This section highlights FDA-related milestones and regulatory updates for drugs developed by Genprex (GNPX).
Over the past two years, Genprex has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Reqorsa®, GPX-002, Oncoprex, REQORSA®+, EORTC-NCI-AACR, Acclaim-3, and Acclaim-1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Reqorsa® Gene Therapy FDA Regulatory Timeline and Events
Reqorsa® Gene Therapy is a drug developed by Genprex for the following indication: For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- April 30, 2026
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc. announced that The Israel Patent Office (ILPO) has granted Genprex a patent covering the use of Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in combination with PD-1 antibodies for the treatment of cancer.
AI Summary
Genprex announced that the Israel Patent Office (ILPO) has granted a patent covering the use of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with PD‑1 antibodies to treat cancer. This award extends Genprex’s intellectual property protection into another target market and builds on patents the company has already secured in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Singapore and Europe.
Reqorsa is a gene therapy being developed alongside prominent, approved cancer drugs, with an initial focus on treating lung cancer. In preclinical studies, Reqorsa has shown complementary activity with targeted therapies and immunotherapies. Genprex says the therapy’s unique attributes may help improve existing treatments for lung cancer and potentially other cancers, strengthening its position as a combination partner for PD‑1 antibodies and other cancer drugs. The ILPO patent is part of the company’s broader effort to protect and commercialize Reqorsa worldwide.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- April 20, 2026
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc announced that its research collaborators presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting being held April 17-22, 2026 in San Diego, California.
AI Summary
Genprex announced that its research collaborators presented Genprex-supported abstracts and posters at the American Association for Cancer Research (AACR) Annual Meeting, held April 17–22, 2026 in San Diego. The company said the posters and abstracts are available on Genprex’s website for review.
Key findings highlighted that the biomarkers TROP2 and PTEN may help predict which patients are most likely to respond to Reqorsa® gene therapy. This suggests these markers could guide patient selection and improve treatment planning in future studies.
Preclinical results reported that Reqorsa induced apoptosis and decreased tumor volume in ALK‑EML4 positive translocated non‑small cell lung cancer cell lines and in vivo mouse models. These data support antitumor activity of Reqorsa in this genetic subtype.
Additional results showed Reqorsa boosted natural killer (NK) cell antitumor activity, indicating an immune component to its effects. Interested readers can find the full posters and abstracts on Genprex’s website.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- March 18, 2026
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc. announced that its research collaborators will present at the upcoming 2026 American Association for Cancer Research (AACR) Annual Meeting being held April 17-22, 2026 in San Diego, California.
AI Summary
Genprex, Inc. announced that its research collaborators will present findings at the 2026 American Association for Cancer Research (AACR) Annual Meeting in San Diego, April 17–22, 2026. The presentations focus on biomarkers that may help predict which patients respond to Reqorsa®, Genprex’s gene therapy candidate. The collaborators will also report data showing Reqorsa’s potential as a treatment for ALK‑EML4 positive translocated non‑small cell lung cancer and findings that Reqorsa can boost natural killer (NK) cell antitumor activity.
The Genprex‑supported posters will be shown live at AACR 2026 and will be made available on Genprex’s website after their presentations. These updates aim to give researchers and clinicians new insight into patient selection and immune effects tied to Reqorsa as it advances in development.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- February 23, 2026
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc. announced that the Japanese Patent Office has issued a favorable Appeal Decision to grant a patent claiming the use of Reqorsa® Gene Therapy in combination with PD-L1 antibodies to treat cancer. Also, the European Patent Office has issued a Decision to Grant relating to a patent for the combination of REQORSA and PD-1 antibodies to treat cancer. Genprex maintains an exclusive license to these patents.
AI Summary
Genprex, Inc. announced two important patent decisions covering the use of its REQORSA® gene therapy combined with immune checkpoint antibodies to treat cancer. The Japanese Patent Office issued a favorable Appeal Decision to grant a patent for using REQORSA together with PD-L1 antibodies. Separately, the European Patent Office issued a Decision to Grant a patent for the combination of REQORSA and PD-1 antibodies. Both patents specifically claim the therapeutic pairing of Genprex’s gene therapy with these classes of cancer immunotherapy antibodies.
Genprex maintains an exclusive license to these newly granted patents, strengthening its intellectual property position in Japan and Europe for combination treatments with PD-1/PD-L1 agents. These decisions could help protect and support future development, collaborations, or commercialization of REQORSA-based combination therapies in those regions.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- February 10, 2026
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc announced that IP Australia, the Australian government agency responsible for administering Australia's intellectual property rights system, has issued a Notice of Acceptance, on February 5, 2026, of the Genprex patent application claiming the use of Reqorsa® Gene Therapy in combination with PD-L1 antibodies for the treatment of cancers.
