On April 22, 2025 Egle Therapeutics, a clinical-stage biotechnology company developing therapies targeting regulatory T cells (Tregs) for immuno-oncology and autoimmune diseases, reported that it will present two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) 2025 being held in Chicago April 25-30, 2025 (Press release, Egle Therapeutics, APR 22, 2025, View Source [SID1234652036]).

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In the poster, entitled "Preferential tumor uptake and retention of EGL-001, an anti-CTLA4-IL2 mutein fusion antibody achieving selective tumor Treg depletion".

Egle Therapeutics unveils preclinical biodistribution data on EGL-001, a novel anti-CTLA4-IL2 mutein fusion antibody designed to selectively deplete tumor-infiltrating regulatory T cells (Tregs). EGL-001 mode of action combines competitive inhibition of IL-2 signaling and potent downregulation of surface CD25, leading to induction of Treg apoptosis.

In vivo EGL-001 preferentially bound to the surface of Tregs due to their high CTLA-4 and CD25 expression and depleted them from the tumor microenvironment without affecting other immune cells. In a biodistribution study, EGL-001 accumulated and persisted in tumors while rapidly clearing from healthy tissues. This targeted approach resulted in deep tumor Treg depletion and was associated with compelling anti-tumor efficacy in multiple mouse tumor models.

EGL-001 is currently under evaluation in a First-In-Human clinical trial (NCT06622486), offering a new therapeutic strategy for alleviating immune suppression mediated by Treg to overcome resistance to immune checkpoint inhibitors.

Session Title: Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators; Session Date and Time: Tuesday, Apr. 29, 2025 02:00 PM – 05:00 PM; Location: Poster Section 37; Poster Board Number: 21 Presentation Number: 6080

In the poster, entitled "Enhanced anti-tumor efficacy through prolonged plasma membrane retention of a novel anti-CCR8/IL2 mutein fusion antibody".

Egle scientists present evidence on EGL-002, a novel anti-CCR8/IL2 mutein fusion antibody engineered to enhance Treg depletion in solid tumors. Via the dual binding of CCR8 and CD25 EGL-002 showed prolonged retention on the surface of tumor-infiltrating Tregs, avoiding the rapid internalization that limited the efficacy of conventional CCR8 antibodies. This led to superior ADCC and ADCP potency, resulting in near complete tumor Treg depletion and potent anti-tumor activity in mouse models and ex vivo human tumors. These findings position EGL-002 as a best-in-class anti-CCR8 and a promising monotherapy or combination partner for immune checkpoint blockade.

Session Title: Enhanced Antibodies, TCR Constructs, Cytokines and Chimeric Proteins; Session Date and Time: Monday, Apr. 28, 2025 02:00 PM – 05:00 PM; Location: Poster Section 35; Poster Board Number: 26 Presentation Number: 3767

On April 22, 2025 NeoGenomics, Inc. ("NeoGenomics" or the "Company") (NASDAQ:NEO), a leading provider of oncology testing services, reported the analytical validation of its PanTracer LBx assay, a next-generation sequencing (NGS) liquid biopsy panel designed for comprehensive pan-solid tumor profiling (Press release, NeoGenomics Laboratories, APR 22, 2025, View Source [SID1234652035]). The validation study, along with five additional abstracts, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago, April 25–30.

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PanTracer LBx is a blood-based test that analyzes circulating tumor DNA to identify key genomic alterations in patients with advanced-stage solid tumors. It is designed to support treatment decisions when tumor tissue is unavailable or insufficient—a common challenge in oncology care. In the validation study, PanTracer LBx demonstrated high performance in identifying key biomarkers—including MSI (microsatellite instability) and TMB (tumor mutational burden)—across multiple cancer types, reinforcing its potential to guide therapy selection and expand access to precision oncology. The poster, "Analytical validation of PanTracer LBx performance, a comprehensive pan-solid tumor liquid biopsy assay," will be presented on Tuesday, April 29, from 9 AM – 12 PM CT, Section 10, Poster 27.

