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Genprex Announces U.S. Patent for Reqorsa® Gene Therapy in Combination with PD-L1 Antibodies to Treat Cancers

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Genprex (NASDAQ: GNPX) announced the USPTO granted a U.S. patent covering use of its lead candidate Reqorsa gene therapy in combination with PD-L1 antibodies (example: Tecentriq) for cancer treatment, with protection through 2037. The patent is said to apply to Genprex's Acclaim-3 clinical trial in small cell lung cancer and is already granted in the U.S. and Korea. Genprex is pursuing additional patent applications in Europe, Canada, Brazil, China, and Israel, which the company says would extend protection to those trials if granted.

Genprex (NASDAQ: GNPX) ha annunciato che l'USPTO ha concesso un brevetto statunitense che copre l'uso del suo principale candidato Reqorsa terapia genica in combinazione con anticorpi PD-L1 (esempio: Tecentriq) per il trattamento del cancro, con protezione fino al 2037. Si dice che il brevetto riguardi lo studio clinico Acclaim-3 di Genprex sul cancro polmonare a piccole cellule ed è già concesso negli Stati Uniti e in Corea. Genprex sta perseguendo ulteriori domande di brevetto in Europa, Canada, Brasile, Cina e Israele, che l'azienda dice estenderebbe la protezione a quegli studi se concessa.

Genprex (NASDAQ: GNPX) anunció que la USPTO concedió una patente estadounidense que cubre el uso de su candidato principal Reqorsa terapia génica en combinación con anticuerpos PD-L1 (ejemplo: Tecentriq) para el tratamiento del cáncer, con protección hasta 2037. Se dice que la patente se aplica al ensayo clínico Acclaim-3 de Genprex en el cáncer de pulmón de células pequeñas y ya está concedida en EE. UU. y Corea. Genprex está buscando solicitudes de patente adicionales en Europa, Canadá, Brasil, China e Israel, lo que la empresa afirma extendería la protección a esos ensayos si se concede.

Genprex (NASDAQ: GNPX)은 USPTO가 자사의 주요 후보)Reqorsa 유전자 치료제를 PD-L1 항체(예: Tecentriq)와 병용한 암 치료용 사용에 대한 미국 특허를 부여했다고 발표했으며, 보호 기간은 2037년까지입니다. 이 특허는 Genprex의 Acclaim-3 임상시험(소세포폐암)에 적용된다고 하며 미국과 한국에서 이미 허가되었습니다. Genprex는 유럽, 캐나다, 브라질, 중국, 이스라엘에서 추가 특허 출원을 추진 중이며, 승인이 되면 해당 시험에도 보호가 확대될 것이라고 회사는 말합니다.

Genprex (NASDAQ : GNPX) a annoncé que l'USPTO a accordé un brevet américain couvrant l'utilisation de son principal candidat Reqorsa, thérapie génique, en association avec des anticorps PD-L1 (exemple : Tecentriq) pour le traitement du cancer, avec une protection jusqu'en 2037. Le brevet serait applicable à l'essai clinique Acclaim-3 de Genprex dans le cancer du poumon à petites cellules et est déjà délivré aux États-Unis et en Corée. Genprex poursuit des demandes de brevets supplémentaires en Europe, Canada, Brésil, Chine et Israël, ce qui, selon l'entreprise, étendrait la protection à ces essais si elles sont accordées.

Genprex (NASDAQ: GNPX) gab bekannt, dass das USPTO ein US-Patent gewährt hat, das die Verwendung ihres Lead-Kandidaten Reqorsa-Gentherapie in Kombination mit PD-L1-Antikörpern (Beispiel: Tecentriq) zur Krebsbehandlung abdeckt, mit Schutz bis zum 2037. Das Patent soll laut Angaben für die Genprex-Studie Acclaim-3 im kleinzelligen Lungenkrebs gelten und ist bereits in den USA und Korea erteilt. Genprex verfolgt weitere Patentanmeldungen in Europa, Kanada, Brasilien, China und Israel, von denen das Unternehmen sagt, dass sie den Schutz auf diese Studien erweitern würden, falls genehmigt.

Genprex (NASDAQ: GNPX) أعلنت أن مكتب براءات الاختراع الأمريكي (USPTO) منح براءة لاستخدام مرشحها الرئيسي Reqorsa للعلاج الجيني بالتعاون مع أضداد PD-L1 (مثال: Tecentriq) لعلاج السرطان، مع حماية حتى 2037. وتُذكر أن البراءة تنطبق على تجربة Genprex الإكلينيكية Acclaim-3 لسرطان الرئة بالخلايا الصغيرة وهي مُنحت بالفعل في الولايات المتحدة وكوريا. تسعى Genprex إلى تقديم طلبات براءات إضافية في أوروبا وكندا والبرازيل والصين وإسرائيل، وتقول الشركة إن ذلك سيمتد بالحماية إلى تلك التجارب إذا ما مُنحت.

