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Vividion Secures Exclusive Rights to First-in-Class WRN Inhibitor VVD-214 for MSI-High Cancers

Precision MedicineOncology
  • Vividion Therapeutics has secured exclusive worldwide rights to develop VVD-214, the only clinical-stage covalent inhibitor of Werner helicase (WRN) currently in development globally.
  • Preliminary data from a first-in-human Phase I study presented at AACR showed VVD-214 is well tolerated with promising signs of activity in solid tumors with high microsatellite instability.
  • The compound targets a synthetic lethal pathway in MSI-high cancers including colorectal, endometrial, ovarian, and gastric tumors, addressing significant unmet medical need in patients who relapse or become refractory to immune checkpoint inhibitors.

A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of RO7589831 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

NCT06004245RecruitingPhase 1
Hoffmann-La Roche
Posted 1/25/2024

FDA Grants First-Ever Authorization for AI Platform to Predict Breast Cancer Risk from Mammograms

AIPrecision Medicine
  • Clairity receives FDA De Novo authorization for CLAIRITY BREAST, the first AI platform to predict five-year breast cancer risk using routine screening mammograms alone.
  • The platform analyzes subtle imaging features invisible to the human eye to deliver validated risk scores through existing clinical infrastructures.
  • This breakthrough addresses limitations of traditional risk models that rely on age and family history, despite 85% of breast cancer patients having no family history.
  • The technology promises more equitable healthcare by overcoming biases in traditional models built primarily on European Caucasian women data.

Novel Antibody-Drug Conjugate Achieves 85% Response Rate in Rare Blood Cancer Trial

Targeted TherapyPrecision Medicine
  • Pivekimab sunirine (PVEK), a first-in-class antibody-drug conjugate, demonstrated an 85% overall response rate and 70% complete response rate as frontline treatment for newly diagnosed BPDCN patients.
  • The Phase I/II CADENZA trial enrolled 84 patients with CD123-positive blastic plasmacytoid dendritic cell neoplasm, showing a median overall survival of 16.6 months in the frontline cohort.
  • PVEK targets CD123 receptors highly expressed on BPDCN cells and showed manageable safety profile with peripheral edema as the most common reversible side effect.
  • Researchers suggest PVEK should be considered as a new standard-of-care treatment for this rare, aggressive blood cancer that affects bone marrow, skin, and lymph nodes.

Biocartis Achieves First IVDR Class C Companion Diagnostic Certification for EGFR Mutation Test in Europe

Precision Medicine
  • Biocartis' Idylla™ EGFR Mutation Test becomes the first test in the company's portfolio to receive IVDR Class C companion diagnostic certification in Europe.
  • The test detects 44 EGFR mutations in under 3 hours with 99.2% sensitivity and 99.0% specificity for key biomarkers guiding NSCLC treatment decisions.
  • The certification enables European availability of the automated diagnostic platform, while US development continues in partnership with AstraZeneca for Tagrisso treatment selection.

Oxford Cancer Biomarkers Partners with Mira Precision Health to Advance ToxNav® Test for 5FU/Capecitabine Toxicity Prediction in US Market

Precision Medicine
  • Oxford Cancer Biomarkers has partnered with Mira Precision Health to advance its ToxNav® test in the United States, a precision oncology diagnostic that identifies patients at high risk of severe toxicity from 5FU/capecitabine treatment.
  • The ToxNav® test enhances clinical decision-making through comprehensive genetic profiling and aligns with recent NCCN Guidelines updates recommending DPYD testing for colorectal cancer patients receiving fluoropyrimidine-based treatments.
  • The partnership aims to establish substantial market presence in the US, with ToxNav® already backed by multiple peer-reviewed studies and CE-IVD certification in the UK, potentially saving patient lives by preventing avoidable treatment toxicity.

