On April 22, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will present 18 abstracts, including four oral sessions, showcasing advances in multi-cancer detection and multiomic precision oncology testing enabled by its Guardant Infinity smart liquid biopsy platform at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 25-30 in Chicago (Press release, Guardant Health, APR 22, 2025, View Source [SID1234652030]).

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Key data that will be highlighted include:

An oral presentation of performance data for the Shield MCD test, selected for the National Cancer Institute’s Vanguard Study evaluating emerging multi-cancer detection (MCD) technology
Additional oral presentations on methylation-based cancer signal of origin identification, methylation profiling for lung cancer subtyping, and a real-world data analysis of BRAF mutations in non-small cell lung cancer
Analytical validation of Guardant’s new tissue profiling assay with integrated multiomics, showing a high success rate with minimal tissue input and supporting the acceleration of novel biomarker discovery
New methylation-based applications for liquid biopsy, including molecular subtyping of lung and breast cancer, rule-out of actionable genomic mutations, and identification of promoter methylation and MTAP deletions
"We look forward to sharing new data demonstrating the tremendous potential of the Guardant Infinity smart liquid biopsy platform to provide researchers and healthcare providers with a more complete picture of cancer, including genomics, epigenomics and more," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "This multidimensional view of cancer biology is enabling advances in precision oncology ranging from blood-based multi-cancer detection to identification of novel biomarkers that can help bring the next generation of cancer therapeutics to patients sooner."

The full abstracts for Guardant Health and a list of all abstracts being presented at AACR (Free AACR Whitepaper) 2025 can be found on the AACR (Free AACR Whitepaper) website.

For information and updates from the conference, follow Guardant Health on LinkedIn, X (Twitter) and Facebook or visit AACR (Free AACR Whitepaper) booth #1523.

Full List of Guardant Health Presentations

Date and Time (CDT)

Title

Abstract and Poster Section/Board

Guardant Product

Multi-Cancer

Sunday, April 27, 2:00-5:00pm

Analytical validation of a tissue-free epigenomic assay for circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) detection in early-stage cancer

Abstract #692

Poster Section 29 Poster Board #25

Guardant Reveal

Sunday, April 27, 2:00-5:00pm

Development and characterization of a negative prediction algorithm for actionable mutations utilizing genomic and epigenomic profiling in cfDNA

Abstract #733

Poster Section 31 Poster Board #18

Guardant Infinity

Sunday, April 27, 3:00-5:00pm

A novel methylation-based classifier to identify cancer signal of origin using blood-based testing

Oral Minisymposium Session

Abstract #6365

Guardant Infinity Screening

Monday, April 28, 9:00am-12:00pm

Inferring immune and tissue cell type contributions to cell-free DNA (cfDNA) with a DNA methylation assay

Abstract #1951

Poster Section 28

Poster Board #19

Guardant Infinity

Monday, April 28, 9:00am-12:00pm

Detection of clinically actionable somatic variants in post-operative samples from patients with molecular residual disease

Abstract #1953

Poster Section 28

Poster Board #21

Guardant Reveal

Monday, April 28, 9:00am-12:00pm

Blood-based mapping of the personalized tumor epigenomic landscape

Abstract #1955

Poster Section 28 Poster Board #23

Guardant Infinity

Monday, April 28, 2:00-5:00pm

Analytical validation of cancer gene promoter methylation detection in cfDNA liquid biopsy assay

Abstract #3255

Poster Section 29 Poster Board #20

Guardant Infinity

Tuesday, April 29, 2:30-4:30pm

Evaluation of a plasma cell-free DNA methylation-based multi-cancer detection test

Oral Minisymposium

Session

Abstract #6425

Shield MCD Test

Tuesday, April 29, 2:00-5:00pm

A tumor-specific, methylation-based algorithm to identify MTAP gene deletions via tissue-free circulating tumor DNA

Abstract #5924

Poster Section 30 Poster Board #16

Guardant Infinity

Tuesday, April 29, 2:00-5:00pm

Analytical validation of a robust, integrated multiomics tissue assay powered by the Guardant Infinity platform