AI Summary
Genprex, Inc. announced that IP Australia issued a Notice of Acceptance on February 5, 2026, for a patent application covering the use of its REQORSA® gene therapy in combination with PD‑L1 antibodies to treat cancers. The acceptance advances intellectual property protection in Australia for the specific therapeutic combination, which could support broader clinical and commercial efforts for the therapy.
The patent is reported to cover the Acclaim‑3 clinical trial, which tests REQORSA combined with Genentech’s Tecentriq® (a PD‑L1 antibody). Genprex also added another site to the Acclaim‑3 trial. The Phase 2 expansion follows a Phase 1 dose‑escalation stage that found REQORSA generally well tolerated with no dose‑limiting toxicities; Phase 2 patients are receiving the same dose used in a prior Phase 2 cohort. The patent acceptance may strengthen Genprex’s position as it advances these combination studies in cancer.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- November 24, 2025
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc. announced the publication of data from its Acclaim-1 Phase 1 clinical trial of Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in combination with Tagrisso® (osimertinib) in patients with advanced non-small cell lung cancer (NSCLC) in the peer-reviewed journal Clinical Lung Cancer.
AI Summary
Genprex announced that data from its Acclaim-1 Phase 1 trial of REQORSA® Gene Therapy (quaratusugene ozeplasmid) combined with Tagrisso® (osimertinib) in patients with advanced non-small cell lung cancer (NSCLC) were published in the peer‑reviewed journal Clinical Lung Cancer.
The open‑label, multi‑center Phase 1 dose‑escalation portion focused on safety and found no dose‑limiting toxicities, establishing a recommended Phase 2 dose (RP2D) of 0.12 mg/kg—the highest dose tested. The company reported early signs of efficacy in addition to the safety findings.
Of 12 patients who had progressed on prior osimertinib regimens, three experienced prolonged time to progression. One patient at 0.06 mg/kg had a partial response and remained on treatment for 47 cycles (about 32 months) and continues more than three years after enrollment. A second at 0.12 mg/kg had stable disease for 32 cycles (~24 months) and a third at 0.09 mg/kg had stable disease for 14 cycles (~10 months).
REQORSA was generally well tolerated. Some patients had delayed infusion‑related reactions (muscle aches, fever, chills) that were managed with prophylactic steroids, acetaminophen and diphenhydramine. Genprex said the published data add to the scientific evidence for this combination approach in NSCLC.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- November 19, 2025
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc. announced the Company has added Gabrail Cancer Center in Canton, Ohio, as a new clinical trial site for the Acclaim-1 and Acclaim-3 clinical trials studying its lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), in lung cancer.
AI Summary
Genprex, Inc. has added Gabrail Cancer Center in Canton, Ohio as a new clinical trial site for its Acclaim-1 and Acclaim-3 studies of Reqorsa® Gene Therapy (quaratusugene ozeplasmid) for lung cancer. The company plans to open additional sites in the coming months to reach more patients and speed enrollment. CEO Ryan Confer said the partnership with Gabrail could help expand patient access and accelerate trial progress.
Acclaim-1 is a Phase 1/2 trial testing Reqorsa combined with AstraZeneca’s Tagrisso in late-stage non-small cell lung cancer patients with EGFR mutations after progression on Tagrisso; the Phase 2a expansion aims to enroll about 33 patients with an interim analysis after 19. Acclaim-3 is a Phase 1/2 trial testing Reqorsa with Genentech’s Tecentriq as maintenance therapy in extensive-stage small cell lung cancer; its Phase 2 expansion plans roughly 50 patients with an interim look after 25 reach 18 weeks of follow-up.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- November 18, 2025
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc announced that the United States Patent and Trademark Office (USPTO) has granted Genprex a patent that covers the use of the Company's lead drug candidate, Reqorsa® Gene Therapy, in combination with PD-L1 antibodies, such as Tecentriq®, through 2037.
AI Summary
Genprex announced that the U.S. Patent and Trademark Office has issued a patent covering the use of the company’s lead gene therapy, Reqorsa®, in combination with PD-L1 antibodies such as Tecentriq® through 2037. The patent is intended to strengthen Genprex’s intellectual property around the combination used in its Acclaim-3 clinical trial for small cell lung cancer and to protect the company’s commercial rights to this specific therapeutic pairing.
