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Worldwide Clinical Trials - Oncology

Genenta's Ongoing Clinical Trial Progress and Ambitious Plans for Solid Tumor Treatments

Saturday, July 29, 2023

Genenta Science (NASDAQ: GNTA) has provided an update on its clinical-stage immuno-oncology (I/O) efforts, focusing on the development of Temferon™, a cell-based platform aimed at providing safe and durable treatments for solid tumors.

The company has made significant progress in its Phase 1 dose-ranging clinical trial for Glioblastoma Multiforme (TEM1-GBM), with Cohort 7 (3x10E/kg Temferon™) patients successfully dosed, and enrollment for Cohort 8 (4x10E/kg) completed. So far, there have been no indications of dose-limiting toxicity.

Notably, the median Overall Survival (OS) of 17 months in the trial is a positive outcome, considering the challenges associated with Glioblastoma Multiforme.

Genenta Science has also chosen Refractory Advanced Genitourinary Malignancies, specifically Renal Cell Cancer (RCC), as the next target indication for Temferon. RCC is an orphan disease with poor prognoses for Stage IV patients, where the current standard of care offers a median OS of only 6 months. By addressing this unmet medical need, the company aims to improve outcomes for RCC patients.

Temferon, the company's most advanced product, employs the patient's own stem progenitor cells, which are genetically modified to express Interferon Alpha (IFN-α) within solid tumors. IFN-α is a well-known immunomodulatory protein used in cancer treatment for many years, but its systemic toxicity has limited its widespread use. However, Genenta's platform aims to overcome this limitation by delivering therapeutic IFN-α activity specifically to the tumor site, thus avoiding systemic toxicity.

The targeted release of IFN-α is seen as an innovative and clinically relevant approach, particularly for immunogenic malignancies like metastatic RCC or Urogenital Cancer (UC). As IFN has demonstrated efficacy in UC and immunotherapy has shown promise in this cancer type, combining Temferon with other I/O products, such as checkpoint inhibitors, could enhance treatment outcomes.

Pierluigi Paracchi, the CEO of Genenta Science, expressed confidence in the clinical data from the GBM trial, emphasizing the platform's safety, tolerability, and biological activity. The company is eager to expand the platform's application to address the treatment challenges in Urogenital Cancer patients, showcasing its potential that has already been demonstrated in various animal tumor models.

In conclusion, Genenta Science's Temferon platform holds great promise in advancing the treatment landscape for solid tumors, especially in challenging cancers like Glioblastoma Multiforme and Renal Cell Cancer. With its ability to selectively deliver therapeutic activity within solid tumors and its immunomodulatory effects, the platform offers the potential for more effective and safer treatments for patients in the future.

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