Abstract #5935

Poster Section 30 Poster Board #27

Guardant Infinity

Tuesday, April 29, 2:00-5:00pm

Landscape of epigenomic tumor fraction in large pan-cancer cfDNA cohort

Abstract #5936

Poster Section 30 Poster Board #28

Guardant Infinity

Wednesday, April 30, 9:00am-12:00pm

Analytical validation of a new plasma-only bioinformatics classifier to identify variants from clonal hematopoiesis (CH) in cfDNA liquid biopsy assays

Abstract #6603

Poster Section 9 Poster Board #10

Guardant Infinity

Lung

Sunday, April 27, 3:00-5:00pm

Non-invasive cell free DNA (cfDNA) methylation profiling for accurate proportional quantification of lung cancer subtypes

Oral Minisymposium

Session

Abstract #1142

Guardant Infinity

Tuesday, April 29, 9:00am-12:00pm

EGFR PACC mutations occur more frequently as compound mutations with better responses to EGFR TKIs

Abstract #4594

Poster Section 30 Poster Board #14

Guardant360

Tuesday, April 29, 2:30-4:30pm

Unveiling the potent anti-tumor activity and underlying mechanism of action of the novel pan-RAF inhibitor exarafenib in BRAF-mutated NSCLC

Oral Minisymposium Session

Abstract #6389

Guardant Inform

Breast

Monday, April 28, 2:00-5:00pm

Pre- and post-operative analysis of circulating tumor DNA in patients with breast cancer treated with neoadjuvant therapy using a tissue-free, methylation-based approach

Abstract #3360

Poster Section 32 Poster Board #30

Guardant Reveal

Monday, April 28, 2:00-5:00pm

Liquid based methylation profiling for quantification of breast cancer subtypes

Abstract #3247

Poster Section 29 Poster Board #12

Guardant Infinity

Colorectal

Monday, April 28, 9:00am-12:00pm

Employing joint modeling to support clinical interpretation of ctDNA dynamics during the treatment of advanced colorectal cancer

Abstract #2481

Poster Section 41 Poster Board #2

Guardant Inform

On April 22, 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’ abstract was published in the online Proceedings supplement of Cancer Research, a scientific journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Genprex, APR 22, 2025, View Source [SID1234652014]).

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Genprex collaborators will present the published abstract in a poster presentation at the 2025 AACR (Free AACR Whitepaper) Annual Meeting being held April 25-30, 2025 in Chicago, Illinois. The collaborators will present positive preclinical data from a study of Genprex’s lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of KRASG12Cmutant non-small cell lung cancer (NSCLC).

"We are pleased to have our collaborators’ abstract selected for both publication and presentation before the world’s top cancer researchers, investigators and healthcare professionals," said Ryan Confer, President and Chief Executive Officer at Genprex. "This publication highlights research-driven advances against cancer, and we are gratified to be featured among those advances. We look forward to this week’s presentation of positive preclinical data on our lead drug candidate, REQORSA, as a potential therapeutic treatment for Ras inhibitor resistant lung cancer."

The featured Genprex-supported poster to be 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

The featured Genprex-supported abstract to be presented at AACR (Free AACR Whitepaper) 2025:

Acquired resistance (AR) to Lumakras (sotorasib), the first FDA-approved KRASi, poses a significant challenge in the treatment of KRASG12C mutant NSCLC. Despite initial responses, patients invariably develop resistance, necessitating alternative therapeutic strategies. The mechanisms underlying AR include the emergence of additional mutations in the KRAS gene, reactivation of the KRAS pathway, or activation of alternative signaling pathways. TUSC2, a potent tumor suppressor gene with immunogenic properties, exhibits multifunctional activity by inhibiting downstream signaling pathways, including MAPK and mTOR; arresting the growth and proliferation of cancer cells; inducing tumor cell death; and activating innate and adaptive immune responses. In this study, researchers demonstrated that TUSC2 gene therapy (REQORSA) effectively overcomes sotorasib AR in KRASG12C mutant NSCLC mouse xenografts.

The data indicate that TUSC2 transfection significantly reduced colony formation in two AR cell lines. Transfection of TUSC2 also markedly increased apoptosis in AR cells. Re-expression of TUSC2 into 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.

