Paul O'Connell’s Post

New publication shows Comprehensive Genomic Profilling (CGP), when compared to small panels, improves detection of actionable biomarkers and greater use of matched therapies, both of which were associated with significant increases in survival in patients with Advanced Non–Small Cell Lung Cancer (aNSCLC). Therefore, broadening the access and uptake of CGP testing enabling patients to receive molecularly driven precision therapies is paramount to improving outcomes in patients with aNSCLC. https://lnkd.in/dxpgc4zg

Boundless Bio Announces First Patient Dosed in First-in-Human Phase 1/2 Clinical Trial of BBI-825 in Cancer Patients with Resistance Gene Amplifications. We are excited to announce dosing of the first patient in our first-in-human study of BBI-825, our second program to enter the clinic, said Klaus Wagner M.D., Ph.D., Chief Medical Officer at Boundless Bio. BBI-825 represents a new approach in the potential treatment of oncogene amplifications, particularly in resistance associated with targeted therapy treatment of MAPK pathway-activated cancers. STARMAP (Study Treating Acquired Resistance: MAPK Amplifications) is an open-label, non-randomized, three-part Phase 1/2 clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamic biomarkers, preliminary antitumor activity, and identify the maximum tolerated dose and recommended Phase 2 dose (RP2D) of BBI 825 administered as a single agent or in combination with select targeted therapies (NCT06299761). Part 1 is a dose escalation of BBI-825 as a monotherapy in patients with solid tumors. Part 2 is a combination dose escalation of BBI-825 and targeted therapies, encorafenib and cetuximab, or adagrasib and cetuximab, in patients with advanced or metastatic colorectal cancer with BRAFV600E or KRASG12C mutations, respectively, and co-occurring resistance gene amplifications. Part 3 is a combination dose expansion to evaluate preliminary anti-tumor activity at the RP2D of BBI-825 and each targeted therapy combination from Part 2. #oncology #oncologyresearch #clinicalresearch #clinicaltrials

Mainz Biomed Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm for Integration into Pivotal FDA PMA Clinical Trial for Next Generation Colorectal Cancer Diagnostic #stockmarket #stocks #investing #businessnews #trading #daytrading #clinicaltrial #AI #artificialintelligence

Next-generation-sequencing-based homologous recombination deficiency (HRD) assay based on QIAGEN’s QIAseq xHYB technology, QIAGEN Digitial Insight solutions, and Myriad’s proprietary, FDA-approved MyChoice CDx® biomarkers #pharma #diagnostics #ngs #oncology #cancer #pathology

There are more than 10 biomarkers recommended for #NSCLC on the NCCN Biomarker Compendia. In this study, 54% of pts received testing for PD-L1, EGFR, and ALK. 16% received no molecular testing at all. #precisionmedicine #precisiononcology #lungcancer #genomics #genetics #cancer #cancercare #ASCO https://lnkd.in/gegxAdrK

🌟Exciting News in Breast Cancer Diagnostics! 🌟 We are thrilled to announce the latest update to the German Uniform Evaluation Standard (EBM) catalogue for the third quarter of 2024, which includes the introduction of a groundbreaking new code, 19466. This code represents a significant advancement in the fight against breast cancer. Code 19466 allows for the targeted determination of ESR1 mutations using circulating tumour #DNA. This test is crucial for postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer. It provides a targeted treatment pathway for those whose disease has progressed after at least one line of endocrine therapy, including a CDK 4/6 inhibitor. 🧬 Why is this important? This new code covers the detection of activating mutations E380Q, L536H, Y537C/N/S, and D538G, along with up to four additional activating mutations in the ligand binding domain using PCR-based methods. This precision in detecting mutations ensures that patients receive the most effective, tailored treatment possible, enhancing their chances of positive outcomes. 💰 Tariff and Billing: The tariff for this test is set at €250.61 and can be billed twice if the disease persists. This makes the test not only a scientific breakthrough but also a financially viable option for ongoing patient management. 🔬 Manufactured by: This innovative diagnostic test is developed by QuantideX qPCR ESR1 Mutation Kita leader in precision medicine and diagnostic solutions. Their commitment to advancing healthcare and improving patient outcomes is evident in the introduction of this essential diagnostic tool. By integrating Code 19466 into the #EBM catalogue, Germany is taking a decisive step towards enhancing personalised medicine and providing hope to many battling #breastcancer. This development underscores the importance of continued investment in medical research and the swift adaptation of new technologies into clinical practice. #BreastCancerAwareness #MedicalInnovation #Healthcare #Diagnostics #PrecisionMedicine #Oncology #EBMUpdate #Germany #CancerTreatment #PersonalizedMedicine #HealthcareInnovation www.asuragen.com

Cancer immunotherapy is moving toward combination regimens with agents of complementary mechanisms of action to achieve more frequent and robust efficacy. Dual combinations also rendered checkpoint inhibitor (CPI)–resistant genetically engineered melanoma model responsive to CPI. Thus, this approach provides a framework for the evaluation of rationally designed combinations in immuno-oncology and yields a promising therapy p/b University of Chicago, Imperial College London, Aslan Mansurov, Trevin Kurtanich, Anna Slezak, Lisa Volpatti, Ph.D., Kevin Chang, Aaron T. Alpar, PhD, Kirsten Refvik, Gustavo Borjas, Ha-Na Shim, Kevin Hultgren, Suzana A Gomes, JUN ISHIHARA, Melody Swartz #immunotherapy #melanoma #translationalmedicine https://lnkd.in/d2Xj6Ey6

Hepatocellular carcinoma (HCC) accounts for roughly 90% of primary liver cancer cases, is highly complex and heterogeneous, and is often associated with underlying chronic liver disease, such as hepatitis. This new study proposes a novel classification of HCC subtypes based on fatty acid degradation (FAD) pathway activity, which correlates with prognosis and treatment response in patients. Furthermore, PDX HCC models showed great utility as preclinical tools as they validated the sorafenib responder and non-responder profiles based on FAD activity. Read this blog post to learn more! #LiverCancer #Hepatitis #Oncology #CancerResearch #Biotech #Bioscience

Black Diamond is developing oral therapeutics for patients with #NSCLC and #GBM. CEO Mark Velleca recently spoke with PharmaVoice about Black Diamond’s vision and clinical programs. Read more in this Biotech Spotlight below, and find us at the American Association for Cancer Research Annual Meeting on April 7 where Etienne Dardenne will be presenting real world data of the evolving #EGFR mutation landscape in #NSCLC, and the first- and best-in-class profile of BDTX-1535. #AACR2024