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Genenta Science S.p.A. (symbol: GNTA) is a cutting-edge biotechnology company specializing in the development of hematopoietic stem cell gene therapies for the treatment of solid tumors and various types of cancer. The company leverages an innovative gene transfer strategy into autologous hematopoietic stem/progenitor cells (HSPCs) to target interferon-α expression specifically to tumor-infiltrating monocytes/macrophages. Utilizing a genetically modified, HIV-derived lentiviral vector, Genenta delivers the therapeutic gene into HSPCs, enabling these cells to selectively express interferon within the tumor microenvironment, thereby minimizing systemic toxicity.
One of Genenta's flagship products, Temferon, is designed to treat glioblastoma multiforme, a highly aggressive brain tumor. Another key product focuses on TIE2-expressing monocytes (TEMs), which are engineered to attack solid tumors using an innovative combination of transcriptional and microRNA-mediated control mechanisms.
In recent developments, Genenta Science has expanded its research to include refractory advanced genitourinary malignancies, such as renal cell cancer, as a second indication. The company's latest news highlights preliminary data from its ongoing Phase 1/2 clinical trials, demonstrating promising results in the dose-ranging stage.
With its headquarters in Milan, Italy, and extensive clinical operations in New York, Genenta Science is at the forefront of immuno-oncology, aiming to harness the body's own immune system to combat cancer effectively and safely. The company remains committed to advancing its pipeline and achieving breakthroughs in cancer treatment.
- Company Selects Refractory Advanced Genitourinary Malignancies including Renal Cell Cancer as Second Indication.
- Based on Preliminary Data from Ongoing Dose Ranging Stage of the Phase 1/2 Clinical Trial.
Genenta Science (NASDAQ: GNTA) announces CEO Pierluigi Paracchi's participation as a speaker at the Italy-U.S. meeting on 'Cross-Border Investments and Strategies in the Biotechnology Sector: A Transatlantic Perspective' at the U.S. Senate on October 25th, 2024. The event, organized by the U.S. National Security Commission on Emerging Biotechnology and Italian Embassy, features distinguished speakers including Michelle Rozo, Mariangela Zappia, and Patrick Soon-Shiong.
As moderator of the Italian Working Group on Internationalization of Biotech Sector (NWTIB), Paracchi will present the Interim Report, emphasizing the strategic importance of biotechnologies post-pandemic and Italy's role in preserving and advancing these innovations while attracting international investments.
Genenta Science (NASDAQ: GNTA) has received approval from AIFA for a new Phase 1 clinical trial for metastatic Renal Cell Cancer (mRCC), expanding potential applications for its flagship product, Temferon™. This approval aligns with EMA standards. The company's ongoing TEM-GBM development program has completed a Phase 1 dose-ranging trial, confirming no dose-limiting toxicities across 24 patients. Temferon-derived cells remained detectable for over two years post-infusion, with treatment associated with a median survival of 16.8 months and a 25% increase in 2-year overall survival.
The new mRCC trial, targeting high-risk patients with a median overall survival of less than 2 years after multiple therapies, is expected to start in Q4 2024. Recent preclinical studies show synergy between Temferon and other immunotherapies in solid tumors. Genenta will present these developments at upcoming events, including Maxim Group's 2024 Healthcare Virtual Summit and the Society for Neuro-Oncology Annual Meeting.
Genenta Science (NASDAQ: GNTA) recently appointed five new directors to its Board of Directors, including John L. Cantello, Lauren H. Chung, Armon R. Sharei, and Todd Wider. The company aims to leverage the expertise of these new members to further develop its cell-based platform for treating solid tumors. The shareholders' meeting held on May 2, 2024, marked a significant step towards strengthening the company's leadership and strategic direction.
Genenta Science (NASDAQ: GNTA) announced its fiscal year 2022 financial results, revealing a net loss of €8.5 million, an increase from €5.5 million in 2021. The loss includes a net exchange rate gain of €2.3 million from USD to EUR conversion. The company reported no revenues for 2022, with R&D expenses rising to €5.3 million and G&A expenses at €5.7 million. Genenta holds a €6.4 million tax credit and €29.8 million in cash, estimated to sustain operations into Q1 2025. CEO Pierluigi Paracchi emphasized progress on their lead technology, Temferon, aimed at treating glioblastoma. The annual report is available on the company's investor relations site.
Genenta Science (NASDAQ: GNTA) has announced an amendment to its license agreement with Ospedale San Raffaele (OSR), now allowing access to all solid tumor indications, pending governmental consent. This expansion is expected to enhance Genenta's intellectual property position and treatment options for various cancers. CEO Pierluigi Paracchi highlighted promising preliminary data from the ongoing glioblastoma study, bolstering the decision for broader access. The amended agreement requires approval from the Italian government, which must respond within 90 days for the changes to take effect.
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