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DiviTum® TKa Blood Test Shows Promise in Predicting Immunotherapy Response Across Multiple Cancers

Precision MedicineOncology
  • New research from Karolinska Institutet demonstrates that Biovica's DiviTum® TKa blood test, when combined with inflammation protein biomarkers, significantly improves prediction of immunotherapy efficacy in melanoma patients.
  • Patients with favorable biomarker profiles showed dramatically improved 5-year survival rates of 83% compared to just 11% in those with high-risk profiles, potentially addressing the challenge that less than half of patients benefit from immune checkpoint inhibitors.
  • Additional DiviTum® TKa data will be presented at the upcoming ASCO meeting, expanding its application as a predictive biomarker across three cancer types: hormone receptor-positive metastatic breast cancer, BRAF V600-mutated melanoma, and ovarian cancer.

MR-LINAC Technology Advances Precision Radiation Therapy Across Multiple Cancer Types

Precision MedicineAIOncology
  • MR-LINAC technology enables adaptive radiation treatment planning with real-time imaging, allowing clinicians to customize radiation delivery based on daily changes in patient anatomy and tumor position.
  • The technology has shown promising early results in reducing toxicity rates in pancreatic and prostate cancers by precisely targeting tumors while sparing nearby sensitive organs.
  • Despite longer treatment sessions and potential claustrophobia issues, MR-LINAC offers significant advantages for treating cancers near sensitive organs, with ongoing research exploring novel MR contrast agents and biology-adaptive radiation approaches.

The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

NCT04075305Recruiting
UMC Utrecht
Posted 2/1/2019

Phase 3 MoonRISe-1 Trial Evaluates TAR-210 Erdafitinib System for Bladder Cancer

Targeted TherapyOncologyPrecision Medicine
  • Johnson & Johnson launches Phase 3 MoonRISe-1 trial investigating TAR-210, a novel intravesical erdafitinib-releasing system, versus standard BCG therapy for non-muscle invasive bladder cancer.
  • TAR-210 represents an innovative targeted approach for FGFR-positive bladder cancer patients, potentially offering improved local drug delivery with reduced systemic side effects.
  • The study aims to assess efficacy and safety outcomes in patients with high-risk non-muscle invasive bladder cancer, addressing a significant unmet need in bladder cancer treatment.

Digital Twins Transform Rare Disease Drug Development with Virtual Trials and AI-Powered Simulations

Rare DiseaseAIPrecision Medicine
  • Digital twins enable researchers to simulate patient responses in rare diseases like Pompe disease, reducing the need for large patient populations in clinical trials.
  • Virtual trials leveraging digital twin technology allow remote monitoring and continuous data collection, particularly beneficial for rare diseases with limited patient populations.
  • Model-informed drug development using digital twins can save an average of 10 months and $5 million per program, according to recent Pfizer findings.
  • The European Medicines Agency has issued a draft qualification opinion on Unlearn.AI's digital twin platform, marking significant regulatory progress for the technology.

Targeted Therapies and Immunotherapy Advances in Non-Small Cell Lung Cancer: A Comprehensive Review

Targeted TherapyCAR-TOncologyPrecision Medicine
  • Targeted therapies for NSCLC have revolutionized treatment for patients with specific genetic alterations, with EGFR, ALK, and ROS1 inhibitors showing significant improvements in progression-free survival compared to traditional chemotherapy.
  • Immunotherapy, particularly immune checkpoint inhibitors targeting PD-1/PD-L1 and CTLA-4, has become a cornerstone in NSCLC treatment, with newer targets like LAG-3, TIM-3, and TIGIT showing promise in ongoing clinical trials.
  • Advanced cellular therapies including adoptive cell transfer, CAR-T cells, and cancer vaccines represent the next frontier in NSCLC treatment, particularly for patients with "cold tumors" who don't respond to standard immunotherapies.

