Naveris to Present New Data Highlighting Clinical Utility of the NavDx® Test at the 2024 ASCO Annual Meeting

On May 29, 2024 Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, reported new data to be presented at The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL from May 31 – June 2, 2024 (Press release, Naveris, MAY 29, 2024, View Source [SID1234643829]). These presentations underscore Naveris’ continued innovation with the NavDx test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA blood test aiding in the detection and management of HPV-driven cancers.

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"ASCO provides an unparalleled platform to showcase the versatility and clinical value of NavDx across various stages of cancer management from early detection to post-treatment surveillance," said Barry M. Berger, MD, Chief Medical Officer at Naveris. "We are pleased to present new data highlighting the high predictive value of TTMV-HPV DNA and its utility in monitoring disease status during treatment. These results demonstrate how NavDx is transforming the care landscape for patients with HPV-driven cancers."

These presentations also highlight Naveris’ on-going commitment to patient-centered innovation and collaboration with stakeholders across the cancer care ecosystem. Lillian Kreppel, Co-Founder and Executive Director of the HPV Cancers Alliance, commented, "The HPV Cancers Alliance celebrates the innovation of tests that can more accurately detect a recurrence of cancer before it is found through a visual exam. This can result in more informed patients, an earlier indication of possible recurrence, more targeted care options for patients, and ultimately more lives saved. The HPV Cancers Alliance desires the best quality of life and outcomes possible for all cancer survivors and their families."

The presentations at ASCO (Free ASCO Whitepaper) will report on the efficacy of Naveris’ circulating tumor HPV DNA-based approach for monitoring disease status, predicting recurrence, and guiding therapy in HPV-driven cancers:

Poster Presentation | Abstract #6066
Presenter: Krzysztof Misiukiewicz, MD, Icahn School of Medicine at Mount Sinai
Can TTMV clearance predict recurrence in HPV HNSCC?

This study evaluates the predictive value of TTMV-HPV DNA in patients with locally advanced HPV-positive head and neck squamous cell carcinoma (HNSCC). Patients with rapid clearance of TTMV after induction chemotherapy (IC) remained disease-free, while 27% of those with persistent TTMV experienced relapses. The negative predictive value (NPV) of TTMV was 100%, and the positive predictive value (PPV) was 96%, supporting its use in guiding treatment intensity and surveillance.
Poster Presentation | Abstract #6067
Presenter: Krzysztof Misiukiewicz, MD, Icahn School of Medicine at Mount Sinai
TTMV and association with relapse in patients with HPV-related SCCHN undergoing CRT

This study explores the use of TTMV-HPV DNA to monitor disease status in patients with HPV-related squamous cell carcinoma of the head and neck (SCCHN) undergoing chemoradiation therapy (CRT). TTMV can identify recurrence or persistence and can synergize with PET to guide therapy, as all 3 post-CRT recurrences were detected using TTMV and confirmed with PET and biopsy. The combination of TTMV with PET enhances response assessment and helps guide treatment strategies.
Poster Presentation | Abstract #TPS6119
Presenter: James Edward Bates, MD, Emory University
Biomarker-driven radiation therapy dose reduction after transoral robotic surgery for the treatment of HPV-positive oropharyngeal cancer

This trials in progress abstract highlights an ongoing multi-institutional phase II trial evaluating the efficacy of reducing radiation therapy doses based on biomarker data post-transoral robotic surgery for HPV-positive oropharyngeal cancer. Patients with undetectable post-operative TTMV-HPV DNA without high-risk pathologic factors undergo de-escalation of adjuvant radiation therapy to 36 Gy, aiming to improve long-term swallowing function.
Publication Only | Abstract #e15045
Presenter: Scott Roof, MD, Icahn School of Medicine at Mount Sinai
The NAVigate-HPV Registry: A comprehensive biomarker evidence base for HPV-driven cancers

