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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.

Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma

NCT02125240Unknown StatusPhase 3
Betta Pharmaceuticals Co., Ltd.
Posted 9/1/2014

Evaluating High-dose Furmonertinib with Bevacizumab and Pemetrexed for EGFRm NSCLC with Leptomeningeal Metastasis

NCT06643000RecruitingNot Applicable
Henan Cancer Hospital
Posted 12/20/2024

Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC

NCT02504489CompletedPhase 3
BeyondSpring Pharmaceuticals Inc.
Posted 12/1/2015

A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

NCT05120349Active, Not RecruitingPhase 3
AstraZeneca
Posted 2/21/2022

To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

NCT04853342RecruitingPhase 3
Allist Pharmaceuticals, Inc.
Posted 6/7/2021

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 trial to learn how safe Dato-DXd is when given with osimertinib, and how well it works compared to osimertinib alone in people who have advanced or metastatic non-small cell lung cancer (NSCLC) with a mutation in the EGFR gene

2023-509883-89-00RecruitingPhase 3
AstraZeneca AB
Posted 4/29/2024

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

NCT02609776Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/24/2016

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

Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation

NCT01996098Unknown StatusPhase 3
Sun Yat-sen University
Posted 1/1/2014

A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer

NCT04036682Active, Not RecruitingPhase 1
Cullinan Therapeutics Inc.
Posted 10/31/2019

TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

NCT04129502Active, Not RecruitingPhase 3
Takeda
Posted 1/10/2020

REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

NCT05973773RecruitingPhase 3
Taiho Oncology, Inc.
Posted 6/30/2023

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

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

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

Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer

NCT04181060RecruitingPhase 3
National Cancer Institute (NCI)
Posted 12/28/2020

Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Tumor Suppressor Gene Mutation

NCT04500717Unknown StatusPhase 3
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Posted 10/1/2020

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT02296125Active, Not RecruitingPhase 3
AstraZeneca
Posted 12/3/2014

Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations

NCT06041776RecruitingPhase 3
Betta Pharmaceuticals Co., Ltd.
Posted 3/28/2023

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

NCT04538664Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/13/2020

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

NCT05388669Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 8/5/2022

Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT03909334Active, Not RecruitingPhase 2
Xiuning Le
Posted 7/25/2019

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer with EGFR or HER2 Mutation (WU-KONG1)

NCT03974022Active, Not RecruitingPhase 1
Dizal Pharmaceuticals
Posted 7/9/2019

A Study of TAVO412 in Patients with Cancer (TAVO412)

NCT06761651RecruitingPhase 1
Tavotek Biotherapeutics
Posted 12/20/2023

Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib

NCT06120140RecruitingPhase 2
Janssen Research & Development, LLC
Posted 2/16/2024

Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

NCT03944772Active, Not RecruitingPhase 2
AstraZeneca
Posted 6/25/2019

A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)

NCT03521154Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/19/2018

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

Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection

NCT04762459Enrolling by InvitationPhase 3
Chinese Academy of Medical Sciences
Posted 8/1/2021

AK112 in Advanced Non-Small Cell Lung Cancer

NCT05499390Active, Not RecruitingPhase 3
Akeso
Posted 11/9/2022

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

NCT04035486Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/2/2019

A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

NCT02912949Active, Not RecruitingPhase 2
Partner Therapeutics, Inc.
Posted 1/1/2015

Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

NCT05607550Active, Not RecruitingPhase 3
ArriVent BioPharma, Inc.
Posted 6/1/2023

A trial to learn how safe Dato-DXd is and how well it works in people with NSCLC that has advanced after receiving osimertinib

2024-511362-37-00RecruitingPhase 3
AstraZeneca AB
Posted 10/4/2024

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.

Finnish Researchers Develop Gene Signature Test to Predict Cancer Immunotherapy Response

Precision MedicineOncology
  • University of Turku scientists have identified a five-gene signature that predicts which cancer patients will respond to bexmarilimab immunotherapy, potentially improving treatment outcomes through personalized selection.
  • The study revealed bexmarilimab works best in "immunologically silent" tumor environments by activating macrophages against cancer cells, while also triggering B cell responses in adjacent healthy tissue.
  • This Finnish-developed immunotherapy has shown promising results across multiple solid tumor types, with researchers now working toward clinical validation of the gene signature for patient profiling.

