Workflow
Immuno - oncology
icon
Search documents
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]
Genelux Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-03-28 20:10
Core Insights - Genelux Corporation has reached alignment with the U.S. FDA on key elements of the approval pathway for Olvi-Vec in treating platinum-resistant/refractory ovarian cancer [1][4] - The company reported a net loss of $29.9 million for the year ending December 31, 2024, compared to a net loss of $28.3 million in 2023 [15][21] - Genelux has strengthened its management team and balance sheet, positioning itself for future growth and clinical development [2][7] Pipeline Highlights - The ongoing Phase 3 OnPrime/GOG-3076 trial is focused on platinum-resistant/refractory ovarian cancer, with a primary endpoint of progression-free survival (PFS) [3] - The FDA indicated that an interim analysis of overall survival (OS) should be planned alongside the primary PFS analysis, which could support traditional approval if a meaningful PFS advantage is demonstrated [4] - The trial aims to enroll enough patients to achieve 127 events, with topline data expected in the first half of 2026 [5] Clinical Trials Updates - Preliminary data from the Phase 1b/2 Olvi-Vec-SCLC-202 trial showed a 71% disease control rate in patients with extensive small cell lung cancer [11] - The Phase 2 VIRO-25 trial is actively enrolling patients with recurrent non-small cell lung cancer, with interim data anticipated in the second half of 2025 [6] Financial Overview - The company closed an underwritten offering of 3 million shares at $3.50 per share, raising approximately $10.5 million for working capital and clinical development [8][10] - As of December 31, 2024, cash, cash equivalents, and short-term investments totaled $30.9 million, providing a runway into the first quarter of 2026 [12] - Research and development expenses increased to $19.0 million in 2024 from $12.8 million in 2023, primarily due to higher clinical trial costs [13] Management Changes - Matt Pulisic has joined Genelux as the new Chief Financial Officer, bringing over 19 years of experience in the biopharmaceutical industry [7]
GT Biopharma to Participate in the 10th Anniversary of the Innate Killer Summit
Globenewswire· 2025-03-04 12:00
Core Insights - GT Biopharma, Inc. is a clinical stage immuno-oncology company focused on developing therapeutics based on its proprietary TriKE NK cell engager platform [1][4] - Dr. Jeffrey Miller from the University of Minnesota will present at the 10th Anniversary of the Innate Killer Summit, discussing the advantages of tri-specific engagers in enhancing NK cell activity [2] Company Developments - GTB-3650, a second-generation TriKE, is currently in a Phase 1 dose escalation study for patients with hematological malignancies, with enrollment proceeding as expected [3] - The study will evaluate GTB-3650 in approximately 14 patients with relapsed or refractory CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome [3] - Initial data from the GTB-3650 study is anticipated to be shared in 2025 [3] Technology and Collaboration - The TriKE platform is designed to enhance the cancer-killing abilities of natural killer cells in patients [4] - GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to develop and commercialize therapies using TriKE technology [4]