This abstract outlines the structure and objectives of the recently launched NAVigate-HPV Registry, emphasizing its role in establishing a robust evidence base for the clinical utility of circulating tumor HPV DNA in managing HPV-driven cancers. The registry will systematically collect and analyze integrated biomarker and clinical data from various US cancer centers. The registry brings together representatives from 14 geographically diverse sites, expected to include over 1,000 patients within one year and grow to over 5,000 within five years.
Publication Only | Abstract #e18032
Presenter: Olga Russial, MD, Thomas Jefferson University Hospital
Clinical utility of circulating tumor tissue-modified viral HPV DNA testing in HPV-driven oropharyngeal cancer arising in women

This study evaluates the clinical utility of TTMV-HPV DNA testing in women with HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). This is the first single institutional report evaluating the clinical utility of TTMV-HPV DNA in a female cohort treated for HPV+ OPSCC. Utilization of this testing in a female population appears feasible in a community-based hospital setting. All patients had TTMV resolution after treatment and remained undetectable without recurrence.
Naveris and the NavDx test will be on exhibit at ASCO (Free ASCO Whitepaper) 2024 at Booth #31142. More information can be found on the ASCO (Free ASCO Whitepaper) website here.

Blue Earth Diagnostics Highlights Presentations on POSLUMA® (Flotufolastat F 18), Axumin® (Fluciclovine F 18) and Investigational 18F-Flotufolastat/18F-rhPSMA-7 at Upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting

On May 29, 2024 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported upcoming presentations by its collaborators at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, to be held June 8 to 11, 2024, in Toronto, Canada (Press release, Blue Earth Diagnostics, MAY 29, 2024, View Source [SID1234643828]). POSLUMA (formerly referred to as 18F-rhPSMA-7.3) is approved and indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Axumin is approved and indicated for PET imaging in men with suspected prostate cancer recurrence based on elevated PSA levels following prior treatment.

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"We are pleased that our collaborators will be sharing important scientific information about POSLUMA, Axumin and investigational experience with 18F-flotufolastat with the imaging community at SNMMI," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. "Two presentations relate to the use of POSLUMA and 18F-flotufolastat and the effects of urinary bladder activity on imaging quality. Results from a head-to-head study to be presented by Dr. Isabel Rauscher of the Technical University of Munich examine parameters of PET imaging between 18F-flotufolastat and 68Ga-PSMA-11 in primary prostate cancer, and a presentation by Dr. Ismaheel Lawal will discuss interim results from a study at Emory assessing PET imaging quality with and without the diuretic furosemide in patients with biochemical recurrence of prostate cancer (BCR). Dr. Nadine Mallak of Oregon Health and Science University will present interim results from an ongoing study of the use of Axumin in PSMA/PET-negative BCR patients, and Dr. Rauscher will also describe clinical experience with 18F-rhPSMA-7 and 18F-flotufolastat PET in salvage therapy planning for BCR."

Details of selected oral and poster presentations by Blue Earth Diagnostics collaborators are listed below. Presentations noted by "*" discuss results of experiences with an investigational agent for which the safety and efficacy have not been established by the FDA.

POSLUMA (flotufolastat F 18), investigational 18F-flotufolastat and 18F-rhPSMA-7

DATE:

Sunday, June 9, 2024

Title:

Impact of forced diuresis with furosemide in the evaluation of biochemical recurrence of prostate cancer with 18F-rhPSMA 7.3 PET/CT: Interim analysis of an ongoing prospective trial

Presenter:

Ismaheel Lawal, MD, PhD, Resident Physician, Department of Radiology and Imaging Sciences, Emory University, Atlanta Ga.