Genprex said the patent will help prevent competitors from making, using, or selling the same drug combination. The company already holds related patents in the U.S. and Korea and is pursuing applications in Europe, Canada, Brazil, China and Israel. PD-L1 antibodies are immune checkpoint drugs that block PD-L1 proteins on cell surfaces to help the immune system target cancer. The new U.S. patent gives Genprex exclusivity for this combination approach in the U.S. until 2037.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- November 4, 2025
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc. announced that the European Patent Office (EPO) has communicated its intent to grant Genprex a patent for the use of Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in combination with PD-1 antibodies for the treatment of cancer.
AI Summary
Genprex announced today that the European Patent Office (EPO) has communicated its intent to grant the company a patent for using Reqorsa® Gene Therapy (quaratusugene ozeplasmid) combined with PD-1 antibodies to treat cancer. This news adds to Genprex’s existing patents for Reqorsa in combination with PD-1 and PD-L1 antibodies across multiple regions.
The new European patent strengthens Genprex’s intellectual property portfolio and secures important market protection in Europe. Reqorsa is designed to work alongside approved cancer drugs to improve outcomes. In preclinical studies, it showed complementary effects with targeted therapies and immunotherapies.
Lung cancer remains one of the deadliest cancers in Europe, causing nearly a quarter of a million deaths in 2021. With high rates of new cases and mortality, the expanded patent coverage supports ongoing development of novel approaches to treat lung cancer and potentially other tumor types.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- October 28, 2025
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc announced that its research collaborators presented positive preclinical data for Reqorsa® Gene Therapy (quaratusugene ozeplasmid) for the treatment of ALK-EML4 positive (ALK+) non-small cell lung cancer (NSCLC).
AI Summary
Genprex, Inc. announced that researchers presented positive preclinical data for Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in ALK-EML4 positive non-small cell lung cancer (NSCLC) at the 2025 AACR-NCI-EORTC conference. The study focused on how Reqorsa® delivers the tumor suppressor gene TUSC2 into cancer cells.
In lab tests, Reqorsa® increased TUSC2 levels in ALK-EML4 NSCLC cell lines and patient-derived organoids. This upregulation triggered cell death (apoptosis), even in cells that had become resistant to the ALK inhibitor alectinib.
When combined with alectinib in a mouse xenograft model, Reqorsa® further boosted cancer cell apoptosis and led to longer survival compared to control animals. These findings suggest a stronger treatment effect using the two therapies together.
Reqorsa® is a plasmid carrying TUSC2 encapsulated in lipid-based nanoparticles, designed to target cancer cells via intravenous injection. Genprex believes these results support moving toward a future clinical trial in ALK-positive NSCLC patients.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- October 23, 2025
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc announced that its research collaborators will present positive preclinical data at the upcoming 2025 AACR-NCI-EROTC International Conference on Molecular Targets and Cancer Therapeutics taking place October 22-26, 2025 at the Hynes Convention Center in Boston.
AI Summary
Genprex, Inc. announced that its research collaborators will present encouraging preclinical results for its lead candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), at the 2025 AACR-NCI-EROTC International Conference on Molecular Targets and Cancer Therapeutics. The study focused on ALK-EML4 positive non-small cell lung cancer (NSCLC), a form of disease that often develops resistance to current treatments.
In cell studies and mouse models, researchers found that Reqorsa alone or combined with the ALK inhibitor alectinib reduced tumor growth by up to 79 percent, compared to 60 percent with alectinib alone. The therapy works by delivering a functional TUSC2 tumor suppressor gene directly into cancer cells. Results showed increased markers of cell death and slower tumor regrowth, supporting plans for future clinical trials.
The data will be shared October 22–26, 2025, at Boston’s Hynes Convention Center, highlighting Genprex’s effort to advance novel gene therapies for difficult-to-treat lung cancers.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- May 6, 2025
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc announced it has entered into an exclusive patent license agreement with UTHealth Houston granting Genprex exclusivity and commercial rights relating to its lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid) for the potential treatment of glioblastoma.
AI Summary
Genprex, Inc. has entered an exclusive patent license agreement with UTHealth Houston. This deal grants Genprex the sole commercial rights and patent exclusivity for its lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), aimed at treating glioblastoma, a challenging and deadly brain cancer. The patent, co-owned by Genprex and UTHealth Houston, allows the company to further its development of Reqorsa for this new indication by restoring TUSC2 gene function in cancer cells. This move represents a significant expansion of Genprex’s portfolio in oncology gene therapies, emphasizing its commitment to addressing unmet medical needs in difficult-to-treat cancers. With promising results in preclinical studies, the company plans to advance further evaluations of Reqorsa in hopes of providing an innovative treatment option for glioblastoma patients.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- April 30, 2025
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc. announced that its research collaborators presented positive preclinical data for Reqorsa® Gene Therapy (quaratusugene ozeplasmid), for the treatment of KRASG12C mutant non-small cell lung cancer (NSCLC).
