Genprex Selects Leading Clinical and Commercial Contract Development and Manufacturing Organization for Manufacturing Scale Up of Diabetes Gene Therapy
Rhea-AI Summary
Genprex (NASDAQ:GNPX) announced a development and manufacturing agreement with a leading U.S.-based clinical and commercial CDMO to scale up manufacturing of its AAV-based diabetes gene therapy program. The CDMO will produce cGMP-compliant drug product for Genprex’s IND-enabling preclinical studies and planned future clinical trials.
The roadmap includes process optimization using advanced AAV technologies, bioreactor scale-up, analytical qualification and potency assay development, and strict GMP compliance. Genprex’s candidate delivers Pdx1 and MafA genes to the pancreas, aiming to convert alpha cells into insulin-producing beta-like cells in T1D and rejuvenate exhausted beta cells in T2D, with supporting mouse and NHP preclinical data.
Positive
- CDMO agreement to scale diabetes gene therapy from research-grade to clinical/commercial-ready manufacturing
- cGMP-compliant production to supply material for IND-enabling studies and future clinical trials
- Defined manufacturing roadmap including process optimization, bioreactor scale-up, and potency assay development
- Preclinical T1D data showing restored normal blood glucose for extended periods in mouse models
- NHP T1D studies showing decreased insulin needs, increased c‑peptide, and improved glucose tolerance
- Preclinical T2D models indicating replenishment and rejuvenation of exhausted beta cells in mouse and NHP studies
Negative
- None.
News Explained
The disclosure adds that the manufacturing transition has begun: Genprex says the process moved from an academic setting to the CDMO and the new plasmid is already being used to manufacture AAV, while clinical drug-product supply remains planned.
Market Reaction – GNPX
Following this news, GNPX has gained 2.35%, reflecting a moderate positive market reaction. Argus tracked a peak move of +48.3% during the session. Argus tracked a trough of -16.7% from its starting point during tracking. Our momentum scanner has triggered 35 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $4.58. Trading volume is exceptionally heavy at 3023.8x the average, suggesting very strong buying interest.
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Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Aug 03 | Roche collaboration | Positive | -20.7% | Biomarker assay validation collaboration with Roche Diagnostics for NSCLC trials |
| Jun 22 | Patent allowance | Positive | -7.1% | Canadian patent allowance covered Reqorsa combinations with PD-1 or PD-L1 antibodies |
| Jun 17 | BIO conference participation | Positive | +10.9% | Company announced participation and investor meetings at BIO International Convention 2026 |
| May 26 | Clinical biomarker data | Positive | -6.0% | Biomarker associations with progression-free survival were presented in lung cancer patients |
| May 14 | Preclinical diabetes data | Positive | +1.2% | Pdx1/MafA delivery reversed hyperglycemia and improved beta-cell function in mice |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent positive Genprex announcements more often coincided with negative 24-hour reactions, with three of five events diverging from the announcement sentiment.
Key Terms
cdmo technical
aav-based therapy technical
cgmp regulatory
ind-enabling regulatory
potency assay technical
lipid nanoparticle delivery technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Collaboration Allows Genprex to Accelerate Manufacturing Processes for IND-Enabling Preclinical Studies and Future Clinical Trials
This collaboration provides the infrastructure necessary to produce the Company's AAV-based therapy in a current Good Manufacturing Practices (cGMP) compliant facility. The CDMO will manufacture and supply drug product to be used in Genprex's IND-enabling preclinical studies and future clinical trials.
"This strategic partnership represents a significant advancement for our diabetes gene therapy clinical program," said Ryan Confer, President and Chief Executive Officer at Genprex. "We have transferred the manufacturing process for our diabetes product candidate from the academic setting, where it was previously manufactured, into a reputable cGMP compliant CDMO. Through this collaboration, Genprex aims to advance its diabetes gene therapy program toward clinical evaluation, focusing on the safety and efficacy required for upcoming toxicology studies."
By partnering with an established CDMO, the Company gains access to specialized expertise in scaling complex biologics, ensuring consistent delivery of the therapeutic payload, a critical factor for administration in patients with Type 1 diabetes (T1D) and Type 2 diabetes (T2D).
The manufacturing roadmap includes several technical priorities:
- Process Optimization: Using latest AAV production technologies to increase production efficiency.
- Scale Up: Use of capacity bioreactors to increase dose availability in preparation for multi-center trials.
- Analytical Qualification and Development of Potency Assay: Implementing rigorous quality control protocols to ensure AAV potency, stability and purity.
- GMP Compliance: Maintaining strict adherence to cGMP standards to support future regulatory submissions.
Genprex's diabetes gene therapy product candidate involves the delivery of the Pdx1 and MafA genes into the pancreas via the pancreatic duct utilizing an AAV vector. Novel advanced technologies were incorporated in these processes to optimize the plasmid construct to increase stability of expression and modify the backbone to align with other plasmids used for AAV products. The new plasmid was cloned, purified, and manufactured and is currently being used in the manufacture of AAV.
Genprex is continuing work with CDMOs and research partners to optimize constructs and evaluate alternative second-generation approaches including different AAV and non-viral constructs. The Company's strategic collaboration with a CDMO to research a non-viral lipid nanoparticle delivery of its diabetes gene therapy drug candidate could allow for potential re-dosing of patients to optimize treatment.
Genprex's diabetes gene therapy product candidate is under development as a potential treatment for both T1D and T2D. In T1D, the drug candidate is designed to work by transforming 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 vivo, preclinical studies show that the drug candidate restored normal blood glucose levels for an extended period of time in T1D mouse models. In T1D NHP in vivo models, the drug candidate demonstrated the ability to decrease insulin requirements, increase c-peptide levels and improve glucose tolerance.
In a similar approach for T2D, where autoimmunity is not at play, the drug candidate demonstrated the ability to replenish and rejuvenate exhausted beta cells that make insulin in both mouse and NHP models.
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, 2025.
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; 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
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SOURCE Genprex, Inc.