Session Title:

MTA05 POPs/Meet the Author: Oncology: Clinical Therapy & Diagnosis 1

Session Type:

Poster presentation

Session Time:

5:00 – 6:15 PM ET

Abstract ID.:

241368

DATE:

Sunday, June 9, 2024

Title:

*Evaluation of qualitative and quantitative PET parameters in primary prostate cancer patients: double-match comparison of 18F-flotufolastat and 68Ga-PSMA-11-PET

Presenter:

Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany

Session Title:

MTA05 POPs/Meet the Author: Oncology: Clinical Therapy & Diagnosis 1

Session Type:

Poster presentation

Session Time:

5:00 – 6:15 PM ET

Abstract ID.:

241424

DATE:

Saturday, June 8, 2024

Title:

*18F-rhPSMA-7 and 18F-flotufolastat PET-guided salvage radiotherapy in recurrent prostate cancer

Presenter:

Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany

Session Title:

Prostate Cancer: Focus on Imaging

Session Type:

Oral presentation

Session Time:

3:30 – 4:45 PM ET

Presentation:

3:35 – 3:45 PM ET

Abstract ID.:

241112

Axumin (fluciclovine F 18)

DATE:

Sunday, June 9, 2024

Title:

Role of 18F-fluciclovine PET/CT in patients with biochemical recurrence of prostate cancer and a negative PSMA PET/CT: interim results from a prospective trial

Presenter:

Nadine Mallak, MD, Associate Professor, Department of Diagnostic Radiology | Molecular Imaging & Therapy, Body Imaging Director, PET/MRI, Clinical, Oregon Health and Science University, Portland, Ore.

Session Title:

MTA05 POPs/Meet the Author: Oncology: Clinical Therapy & Diagnosis 1

Session Type:

Poster presentation

Session Time:

5:00 – 6:15 PM ET

Abstract ID.:

241835

Blue Earth Diagnostics invites participants at the 2024 SNMMI Annual Meeting to attend the presentations above and to visit the Company at Exhibit Booth 1639. The Company is hosting a Satellite Symposium, "Let’s Talk about POSLUMA," which will discuss the most recent innovations in PSMA-PET imaging for prostate cancer. It will feature invited speakers Sean Collins, MD, PhD, Professor, Georgetown University Hospital, and Elizabeth Hawk, MD, PhD, DABNM DABR, University of California San Diego, and be moderated by Todd Cohen, MD, VP of Medical Affairs, Blue Earth Diagnostics, Inc. The symposium will be held on Sunday, June 9, 2024, from 11:15 AM – 12:15 PM ET in the Toronto Convention Center, Room 701A, South Building – 700 Level. Blue Earth Diagnostics also has a Medical Affairs information booth at SNMMI, where attendees can learn about the Company’s clinical research. For full session details and scientific presentation lists, please see the SNMMI online program here.

Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at View Source

Indication and Important Safety Information About POSLUMA

INDICATION

POSLUMA (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

with suspected metastasis who are candidates for initial definitive therapy
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.
To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf.

A2 Bio Highlights Progress of CAR T-Cell Clinical Programs in Three Poster Presentations during the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting

On May 29, 2024 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies for solid tumors, reported that it will present updates on three ongoing clinical trials in poster presentations during the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, A2 Biotherapeutics, MAY 29, 2024, View Source [SID1234643827]). A2 Bio will present two Trials in Progress posters on its first-in-human (FIH) Phase 1/2 studies, EVEREST-1 and EVEREST-2, as well as a poster highlighting how a greater understanding of the structure of Tmod allowed the BASECAMP-1 master prescreening study to increase the ethnic and racial diversity of patients enrolled in its clinical trials.

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"Diversity in clinical studies is essential to address racial and ethnic groups who are often underrepresented in clinical trials, especially in precision medicine studies using genetic data. We are creating the future of precision medicine by applying advanced bioinformatics in our BASECAMP-1 prescreening protocol to efficiently screen patients for enrollment in these ongoing CAR T-cell clinical trials. Expanding the enrollment criteria to include all HLA-A*02 patients will further enhance the diversity in our trial," said Julian R. Molina, M.D., Ph.D., Professor of Oncology, Mayo Clinic, Rochester, MN.