AI Summary
Genprex, Inc. recently announced that its research collaborators presented positive preclinical data for Reqorsa® Gene Therapy (quaratusugene ozeplasmid) at the 2025 American Association for Cancer Research Annual Meeting in Chicago. The study focused on the treatment of KRASG12C mutant non-small cell lung cancer (NSCLC), a form of lung cancer that is often resistant to standard treatments.
The preclinical data showed that Reqorsa, which delivers the functioning TUSC2 gene using lipid-based nanoparticles, produced strong anti-tumor effects. When used alone or in combination with targeted therapies, Reqorsa significantly reduced colony formation and increased cell death in resistant NSCLC models. These promising results support further clinical studies to explore Reqorsa’s potential as a treatment option for patients with Ras inhibitor resistant lung cancer.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- April 24, 2025
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc announced that it has been selected to present at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 – June 3 in Chicago, Illinois and online.
AI Summary
Genprex, Inc has been selected to present its study at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 30 to June 3 in Chicago, Illinois and online. The company’s abstract has been chosen for a poster session to showcase the trial design of its Acclaim-3 Phase 1/2 clinical trial.
This trial is evaluating Reqorsa Gene Therapy, known as quaratusugene ozeplasmid, in combination with Tecentriq® (atezolizumab) as a maintenance therapy for patients with extensive stage small cell lung cancer. The presentation offers a chance for Genprex to share innovative insights on combining gene therapy with established immunotherapy. Attendees will gain a deeper understanding of the design and objectives of the trial, which aims to provide new treatment options and improve outcomes for lung cancer patients.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- April 22, 2025
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc announced that its research collaborators' abstract was published in the online Proceedings supplement of Cancer Research, a scientific journal published by the American Association for Cancer Research (AACR).
AI Summary
Genprex, Inc. announced that an abstract by its research collaborators has been published in the online Proceedings supplement of Cancer Research, the official journal of the American Association for Cancer Research (AACR). This publication highlights positive preclinical data on Reqorsa® Gene Therapy, the company’s lead candidate for treating KRASG12C mutant non-small cell lung cancer.
The abstract details how the TUSC2 gene, delivered via Reqorsa, was used to overcome resistance seen with current KRAS inhibitors. The preclinical research showed promising results in reducing tumor growth and increasing cancer cell death. The recognition in this respected journal marks an important milestone, emphasizing Genprex’s commitment to advancing innovative therapies for hard-to-treat lung cancer.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- March 26, 2025
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc. announced that its research collaborators will present at the upcoming 2025 American Association for Cancer Research (AACR) Annual Meeting being held April 25-30, 2025 in Chicago, Illinois.
AI Summary
Genprex, Inc., a clinical-stage gene therapy company, announced that its research collaborators will present at the upcoming American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois, from April 25-30, 2025. At the meeting, the collaborators will share promising preclinical data for the company’s lead candidate, Reqorsa® Gene Therapy, which is being studied for treating KRASG12C mutant non-small cell lung cancer (NSCLC) resistant to Ras inhibitors. The research highlights how the delivery of the TUSC2 gene using a lipid-based nanoparticle system in Reqorsa® may overcome resistance to treatments like sotorasib, leading to reduced tumor growth and enhanced cell death. Genprex is encouraged by these results and looks forward to further discussions and insights, which could help pave the way for new therapeutic options for patients with difficult-to-treat lung cancer.
Read Announcement - Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- December 16, 2024
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc announced that it has completed the Phase 1 dose escalation portion of the Acclaim-3 clinical trial of Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in combination with Tecentriq® (atezolizumab) as maintenance therapy to treat patients with extensive stage small cell lung cancer (ES-SCLC).
AI Summary
Genprex, Inc announced that it has completed the Phase 1 dose escalation portion of its Acclaim-3 clinical trial. This trial is testing Reqorsa® gene therapy in combination with Tecentriq® as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC). The main goal was to evaluate safety, and the results showed a favorable profile with no dose limiting toxicities (DLTs) observed. The highest dose level tested, 0.12 mg/kg, was chosen as the Recommended Phase 2 Dose (RP2D). Based on these positive findings, the Safety Review Committee has approved the opening of the Phase 2 expansion portion of the trial. This next phase will enroll additional patients across multiple U.S. sites to further assess the treatment’s effectiveness and build on the encouraging early data seen in ES-SCLC patients.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- November 20, 2024
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc announced it has entered into an exclusive license agreement with the University of Michigan, granting Genprex a worldwide, exclusive license to the University's patent rights relating toits lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), in combination with ALK-inhibitors for the potential treatment of ALK-EML4 positive translocated lung cancer.
