On April 30, 2025 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, reported that its research collaborators presented positive preclinical data for Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of KRASG12C mutant non-small cell lung cancer (NSCLC) (Press release, Genprex, APR 30, 2025, View Source [SID1234652385]).

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This data were presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 25-30, 2025 in Chicago, Illinois.

"We are pleased to have this positive preclinical data presented before an audience of the world’s leading cancer researchers, which provides further support for the therapeutic potential of REQORSA both alone and in combination with targeted therapies in NSCLC," said Ryan Confer, President and Chief Executive Officer at Genprex. "We believe REQORSA could be a potential therapeutic treatment for Ras inhibitor resistant lung cancer either alone or in combination with Ras inhibitors, and these studies support the potential expansion of future clinical studies in our pipeline."

The featured Genprex-supported poster presented at AACR (Free AACR Whitepaper) 2025:

Title: Overcoming sotorasib acquired resistance in KRASG12C mutant NSCLC by TUSC2 gene therapy

Session Category: Experimental and Molecular Therapeutics

Session Title: Drug Resistance in Molecular Targeted Therapies 3

Session Date and Time: Tuesday, April 29 from 2-5 p.m. CT

Location: Poster Section 17

Poster Board Number: 12

Abstract Presentation Number: 5517

In the poster, entitled, "Overcoming sotorasib acquired resistance in KRASG12C mutant NSCLC by TUSC2 gene therapy," researchers demonstrated that TUSC2 gene therapy (REQORSA) effectively overcomes sotorasib (LUMAKRAS) acquired resistance (AR) in KRASG12C mutant NSCLC mouse xenografts. The data indicate that TUSC2 transfection significantly reduced colony formation and markedly increased apoptosis in two AR cell lines. Re-expression of TUSC2 in AR PDXOs significantly decreased the viability of organoids compared with the empty vector. The H23AR tumors exhibited significantly lower sensitivity to sotorasib than their parental counterparts. However, treatment with REQORSA was highly effective in controlling tumor growth compared to treatment with sotorasib alone or the control groups. REQORSA alone also exhibited a strong antitumor effect on TC314AR PDXs. Sotorasib alone showed no significant antitumor activity in these models. However, a synergistic antitumor effect was observed when TC314AR PDX tumors were treated with the combination of REQORSA and sotorasib. In conclusion, researchers demonstrated that REQORSA, alone or in combination with sotorasib, induced apoptosis, inhibited colony formation, and showed significant antitumor efficacy in KRASG12C mutant sotorasib-acquired resistant xenograft and PDX tumors.

This AACR (Free AACR Whitepaper) poster has been made available on Genprex’s website at www.genprex.com.

About Reqorsa Gene Therapy

REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene 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.

On April 30, 2025 PanGIA Biotech, a company advancing urine-based, AI-driven diagnostics for early cancer detection, reported that an abstract co-authored by researchers from PanGIA Biotech, Entopsis Inc., and Genetics Institute of America has been accepted for presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), taking place May 30–June 3, 2025, in Chicago, Illinois (Press release, PanGIA Biotech, APR 30, 2025, View Source [SID1234652402]).

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The abstract, titled Development and validation of an AI-enabled prediction of prostate cancer (PCa) using urine-based liquid biopsy (Abstract #3080), has been accepted for presentation in the poster session titled Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology.

The presentation highlights collaborative research contributing to PanGIA’s AI-driven, urine-based diagnostic platform. The work integrates biomolecular pattern analysis and machine learning to support the development of scalable, non-invasive solutions in cancer care.

ASCO 2025 Presentation Details

Date: June 2, 2025
Time: 1:30 – 4:30 p.m. CDT
Location: McCormick Place, Chicago, IL
"This presentation reflects our focus on developing non-invasive, scalable diagnostics rooted in the promise of liquid biopsy innovation," said Holly Magliochetti, CEO of PanGIA Biotech. "We remain committed to advancing technologies that may support earlier cancer detection and improve access to care globally."

Co-authors on the abstract include researchers from PanGIA Biotech, Entopsis Inc., and the Genetics Institute of America.

On April 29, 2025 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the VENTANA TROP2 (EPR20043) RxDx Device (Press release, Hoffmann-La Roche, APR 29, 2025, View Source [SID1234652307]). This is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic (CDx) device.

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"This FDA Breakthrough Device Designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology," said Matt Sause, CEO of Roche Diagnostics. "This solution, which leverages our industry-leading expertise in companion diagnostics development, uses artificial intelligence for a greater depth of sample analysis, helping to deliver truly personalised treatment."

The VENTANA TROP2 (EPR20043) RxDx Device is a computational pathology device, consisting of the TROP2 algorithm, navify Digital Pathology Image Management System, Roche Digital Pathology scanners (DP 200, DP 600) and the VENTANA TROP2 (EPR20043) RxDx Assay used with OptiView DAB Detection Kit for staining on a BenchMark ULTRA IHC/ISH staining instrument. The VENTANA TROP2 (EPR20043) RxDx Device analyses whole slide images of non-small cell lung cancer (NSCLC) tissue stained with TROP2 to compute a quantitative TROP2 score.

The algorithm incorporates AstraZeneca’s proprietary computational pathology platform, Quantitative Continuous Scoring (QCS), which enables a level of diagnostic precision not possible with traditional manual scoring methods.

"This FDA Breakthrough Device Designation underscores the potential of our computational pathology platform to enable more personalised treatment decisions for people with cancer," said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca.

