Genprex Inc - GNPX STOCK NEWS

Genprex (NASDAQ: GNPX) has announced the dosing of the first patient in the Phase 2 expansion portion of its Acclaim-3 clinical study, evaluating Reqorsa® Gene Therapy combined with Tecentriq® as maintenance therapy for extensive stage small cell lung cancer (ES-SCLC).

The Phase 2 expansion will enroll 50 patients across 10-15 U.S. sites, with an interim analysis planned after the first 25 patients reach 18 weeks of follow-up, expected in the second half of 2025. The study's primary endpoint is to determine the 18-week progression-free survival rate.

Current ES-SCLC patients have a median progression-free survival of 5.2 months, with those receiving Tecentriq maintenance therapy showing 2.6 months. The treatment combination has received both FDA Fast Track and Orphan Drug Designations. Preclinical data from October 2023 showed the combination therapy provided better tumor control than either agent alone.

Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company, announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference from January 13-16, 2025, in San Francisco. The company's executive team, including Ryan Confer (President, CEO, and CFO), Dr. Mark Berger (Chief Medical Officer), and Thomas Gallagher (SVP of Intellectual Property and Licensing), will attend the conference.

The executives will be available for one-on-one meetings with industry and investor groups to discuss Genprex's gene therapies for cancer and diabetes. Interested parties can schedule meetings through Investor Relations at investors@genprex.com.

Genprex (NASDAQ: GNPX) has completed the Phase 1 dose escalation portion of its Acclaim-3 clinical trial, testing Reqorsa® Gene Therapy with Tecentriq® for extensive stage small cell lung cancer (ES-SCLC). The Safety Review Committee approved advancing to Phase 2 after finding no dose limiting toxicities, setting the Recommended Phase 2 Dose at 0.12 mg/kg.

The first patient showed a partial remission with a 30% tumor decrease after two cycles, though progression was noted after four cycles. The Phase 2 expansion will enroll approximately 50 patients across 10-15 U.S. sites, focusing on 18-week progression-free survival rates. The combination therapy has received FDA Fast Track Designation and Orphan Drug Designation for SCLC treatment.

Genprex (NASDAQ: GNPX) has secured a worldwide exclusive license from the University of Michigan for patent rights relating to Reqorsa® Gene Therapy in combination with ALK-inhibitors for treating ALK-EML4 positive lung cancer. Preclinical data showed that Reqorsa induced apoptosis in alectinib resistant EML4-ALK positive non-small cell lung cancer cells. The research indicates that TUSC2, a tumor suppressor gene frequently deleted in lung cancer, when overexpressed in ALK+ NSCLC cell lines, effectively decreased cell growth through activation of apoptotic pathways.

Genprex announced positive preclinical data for its lead drug candidate Reqorsa® Gene Therapy at the Society for Immunotherapy of Cancer Meeting. Research collaborators at Meharry Medical College demonstrated that Reqorsa effectively modulates immune responses against cancers. The study showed that in TUSC2 Knock Out mice treated with Reqorsa, tumor growth was diminished, with significant reduction in T reg cells and increase in Cytotoxic T cells and NK cells within tumor infiltrating leucocytes. The research validates Reqorsa's anti-tumor mechanisms and its potential to treat various cancers, particularly in individuals with low TUSC levels due to aging, chronic inflammation, or metabolic diseases.

Genprex (NASDAQ: GNPX) announced its participation in the 2024 BIO Europe Conference, scheduled for Nov. 4-6, 2024 in Stockholm, Sweden, with virtual sessions on Nov. 12-13, 2024. Senior VP of Intellectual Property and Licensing Thomas Gallagher will attend in person, while CEO Ryan Confer and CMO Mark Berger will participate virtually.

The clinical-stage gene therapy company, focused on developing therapies for cancer and diabetes, will conduct one-on-one meetings with industry and investor groups during the conference. Interested parties can request meetings through the conference portal or contact Investor Relations directly.

Genprex announced positive preclinical data for its lead drug candidate, Reqorsa® Gene Therapy, presented at the 2024 EORTC-NCI-AACR Symposium. The research showed promising results in treating Ras inhibitor resistant lung cancer, mesothelioma, and glioblastoma. The company filed two provisional patent applications based on the data for treating mesothelioma and glioblastoma. The presentations, delivered by research collaborators from prestigious institutions including MD Anderson Cancer Center, NYU Langone Health, and UT Health Science Center, focused on TUSC2 gene therapy's potential in treating these challenging cancers.

Genprex (NASDAQ: GNPX) has entered into a Sponsored Research Agreement with the University of Michigan Rogel Cancer Center to study TUSC2 combined with ALK-inhibitors in ALK-EML4 positive lung cancer. The company also announced a collaboration with ALK Positive, a non-profit patient research organization. Preclinical data presented at AACR 2024 showed REQORSA induced apoptosis in alectinib resistant EML4-ALK positive NSCLC cell lines. The research targets ALK+ lung cancer, found in approximately 5% of NSCLCs, where about 82% have decreased TUSC2 tumor suppressor protein. While current ALK-targeted therapies show initial benefits, resistance develops over time, with a 5-year survival rate of 40.9%.

Genprex (NASDAQ: GNPX) has announced progress in its Acclaim-3 clinical trial for Reqorsa® Gene Therapy combined with Tecentriq® in extensive stage small cell lung cancer (ES-SCLC). The company has completed the 0.09 mg/kg dose group and received approval to advance to the highest dose group of 0.12 mg/kg. Key points include:

- No dose limiting toxicities observed
- A partial remission noted in the first patient treated
- The combination therapy has received FDA Fast Track Designation and Orphan Drug Designation
- Phase 1 dose escalation is expected to complete in the second half of 2024
- Phase 2 expansion will enroll 50 patients at 10-15 U.S. sites

Preclinical data showed the combination therapy provided better tumor control than either agent alone in SCLC mouse models.