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FORE Biotherapeutics Secures $38 Million in Series D-2 Financing to Advance Plixorafenib Clinical Trials

Targeted TherapyOncologyPrecision Medicine
  • FORE Biotherapeutics has raised $38 million in Series D-2 financing to advance its global Phase 2 FORTE Master Protocol evaluating plixorafenib across multiple BRAF-mutated cancer indications.
  • The company anticipates interim analyses in 2025 across three monotherapy indications: BRAF V600 primary recurrent CNS tumors, rare BRAF V600 mutated solid tumors, and advanced solid tumors with BRAF fusions.
  • Plixorafenib, designed with a first-in-class mechanism to address limitations of earlier BRAF inhibitors, has previously demonstrated promising efficacy with a 67% overall response rate in BRAF V600 primary recurrent CNS tumors.

Syantra Expands IP Portfolio with Novel "Tumor Education" Approach for Cancer Detection and Treatment

Precision MedicineOncology
  • Syantra has filed new patents expanding their cancer molecular diagnostics platform to include novel drug targets and therapeutics based on their "tumor education" approach.
  • The company's Onco-ID platform uses whole blood mRNA analysis to detect early-stage cancer by monitoring the body's immune response rather than cancer cells or DNA fragments.
  • Syantra's proprietary cellular discovery models have enabled researchers to investigate molecular pathways and chemical compounds in ways that could significantly impact understanding of cancer progression.

NeoGenomics Launches c-MET Companion Diagnostic for Advanced Non-Small Cell Lung Cancer Treatment

Targeted TherapyDrug ApprovalOncologyPrecision Medicine
  • NeoGenomics has commercially launched c-MET CDx for NSCLC, a companion diagnostic assay that detects c-Met protein overexpression in advanced non-small cell lung cancer patients with a 48-hour turnaround time.
  • The diagnostic test supports patient selection for newly FDA-approved targeted therapy EMRELIS™ (telisotuzumab vedotin-tllv), offering a precision medicine approach for a biomarker observed in up to 50% of advanced NSCLC patients.
  • This validated companion diagnostic complements NeoGenomics' broader PanTracer™ portfolio, enhancing comprehensive biomarker profiling capabilities for lung cancer treatment decisions.

NIH-Funded Teams Develop Precision Gene Delivery Systems for Neural Cells

Precision MedicineAI
  • Research teams funded by the NIH have created a versatile toolkit of gene delivery systems that can target specific neural cell types in the human brain and spinal cord with unprecedented precision.
  • The new delivery platform uses modified adeno-associated viruses (AAVs) to transport genetic material into targeted cells, potentially transforming how scientists study neural circuits without requiring genetically modified animals.
  • This breakthrough could accelerate the development of precise gene therapies for neurological disorders like ALS, Alzheimer's, and Parkinson's disease by targeting only affected cells rather than merely treating symptoms.

AI Tools Show Promise in Improving HER2 Breast Cancer Classification and Treatment Eligibility

AIPrecision MedicineOncology
  • A multinational study demonstrates that AI assistance significantly improves pathologists' accuracy in HER2 breast cancer scoring, with accuracy rates increasing from 89.1% to 96.1% when AI tools were utilized.
  • The Digital PATH Project, involving 31 partners including pharmaceutical companies and academic centers, validated AI diagnostic technologies using 1,100 breast cancer tissue samples to assess consistency in HER2 expression identification.
  • AI tools particularly enhanced detection of HER2-low and HER2-ultralow expression levels, reducing misclassification by 24.4% and potentially expanding treatment eligibility for antibody-drug conjugates to patients previously classified as HER2-negative.

