Genprex Receives Notice of Allowance for Multiple Patents for Reqorsa庐 Gene Therapy with PD-L1 and PD-1 Antibodies to Treat Cancers
Genprex (NASDAQ: GNPX) has received significant patent allowances for its lead drug candidate Reqorsa庐 Gene Therapy in combination with immune checkpoint inhibitors. The U.S. Patent Office has allowed a patent for Reqorsa with PD-L1 antibodies, while the European Patent Office has allowed one for combination with PD-1 antibodies. Both patents extend until at least 2037.
The company's Acclaim-3 Phase 1/2 clinical trial combines Reqorsa with Tecentriq庐 as maintenance therapy for extensive stage small cell lung cancer (ES-SCLC) patients. This trial has received both FDA Fast Track Designation and Orphan Drug Designation. Genprex has already secured similar patents in multiple countries including Korea, Japan, Mexico, Russia, and China.
Genprex (NASDAQ: GNPX) ha ottenuto significative concessioni di brevetto per il suo principale candidato terapeutico, la terapia genica Reqorsa庐, in combinazione con inibitori del checkpoint immunitario. L'Ufficio Brevetti statunitense ha ammesso un brevetto per Reqorsa in associazione ad anticorpi anti鈥慞D鈥慙1, mentre l'Ufficio Europeo dei Brevetti ha concesso uno per la combinazione con anticorpi anti鈥慞D鈥�1. Entrambi i brevetti hanno scadenza almeno fino al 2037.
Lo studio clinico Acclaim鈥�3 di fase 1/2 della societ脿 prevede la combinazione di Reqorsa con Tecentriq庐 come terapia di mantenimento per pazienti con carcinoma polmonare microcitico in stadio esteso (ES鈥慡CLC). Questo trial ha ricevuto la Fast Track Designation e la Orphan Drug Designation dalla FDA. Genprex ha gi脿 ottenuto brevetti analoghi in diversi Paesi, tra cui Corea, Giappone, Messico, Russia e Cina.
Genprex (NASDAQ: GNPX) ha logrado importantes concesiones de patentes para su principal candidato terap茅utico, la terapia g茅nica Reqorsa庐, en combinaci贸n con inhibidores del punto de control inmunitario. La Oficina de Patentes de EE.聽UU. ha permitido una patente para Reqorsa junto a anticuerpos anti鈥慞D鈥慙1, mientras que la Oficina Europea de Patentes ha aprobado una para la combinaci贸n con anticuerpos anti鈥慞D鈥�1. Ambas patentes se extienden al menos hasta 2037.
El ensayo cl铆nico Acclaim鈥�3 de fase 1/2 de la compa帽铆a combina Reqorsa con Tecentriq庐 como terapia de mantenimiento para pacientes con c谩ncer de pulm贸n de c茅lulas peque帽as en estadio extenso (ES鈥慡CLC). Este ensayo ha obtenido la Fast Track Designation y la Orphan Drug Designation de la FDA. Genprex ya ha asegurado patentes similares en varios pa铆ses, incluidos Corea, Jap贸n, M茅xico, Rusia y China.
Genprex (NASDAQ: GNPX)電� 欤检殧 臧滊皽 鞎诫鞚� Reqorsa庐 鞙犾爠鞛� 旃橂鞝�毳� 氅挫棴甏�氍胳柕鞝滌牅鞕� 氤戩毄頃橂姅 瓴冹棎 雽�頃� 欷戩殧頃� 韸鬼棃 項堦皜毳� 氚涭晿鞀惦媹雼�. 氙戈淡 韸鬼棃觳潃 PD鈥慙1 頃泊鞕�鞚� 臁绊暕鞐� 甏�頃� Reqorsa 韸鬼棃毳� 項堦皜頄堨溂氅�, 鞙犽熃 韸鬼棃觳潃 PD鈥�1 頃泊鞕�鞚� 氤戩毄鞐� 甏�頃� 韸鬼棃毳� 項堦皜頄堨姷雼堧嫟. 霊� 韸鬼棃 氇憪 斓滌唽 2037雲勱箤歆� 鞙犿毃頃╇媹雼�.
须岇偓鞚� Acclaim鈥�3 鞝�1/2靸� 鞛勳儊鞁滍棙鞚� 鞙犾鞖旊矔鞙茧 Tecentriq庐瓿� Reqorsa毳� 氤戩毄頃� 歆勴枆霅橂┌ 甏戨矓鞙� 氤戧赴 靻岇劯韽彁鞎�(ES鈥慡CLC) 頇橃瀽毳� 雽�靸侅溂搿� 頃╇媹雼�. 鞚� 鞁滍棙鞚� FDA搿滊秬韯� 韺姢韸疙姼霝� 歆�鞝�瓿� 頋穩鞚橃暯頀� 歆�鞝�鞚� 氚涭晿鞀惦媹雼�. Genprex電� 鞚措 頃滉淡, 鞚茧掣, 氅曥嫓旖�, 霟嫓鞎�, 欷戧淡 霌� 鞐煬 甑皜鞐愳劀 鞙犾偓頃� 韸鬼棃毳� 頇曤炒頄堨姷雼堧嫟.
