Genprex Granted Patent in Singapore for Reqorsa® Gene Therapy with PD-1 Antibodies to Treat Cancers
Genprex (NASDAQ: GNPX) has been granted a patent in Singapore for its lead drug candidate, Reqorsa® Gene Therapy, in combination with anti-PD-1 antibodies for cancer treatment. This patent, valid through 2037, expands on previously granted patents in other countries and covers the use of REQORSA with immune checkpoint inhibitors. The company plans to pursue additional patents for REQORSA combined with PD-L1 antibodies in various countries, which could apply to their Acclaim-3 clinical trial.
The patent strengthens Genprex's intellectual property portfolio, particularly in Asian markets where lung cancer is prevalent. In 2022, Asia accounted for 63% of new lung cancer cases worldwide. The Acclaim-3 study, a Phase 1/2 clinical trial, combines REQORSA with Genentech's Tecentriq® for extensive stage small cell lung cancer (ES-SCLC) patients. This trial has received FDA Fast Track Designation and Orphan Drug Designation.
Genprex (NASDAQ: GNPX) ha ottenuto un brevetto a Singapore per il suo principale candidato farmaceutico, Reqorsa® Gene Therapy, in combinazione con anticorpi anti-PD-1 per il trattamento del cancro. Questo brevetto, valido fino al 2037, amplia i brevetti già concessi in altri paesi e copre l'uso di REQORSA con inibitori dei checkpoint immunitari. L'azienda prevede di perseguire ulteriori brevetti per REQORSA in combinazione con anticorpi PD-L1 in vari paesi, il che potrebbe interessare il loro studio clinico Acclaim-3.
Il brevetto rafforza il portfolio di proprietà intellettuale di Genprex, in particolare nei mercati asiatici dove il cancro ai polmoni è prevalente. Nel 2022, l'Asia ha rappresentato il 63% dei nuovi casi di cancro ai polmoni a livello mondiale. Lo studio Acclaim-3, un trial clinico di fase 1/2, combina REQORSA con il Tecentriq® di Genentech per i pazienti affetti da cancro ai polmoni a piccole cellule in stadio avanzato (ES-SCLC). Questo trial ha ricevuto la Designazione di Percorso Veloce della FDA e la Designazione di Farmaco Orfano.
Genprex (NASDAQ: GNPX) ha sido otorgada una patente en Singapur para su principal candidato a fármaco, Reqorsa® Gene Therapy, en combinación con anticuerpos anti-PD-1 para el tratamiento del cáncer. Esta patente, válida hasta 2037, amplía las patentes concedidas anteriormente en otros países y cubre el uso de REQORSA con inhibidores de puntos de control inmunitarios. La compañía planea seguir buscando patentes adicionales para REQORSA combinado con anticuerpos PD-L1 en varios países, lo que podría aplicarse a su ensayo clínico Acclaim-3.
La patente fortalece el portafolio de propiedad intelectual de Genprex, particularmente en mercados asiáticos donde el cáncer de pulmón es prevalente. En 2022, Asia representó el 63% de los nuevos casos de cáncer de pulmón en todo el mundo. El estudio Acclaim-3, un ensayo clínico de fase 1/2, combina REQORSA con el Tecentriq® de Genentech para pacientes con cáncer de pulmón de células pequeñas en etapa extensa (ES-SCLC). Este ensayo ha recibido la Designación de Vía Rápida de la FDA y la Designación de Medicamento Huérfano.
Genprex (NASDAQ: GNPX)는 싱가포르에서 주력 약물 후보인 Reqorsa® 유전자 요법에 대한 특허를 승인받았습니다. 이 특허는 항-PD-1 항체와 함께 사용되는 암 치료를 포함하며, 2037년까지 유효합니다. 이 특허는 다른 국가에서 이미 부여된 특허를 확장하며, REQORSA와 면역 체크포인트 억제제의 사용을 포함합니다. 회사는 REQORSA와 PD-L1 항체의 조합에 대해 다양한 국가에서 추가 특허를 추구할 계획이며, 이는 그들의 Acclaim-3 임상 시험에 적용될 수 있습니다.
이 특허는 특히 폐암이 흔한 아시아 시장에서 Genprex의 지적 재산 포트폴리오를 강화합니다. 2022년, 아시아는 전 세계 신규 폐암 사례의 63%를 차지했습니다. Acclaim-3 연구는 REQORSA와 Genentech의 Tecentriq®를 결합하여 진행성 소세포 폐암 (ES-SCLC) 환자를 대상으로 하는 1/2상 임상 시험입니다. 이 시험은 FDA의 신속 심사 지정 및 희귀 의약품 지정도 받았습니다.
Genprex (NASDAQ: GNPX) a obtenu un brevet à Singapour pour son principal candidat médicament, Reqorsa® Thérapie génique, en combinaison avec des anticorps anti-PD-1 pour le traitement du cancer. Ce brevet, valable jusqu'en 2037, élargit les brevets déjà accordés dans d'autres pays et couvre l'utilisation de REQORSA avec des inhibiteurs de points de contrôle immunitaire. La société prévoit de demander des brevets supplémentaires pour REQORSA combiné avec des anticorps PD-L1 dans divers pays, ce qui pourrait s'appliquer à leur essai clinique Acclaim-3.