Significant challenges remain in harnessing the potential of cell-based therapies due to a lack of tumor‑specific targets that discriminate cancer from normal cells, resulting in on‑target, off‑tumor toxicity. The investigational therapies being studied by A2 Bio in EVEREST-1 (A2B530 targeting carcinoembryonic antigen [CEA]) and EVEREST-2 (A2B694 targeting mesothelin [MSLN]) apply the company’s proprietary Tmod platform which utilizes a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells to provide selective tumor killing.1

"We are encouraged by the clinical trial progress presented during ASCO (Free ASCO Whitepaper) 2024. A2 Bio is advancing the clinical development of our innovative CAR T-cell therapies and pioneering a new model for enhancing safety, efficiency and diversity in our interventional trials, and therefore addressing important unmet medical needs," said William Go, M.D., Ph.D., chief medical officer of A2 Bio.

The poster presentations are scheduled on Saturday, June 1, 9:00 am – 12:00 pm CT.

EVEREST-1 (NCT05736731) is a FIH study evaluating A2B530 in patients with solid tumors that express CEA and have human leukocyte antigen (HLA)-A*02 loss of heterozygosity (LOH). The first patient in EVEREST-1 was dosed in May 2023 and dose escalation continues, with 10 patients treated to date.

EVEREST-2 (NCT06051695) is also a FIH study evaluating A2B694 in patients with solid tumors that express MSLN and have HLA-A*02 LOH. The first patient was dosed in May 2024 in this study to evaluate the safety and efficacy of A2B694.

BASECAMP-1 (NCT04981119) is a master prescreening, precision medicine study identifying patients with unresectable, advanced or metastatic solid tumors with HLA-A*02 LOH; patients undergo leukapheresis and Tmod CAR T cells are manufactured for patients who may enroll in the ongoing EVEREST-1 and EVEREST-2 clinical trials. BASECAMP-1 enrollment began with screening for patients with the HLA-A*02:01 allele only. Nonclinical testing determined that the Tmod blocker was effective against other HLA-A*02:XX alleles, and enrollment was expanded to patients with any HLA-A*02 allele subtype. Because HLA-A*02:XX subtypes are more prevalent in non-whites, this change improved the racial and ethnic diversity of the BASECAMP-1 study population. By expanding enrollment, 16% more Hispanic, 43% more African-American, and 112% more Asian or Pacific Islander patients were identified.

For more information on A2 Bio clinical trials, please visit View Source

About the Tmod Platform

A2 Bio has pioneered a precision-targeting cellular system – the Tmod mechanism – that incorporates two receptors, an activator and a blocker, to aim the powerful armaments of immune cells directly at tumors to unequivocally differentiate tumors from normal tissues. The activator recognizes antigens on tumor cells that trigger their destruction, while the blocker recognizes antigens on normal cells that protect them. This novel blocker technology enables precise, personalized and effective T cell targeting. The blocker component equips Tmod cells with the capacity to identify tumors as distinct from normal cells.

About EVEREST-1

EVEREST-1 (NCT05736731) is a seamless Phase 1/2 study for A2B530, an autologous logic-gated investigational cell therapy developed from A2 Bio’s proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B530 consists of an activator that targets carcinoembryonic antigen (CEA) and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. The study is recruiting patients with non-small cell lung, colorectal and pancreatic cancers.

About EVEREST-2

EVEREST-2 (NCT06051695) is a seamless Phase 1/2 study for A2B694, an autologous logic-gated investigational cell therapy developed from A2 Bio’s proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets mesothelin (MSLN) and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. The study is recruiting patients with non-small cell lung, colorectal, pancreatic, ovarian and mesothelioma cancers.

About BASECAMP-1

BASECAMP-1 (NCT04981119) is a prescreening study to identify patients for potential treatment in A2 Bio’s clinical trials. It is a novel approach to help optimize patient treatment outcomes by enabling patients’ immune cells to be banked in their healthiest state earlier in their course of cancer treatment. Next-generation sequencing is used to identify patients who have lost HLA-A*02, the biomarker of interest for A2 Bio’s studies. Patients then undergo leukapheresis to collect, process, and store patient T cells for future Tmod CAR T cell therapy. BASECAMP-1 is currently enrolling patients with non-small cell lung, colorectal, pancreatic, ovarian and mesothelioma cancers.