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 22, 2025 Ensem Therapeutics, Inc. (ENSEM) reported the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for ETX-636, a potential best-in-class novel allosteric pan-mutant-selective PI3Kα inhibitor and degrader, with its first-in-human study anticipated in the second quarter of 2025 (Press release, ENSEM Therapeutics, APR 22, 2025, View Source [SID1234652031]). In addition, ENSEM will present preclinical data on April 28th at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting in Chicago, Illinois, supporting a differentiated profile of ETX-636 and its potential to deliver clinical benefit to patients with tumors harboring activating PI3Kα mutations.

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Mutant PI3Kα is a key and frequent oncogenic driver across a broad spectrum of cancers, including up to 40 percent of hormone receptor-positive (HR+) /HER2-negative advanced breast cancers. However, wildtype PI3Kα is central to glucose homeostasis, and ATP-binding-site inhibitors target both mutant and wildtype PI3Kα, resulting in hyperglycemia which limits the clinical utility of these therapeutics.

"Targeting mutant PI3Kα within tumors while sparing wildtype PI3Kα in normal tissues represents a significant clinical challenge, which ETX-636 overcomes. The IND clearance is an important milestone for the company, and we are laser-focused on driving ETX-636 through clinical development," said Shengfang Jin, PhD, CEO and Co-Founder of ENSEM.

Dr. Jin noted that ETX-636 is the second novel ENSEM compound entering clinical development. ETX-197, an oral selective CDK2 inhibitor licensed to BeOne and being developed as BG-68501, is currently undergoing Phase 1 clinical development in advanced or metastatic solid tumors associated with CDK2 dependency.

Jeffery Kutok, MD, PhD, ENSEM’s Chief Scientific Officer, added, "ETX-636 is a potent pan mutant-specific allosteric PI3Kα inhibitor and degrader, which differentiates it from other compounds in its class. We are excited to evaluate ETX-636’s therapeutic potential in patients in our upcoming clinical trial. ENSEM also eagerly anticipates INDs for additional pipeline programs in 2026."

The initial first-in-human, Phase 1/2 study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ETX-636 in participants with advanced solid tumors harboring a PI3Kα mutation. ETX-636 will be administered alone and in combination with fulvestrant, a selective estrogen receptor degrader approved for the treatment of advanced hormone receptor HR+/HER2- breast cancer.

Poster Details

Title: ETX-636, a novel allosteric pan-mutant-selective PI3Kα dual inhibitor and degrader with best-in-class potential
Poster ID: 1659
Sessions: Experimental and Molecular Therapeutics – Degraders and Glues 2
Date/Time: Monday, April 28, 2025, from 9am-12pm CT
Location: Poster session 18, Board 19
About ETX-636
ETX-636 was designed to optimally fit into a specific allosteric binding site in p110α, the catalytic subunit of PI3Kα. This allosteric binding site has been shown to selectively inhibit multiple activating mutant forms of PI3Kα, including hotspot kinase and helical domain PI3Kα mutants, while sparing wildtype PI3Kα. The selectivity of ETX-636 for mutant PI3Kα greatly reduces the risk for hyperglycemia and other wildtype PI3Kα-related adverse events compared to non-mutant selective PI3Kα inhibitors. In addition to its potent inhibitory effect on mutant PI3Kα catalytic activity, ETX-636 also leads to proteasome-dependent degradation of mutant PI3Kα, while sparing wildtype protein (a feature not seen with other pan-mutant allosteric inhibitors). This dual mechanism of action results in deep and durable pathway inhibition and induces concordant tumor regression in kinase and helical domain PI3Kα-mutant breast cancer xenograft models as monotherapy and in combination with fulvestrant. In preclinical toxicology studies, blood glucose levels after dosing in multiple species indicate that ETX-636 did not disrupt glucose homeostasis at predicted human efficacious doses.

On April 22, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that it has completed enrollment of the registration phase of its Phase II trial of savolitinib in gastric cancer patients with MET amplification (Press release, HUTCHMED, APR 22, 2025, View Source [SID1234652015]).

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This clinical trial is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and tolerability of savolitinib in treating gastric cancer or gastroesophageal junction ("GEJ") adenocarcinoma patients with MET amplification. Primary endpoint is objective response rate ("ORR") evaluated by the Independent Review Committee ("IRC") (RECIST 1.1). Secondary endpoints include progression free survival (PFS) and incidence of various adverse events (AE), among others. A total of 64 patients have been enrolled in the study. Further details may be found at clinicaltrials.gov using identifier NCT04923932.

As reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, interim results from the study showed a 45% ORR confirmed by IRC and a 50% ORR in patients with high MET gene copy number. 4-month duration of response (DOR) rate was 85.7% with median follow up time of 5.5 months. The most common grade 3 or higher treatment-related adverse events ("TRAE") (≥ 5%) were platelet count decreased, hypersensitivity, anemia, neutropenia and hepatic function abnormal. Only one patient discontinued treatment due to grade 4 liver function abnormal (TRAE) and no patient died due to TRAE.

The China’s National Medical Products Administration ("NMPA") has granted Breakthrough Therapy Designation to savolitinib for the treatment of locally advanced or metastatic gastric cancer or GEJ adenocarcinoma patients with MET amplification who have failed at least two lines of standard therapies. If positive, HUTCHMED may initiate plans to apply for marketing authorization of savolitinib for gastric cancer in China in late 2025.

About Gastric Cancer with MET Amplification

MET-driven gastric cancer has a very poor prognosis.1 It is estimated that MET amplification accounts for approximately 4-6% of gastric cancer patients.2,3 The annual incidence of MET amplification gastric cancer is estimated to be approximately 18,000 in China.4 The ongoing registration trial follows multiple Phase II studies conducted in Asia to study savolitinib in MET-driven gastric cancer patients, including VIKTORY.2 The VIKTORY study reported a 50% ORR in patients whose tumors harbored MET amplification and were treated with savolitinib monotherapy.

About Savolitinib

Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor ("TKI") being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. MET is a tyrosine kinase receptor that has an essential role in normal cell development.5 Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

Savolitinib is approved in China and is marketed under the brand name ORPATHYS by our partner, AstraZeneca, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

On April 22, 2025 Charles River Laboratories International, Inc. (NYSE: CRL), ahead of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL, reported updates to its comprehensive portfolio of products and services supporting the discovery and development of novel oncology drugs (Press release, Charles River Laboratories, APR 22, 2025, View Source [SID1234652032]). Based solely on projected population growth, the number of cancer cases is predicted to increase to 35 million by 2050, and approximately 1 in 5 individuals will develop cancer in their lifetime.

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"Having worked on over 80 percent of the FDA-approved cancer therapies over the last five years, Charles River has a well-established track record of delivering innovative solutions for oncology researchers," said Julia Schueler, DVM, PhD, Therapeutic Area Lead, Oncology, Charles River. "We are consistently looking for ways to leverage new technologies and techniques to enhance our ability to deliver life-changing therapeutics to patients."

Developing a Fully Human Platform
Across several modalities, Charles River is developing and implementing humanized platforms to promote a more effective, translatable way of identifying human-specific drug targets and disease mechanisms, as well as treatments for individual patients. These methodologies include:

3D Tumoroids
Patient-derived xenograft (PDX) models are an increasingly common tool drug developers use when evaluating their new therapies, particularly immunotherapies. Charles River researchers have developed PDX-derived organoids, or tumoroids, which are self-organized 3D cell cultures that aim to mimic the structure, function, and cellular complexity of human organs, making them, in some ways, more translatable than animals.

Julia Schueler is presenting on PDX-derived breast cancer tumoroids on Sunday, April 27, 2025, at 2:00 p.m. and on establishing tumoroids from PDX tissue for in vitro applications on Tuesday, April 29, 2025, at 2:00 p.m.

2D Tumor Killing Assays
Charles River has a range of immune-mediated tumor-killing assays, including cytotoxic T-cell assays and natural killer (NK) cell assays. These assays are analyzed using flow cytometry and live cell imaging with IncuCyte. IncuCyte-based assays quantify the number of viable target cells and can be multiplexed with an apoptotic readout. The selection of target and effector cells can be tailored to the anticipated mechanism of action by selecting from a panel of validated target cell lines.

Ina Rohleff is presenting a comparison of NK-92MI cell line vs. primary NK cells derived from peripheral mononuclear blood cells on Wednesday, April 30, 2025, at 9:00 a.m.