NeoGenomics has also launched an Evaluation Assessment Program for PanTracer LBx, allowing select physicians to use the assay ahead of full commercial availability. The program is intended to identify opportunities to streamline logistics, reporting, and customer support.

"The clinical validation of PanTracer LBx is the result of extensive analytical testing and represents a meaningful addition to our specialized testing menu designed to serve our community oncologists," said Andrew A. Lukowiak, Ph.D., Chief Innovation Officer at NeoGenomics. "Our presence at AACR (Free AACR Whitepaper) reflects a deep commitment to advancing the accessibility of cutting-edge oncology diagnostics and developing practical, real-world solutions that support patients and providers alike."

The company will present five additional posters that span topics such as spatial profiling, tumor biology, and genomic co-occurrence, including:

Characterization of GM-CSF and G-CSF expressing cell subtypes in the tumor microenvironment using the Integrated MultiOmyx-RNAscope assay
April 28, 2:00 PM – 5:00 PM, Section 7, Poster 30
Accurate, high-throughput spatial profiling of whole slide samples with the NeoLYTX pipeline
April 28, 9:00 AM – 12:00 PM, Section 46, Poster 29
High throughput quantitative molecular characterization of cytotoxic antibody-drug conjugates in spheroid models for improved functional characterization, screening and candidate selection
April 28, 9:00 AM – 12:00 PM, Section 1, Poster 14
Co-occurrence of gene fusions with SNV/Indels and with CNVs on solid tumors in a cohort of 795 patients from the community setting
April 28, 2:00 PM – 5:00 PM, Section 31, Poster 27
Comprehensive characterization of renal cell carcinomas identifies metabolic reprogramming of the tumor microenvironment associated with disease progression
April 29, 2:00 PM – 5:00 PM, Section 12, Poster 10
NeoGenomics will also showcase its oncology diagnostics solutions at booth #2449.

On April 22, 2025 Novocure (NASDAQ: NVCR) reported that Optune Lua has received a CE (Conformité Européenne) Mark for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) concurrently with immune checkpoint inhibitors or docetaxel who have progressed on or after a platinum-based regimen (Press release, NovoCure, APR 22, 2025, View Source [SID1234652034]).

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"Optune Lua is an innovative and urgently needed new approach for treating metastatic non-small cell lung cancer," said Joachim Aerts, M.D., a LUNAR investigator and Professor of Pulmonary Oncology at Erasmus MC Cancer Institute. "There are few treatment options for people living with this aggressive cancer. In fact, the results from the Phase 3 trial of Optune Lua were the first in more than eight years to show a treatment providing a significant extension in overall survival. These results and the lack of systemic toxicity observed with Optune Lua provide patients with a promising new treatment option."

Optune Lua is a portable device that produces alternating electric fields known as Tumor Treating Fields (TTFields), which are delivered through non-invasive, wearable arrays. TTFields exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death.

"The CE Mark approval for Optune Lua for metastatic non-small cell lung cancer is a significant milestone in Novocure’s efforts to improve outcomes for people living with aggressive cancers," said Frank Leonard, President, Novocure Oncology. "Tumor Treating Fields therapy has demonstrated effectiveness in multiple tumor types that have historically been very difficult to treat, including lung cancer. We believe the efficacy Optune Lua can offer, paired with its lack of systemic toxicity, has the potential to change the way late-stage lung cancer is treated."

Novocure has initiated the local registration requirements for Optune Lua in Germany and is preparing for launch in the coming weeks. The CE Mark follows the recent approval of Optune Lua by the U.S. Food and Drug Administration in October 2024.

Data Supporting the CE Mark of Optune Lua

The CE Mark approval was supported by data from the Phase 3 LUNAR trial that compared the safety and efficacy of treatment with Optune Lua concurrent with immune checkpoint inhibitors or docetaxel to treatment with immune checkpoint inhibitors or docetaxel alone in patients with metastatic NSCLC who progressed during or after platinum-based therapy.