Le brevet renforce le portefeuille de propriété intellectuelle de Genprex, en particulier sur les marchés asiatiques où le cancer du poumon est courant. En 2022, l'Asie a représenté 63 % des nouveaux cas de cancer du poumon dans le monde. L'étude Acclaim-3, un essai clinique de phase 1/2, combine REQORSA avec le Tecentriq® de Genentech pour des patients atteints de cancer du poumon à petites cellules à un stade avancé (ES-SCLC). Cet essai a reçu la désignation FDA Fast Track et la désignation de médicament orphelin.
Genprex (NASDAQ: GNPX) hat in Singapur ein Patent für seinen führenden Arzneimittelkandidaten, Reqorsa® Gentherapie, in Kombination mit anti-PD-1-Antikörpern zur Krebsbehandlung erhalten. Dieses Patent, gültig bis 2037, erweitert zuvor in anderen Ländern erteilte Patente und deckt die Verwendung von REQORSA mit Immun-Checkpoint-Inhibitoren ab. Das Unternehmen plant, weitere Patente für die Kombination von REQORSA mit PD-L1-Antikörpern in verschiedenen Ländern zu beantragen, was sich auf ihre Acclaim-3-Studie beziehen könnte.
Das Patent stärkt das geistige Eigentum von Genprex, insbesondere in asiatischen Märkten, wo Lungenkrebs weit verbreitet ist. Im Jahr 2022 entfielen 63 % der neuen Lungenkrebsfälle weltweit auf Asien. Die Acclaim-3-Studie, eine klinische Phase-1/2-Studie, kombiniert REQORSA mit Genentechs Tecentriq® für Patienten mit fortgeschrittenem kleinzelligen Lungenkrebs (ES-SCLC). Diese Studie erhielt den Fast Track Status der FDA und die Orphan Drug Designation.
- Granted patent in Singapore for Reqorsa® Gene Therapy in combination with anti-PD-1 antibodies, valid through 2037
- Expands intellectual property portfolio and protection in Asian markets
- Acclaim-3 clinical trial received FDA Fast Track Designation and Orphan Drug Designation
- None.
Insights
The patent grant in Singapore for Reqorsa® Gene Therapy in combination with PD-1 antibodies is a significant development for Genprex. This expands their intellectual property protection in Asia, a important market given that
The combination therapy approach targeting both gene therapy and immunotherapy pathways shows promise in potentially enhancing treatment efficacy. The ongoing Acclaim-3 study, which has received FDA Fast Track and Orphan Drug Designations, further underscores the potential of this approach in addressing the unmet needs in extensive stage small cell lung cancer treatment.
However, it's important to note that while patent protection is crucial, the ultimate success will depend on clinical trial outcomes and regulatory approvals. Investors should closely monitor the progress of the Acclaim-3 study and any forthcoming data releases.
The granting of this patent in Singapore strengthens Genprex's intellectual property portfolio significantly. It's part of a broader strategy to secure global patent protection, with similar patents already granted in several key markets including the U.S., Japan and China. This comprehensive approach to IP protection is important in the biotechnology sector.
The patent's scope, covering the combination of Reqorsa® with PD-1 antibodies, is particularly valuable. It potentially blocks competitors from developing similar combination therapies until 2037, giving Genprex a substantial window for market exclusivity if the therapy proves successful.
The company's pursuit of additional patents for combinations with PD-L1 antibodies in other jurisdictions demonstrates a forward-thinking IP strategy. However, investors should be aware that patent grants don't guarantee market success and the path from patent to profitable product in biotech is often long and uncertain.
Expands on the previously granted patents covering the use of REQORSA in combination with immune checkpoint inhibitors
This patent expands on the previously granted patents in the
PD-1 inhibitors and PD-L1 inhibitors are a type of targeted immunotherapy and a part of a group of checkpoint inhibitor anti-cancer drugs that block the activity of PD-1 and PDL1 immune checkpoint proteins present on the surface of cells.
"This patent expands our intellectual property portfolio, providing us with additional protection and exclusivity for our drug combinations with REQORSA and furthering our patent protection in the Asian markets where lung cancer is the most prevalent," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex.
According to GLOBOCAN, in 2022 Asia accounted for
The Acclaim-3 study is a Phase 1/2 clinical trial that uses a combination of REQORSA and Genentech's Tecentriq® as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who developed tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. The Acclaim-3 clinical trial has received
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 currently 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, GPX-002 for Type 2 diabetes, where autoimmunity is not at play, 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, 2023.
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 and regulatory approvals; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; the effects of any strategic research and development prioritization initiatives, and any other efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex's oncology and/or other clinical development programs including prioritization of resources, and the extent to which Genprex is able to implement such efforts and initiatives successfully to achieve the desired and intended results thereof; 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; and Genprex's intellectual property and licenses.
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.
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FAQ
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