A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer

NCT03789604Active, Not RecruitingPhase 3
CStone Pharmaceuticals
Posted 12/13/2018

A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers

NCT01524978CompletedPhase 2
Hoffmann-La Roche
Posted 4/12/2012

BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)

NCT01121393CompletedPhase 3
Boehringer Ingelheim
Posted 4/19/2010

Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

NCT01203917CompletedPhase 4
AstraZeneca
Posted 9/1/2010

IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC

NCT03562871CompletedPhase 1
IO Biotech
Posted 8/22/2018

Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC

NCT03970746Active, Not RecruitingPhase 1
PDC*line Pharma SAS
Posted 9/10/2019

Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001) ( KEYVIBE-001)

NCT02964013CompletedPhase 1
Merck Sharp & Dohme LLC
Posted 12/13/2016

Efficacy Study of Vx001 Vaccine in NSCLC Patients

NCT01935154CompletedPhase 2
Vaxon Biotech
Posted 8/1/2012

P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors

NCT05239143Active, Not RecruitingPhase 1
Poseida Therapeutics, Inc.
Posted 2/15/2022

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

NCT02075840CompletedPhase 3
Hoffmann-La Roche
Posted 8/19/2014

Avelumab in First-line NSCLC (JAVELIN Lung 100)

NCT02576574CompletedPhase 3
EMD Serono Research & Development Institute, Inc.
Posted 10/29/2015

PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies

NCT03365791CompletedPhase 2
Novartis Pharmaceuticals
Posted 1/24/2018

A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors

NCT03849469CompletedPhase 1
Xencor, Inc.
Posted 5/29/2019

Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR

NCT00446225CompletedPhase 3
Spanish Lung Cancer Group
Posted 2/15/2007

Phase I/II Study of Anti-Mucin1 (MUC1) CAR T Cells for Patients With MUC1+ Advanced Refractory Solid Tumor

NCT02587689Unknown StatusPhase 1
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Posted 10/1/2015

Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin

NCT02414269Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 5/1/2015

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

NCT00949650CompletedPhase 3
Boehringer Ingelheim
Posted 8/14/2009

Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for NSCLC

NCT03525782Unknown StatusPhase 1
The First Affiliated Hospital of Guangdong Pharmaceutical University
Posted 2/1/2018

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

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

NCT00585195CompletedPhase 1
Pfizer
Posted 4/19/2006

Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors

NCT04140500Active, Not RecruitingPhase 1
Hoffmann-La Roche
Posted 11/11/2019

A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

NCT02125461CompletedPhase 3
AstraZeneca
Posted 5/7/2014

Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

NCT02608268TerminatedPhase 1
Novartis Pharmaceuticals
Posted 11/23/2015

Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001)

NCT01295827CompletedPhase 1
Merck Sharp & Dohme LLC
Posted 3/4/2011

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

NCT01774721CompletedPhase 3
Pfizer
Posted 5/9/2013

A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer

NCT04931654Active, Not RecruitingPhase 1
AstraZeneca
Posted 9/28/2021

Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.

NCT01336634CompletedPhase 2
Novartis Pharmaceuticals
Posted 8/5/2011

A Trial of ChAdOx1 and MVA Vaccines Against MAGE-A3 and NY-ESO-1

NCT04908111SuspendedPhase 1
Cancer Research UK
Posted 10/15/2021

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

NCT02477826CompletedPhase 3
Bristol-Myers Squibb
Posted 8/5/2015

Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab

NCT03709706TerminatedPhase 1
GlaxoSmithKline
Posted 12/31/2018

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

NCT03409614CompletedPhase 3
Regeneron Pharmaceuticals
Posted 3/6/2018

A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT03563716Active, Not RecruitingPhase 2
Genentech, Inc.
Posted 8/10/2018

Trial of RNActive®-Derived Cancer Vaccine and Local Radiation in in Stage IV Non Small Cell Lung Cancer (NSCLC)

NCT01915524TerminatedPhase 1
CureVac
Posted 4/1/2013

Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC

NCT03625323CompletedPhase 2
Immutep S.A.S.
Posted 2/18/2019

Biological Therapy in Treating Patients With Metastatic Cancer

NCT00004604CompletedPhase 1
Duke University
Posted 2/1/1997

CTLA-4 and PD-1 Antibodies Expressing EGFR-CAR-T Cells for EGFR Positive Advanced Solid Tumor