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

NCT04494425Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/24/2020

Patient-Derived Organoids and CRISPR Technology Transform Cancer Research and Precision Medicine

Precision Medicine
  • Patient-derived organoids (PDOs) have emerged as a transformative platform in cancer research, providing three-dimensional cell culture systems that retain the genetic variability and phenotypic diversity of primary tumors while enabling more accurate modeling of the tumor microenvironment compared to traditional 2D cultures.
  • CRISPR screening technology integrated with PDOs offers unprecedented capabilities for identifying genetic vulnerabilities in cancer cells, revealing drug resistance mechanisms, and discovering novel therapeutic targets through systematic gene editing and functional genomics approaches.
  • The combination of PDOs and CRISPR screening has demonstrated significant potential in advancing precision oncology by enabling patient-specific drug screening, identifying biomarkers for immunotherapy response, and developing personalized treatment strategies that could improve outcomes for cancer patients.

AstraZeneca Showcases Groundbreaking Cancer Research at ASCO 2025 with Two Plenary Presentations

OncologyTargeted TherapyPrecision MedicineRare Disease
  • AstraZeneca will present over 80 abstracts at ASCO 2025, including two plenary presentations featuring camizestrant for HR-positive breast cancer and IMFINZI for early gastric cancer, marking their seventh consecutive year with plenary data.
  • The SERENA-6 trial is the first positive Phase III study for a next-generation oral SERD in first-line HR-positive breast cancer, pioneering the use of circulating tumor DNA to guide treatment decisions.
  • DESTINY-Breast09 data shows ENHERTU plus pertuzumab is the first treatment in over a decade to demonstrate superiority over standard care in first-line HER2-positive metastatic breast cancer.

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

NCT02564900CompletedPhase 1
Daiichi Sankyo Co., Ltd.
Posted 9/1/2015

Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas

NCT04924608Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/19/2021

Closed Loop Medicine Appoints Kate Woolland as CEO to Drive Precision Dosing Commercialization

Precision Medicine
  • Closed Loop Medicine has appointed Kate Woolland as CEO to lead the company's transition from product development to commercial deployment of its pharmaceutical precision dosing platform.
  • The company has built an extensive IP portfolio with over 60 filings across 16 patent families, covering precision dosing technologies for GLP-1 therapies, hypertension, and other therapeutic areas.
  • CLM's proprietary approach has demonstrated improved patient medication adherence rates exceeding 90% through personalized titration, positioning the company to pursue strategic partnerships and licensing opportunities.

CCM Biosciences to Present Breakthrough 4th-Generation EGFR Inhibitors for NSCLC at ASCO 2025

OncologyPrecision MedicineTargeted Therapy
  • CCM Biosciences will present data on novel 4th-generation EGFR inhibitors (CCM-205, CCM-245, and CCM-308) that overcome both mutational and non-mutational resistance to 3rd-generation inhibitors in NSCLC at ASCO 2025.
  • The company's compounds significantly outperform other investigational 4th-generation inhibitors in various drug resistance models and show efficacy as both monotherapies and in combination with existing treatments.
  • CCM Biosciences plans to file an Investigational New Drug (IND) application this year to advance clinical candidates from its EGFR inhibitor program into clinical trials.

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

NCT04077463Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 9/4/2019

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT04988295Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/17/2021

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

NCT05663866Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 5/18/2023

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04487080Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/30/2020

A Study of TAVO412 in Patients with Cancer (TAVO412)

NCT06761651RecruitingPhase 1
Tavotek Biotherapeutics
Posted 12/20/2023

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

NCT01942135CompletedPhase 3
Pfizer
Posted 9/26/2013

Tempus and Verastem Partner to Develop Companion Diagnostic for First FDA-Approved KRAS-Mutant LGSOC Treatment

Precision MedicineDrug ApprovalOncologyTargeted Therapy
  • Tempus AI and Verastem Oncology have announced a collaboration to develop a companion diagnostic test for the recently FDA-approved combination therapy of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer.
  • The partnership builds on Tempus' confirmatory testing in Verastem's Phase 2 RAMP-201 clinical trial, with their FDA-approved xT CDx assay now being used as an investigational assay in the global Phase 3 RAMP-301 trial.
  • Low-grade serous ovarian cancer (LGSOC) is a rare form affecting younger women, accounting for 6-10% of serous ovarian cancers, with historically poor response to chemotherapy and limited treatment options.
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