The FDA granting Breakthrough Device Designation has the potential to make a TROP2 CDx AI-driven system available sooner, which could aid in identifying patients with NSCLC most likely to benefit from treatment with Daiichi Sankyo and AstraZeneca’s DATROWAY (datopotamab deruxtecan-dlnk). DATROWAY is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.

About the VENTANA TROP2 (EPR20043) RxDx Device
The VENTANA TROP2 (EPR20043) RxDx Device is indicated as an aid in identifying patients with previously treated advanced or metastatic non-squamous NSCLC without actionable genomic alteration (AGA) most likely to benefit from treatment with Daiichi Sanko and AstraZeneca’s DATROWAY (datopotamab deruxtecan-dlnk). A qualified pathologist is responsible for reviewing staining and image quality, as well as ensuring adequate tumor detection sensitivity and precision, in conjunction with histological examination, relevant clinical information, and proper controls.

Following the pathologist assessment, the nDP TROP2 algorithm independently detects tumor cells and generates associated measures of TROP2 IHC staining intensity in both membrane and cytoplasm to compute the Normalised Membrane Ratio (NMR) score. The algorithm then classifies the TROP2 status as positive or negative based upon the pre-defined NMR cutoff.

On April 29, 2025 Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, reported that it has signed a global collaboration agreement with Shanghai Henlius Biotech, Inc. (Henlius, HKEX:02696) to commercialize a biosimilar of leading oncology therapy, ipilimumab (Press release, Shanghai Henlius Biotech, APR 29, 2025, View Source [SID1234652328]). The agreement is milestone-based for a total consideration of up to USD 301 million, including an upfront payment of USD 31 million, and will target net reference-medicine sales of USD 2.5 billion[1].

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Under the terms of the agreement, Sandoz has exclusive commercial rights for a biosimilar of ipilimumab in Australia, Canada, Europe, Japan and the US. The core sequence patent for ipilimumab expired in March 2025 in the US and will expire no later than February 2026 in the EU.

Richard Saynor, CEO of Sandoz, said: "The global burden of cancer continues to grow and the potential to address unmet patient needs has never been greater.[3] This agreement offers us the chance to reach many more millions of patients, while helping to drive the long-term sustainability of healthcare systems."

The reference medicine, ipilimumab, is a monoclonal (CTLA-4) antibody-blocking medication, which is used alone or with other medicines to treat certain types of colorectal cancer, esophageal cancer, hepatocellular carcinoma (a type of liver cancer), malignant pleural mesothelioma, melanoma, non-small cell lung cancer, and renal cell carcinoma (a type of kidney cancer).[4,5,6]

Henlius is developing its own proposed biosimilar of ipilimumab in an integrated Phase I/III trial in the unresectable hepatocellular carcinoma setting, targeting 656 patients to be enrolled (NCT06841185).

Sandoz is developing its own proposed biosimilar of nivolumab in an integrated Phase I/III trial in the advanced melanoma setting, targeting 720 patients to be enrolled (NCT06587451). The reference medicine, nivolumab, (Opdivo**) is a monoclonal (PD-1) antibody-blocking medication, which is used alone or with other medicines to treat more than 10 different cancer types. In combination with ipilimumab, nivolumab is indicated for the treatment of melanoma, malignant pleural mesothelioma, renal cell carcinoma, certain types of colorectal cancer, esophageal cancer, non-small cell lung cancer and hepatocellular carcinoma.[7,8]

Sandoz is the leading biosimilar provider globally and has recently moved up to third position in the US, with a strategic ambition to occupy the leading position in that market.[9] The Company’s industry-leading biosimilars pipeline comprises 28 molecules, complemented by around 450 generic pipeline medicines to support its goal of sustainable and broadly-based long-term growth. The marketed biosimilar oncology portfolio includes Rixathon, Zarzio, Ziextenzo, and Binocrit. This year, Sandoz expects to launch its biosimilars Wyost/Jubbonti (denosumab) in the US in the second quarter and in Europe in the fourth quarter.

On April 29, 2025 AbCellera (Nasdaq: ABCL) reported new data on its PSMA x CD3 T-cell engagers (TCEs), presented as a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)Ⓡ (AACR) (Free AACR Whitepaper) 116th Annual Meeting at the McCormick Place Convention Center in Chicago, Illinois, taking place April 25 to 30, 2025 (Press release, AbCellera, APR 29, 2025, View Source [SID1234652344]).

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Targeting prostate-specific membrane antigen (PSMA) with a CD3 TCE could provide an effective treatment option for metastatic castration-resistant prostate cancer (mCRPC). In its poster presentation at AACR (Free AACR Whitepaper), AbCellera demonstrated that its PSMA x CD3 TCEs show promising preclinical activity, including:

Potent in vitro tumor-cell killing, with one molecule showing ~10x higher EC50 than benchmark
Sustained in vitro activity across four rounds of serial T-cell killing
Preclinical in vivo efficacy, with significant tumor growth inhibition in a xenograft mouse model
Potential for enhanced potency when combined with costimulatory PSMA x CD28 bispecifics
"The preclinical data package presented at AACR (Free AACR Whitepaper) is the first demonstration that our novel CD3-binders can be used to generate molecules with potent anti-tumor efficacy in vivo," said Adam Clarke, Ph.D., SVP, Discovery at AbCellera. "The poster underscores the strength of our TCE platform strategy, which is to combine diverse CD3- and tumor-binding antibodies and use empirical testing to engineer optimized therapeutic candidates. In addition, the data strongly support the use of costimulation to further increase anti-tumor activity."