Viz.ai Partners with Novartis to Develop AI-Powered Cancer Care Solutions for Prostate and Breast Cancer

AIOncologyPrecision Medicine
  • Viz.ai and Novartis announced a multi-year strategic collaboration to develop AI-powered workflows within the Viz Oncology Suite, focusing on prostate and breast cancer patient identification and care coordination.
  • The partnership will create two new solutions: Viz Prostate Cancer to streamline patient identification for guideline-based treatments, and Viz Breast Cancer to automate patient review and facilitate multidisciplinary care coordination.
  • The collaboration addresses critical gaps in cancer care, as only one in four prostate cancer patients receive guideline-recommended therapy, while breast cancer remains the most widely diagnosed cancer in the United States with complex care journeys.
  • This strategic alliance marks Viz.ai's expansion into oncology, building on their AI-powered disease detection platform that currently serves over 1,700 hospitals and health systems across the U.S. and Europe.

Breakthrough Immunotherapy Response in Rare Lung Adenosquamous Carcinoma with Multiple Driver Mutations

Precision Medicine
  • A 63-year-old patient with advanced lung adenosquamous carcinoma harboring concurrent KRAS G12C, BRAF, PIK3CA, and FLT1 mutations achieved complete remission with tislelizumab plus chemotherapy, maintaining progression-free survival exceeding 46.5 months.
  • This represents the first documented case of such exceptional response in molecularly complex adenosquamous carcinoma, challenging conventional assumptions about multiple driver mutations and immune resistance.
  • The patient's tumor demonstrated PD-L1 positivity (18.11%) and low tumor mutational burden (3.7 muts/Mb), suggesting that biomarker-guided immunotherapy may overcome therapeutic limitations in this aggressive malignancy.
  • Literature review reveals that adenosquamous carcinoma patients typically achieve median progression-free survival of 5.7-14 months with conventional therapy, making this 46.5-month response unprecedented in the field.

Relay Therapeutics Reports Sustained Efficacy for RLY-2608 in PI3Kα-Mutated Breast Cancer at ASCO 2025

Precision Medicine
  • Relay Therapeutics presented updated interim data for RLY-2608 plus fulvestrant showing consistent median progression-free survival of 11.0 months in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer.
  • The first-in-human ReDiscover study enrolled 118 patients, with RLY-2608 demonstrating a favorable tolerability profile including 92% median dose intensity and only 36% experiencing Grade 3 treatment-related adverse events.
  • The company plans to initiate the pivotal Phase 3 ReDiscover-2 trial in mid-2025, marking the first mutant-selective PI3Kα inhibitor to advance to Phase 3 testing.
  • RLY-2608 represents a novel allosteric, pan-mutant, and isoform-selective approach to PI3Kα inhibition, potentially addressing over 300,000 patients annually in the United States.

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

NCT06982521RecruitingPhase 3
Relay Therapeutics, Inc.
Posted 8/26/2025

Mirvie's RNA Blood Test Predicts Preeclampsia Risk Months Before Symptoms in Major Study

Precision Medicine
  • Mirvie's blood test successfully identified 91% of preterm preeclampsia cases in women over 35 without pre-existing conditions, using RNA signatures detectable at 17.5-22 weeks gestation.
  • The study analyzed over 9,000 pregnancies and discovered molecular signatures that distinguish between severe and mild hypertensive disorders of pregnancy for the first time.
  • Preeclampsia rates have nearly doubled in the past decade, now affecting 1 in 12 pregnancies, highlighting the urgent need for better predictive tools.
  • The clinically validated test will be available under the Encompass brand, enabling proactive care plans including low-dose aspirin therapy months before symptoms appear.

Artera's AI Algorithm Identifies Which Prostate Cancer Patients Benefit from Intensive Therapy, Earning Best of ASCO Recognition

AIPrecision Medicine
  • Artera's multimodal AI algorithm successfully identified that only 25% of high-risk prostate cancer patients derive meaningful benefit from androgen receptor pathway inhibitor intensification, potentially sparing 75% from unnecessary toxicities.
  • The company's oral presentation was selected for Best of ASCO 2025, representing the first validated AI algorithm to personalize treatment decisions for high-risk, non-metastatic prostate cancer patients.
  • The ArteraAI Prostate Test works with routine pathology and clinical data without requiring extra tissue or complex molecular testing, making it broadly scalable and cost-effective for clinical implementation.

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