Genenta Announces Ongoing Clinical Trial Progress and Proposed Expansion in Solid Tumor Treatments

Company Selects Refractory Advanced Genitourinary Malignancies including Renal Cell Cancer as Second Indication

Company Selects Refractory Advanced Genitourinary Malignancies including Renal Cell Cancer as Second Indication

MILAN, Italy and NEW YORK, July 28, 2023 (GLOBE NEWSWIRE) -- Genenta Science (NASDAQ: GNTA), a clinical-stage immuno-oncology (I/O) company developing a cell-based platform harnessing the power of hematopoietic stem cells to provide durable and safe treatments for solid tumors, today announced that:

1. the Phase 1 dose-ranging clinical trial in Glioblastoma Multiforme (TEM¹-GBM) is progressing in line with the development program.
   • All the patients assigned to Cohort 7 (3x10E/kg Temferon) are dosed.
   • Enrollment of the patients in Cohort 8 (4x10E/kg) is completed.
   • No dose-limiting toxicity has been observed at this point.
   • The median Overall Survival (OS) is currently equal to 17 months.
     
2. We have selected Refractory Advanced Genitourinary Malignancies including Renal Cell Cancer (RCC) as the second solid tumor indication for Temferon. Late-stage RCC is considered an orphan disease with an unfavorable prognosis for Stage IV RCC patients.
   
   • The median OS in high-risk patients is only 6 months with the current standard of care.
   • 20% of newly diagnosed patients have metastatic disease.
   • Targeted release of IFN-α (Interferon alpha), which is the anti-tumor payload of our platform, we believe the use of a cell-based delivery mechanism is an innovative and clinically relevant approach to modulating the immune microenvironment in patients with immunogenic malignancies, such as metastatic RCC or Urogenital Cancer (UC).
   • IFN efficacy has been established in UC and immunotherapy is also now well established in this type of cancer, offering the potential opportunity of using Temferon in combination with other I/O products such as checkpoint inhibitors.
     

“We believe the clinical data we are observing in the GBM trial on safety, tolerability, and biological activity allow us to progress the expansion of our platform,” said Pierluigi Paracchi, Chief Executive Officer of Genenta. "The use of Temferon for the treatment of Urogenital Cancer patients is an important step for validating in humans the agnostic nature of our product that has already been demonstrated in several tumor animal models”, continued Pierluigi Paracchi.