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.

On April 22, 2025 OncoSpherix, a biotech company pioneering innovative therapies for tumor hypoxia, reported its participation in Portal Innovations’ ‘Rising Stars in Oncology’ event during the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago (Press release, OncoSpherix, APR 22, 2025, View Source [SID1234652016]).

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The event, taking place on April 25, 2025, will spotlight emerging biotech companies developing breakthrough cancer treatments. OncoSpherix will present its latest advancements in targeting the hypoxia-inducible factor 1 (HIF-1) pathway, thereby disrupting essential processes that fuel tumor growth, metastasis, and resistance to therapy.

"We are honored to be recognized as a rising innovator in oncology," said OncoSpherix CEO, Margaret Offermann, MD, PhD. "This event provides a unique platform to share our mission and engage with leading investors, researchers, and industry experts."

The ‘Rising Stars in Oncology’ event, hosted by Portal Innovations, brings together cutting-edge biotech companies, venture investors, and scientific leaders to showcase promising advancements in cancer therapeutics.

For more details on the event, visit: View Source

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a series of product and partnership updates designed to strengthen its portfolio for cancer genomic profiling (Press release, Qiagen, APR 22, 2025, View Source [SID1234652017]).

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These new developments will be showcased at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, from April 25-30 in Chicago.

Important updates include a new set of QIAseq panels for comprehensive genomic profiling (CGP) and a new QIAcuity digital PCR (dPCR) kit and assays for cell and gene therapy quality control along with a new free, limited version of the Human Somatic Mutation Database (HSMD) from the QIAGEN Digital Insights (QDI) bioinformatics business.

"The launch of the new QIAseq panels represents a significant step forward in enabling researchers to gain deeper, more accurate insights into cancer biology and biomarker discovery along the complete workflow from sample technologies to QIAGEN Digital Insights for powerful genomic data analysis and interpretation," said Nitin Sood, Senior Vice President and Head of Product Portfolio & Innovation at QIAGEN. "Additionally, our new QIAcuity digital PCR kit and assays support pharma companies in developing safe and effective biotherapeutics also for cancer patients. We are moving ahead in supporting scientists and clinicians in advancing cancer research and precision medicine."

The new products and partnership updates include the following:

The QIAseq xHYB CGP portfolio is being expanded to offer a highly curated solution for multimodal cancer genomic profiling. It includes DNA and RNA panels to capture critical genomic regions, and is designed to leverage actionable and interpretable variants sourced from the Human Somatic Mutation Database (HSMD) from QDI. QIAGEN will highlight the panel’s capabilities at AACR (Free AACR Whitepaper) 2025 during a Spotlight Theater talk. Dr. Christopher Reynolds of Myriad Genetics will present a proof-of-concept study assessing the panel’s performance in variant detection using matched tumor/plasma samples from Stage III/IV prostate and ovarian cancer patients.

TheQIAcuity RCL Quant Kit and new QIAcuity CGT dPCR assays support quality control in cell and gene therapy with solutions for lentivirus-based applications that are used for applications including the manufacturing of CAR-T therapies, a novel type of cancer treatment. The new kit and assays reliably detect critical quality attributes in lentivirus-based biotherapeutics, ensuring therapy safety and efficacy.

QIAGEN and Element Biosciences are building on their existing partnership by adding the new QIAseq xHYB CGP Panels to Element’s AVITI platform and Trinity workflow. This update, expected by late 2025, will make cancer genomic profiling faster, easier and more cost-effective by reducing hands-on time and equipment needs.

In the partnership with Myriad Genetics, QIAGEN plans to launch globally (excluding Japan) a sequencing-based homologous recombination deficiency (HRD) assay designed to enable deeper molecular insights into DNA repair deficiencies. This solution will enhance the ability of researchers to investigate mechanisms of homologous recombination and optimize treatment strategies.

Further supporting the research community, QIAGEN is introducing HSMD Research, a free, limited version of its HSMD database to make genomic data more widely available. This resource offers academic researchers curated insights on 25 key genes involved in solid tumors and blood cancers while covering gene annotations, variant distributions, functional impacts and clinical significance.
To learn more about QIAGEN’s latest innovations, visit booth #2620 at the AACR (Free AACR Whitepaper) Annual Meeting 2025. More details about featured talks, poster presentations and product demonstrations are available at View Source

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.