Tumor Microenvironment
Leveraging knowledge of the tumor microenvironment (TME), Charles River is able to target different components of the TME that promote tumor growth and metastasis through anti-tumor immune suppression.

Louise Brackenbury is presenting on leveraging the tumor microenvironment for candidate vaccine screening on Tuesday, April 29, 2025, at 2:00 p.m.

Through a partnership with Cypre, Charles River clients can access Cypre’s 3D tumor models to predict therapeutic efficacy and mechanism of action in an accurate tumor microenvironment model. Utilizing Cypre’s patented 3D hydrogel technology and proprietary methods that synergize with Charles River’s PDX tumor model collection, the platform recreates the tumor microenvironment and enables predictive screening of innovative immune-oncology compounds.

Humanized Models
Charles River offers a comprehensive line of humanized mice models to support researchers in replicating human immune interactions and therapeutics responses in controlled, in vivo environments. Charles River has expanded its offering of humanized mouse models by introducing two new PBMC models that reduce the onset of graft versus host disease (GvHD). Along those lines, the Company offers a PBMC Select Humanization Kit, giving researchers the ability to leverage pre-qualified PMBCs and engraft specific NCG mice for improved study flexibility.

Eva Oswald is presenting on a PDX biobank in humanized mice and Steve Bronson is presenting on PMBC-humanized, MHC-deficient NCG mice that support human tumor xenographs without rapid onset GvHD, both beginning on Monday, April 28, 2025, at 9:00 a.m.

Leveraging AI in Oncology
The influence of artificial intelligence (AI) and machine learning (ML) tools is beginning to impact how researchers analyze cancer research data. Charles River recently collaborated with Revvity, Inc., to determine the feasibility of automatic organ volumetric analysis from 3D ultrasound images of mice using deep learning. Segmentation of 3D imaging data is labor intensive and measurements derived from human-annotated data are prone to inter-user variability and user error. To address these challenges, an AI model was generated to segment spleens from diverse 3D ultrasound images taken from several in vivo models.

David Harris is presenting on longitudinal ultrasound imaging as a novel pharmacodynamic marker of graft versus host disease progression in mice with Revvity on Monday, April 28, 2025, at 2:00 p.m.

Charles River is also partnering with Aitia to develop virtual control groups (VCGs) supported by Charles River’s extensive and well-categorized library of PDX data. VCGs, combined with insights from PDXs, allow researchers to predict tumor evolution over time in a specific model, reducing the need for control animals in future experiments and supporting the principles of the 3Rs (Replacement, Reduction, and Refinement).

Global Support for the RACE Act
As part of our broad oncology portfolio, Charles River, via the ITCC-P4 consortium, offers over 200 annotated, well-characterized, and Research to Accelerate Cures and Equity (RACE) for Children Act-compliant pediatric PDX models to accelerate time to clinic. These are critical models for research, as the U.S. Food and Drug Administration’s RACE Act requires nearly all oncology drugs to be tested for pediatric indications before approval.

"Globally, 400,000 children and adolescents develop cancer each year, and approximately one in four cannot be cured with currently available therapies," added Schueler. "Combined with our comprehensive portfolio of oncology drug discovery and development services, we are positioned to assess the safety and efficacy of new oncology treatments, specifically in this critically important patient population."

Charles River is proud to sponsor the Richi Childhood Cancer Foundation at AACR (Free AACR Whitepaper) 2025. Attendees can stop at Booth #1642 to learn how to actively support the mission to connect, support, and uplift children, youth with cancer, and survivors through the Richi House.

AACR Annual Meeting 2025: Transforming Oncology Drug Development
Charles River’s team has the capability to optimize workflows and maximize success across modalities including small and large molecules, cell and gene therapies, vaccines, and combination therapies. Charles River also recently launched an alliance with NJ Bio to optimize the development and manufacturing of antibody drug conjugates (ADCs.)

During the show, Charles River is presenting a Spotlight on HER2 therapy development on Monday, April 28, 2025 from 3:00-4:00 p.m. Visit Charles River during AACR (Free AACR Whitepaper) at Booth #1642 during the show, and visit criver.com to schedule a meeting, view a full schedule of activities, and explore oncology resources.