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Genprex Collaborators Present Positive Preclinical Data on Reqorsa® Gene Therapy at the Society for Immunotherapy of Cancer 2024 Annual Meeting

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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 ha annunciato dati preclinici positivi per il suo candidato principale Reqorsa® Gene Therapy durante la riunione della Società per l'Immunoterapia del Cancro. I collaboratori della ricerca presso il Meharry Medical College hanno dimostrato che Reqorsa modula efficacemente le risposte immunitarie contro i tumori. Lo studio ha mostrato che nei topi Knock Out TUSC2 trattati con Reqorsa, la crescita tumorale è diminuita, con una significativa riduzione delle cellule T regolatorie e un aumento delle cellule T citotossiche e delle cellule NK all'interno dei leucociti infiltranti tumorali. La ricerca convalida i meccanismi antitumorali di Reqorsa e il suo potenziale nel trattamento di vari tipi di cancro, in particolare negli individui con bassi livelli di TUSC dovuti all'invecchiamento, a infiammazioni croniche o a malattie metaboliche.

Genprex anunció datos preclínicos positivos para su principal candidato a fármaco Reqorsa® Gene Therapy en la reunión de la Sociedad de Inmunoterapia del Cáncer. Colaboradores de investigación en el Meharry Medical College demostraron que Reqorsa modula eficazmente las respuestas inmunitarias contra el cáncer. El estudio mostró que en ratones Knock Out TUSC2 tratados con Reqorsa, el crecimiento tumoral se redujo, con una disminución significativa en las células T reguladoras y un aumento en las células T citotóxicas y células NK dentro de los leucocitos infiltrantes tumoriales. La investigación valida los mecanismos antitumorales de Reqorsa y su potencial para tratar varios tipos de cáncer, particularmente en individuos con bajos niveles de TUSC debido al envejecimiento, inflamación crónica o enfermedades metabólicas.

Genprex는 암 면역 치료 학회에서 주요 약물 후보인 Reqorsa® 유전자 치료에 대한 긍정적인 전임상 데이터를 발표했습니다. Meharry Medical College의 연구 협력자들은 Reqorsa가 암에 대한 면역 반응을 효과적으로 조절한다는 것을 입증했습니다. 연구 결과, Reqorsa로 치료받은 TUSC2 Knock Out 쥐에서 종양 성장이 감소하고, Treg 세포는 큰 폭으로 줄어들며, 세포독성 T 세포와 NK 세포는 종양 침윤 백혈구 내에서 증가하였습니다. 이 연구는 Reqorsa의 항종양 메커니즘과 노화, 만성 염증 또는 대사 질환으로 인해 낮은 TUSC 수준을 가진 개인에서 다양한 암을 치료할 수 있는 잠재력을 검증합니다.

Genprex a annoncé des données précliniques positives pour son principal candidat médicament Reqorsa® Thérapie Génique lors de la réunion de la Société d'Immunothérapie du Cancer. Des collaborateurs de recherche du Meharry Medical College ont démontré que Reqorsa module efficacement les réponses immunitaires contre les cancers. L'étude a montré que chez les souris Knock Out TUSC2 traitées avec Reqorsa, la croissance tumorale était diminuée, avec une réduction significative des cellules T régulatrices et une augmentation des cellules T cytotoxiques et des cellules NK au sein des leucocytes infiltrant les tumeurs. La recherche valide les mécanismes anti-tumoraux de Reqorsa et son potentiel pour traiter divers cancers, en particulier chez les individus ayant de faibles niveaux de TUSC en raison du vieillissement, de l'inflammation chronique ou de maladies métaboliques.

Genprex hat bei der Sitzung der Gesellschaft für Immuntherapie von Krebs positive präklinische Daten für seinen Hauptkandidaten Reqorsa® Gentherapie bekanntgegeben. Forschungskooperationspartner am Meharry Medical College haben gezeigt, dass Reqorsa effektiv Immunantworten gegen Krebs moduliert. Die Studie zeigte, dass bei mit Reqorsa behandelten TUSC2 Knock Out-Mäusen das Tumorwachstum verringert wurde, mit einem signifikanten Rückgang der T-reg-Zellen und einem Anstieg der zytotoxischen T-Zellen sowie der NK-Zellen innerhalb der tumorinfiltrierenden Leukozyten. Die Forschung validiert die antitumoralen Mechanismen von Reqorsa und das Potenzial zur Behandlung verschiedener Krebsarten, insbesondere bei Personen mit niedrigen TUSC-Spiegeln aufgrund von Alterung, chronischer Entzündung oder Stoffwechselerkrankungen.