AI Summary
Genprex, Inc. has entered into an exclusive global license agreement with the University of Michigan for its lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid). This license grants Genprex the exclusive rights to use the University’s patents for combining Reqorsa® with ALK inhibitors to potentially treat ALK-EML4 positive translocated lung cancer. Positive preclinical data suggest that this combination may trigger cancer cell death, offering hope for patients who have become resistant to other ALK inhibitors. Genprex believes that this approach could widen the treatment options available for a subset of lung cancer patients. The agreement strengthens the company’s intellectual property portfolio and supports its ongoing strategy to develop innovative gene therapies. Future clinical studies will further explore the treatment’s effectiveness and safety for patients with ALK-positive lung cancer.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- October 7, 2024
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc announced that its research collaborators at Meharry Medical College were selected to present at the upcoming 39th Annual Society for Immunotherapy of Cancer Meeting being held November 6-10, 2024 in Houston, Texas.
AI Summary
Genprex, Inc announced that its research collaborators from Meharry Medical College will present at the 39th Annual Society for Immunotherapy of Cancer Meeting from November 6-10, 2024, in Houston, Texas. The presentation will focus on preclinical data for Reqorsa® Gene Therapy, highlighting how the therapy uses the tumor suppressor gene TUSC2 to modulate immune responses against cancer.
The poster presentation titled "TUSC2 Modulates Cancer Immune Responses" will share positive findings from studies that examine Reqorsa’s ability to target and enhance the immune system's response in cancer cells while reducing effects on normal cells. This development underlines the growing potential of Reqorsa in the treatment of various cancers and reinforces Genprex’s commitment to advancing innovative gene therapies with the help of academic partners.
Read Announcement- Drug:
- Reqorsa® Gene Therapy
- Announced Date:
- September 9, 2024
- Indication:
- For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
Announcement
Genprex, Inc announced that its research collaborators were selected to present at the upcoming 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics being held October 23-25, 2024 in Barcelona, Spain.
AI Summary
Genprex, Inc. announced that its research collaborators have been selected to present their work at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. The symposium will be held in Barcelona, Spain, from October 23-25, 2024. At the event, academic partners will share promising preclinical data on Reqorsa®, a gene therapy designed to treat Ras inhibitor resistant lung cancer, mesothelioma, and glioblastoma.
Experts from prestigious institutions such as MD Anderson Cancer Center, New York University Langone Health, and the University of Texas Health Science Center at Houston will present posters detailing how Reqorsa delivers the TUSC2 tumor suppressor gene to target cancer cells while sparing normal cells. Genprex believes these findings lay the groundwork for future clinical studies that may expand treatment options for these difficult-to-treat cancers.
Read Announcement
GPX-002 FDA Regulatory Timeline and Events
GPX-002 is a drug developed by Genprex for the following indication: Diabetes Gene Therapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- GPX-002
- Announced Date:
- January 7, 2026
- Indication:
- Diabetes Gene Therapy
Announcement
Genprex, Inc. announced a clinical program update on its diabetes gene therapy program for GPX-002, the Company's diabetes gene therapy drug candidate, detailing recent achievements and future advancements.
Read Announcement- Drug:
- GPX-002
- Announced Date:
- January 6, 2026
- Indication:
- Diabetes Gene Therapy
Announcement
Genprex, Inc announced preliminary in vivo preclinical proof-of-concept data for GPX-002, the Company's diabetes gene therapy drug candidate which may have the potential for long-term control of Type 1 diabetes (T1D) and Type 2 diabetes (T2D), in a non-human primate (NHP) model of T2D and in a mouse model of T2D.
AI Summary
Genprex reported preliminary in vivo preclinical proof-of-concept for GPX-002, a gene therapy using an AAV vector carrying Pdx1 and MafA, in Type 2 diabetes models. In two T2D non‑human primates (NHPs) researchers compared pancreatic duct infusion versus direct pancreatic injection. The NHP treated by intraductal AAV infusion showed improved glucose tolerance over months and achieved normal glucose tolerance at seven months with reduced insulin needs, suggesting rejuvenation of exhausted beta cells. The NHP given direct pancreatic injection had significant improvement at three months but did not fully normalize glucose. Researchers found that short-term immunosuppression may be needed in NHPs to limit immune responses to AAV, with AAV expression and the need for suppression appearing to last about six months.