BostonGene Announces Seven Abstract Acceptances at the 2024 American Society of Clinical Oncology Annual Meeting

On May 29, 2024 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported that seven abstracts have been accepted for the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), scheduled to take place May 31 – June 3, 2024, at McCormick Place Convention Center in Chicago, IL (Press release, BostonGene, MAY 29, 2024, View Source [SID1234643826]). BostonGene will deliver one oral presentation and present two posters, while four abstract presentations will be available online. BostonGene will also exhibit at booth 22157.

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At the event, BostonGene will feature its AI-powered multiomics platform that rapidly accelerates new research and drug development while precisely matching each patient with the best available therapy.

BostonGene will also highlight its recently announced immune system profiling platform, a novel classification method and a scoring system based on this classification of systemic immunity with patient responses to various cancer treatments. This diagnostic and analytical immune system profiling framework underscores the potential of a straightforward blood test, supported by additional clinical validation, as a tool to stratify cancer patients into responders and non-responders across different treatments.

Details about the abstracts selected for presentation can be found below:

Oral presentation

Abstract: 2015
Title: A phase Ib, window-of-opportunity study of neoadjuvant avelumab and hypofractionated proton beam therapy for recurrent radiation-relapsed meningioma
Date and time: Sunday, June 2, 2024 | 11:30 AM – 1:00 PM
Speaker: Jiayi Huang, MD, Washington University School of Medicine

This study evaluated the immunological effects of combining avelumab, an anti-PD-L1 inhibitor, with radiation therapy (RT) for recurrent radiation-relapsed meningioma. The use of RNA-seq and MxIF on pre- and post-avelumab tumor tissues revealed that for some patients the combination (avelumab + RT) may cause an immunological response leading to prolonged remission, warranting further larger prospective studies and biomarker investigations.

Research done in collaboration with the Washington University School of Medicine

Poster presentations

Abstract: 11523
Title: Transcriptomic analysis of novel tumor suppressor gene fusions in bone sarcomas
Date and time: Saturday, June 1, 2024 | 1:30 PM – 4:30 PM
Poster: 449
Speaker: Nikita Kotlov, BostonGene

Transcriptomic analysis of treated bone sarcomas revealed a unique breakpoint combination in an oncogene and previously unknown gene fusions involving tumor suppressor genes. These findings highlight the importance of RNA-seq to advance research and identify potential biomarkers for sarcomas.

Research done in collaboration with The University of Texas MD Anderson Cancer Center, Massachusetts General Hospital Cancer Center and the Sarcoma Oncology Center

Abstract: 1044
Title: The multiomic tumor microenvironment landscape of invasive lobular carcinoma of the breast
Date and time: Sunday, June 2, 2024 | 9:00 AM – 12:00 PM
Poster: 22
Speaker: Jason Mouabbi, MD, The University of Texas MD Anderson Cancer Center

Multiomic analysis using integrated RNA-seq and MxIF uncovered the intricate heterogeneity of the tumor microenvironment (TME) in invasive lobular carcinoma (ILC) of the breast, emphasizing the critical role of comprehensive TME profiling to understand and develop personalized treatments for ILC.

Research done in collaboration with MD Anderson Cancer Center

Online-only abstracts

Abstract: e13168
Title: Closing classification gaps in luminal breast cancer with single-cell RNA-seq insights from normal breast lineages

In this study, single-cell RNA-seq was used to investigate the connection between breast cancer classification and luminal expression profiles. The findings showed that compared to other breast cancer subtypes, luminal breast cancers are less similar to most luminal epithelial clusters in normal breast tissue, which suggests that the complexity of luminal-type breast cancers is not captured by traditional breast cancer classification methods.