The primary endpoint of the trial, extension in overall survival (OS), was achieved. Patients treated with Optune Lua concurrently with an immune checkpoint inhibitor or docetaxel demonstrated a statistically significant and clinically meaningful 3.3-month extension (P=0.035) in median OS. The group treated with Optune Lua concurrently with an immune checkpoint inhibitor or docetaxel (n=137) had a median OS of 13.2 months (95% CI, 10.3 to 15.5 months) compared to a median OS of 9.9 months (95% CI, 8.2 to 11.5 months) in the group treated with an immune checkpoint inhibitor or docetaxel alone (n=139).

Patients randomized to Optune Lua and an immune checkpoint inhibitor (n=66) demonstrated a statistically significant extension of 7.7 months in median OS compared to those treated with an immune checkpoint inhibitor alone (n=68), with median OS of 18.5 months (95% CI, 10.6 to 30.3 months) compared to 10.8 months (95% CI, 8.2 to 18.4 months) respectively (P=0.03).

Patients randomized to receive Optune Lua and docetaxel (n=71) had a median OS of 11.1 months (95% CI, 8.2 to 14.1 months) compared to a median OS of 8.7 months (95% CI, 6.3 to 11.3 months) in patients treated with docetaxel alone (n=71). This 2.4-month extension in median OS did not provide a statistically significant benefit, but did show a positive trend.

Device-related adverse events (AEs) of skin-related disorders under the transducer arrays occurred in 65.4% of patients (n=87). The majority of these events were low grade (Grade 1-2), with only 5% (n=6) experiencing a Grade 3 skin event that required a break from treatment. There were no Grade 4 or Grade 5 toxicities related to Optune Lua, and no device-related AEs that caused death.

As a condition to receiving the CE Mark, Novocure will conduct a post-market study of TTFields concomitant with docetaxel in patients with metastatic NSCLC to assess overall survival in the routine care setting. The trial is designed to include 180 patients with a 12-month follow-up. These results will be compared to a matched control group of docetaxel-only treated patients.

Optune Lua previously received CE Mark approval for the treatment of patients with stage IV, non-squamous NSCLC in combination with pemetrexed (Alimta), after failure of first-line treatments.

Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the most common cause of cancer-related death in the EU and NSCLC accounts for approximately 85% of all lung cancers.i In Europe, more than 400,000 people are diagnosed with NSCLC each year.ii

Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC depending on the stage of the disease.

Certain immune checkpoint inhibitors, including both PD-1 and PD-L1 inhibitors, have been approved for the first-line treatment of NSCLC and the standard of care in this setting continues to evolve rapidly.

The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, pemetrexed, docetaxel, immune checkpoint inhibitors or anti-angiogenic therapies.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi-mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

On April 22, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported that the US Food & Drug Administration ("FDA") granted the Company’s meeting request to gain alignment on the surrogate endpoint to support Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma (Press release, OS Therapies, APR 22, 2025, View Source [SID1234652033]). FDA granted a written response-only meeting and confirmed that its response would be received by mid-June 2025, in time for the Company to present the statistical analysis as part of the keynote presentation closing out major osteosarcoma conference MIB Factor on June 28, 2025 at 3:30pm MDT.

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"We are pleased that FDA agreed to the requested meeting forward and work within the timelines of the meeting type requested so that we would be able to share our analysis with the patient and physician communities that will be represented at MIB Factor in late June," said Robert Petit, Chief Medical & Scientific Officer of OS Therapies.

"We remain on track for an early third quarter submission and are hopeful to receive approval by year-end 2025 in order to bring this life saving treatment to patients in early 2026," said Paul Romness, CEO of OS Therapies.

OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale, valued at $150 million, occurred in February 2025.

The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following surgical resection and chemotherapy. 3-year survival rates in patients who were not diagnosed with a metastasis are 59%. 3-year survival rates in patients who were diagnosed with pulmonary metastasis were 30%. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million.

OST-HER2, an immunotherapy for osteosarcoma using a HER2 bioengineered form of the bacteria Listeria monocytogenes to trigger a strong immune response against cancer cells expressing HER2, is being featured in the upcoming movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. A trailer for the movie is available here. The movie will air live nationally on PBS and be available via streaming on PBS’ website in early May 2025.

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.