In T2D mice, intraductal GPX-002 increased glucose-stimulated insulin secretion, reversed hyperglycemia, and restored normal glucose levels by four weeks without immunosuppression. Genprex is continuing NHP studies, planning formal toxicology work and preparing for an IND submission. Results are preliminary and may not predict human outcomes.
Read Announcement- Drug:
- GPX-002
- Announced Date:
- June 24, 2025
- Indication:
- Diabetes Gene Therapy
Announcement
Genprex, Inc announced that its research collaborators presented positive preclinical research from studies of GPX-002, the Company's diabetes gene therapy drug candidate, at the 2025 American Diabetes Association (ADA) 85th Scientific Session in Chicago.
AI Summary
At the 2025 American Diabetes Association (ADA) Scientific Session in Chicago, Genprex, Inc.’s research collaborators presented promising preclinical results on GPX-002, the company’s diabetes gene therapy candidate. The study demonstrated that when GPX-002 was used in animal models, alpha cells were reprogrammed into beta-like cells that could secrete insulin. Notably, these newly formed beta-like cells helped maintain improved glucose control for up to three months without the need for immunosuppression in the models.
Genprex’s CEO, Ryan Confer, highlighted the encouraging data as a significant step toward optimizing the therapy and progressing to human clinical trials. The positive findings suggest that GPX-002 may offer a novel treatment approach for diabetes by restoring natural insulin production and improving glucose homeostasis.
Read Announcement- Drug:
- GPX-002
- Announced Date:
- June 23, 2025
- Indication:
- Diabetes Gene Therapy
Announcement
Genprex, Inc. announced that its research collaborators presented positive preclinical data and research from studies of GPX-002, the Company's diabetes gene therapy drug candidate, at the 2025 American Diabetes Association (ADA) 85th Scientific Session in Chicago.
AI Summary
At the 2025 American Diabetes Association 85th Scientific Session in Chicago, Genprex, Inc. reported positive preclinical data for its diabetes gene therapy candidate, GPX-002. Collaborators showcased studies that used a non-viral lipid nanoparticle delivery system to transport a nucleic acid payload directly to pancreatic cells via the biliary and pancreatic ducts. This novel method successfully transfected cells in the islets of Langerhans in mouse models, demonstrating an efficient and targeted approach. The data suggest that using lipid nanoparticles may allow for repeat dosing of the therapy, a potential advantage over traditional viral methods. These promising results support the next stage of research and could pave the way for new treatment options for patients with Type 1 Diabetes, highlighting Genprex’s innovative efforts to improve gene therapy delivery for diabetes care.
Read Announcement- Drug:
- GPX-002
- Announced Date:
- May 28, 2025
- Indication:
- Diabetes Gene Therapy
Announcement
Genprex, Inc. announced that its research collaborators presented positive preclinical data and research from studies of GPX-002, the Company's diabetes gene therapy drug candidate, in an oral presentation at the American Society of Gene and Cell Therapy's (ASGCT) 28th Annual Meeting which took place May 13-17, 2025 in New Orleans, Louisiana.
AI Summary
Genprex, Inc. announced that its research collaborators shared positive preclinical data on GPX-002, the company’s novel diabetes gene therapy candidate, during an oral presentation at the American Society of Gene and Cell Therapy’s 28th Annual Meeting in New Orleans, Louisiana, held from May 13-17, 2025. The presentation highlighted studies using a recombinant adeno-associated virus (rAAV) to deliver the Pdx1 and MafA genes directly into the pancreas. This innovative approach converts alpha cells into beta-like cells that naturally secrete insulin, a finding that could pave the way for curative treatments for both Type 1 and Type 2 diabetes.
Preclinical results in non-human primate models showed improved glucose tolerance and a reduction in insulin needs. Although an immune response was observed, researchers demonstrated that a steroid-sparing regimen effectively managed these responses, supporting the potential of GPX-002 as a promising diabetes treatment.
Read Announcement- Drug:
- GPX-002
- Announced Date:
- April 29, 2025
- Indication:
- Diabetes Gene Therapy
Announcement
- Genprex, Inc. announced that its research collaborators have been selected to present at the upcoming American Society of Gene and Cell Therapy's (ASGCT) 28th Annual Meeting being held May 13-17, 2025 in New Orleans, Louisiana.
AI Summary
Genprex, Inc. announced that its research collaborators have been selected to present at the American Society of Gene and Cell Therapy’s (ASGCT) 28th Annual Meeting, taking place from May 13-17, 2025 in New Orleans, Louisiana. The presentation will highlight positive preclinical data from studies of GPX-002, the company’s gene therapy candidate for diabetes. The featured abstract, titled "Immune Modulation Sustains Alpha Cell Reprogramming and Mitigates Immune Responses to AAV in a Diabetic Non-Human Primate Model," demonstrates how the gene therapy treatment converts alpha cells into beta-like cells capable of producing insulin. This work is seen as a major step in advancing gene therapy techniques aimed at offering curative treatment options for diabetes. Genprex’s announcement underscores the growing credibility of its research and its commitment to developing innovative therapies for diabetes management.