Abstract: e15138
Title: Integrated genomic and transcriptomic characterization of neuroendocrine carcinomas for improved treatment decision-making

Integrated whole exome (WES) and RNA sequencing (RNA-seq) detected unique molecular features across diverse neuroendocrine tumors, indicating the potential use of comprehensive molecular profiling for therapy and clinical trial matching to improve outcomes for neuroendocrine carcinoma (NEC) patients.

Research conducted in collaboration with Advanced Cancer Treatment Centers, Mayo Clinic and Duke Cancer Institute

Abstract: e13593
Title: An unsupervised H&E-based machine-learning approach for precise prediction of tumor microenvironment subtypes.

This study describes the development of an H&E-based machine-learning approach using colorectal cancer (CRC) samples. The results show that the H&E-based approach complements next-generation sequencing (NGS) tumor microenvironment (TME) classification, suggesting that the advanced image analysis can help refine prognostic and therapeutic strategies for CRC and warrant further expansion to other cancer types.

Abstract: e15086
Title: Effect of DeltaRex-G ± DeltaRex-G Plus (an FDA-approved drug) on advanced chemoresistant pancreatic cancer, sarcoma, and breast cancer

This study investigated the use of DeltaRex-G, a CCNG1 inhibitor, administered either alone or in combination with an FDA-approved drug (DeltaRex-G Plus) in advanced cancers. RNA sequencing identified enhanced CCNG1 expression in all analyzed tumors and analysis showed that the five patients treated with DeltaRex-G Plus had a partial response or stable disease, supporting the use of DeltaRex-G Plus as a promising therapy.

Research conducted in collaboration with City of Hope Comprehensive Cancer Center, Sarcoma Oncology Center, Duke University and Expression Therapeutics

For more information, please visit the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting website. The abstracts will be published online in the Journal of Clinical Oncology supplement for the ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings.

Median Technologies to Participate in the 2024 ASCO Annual Meeting, May 31 – June 4, 2024, McCormick Place, Chicago, IL, USA

On May 29, 2024 Median Technologies (FR0011049824, ALMDT, PEA/PME scheme eligible, "Median" or "The Company") reported that the Company will be participating in the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from May 31 to June 4, McCormick Place, Chicago, IL, USA (Press release, MEDIAN Technologies, MAY 29, 2024, View Source;June-4-2024-McCormick-Place-Chicago-IL-USA [SID1234643825]). The Median team, with iCRO and eyonis representatives will be pleased to welcome the ASCO (Free ASCO Whitepaper) participants at booth #15142, South Building, Hall A, McCormick place, from June 1 to 3 (exhibition dates), from 9:00 am to 5:00 pm.

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Median Technologies’ abstract selected for online publication is available on the ASCO (Free ASCO Whitepaper) platform:

Abstract #e23010: Double reading performance and the impact of adjudication on progression-free survival estimations: Findings from a lung clinical trial
The FDA recommends Blinded Independent Central Review (BICR) with double reads for imaging in clinical trials, but inter-reader variability raises concerns. Our study examined this variability in lung cancer clinical trials using RECIST. We analyzed 5 phase III trials with 7 readers forming 11 teams, covering 1,017 patients. The study focused on Discrepancy Rate (DR), bias, endorsement rate, and the impact of adjudication on Progression-Free Survival (PFS) estimates. Results showed significant bias among readers, affecting double readings but no correlation between bias and DR. Additionally, adjudication significantly affects PFS estimates. These outcomes highlight the need to improve monitoring in clinical trials.

The ASCO (Free ASCO Whitepaper) Annual Meeting is the world’s premier oncology conference, organized by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the largest oncology society in the world. Each year, the ASCO (Free ASCO Whitepaper) conference brings together more than 35,000 oncologists from all around the globe, and is attended by all medical, educational and industrial stakeholders involved in the field of oncology worldwide. More about the ASCO (Free ASCO Whitepaper) Annual Meeting: View Source