Genprex (NASDAQ: GNPX) a obtenu d'importantes d茅livrances de brevets pour son principal candidat-m茅dicament, la th茅rapie g茅nique Reqorsa庐, en association avec des inhibiteurs des points de contr么le immunitaire. L'Office des brevets des 脡tats鈥慤nis a autoris茅 un brevet pour Reqorsa avec des anticorps anti鈥慞D鈥慙1, tandis que l'Office europ茅en des brevets a d茅livr茅 un brevet pour la combinaison avec des anticorps anti鈥慞D鈥�1. Les deux brevets sont valables au moins jusqu'en 2037.
L'essai clinique Acclaim鈥�3 de phase 1/2 de la soci茅t茅 associe Reqorsa 脿 Tecentriq庐 en th茅rapie d'entretien pour les patients atteints d'un carcinome pulmonaire 脿 petites cellules en stade 茅tendu (ES鈥慡CLC). Cet essai a re莽u la Fast Track Designation et la Orphan Drug Designation de la FDA. Genprex a d茅j脿 obtenu des brevets similaires dans plusieurs pays, dont la Cor茅e, le Japon, le Mexique, la Russie et la Chine.
Genprex (NASDAQ: GNPX) hat bedeutende Patenterteilungen f眉r seinen f眉hrenden Wirkstoffkandidaten, die Reqorsa庐 Gentherapie, in Kombination mit Immun-Checkpoint-Inhibitoren erhalten. Das US-Patentamt hat ein Patent f眉r Reqorsa in Kombination mit PD鈥慙1鈥慉ntik枚rpern zugelassen, w盲hrend das Europ盲ische Patentamt eines f眉r die Kombination mit PD鈥�1鈥慉ntik枚rpern erteilt hat. Beide Patente laufen mindestens bis 2037.
Die Acclaim鈥�3 Phase鈥�1/2鈥慡tudie des Unternehmens kombiniert Reqorsa mit Tecentriq庐 als Erhaltungstherapie f眉r Patientinnen und Patienten mit kleinzelligem Lungenkrebs im ausgedehnten Stadium (ES鈥慡CLC). Diese Studie erhielt sowohl die FDA Fast Track Designation als auch die Orphan Drug Designation. Genprex hat bereits vergleichbare Patente in mehreren L盲ndern wie Korea, Japan, Mexiko, Russland und China gesichert.
- Patent protection secured until at least 2037 for key drug combinations
- FDA Fast Track and Orphan Drug Designations obtained for Acclaim-3 trial
- Extensive international patent coverage across multiple major markets
- Strategic protection for combination therapy with established cancer treatments
- Additional patent applications still pending in several key markets including Europe and China
- Clinical trials still in early phases (Phase 1/2)
Insights
Genprex secures critical patent protection for REQORSA cancer therapy combinations, strengthening their competitive position through 2037.
Genprex has significantly bolstered its intellectual property position with these new patent allowances for REQORSA in combination with important immunotherapy agents. The US patent covering REQORSA with PD-L1 antibodies (like Tecentriq) and the European patent for REQORSA with PD-1 antibodies provide exclusivity until at least 2037 - a substantial runway for commercialization if clinical trials succeed.
The strategic value here is twofold. First, these patents directly protect the combination therapy being evaluated in their Acclaim-3 clinical trial for extensive stage small cell lung cancer. Second, Genprex is building a global intellectual property fortress, having already secured similar patents in multiple countries including Korea, Japan, China, and Australia, with applications pending in several other markets.
This patent portfolio expansion is particularly significant because it covers combinations with checkpoint inhibitors - one of the most important classes of cancer immunotherapies. The FDA's Fast Track and Orphan Drug designations for the Acclaim-3 trial further enhance the value of this intellectual property by potentially accelerating the regulatory pathway and providing additional market exclusivity.
For a clinical-stage biotech company like Genprex, robust patent protection is essential for maintaining competitive advantage and attracting potential commercial partners, as it prevents competitors from easily replicating their therapeutic approach if clinical trials demonstrate efficacy.
Strengthens Intellectual Property Estate for REQORSA Oncology Program with Immune Checkpoint Inhibitors
"We are very proud to continue building a fortress of intellectual property protection around our oncology program for REQORSA, and these newly granted patents strengthen and expand our intellectual property estate for REQORSA in combination with immune checkpoint inhibitors applicable to our Acclaim-3 clinical trial," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex.
Genprex has been granted patents for the use of REQORSA in combination with PD-L1 antibodies in
Genprex has been granted patents for the use of REQORSA in combination with PD-1 antibodies in the
PD-L1 and PD-1 antibodies are a type of targeted immunotherapy and a part of a group of checkpoint inhibitor anti-cancer drugs that block the activity of PD-L1 and PD-1 immune checkpoint proteins present on the surface of cells.
The Acclaim-3 study is a Phase 1/2 clinical trial that uses a combination of REQORSA and Genentech's Tecentriq庐 as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who are candidates for maintenance therapy 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庐 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庐 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.
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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 鈥� 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聽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.
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