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Oncoprex FDA Regulatory Events
Oncoprex is a drug developed by Genprex for the following indication: For the NPRL2 tumor suppressor gene.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Oncoprex
- Announced Date:
- February 13, 2025
- Indication:
- For the NPRL2 tumor suppressor gene
Announcement
Genprex, Inc announced that its research collaborators at a major cancer research center in Houston, Texas have published a new study in eLife titled, "NPRL2 gene therapy induces effective antitumor immunity in KRAS/STK11 mutant anti-PD1 resistant metastatic non-small cell lung cancer (NSCLC) in a humanized mouse model."
AI Summary
Genprex, Inc. announced that researchers at a leading Houston cancer center have published a study in eLife on the effectiveness of NPRL2 gene therapy in treating tough lung cancers. The study, titled "NPRL2 gene therapy induces effective antitumor immunity in KRAS/STK11 mutant anti-PD1 resistant metastatic non-small cell lung cancer (NSCLC) in a humanized mouse model," showed that NPRL2 treatment alone can produce a strong antitumor response. Researchers tested the therapy using Genprex’s non-viral Oncoprex® Delivery System, which delivers the NPRL2 tumor suppressor gene directly to the cancer cells. The findings suggest that this approach successfully triggers the immune system to fight cancer, even in tumors that resist anti-PD1 treatments. This positive data supports the potential expansion of Genprex's clinical development pipeline for lung cancer therapies.
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REQORSA®+ Tecentriq FDA Regulatory Timeline and Events
REQORSA®+ Tecentriq is a drug developed by Genprex for the following indication: For the Treatment of Small Cell Lung Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- REQORSA®+ Tecentriq
- Announced Date:
- January 23, 2025
- Indication:
- For the Treatment of Small Cell Lung Cancer
Announcement
Genprex, Inc announced that the first patient has been enrolled and dosed in the Phase 2 expansion portion of the Company's Acclaim-3 clinical study of Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in combination with Tecentriq® (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC).
AI Summary
Genprex, Inc. has enrolled and dosed the first patient in the Phase 2 expansion of its Acclaim-3 clinical study. The trial will assess the effectiveness of Reqorsa® Gene Therapy combined with Tecentriq® (atezolizumab) as maintenance treatment for patients with extensive stage small cell lung cancer (ES-SCLC). The study aims to evaluate the 18-week progression-free survival rate from the start of maintenance therapy. About 50 patients across 10 to 15 U.S. sites are expected to participate, with an interim analysis planned once 25 patients have reached 18 weeks of follow-up. This enrollment marks an important step for Genprex as it works to advance its innovative gene therapy approach designed to re-express tumor suppressor genes, which may help improve outcomes for patients with ES-SCLC.
Read Announcement- Drug:
- REQORSA®+ Tecentriq
- Announced Date:
- August 13, 2024
- Indication:
- For the Treatment of Small Cell Lung Cancer
Announcement
Genprex, Inc announced that the Singapore Patent Office has granted a patent to Genprex that covers the use of the Company's lead drug candidate, Reqorsa® Gene Therapy, in combination with anti-PD-1 antibodies through 2037.
AI Summary
Genprex, Inc. announced a significant development in its intellectual property portfolio. The Singapore Patent Office granted a patent covering the use of Genprex’s lead drug candidate, Reqorsa® Gene Therapy, when combined with anti-PD-1 antibodies through 2037. This new patent builds on earlier patents obtained in the United States, Japan, Mexico, Russia, Australia, Chile, China, and Korea.
The protection expands the company’s exclusivity for using Reqorsa® as part of combination treatments in cancer therapy. In Korea, the patent grant even includes the application of Reqorsa® together with PD-L1 antibodies. Genprex plans to file additional patent applications in key regions including the US, Brazil, Canada, China, Europe, and Israel for similar combinations. These steps are expected to strengthen Genprex’s market position, especially in Asian markets where lung cancer prevalence is high.
Read Announcement- Drug:
- REQORSA®+ Tecentriq
- Announced Date:
- May 14, 2024
- Indication:
- For the Treatment of Small Cell Lung Cancer
Announcement
Genprex, Inc announced that the first patient has been enrolled and dosed in the Company's Phase 1 dose escalation portion of the Acclaim-3 clinical study of Reqorsa® (quaratusugene ozeplasmid) Immunogene Therapy in combination with Genentech's Tecentriq® to treat patients with extensive-stage small cell lung cancer (ES-SCLC).