NCT03182816Unknown StatusPhase 1
Shanghai Cell Therapy Research Institute
Posted 6/7/2017

Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory Cancer

NCT02381314CompletedPhase 1
MacroGenics
Posted 3/26/2015

MGC018 With or Without MGA012 in Advanced Solid Tumors

NCT03729596TerminatedPhase 1
MacroGenics
Posted 11/21/2018

Evaluation of SAR408701 in Patients With Advanced Solid Tumors

NCT02187848TerminatedPhase 1
Sanofi
Posted 7/23/2014

Genetically Modified T-Cell Therapy in Treating Patients With Advanced ROR1+ Malignancies

NCT02706392TerminatedPhase 1
Fred Hutchinson Cancer Center
Posted 3/16/2016

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

NCT02366143CompletedPhase 3
Hoffmann-La Roche
Posted 3/31/2015

Safety and Efficacy of CEA-Targeted CAR-T Therapy for Relapsed/Refractory CEA+ Cancer

NCT04348643Unknown StatusPhase 1
Chongqing Precision Biotech Co., Ltd
Posted 2/20/2020

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

NCT01642004CompletedPhase 3
Bristol-Myers Squibb
Posted 10/16/2012

Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer

NCT02475213CompletedPhase 1
MacroGenics
Posted 7/1/2015

CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer

NCT01583686TerminatedPhase 1
National Cancer Institute (NCI)
Posted 5/4/2012

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

NCT03470922Active, Not RecruitingPhase 2
Bristol-Myers Squibb
Posted 4/11/2018

A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

NCT04623775Active, Not RecruitingPhase 2
Bristol-Myers Squibb
Posted 2/17/2021

A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies

NCT03652077CompletedPhase 1
Incyte Corporation
Posted 9/24/2018

A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors

NCT03708328CompletedPhase 1
Hoffmann-La Roche
Posted 10/15/2018

Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

NCT00923312CompletedPhase 1
CureVac
Posted 5/1/2009

A Study of RNA Tumor Vaccine in Patients With Advanced Solid Tumors

NCT05202561Unknown StatusPhase 1
First Affiliated Hospital Bengbu Medical College
Posted 3/10/2022

A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

NCT03219268CompletedPhase 1
MacroGenics
Posted 8/18/2017

Oncolytic MG1-MAGEA3 With Ad-MAGEA3 Vaccine in Combination With Pembrolizumab for Non-Small Cell Lung Cancer Patients

NCT02879760CompletedPhase 1
Turnstone Biologics, Corp.
Posted 3/8/2017

Study of CXCR5 Modified EGFR Targeted CAR-T Cells for Advanced NSCLC

NCT05060796RecruitingEarly Phase 1
Second Affiliated Hospital of Guangzhou Medical University
Posted 9/1/2019

Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors

NCT03689192CompletedPhase 1
Herlev Hospital
Posted 12/17/2018

PD-L1 Antibody (TQB2450) Plus Chemotherapy for Previously Untreated Limited- Stage Small-cell Lung Cancer

NCT04539977RecruitingPhase 2
Shanghai Pulmonary Hospital, Shanghai, China
Posted 9/1/2020

A Trial of AK104 Plus Anlotinib in NSCLC

NCT04646330CompletedPhase 1
Akeso
Posted 11/18/2020

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

NCT03703297Active, Not RecruitingPhase 3
AstraZeneca
Posted 9/27/2018

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants

NCT02737501CompletedPhase 3
Ariad Pharmaceuticals
Posted 5/26/2016

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

NCT05834348Completed
Pfizer
Posted 6/23/2023

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

NCT01970865CompletedPhase 1
Pfizer
Posted 1/8/2014

Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected Mismatch Repair Protein (MMR-p) Colorectal and Pancreatic Cancer

NCT04117087Active, Not RecruitingPhase 1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Posted 5/28/2020

A Clinical Research of CAR T Cells Targeting CEA Positive Cancer

NCT02349724Unknown StatusPhase 1
Southwest Hospital, China
Posted 12/1/2014

A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"