Positive
  • U.S. patent granted covering Reqorsa+PD-L1 combos through 2037
  • Patent explicitly tied to Acclaim-3 small cell lung cancer trial
  • Patents already granted in U.S. and Korea
Negative
  • Patent protection currently granted only in U.S. and Korea; other jurisdictions pending

Strengthens Intellectual Property Portfolio and Provides Protection for Therapeutic Combination in Acclaim-3 Clinical Trial

AUSTIN, Texas, Nov. 18, 2025 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today 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.

"We continue to build protection around our lead drug candidate, REQORSA, and this new patent provides the necessary technology protection applicable to our Acclaim-3 clinical trial in small cell lung cancer," said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing at Genprex. "In the Acclaim-3 clinical trial, we are combining REQORSA with Tecentriq, a PD-L1 antibody, and this patent secures exclusivity for this drug combination for the treatment of cancer, preventing would-be competitors from making, using or selling this drug combination."

Genprex has been granted patents for the use of REQORSA in combination with PD-L1 antibodies in the U.S. and Korea. Genprex is pursuing additional patent applications in Europe, Canada, Brazil, China and Israel. Should these applications grant, they would also be applicable to Genprex's Acclaim-3 clinical trial.

PD-L1 antibodies are a type of targeted immunotherapy that block the activity of PD-L1 immune checkpoint proteins present on the surface of cells.

About Acclaim-3
Acclaim-3 is a Phase 1/2 clinical trial evaluating the combination of REQORSA and Genentech's Tecentriq® (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who are candidates for maintenance therapy after receiving Tecentriq and chemotherapy as standard of care initial treatment. In this study, patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.

The Phase 2 expansion study follows the successful completion of the Phase 1 dose escalation portion of the study, which showed REQORSA was generally well tolerated. There were no dose limiting toxicities, and in Acclaim-3, the Phase 2 patients are receiving the same dose of REQORSA as patients in the Phase 2 portion of Acclaim-1.

The Phase 2 expansion portion is expected to enroll approximately 50 patients. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. Genprex's team plans to conduct an interim analysis after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company expects to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026. The Acclaim-3 clinical trial is supported by U.S. Food and Drug Administration (FDA) Fast Track Designation and Orphan Drug Designation.

About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach for Type 2 diabetes, where autoimmunity is not at play, GPX-002 is believed to rejuvenate and replenish exhausted beta cells.

Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following Genprex on Twitter, Facebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2024.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications; the timing and success of Genprex's clinical trials, its intended regulatory submissions and any resulting regulatory approvals; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex's future growth and financial status, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; Genprex's intellectual property and licenses, including the potential for future grants of patent applications globally; and Genprex's current expectations, estimates, forecasts and projections about the industry and markets in which it operates.

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.
(877) 774-GNPX (4679)

GNPX Investor Relations
investors@genprex.com

GNPX Media Contact
Kalyn Dabbs
media@genprex.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/genprex-announces-us-patent-for-reqorsa-gene-therapy-in-combination-with-pd-l1-antibodies-to-treat-cancers-302617555.html

SOURCE Genprex, Inc.

FAQ

What did Genprex announce on November 18, 2025 about GNPX patent protection?

Genprex said the USPTO granted a U.S. patent for Reqorsa used with PD-L1 antibodies, providing exclusivity through 2037.

How does the new patent affect the Acclaim-3 trial for GNPX?

The company states the patent secures technology protection for combining Reqorsa with PD-L1 antibodies in the Acclaim-3 small cell lung cancer trial.

Which PD-L1 antibody example did Genprex reference for the GNPX patent?

Genprex referenced Tecentriq as an example of a PD-L1 antibody covered by the patent.

In which countries does Genprex already have patents for the Reqorsa and PD-L1 combination?

Genprex has been granted patents in the United States and Korea.

Is Genprex seeking patent protection for GNPX in other regions and which ones?

Yes; Genprex is pursuing additional patent applications in Europe, Canada, Brazil, China, and Israel.

What is the length of exclusivity the Genprex press release cites for the new patent?

The press release cites exclusivity for the drug combination in the U.S. through 2037.
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