AI Summary
Genprex, Inc. has recently announced a significant milestone in its clinical development. The company confirmed that the first patient has been enrolled and dosed in the Phase 1 dose escalation portion of the Acclaim-3 clinical study. This study is focused on evaluating Reqorsa® (quaratusugene ozeplasmid) Immunogene Therapy in combination with Genentech's Tecentriq®. The treatment is being tested for its potential to help patients with extensive-stage small cell lung cancer (ES-SCLC). As a Phase 1 study, the main goal is to assess the safety of the treatment while also gathering early signs of its effectiveness. This early enrollment is an important step that may offer new hope for patients suffering from this aggressive form of lung cancer, as the study moves forward to understand the therapy's impact on the disease.
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EORTC-NCI-AACR FDA Regulatory Events
EORTC-NCI-AACR is a drug developed by Genprex for the following indication: Molecular Targets and Cancer Therapeutics.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EORTC-NCI-AACR
- Announced Date:
- October 10, 2024
- Indication:
- Molecular Targets and Cancer Therapeutics
Announcement
Genprex, Inc announced that its research collaborators will present at the upcoming 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics being held October 23-25, 2024 in Barcelona, Spain.
AI Summary
Genprex, Inc. announced that its research collaborators will present promising preclinical data at the upcoming 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. The symposium is set for October 23-25, 2024 in Barcelona, Spain.
The collaborators will share research findings on Reqorsa® Gene Therapy, which utilizes the TUSC2 tumor suppressor gene delivered through lipid-based nanoparticles. Preclinical studies indicate that Reqorsa may overcome resistance in lung cancer and effectively suppress tumor growth in aggressive cancers like mesothelioma and glioblastoma. These presentations aim to highlight Reqorsa’s potential as a new therapeutic strategy for cancers that are difficult to treat with current options, and they pave the way for further clinical development.
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Acclaim-3 FDA Regulatory Events
Acclaim-3 is a drug developed by Genprex for the following indication: In lung cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Acclaim-3
- Announced Date:
- August 15, 2024
- Indication:
- In lung cancer
Announcement
Genprex, Inc. released a new video featuring the Company's Chief Medical Officer, Mark Berger, MD, discussing positive clinical study updates from its Acclaim-3 Phase 1/2 clinical trials in lung cancer and recent updates to the Company's oncology clinical development program.
AI Summary
Genprex, Inc. has released a new video featuring its Chief Medical Officer, Mark Berger, MD, who highlights promising updates from the company’s Acclaim-3 Phase 1/2 clinical trials in lung cancer. In the video, Dr. Berger discusses a remarkable patient response during maintenance therapy in the Acclaim-3 trial, noting that one patient achieved a partial remission—an uncommon outcome in such trials. He also shared positive insights from the Acclaim-1 study, where improved patient outcomes and a decrease in side effects over time were observed. Additionally, Dr. Berger announced adjustments to the oncology clinical development program, including streamlining efforts in both Acclaim-1 and Acclaim-2 studies to speed up patient enrollment and optimize resources. These developments signal a positive step forward in Genprex’s mission to advance gene therapy treatments for lung cancer patients.
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Acclaim-1 FDA Regulatory Events
Acclaim-1 is a drug developed by Genprex for the following indication: In lung cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Acclaim-1
- Announced Date:
- August 15, 2024
- Indication:
- In lung cancer
Announcement
Genprex, Inc. released a new video featuring the Company's Chief Medical Officer, Mark Berger, MD, discussing positive clinical study updates from its Acclaim-1 Phase 1/2 clinical trials in lung cancer and recent updates to the Company's oncology clinical development program.
AI Summary
Genprex, Inc. has released a new video featuring Chief Medical Officer Mark Berger, MD, where he discusses promising updates from the company’s lung cancer clinical trials and recent shifts in its oncology clinical development program. In the Acclaim-1 Phase 1/2 trial, patients with late-stage non-small cell lung cancer (NSCLC) treated with the combination of Reqorsa® Gene Therapy and AstraZeneca’s Tagrisso® have shown encouraging results, including prolonged progression-free survival and diminishing side effects over time. Additionally, early positive data from the Acclaim-3 trial revealed a notable partial remission in a patient receiving maintenance therapy with REQORSA and Genentech’s Tecentriq®. Dr. Berger also outlined adjustments to streamline clinical efforts, such as removing a cohort in Acclaim-1 and closing enrollment in Acclaim-2 to focus resources on faster patient enrollment and data collection.
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