Positive
  • Preclinical data showed tumor growth reduction in treated subjects
  • Demonstrated significant increase in anti-tumor immune response
  • Showed 10-33 times higher uptake in tumor cells compared to normal cells
  • Validated therapeutic potential for various cancer types
Negative
  • Still in preclinical stage, requiring further clinical validation
  • Results to animal studies, human efficacy yet to be proven

Insights

The preclinical data for REQORSA shows promising therapeutic potential in cancer treatment. The study demonstrates that REQORSA can effectively reduce tumor growth and modulate immune responses in TUSC2 knockout mice. Key findings include:

  • Significant reduction in T regulatory cells (which typically suppress immune responses)
  • Increased presence of cytotoxic T cells and NK cells in tumor-infiltrating leucocytes
  • Enhanced expression of Granzyme B, indicating improved tumor-killing capability

The selective targeting mechanism, showing 10-33x higher uptake in tumor cells versus normal cells, suggests a favorable safety profile. However, investors should note that while preclinical results are encouraging, clinical translation remains to be proven. For a micro-cap company ($5.3M), successful development could significantly impact valuation, though substantial risks remain in the clinical development pathway.

REQORSA Modulates In Vivo Immune Responses Against Cancers

AUSTIN, Texas, Nov. 5, 2024 /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 its research collaborators at Meharry Medical College will present a poster detailing positive preclinical data from a study of the Company's lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid) evaluating TUSC2's role in modulating immune responses in cancer. The poster will be presented at the 39th Annual Society for Immunotherapy of Cancer Meeting being held November 6-10, 2024 in Houston, Texas.

"We are pleased to have our academic partner present their findings on REQORSA at this prestigious cancer meeting, expanding on REQORSA's ability to modulate immune responses in cancer," said Ryan Confer, President and Chief Executive Officer at Genprex. "We continue to bolster the growing body of evidence supporting REQORSA's anti-tumor mechanisms, highlighting its therapeutic potential to treat a variety of cancers."

The Genprex-supported poster to be presented at the 2024 Society for Immunotherapy of Cancer Annual Meeting:

Title: "TUSC2 Modulates Cancer Immune Responses"
Collaborator: Meharry Medical College

In this study, researchers used comparative flow cytometry analysis of splenocytes, lymph nodes cells, and tumor infiltrating leucocytes (TILs) from TUSC2 Knock Out (KO) and TUSC2 Wild Type (WT) mice. FACS analysis was focused on the differences in T reg, Cytotoxic T cells and NK cells between the two mice groups. For analysis of immune responses to tumors, researchers challenged two groups of TUSC2 KO mice with syngeneic  129 Sv background metastatic lung cancer 344SQ cells and injected one group with TUSC2-expressing lipoparticles (REQORSA).

In the REQORSA supplemented group, the tumor growth was diminished. A significant reduction in T reg and significant increase in Cytotoxic T cells and NK cells were observed within TILs. A significant increase in Granzyme B expression within Cytotoxic T cells and NK cells was shown in REQORSA supplemented mice compared to the control group. 

This research expanded on previous studies showing that REQORSA modulates immune cells within the Tumor Micro Environment. REQORSA-dependent changes in immune cells correlated with the reduction in tumor size in the experimental group, indicating that REQORSA may carry anti-tumor potential even for individuals with low overall TUSC levels in various tissues due to aging, chronic inflammation, metabolic diseases, etc. This research documents that REQORSA treatment has been shown to lead to increased immune response against tumors in TUSC2 KO mice.

TUSC2 is the tumor suppressor gene used in REQORSA. REQORSA consists of a TUSC2 gene expressing plasmid encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company's Oncoprex® Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

Following the conference, the poster will be made available to download on Genprex's website, where it can be reviewed in greater detail.

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, 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: REQORSA's therapeutic potential to treat a variety of cancers and ability to modulate immune responses in cancer, such as increased immune response against tumors in TUSC2 KO mice; 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 strategic alternatives or other efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex's diabetes, 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.
(877) 774-GNPX (4679)

GNPX Investor Relations
investors@genprex.com

GNPX Media Contact
Kalyn Dabbs
media@genprex.com

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SOURCE Genprex, Inc.

FAQ

What were the key findings of Genprex's (GNPX) Reqorsa preclinical study in November 2024?

The study showed that Reqorsa treatment reduced tumor growth, decreased T reg cells, and increased Cytotoxic T cells and NK cells within tumor infiltrating leucocytes, demonstrating effective immune response modulation against cancers.

How does Genprex's (GNPX) Reqorsa Gene Therapy target cancer cells?

Reqorsa uses lipid-based nanoparticles to deliver the TUSC2 gene specifically to negatively charged cancer cells, showing 10-33 times higher uptake in tumor cells compared to normal cells.

What is the mechanism of action for Genprex's (GNPX) Reqorsa therapy?

Reqorsa works by delivering a functioning TUSC2 tumor suppressor gene to cancer cells using non-viral lipid-based nanoparticles, modulating immune responses within the Tumor Micro Environment.

Genprex, Inc.

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