Biostate AI Secures $12M Series A to Revolutionize RNA Sequencing and Molecular Diagnostics

AIPrecision MedicineOncology
  • Biostate AI has raised $12 million in Series A funding led by Accel to develop affordable RNA sequencing technology and AI-powered diagnostic models.
  • The company's proprietary BIRT and PERD technologies reduce RNAseq costs by nearly an order of magnitude, enabling researchers to run 2-3 times more samples within existing budgets.
  • Founded by former professors David Zhang and Ashwin Gopinath, Biostate AI aims to build "foundation models" for molecular medicine by analyzing billions of RNA expressions to predict disease evolution and drug responses.

Sanofi and Regeneron Announce AIM4 Trial to Advance Personalized Asthma Treatment

Monoclonal AntibodyPrecision Medicine
  • Sanofi and Regeneron revealed plans at ATS 2025 to launch the innovative AIM4 clinical trial, focusing on personalized treatment approaches for asthma patients.
  • The trial represents a significant advancement in precision medicine for respiratory care, aiming to match patients with optimal therapies based on their specific asthma phenotypes.
  • This initiative builds on the companies' existing respiratory portfolio and reflects the growing industry trend toward tailored therapeutic strategies for chronic respiratory conditions.

ACT Technology Shows Promising Results in Enhancing Chemotherapy for Colorectal Liver Metastases

OncologyPrecision Medicine
  • EXACT Therapeutics' Phase 1 ACTIVATE trial demonstrates that Acoustic Cluster Therapy (ACT) significantly enhances chemotherapy effectiveness, with ACT-treated tumors showing 29% reduction in diameter compared to 7% with chemotherapy alone.
  • The innovative treatment demonstrated a clear dose-response relationship, with higher doses (40 μl/kg) of PS101 producing greater tumor shrinkage than lower doses (20 μl/kg), while maintaining an excellent safety profile.
  • These positive results support advancement to the Phase 2 ENACT trial targeting pancreatic cancer, potentially offering new hope for patients with difficult-to-treat solid tumors.

Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer

NCT06850623RecruitingPhase 2
EXACT Therapeutics AS
Posted 6/19/2025

PS101-mediated ACT With Chemotherapy in Liver Metastases From Cancer of Gastrointestinal Origin

NCT04021277TerminatedPhase 1
EXACT Therapeutics AS
Posted 9/17/2019

Enibarcimab Shows Promising Results in Biomarker-Guided Septic Shock Treatment

Monoclonal AntibodyPrecision Medicine
  • Journal of Critical Care has published positive results from AdrenoMed's Phase II AdrenOSS-2 trial, showing enibarcimab improved organ function and reduced 28-day mortality in septic shock patients.
  • The precision medicine approach used two biomarkers (bio-ADM and DPP3) to identify patients most likely to benefit from treatment, with mortality rates of 18% in the enibarcimab group versus 26% in placebo.
  • Based on these promising findings, AdrenoMed is advancing to a confirmatory Phase IIb/III BOOST trial, potentially addressing a critical unmet need in septic shock treatment where mortality rates remain at 30-50%.

Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB

NCT03085758CompletedPhase 2
Adrenomed AG
Posted 12/12/2017

Adrecizumab Phase 1 Trial

NCT02991508CompletedPhase 1
Radboud University Medical Center
Posted 5/23/2016

Adrecizumab-LPS Study

NCT03083171CompletedPhase 1
Adrenomed AG
Posted 1/4/2017

FDA Approves First Blood Test for Alzheimer's Diagnosis, Boosting Roche and BioArctic Shares

FDA ApprovalNeurologyPrecision Medicine
• The U.S. Food and Drug Administration has approved the first blood test for diagnosing Alzheimer's disease, potentially revolutionizing patient identification and treatment pathways.
• The diagnostic breakthrough is expected to drive market activity for pharmaceutical companies Roche and BioArctic, whose shares showed positive movement following the regulatory announcement.
• This blood test could significantly streamline the Alzheimer's diagnostic process, making it more accessible and efficient compared to traditional methods that rely on expensive brain scans and invasive procedures.

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