Genenta Science announced that 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. 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-a (Interferon alpha), which is the anti-tumor payload of 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. Temferon is Genenta's product at the most advanced stage of development and consists of the patient's own stem progenitor cells modified with Genenta's platform to express Interferon Alpha (IFN-a) within solid tumors.

IFN-a is a well-known immunomodulatory protein that has been used in the clinic for decades for the treatment of a variety of cancers, but with limited current use because of the systemic toxicity. Genenta's platform is designed to avoid systemic toxicity and selectively deliver therapeutic activity within the solid tumor. From pre-clinical experiments, it has been observed that Temferon breaks tumor-induced tolerance, thus allowing the immune systemto recognize the tumor and mount a durable immune response.