon in combination with immune checkpoint inhibitors or tyrosine kinase inhibitors [3] Group 3: Mechanism of Action - Temferon works by reprogramming the tumor microenvironment to enhance adaptive immune responses [4] - A scientific manuscript has been accepted for publication, demonstrating Temferon's potential to enhance CAR-T activity in preclinical models [4][5] Group 4: Company Overview - Genenta Science is a clinical-stage immuno-oncology company developing hematopoietic stem cell therapy for solid tumors, with Temferon as its first product candidate [6] - The company has completed a Phase 1 trial for newly diagnosed GBM patients with an unmethylated MGMT gene promoter, suggesting potential for reprogramming the tumor microenvironment [6]
Genenta and Anemocyte announce a collaboration for the manufacturing of starting materials for cutting-edge cell-based therapies
Globenewswire· 2025-05-07 11:00
Core Insights - Genenta Science has announced a collaboration with Anemocyte to establish Cell Banks and produce Plasmids for viral vector production, marking a significant milestone in immuno-oncology therapies [1][2] Company Overview - Genenta Science is a clinical-stage immuno-oncology company focused on developing hematopoietic stem cell therapy for solid tumor cancers, with its lead product candidate being Temferon™ [5] - Anemocyte is a Biotech Manufacturing Organization based in Italy, specializing in the development and production of pDNA and mRNA, with over 25 years of experience in manufacturing innovative therapies [4] Collaboration Details - The partnership aims to leverage Genenta's innovative platform and Anemocyte's expertise in producing high-quality starting materials, which is crucial for advancing clinical trials [2][3] - Anemocyte's team has played a vital role in the manufacturing process, confirming the quality and reliability of their plasmid DNA for therapeutic products [3] Clinical Development - Genenta has completed a Phase 1 trial for newly diagnosed Glioblastoma Multiforme patients and has initiated a Phase 1/2a study for metastatic Renal Cell Carcinoma, which will include combinations with immune checkpoint inhibitors [5]
Genenta Showcases Strategic Vision at Premier Biotech Forum in Qatar
Newsfilter· 2025-04-15 09:00
Core Insights - Genenta Science, a leader in immuno-oncology and cell-based therapeutics, is advancing its pipeline with a strategic financing of €20 million ($22.7 million) through a Mandatory Convertible Bond to ENEA Tech and Biomedical [2] - The company is focused on the development of Temferon™ for metastatic Renal Cell Cancer (mRCC) and has raised an additional €3.0 million ($3.2 million) via an at-the-market facility [2] - CEO Pierluigi Paracchi will present at the "Montalcini Global Biotech Tour" in Doha, Qatar, highlighting the Italian biotech ecosystem and the company's initiatives [1][3] Company Developments - Genenta has completed a Phase 1 trial for newly diagnosed Glioblastoma Multiforme patients, indicating potential for reprogramming the tumor microenvironment [6] - The company has initiated a Phase 1/2a study for metastatic Renal Cell Carcinoma, which will explore combinations with immune checkpoint inhibitors [6] - Temferon™ is designed to express immune-therapeutic payloads within the tumor microenvironment, aiming for a durable and targeted response [6] Strategic Partnerships - The event in Doha will feature key stakeholders, including representatives from the Qatar Investment Authority, which manages over $475 billion in assets, indicating potential for cross-border partnerships [4] - CDP Venture Capital, a long-standing investor in Genenta, participated in the company's IPO on Nasdaq in 2021, showcasing ongoing support from institutional investors [3]