NCT01903993CompletedPhase 2
Hoffmann-La Roche
Posted 8/6/2013

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

NCT00932893CompletedPhase 3
Pfizer
Posted 9/1/2009

Cardiomyopathy Market Projected to Reach $20+ Billion by 2035 as Novel Therapies Advance Through Clinical Development

Drug ApprovalPrecision Medicine
  • The global cardiomyopathy market is expected to grow at a CAGR of 6.13% from 2025-2035, driven by rising cardiovascular disease prevalence and innovative therapeutic developments.
  • Cytokinetics' aficamten received FDA acceptance for its New Drug Application in December 2024, with a target action date of September 26, 2025, representing a potential breakthrough in hypertrophic cardiomyopathy treatment.
  • Novel therapeutic approaches including gene therapy, stem cell treatments, and cardiac myosin inhibitors are revolutionizing cardiomyopathy management beyond traditional beta-blockers and ACE inhibitors.
  • The United States represents the largest patient pool and market for cardiomyopathy treatments, with significant growth opportunities in precision cardiology targeting genetic causes of heart diseases.

Alzheimer's Drug Discovery Foundation Invests Record $10M in Alamar Biosciences for Blood-Based Diagnostic Platform

Precision Medicine
  • The Alzheimer's Drug Discovery Foundation's Diagnostics Accelerator announced its largest investment to date, $10 million in Alamar Biosciences, to advance blood-based biomarker testing for Alzheimer's disease.
  • Alamar's ARGO DX System utilizes NULISA technology to enable ultra-high sensitivity protein detection and multiplexing capabilities for analyzing multiple Alzheimer's biomarkers simultaneously from blood samples.
  • The investment aims to translate Alamar's research platform into an FDA-cleared diagnostic system, potentially creating the first comprehensive blood panel for personalized Alzheimer's diagnosis and treatment selection.
  • This funding represents a significant step toward precision medicine in Alzheimer's care, similar to biomarker-guided treatment approaches already established in cancer therapy.

Two Phase III Trials Target Advanced Breast Cancer with Novel Therapeutic Approaches

Precision Medicine
  • Two Phase III clinical trials are investigating advanced treatment strategies for hormone receptor-positive, HER2-negative breast cancer in postmenopausal women.
  • The first trial examines combination therapy with fulvestrant in patients with PIK3CA mutations who have progressed on aromatase inhibitor therapy.
  • The SERENA-6 study evaluates AZD9833, an investigational SERD, in patients with ESR1 mutations currently receiving CDK4/6 inhibitor and aromatase inhibitor combination therapy.
  • Both trials focus on addressing resistance mechanisms in advanced breast cancer through targeted approaches based on specific genetic mutations.

Regeneron to Acquire 23andMe for $310 Million, Gaining Access to Vast Genetic Database

Precision MedicineDrug Discovery
• Regeneron Pharmaceuticals has reached an agreement to acquire 23andMe for approximately $310 million, gaining access to one of the world's largest consumer genetic databases.
• The acquisition comes as 23andMe has struggled financially in recent years, with its stock price declining significantly since going public in 2021 through a SPAC merger.
• This deal represents a strategic move for Regeneron to enhance its drug discovery capabilities by leveraging 23andMe's genetic data from millions of consenting users.

Yuhan's Lung Cancer Drug Leclaza Secures European Approval in Combination Therapy

Precision MedicineOncologyDrug ApprovalTargeted Therapy
  • Yuhan Corporation's third-generation EGFR-TKI lazertinib (Leclaza) has received European Commission approval in combination with J&J's Rybrevant for first-line treatment of EGFR-mutated non-small cell lung cancer.
  • The Phase 3 MARIPOSA study demonstrated the combination therapy reduced disease progression risk by 30% compared to osimertinib, with median progression-free survival of 23.7 months versus 16.6 months.
  • This milestone marks the first Korean anticancer drug approved in both the U.S. and Europe, triggering a $30 million payment to Yuhan as part of their $1.255 billion licensing deal with Johnson & Johnson.

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