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Lighthouse Pharmaceuticals Secures $49.2 Million NIH Grant for Novel Alzheimer's Disease Treatment Targeting Bacterial Infection

Precision Medicine
  • Lighthouse Pharmaceuticals received a $49.2 million grant from the National Institute on Aging to advance Phase 2 trials of LHP588, targeting Porphyromonas gingivalis infections in Alzheimer's disease patients.
  • The SPRING trial will evaluate LHP588, an oral lysine-gingipain inhibitor, in 300 patients with mild to moderate Alzheimer's disease who test positive for P. gingivalis in saliva samples.
  • Previous clinical studies demonstrated that gingipain inhibitors significantly slowed cognitive decline in P. gingivalis-positive Alzheimer's patients, with bacterial reduction correlating to improved clinical outcomes.
  • The novel therapeutic approach targets the infectious and inflammatory cascade driven by P. gingivalis, which produces neurotoxic proteases that promote neuroinflammation and neurodegeneration in Alzheimer's disease.

Study of LHP588 in Subjects with P. Gingivalis-Positive Alzheimer's Disease

NCT06847321RecruitingPhase 2
Lighthouse Pharmaceuticals, Inc.
Posted 2/17/2025

Scipher Medicine Launches AI Platform to Predict Clinical Trial Failures with Near-Perfect Accuracy

AIPrecision Medicine
  • Scipher Medicine has launched ClinicalTrialRank.com, an AI platform that predicts clinical trial failure with unprecedented accuracy based on over 10 years of research and the human interactome network.
  • The platform demonstrates that poorly ranked therapeutic targets are terminated before market launch nearly 100% of the time, potentially preventing approximately 1,000 failed trials across 25 disease areas.
  • Built on comprehensive protein-protein interaction mapping and validated by over 100 peer-reviewed papers, the technology could redirect billions of dollars from doomed drug development programs to more promising therapeutic targets.
  • The multi-layered approach integrates genotype, phenotype, and treatment models to rank targets based on their relevance to disease genetics and ability to restore patients' molecular profiles to healthy states.

Agilent's MMR IHC Panel PharmDx Receives FDA Approval as Companion Diagnostic for Colorectal Cancer Immunotherapy

FDA ApprovalPrecision Medicine
  • Agilent Technologies received FDA approval for its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic test to identify mismatch repair deficient colorectal cancer patients eligible for Bristol Myers Squibb's Opdivo immunotherapy treatments.
  • The test detects loss of function in four key mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6) in colorectal cancer tissue, making it the only FDA-approved companion diagnostic IHC panel for this specific indication.
  • This diagnostic tool enhances healthcare providers' ability to tailor immunotherapy treatments for colorectal cancer patients, potentially improving tumor control and progression-free survival outcomes.

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

NCT04008030Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 8/5/2019

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

NCT02060188CompletedPhase 2
Bristol-Myers Squibb
Posted 3/12/2014

Dana-Farber Researchers Launch Phase 1 Trial of Novel Cyclin Inhibitor for Small Cell Lung Cancer

OncologyPrecision Medicine
  • Dana-Farber Cancer Institute researchers have developed a first-in-class direct cyclin inhibitor that selectively kills cancer cells with disabled G1/S checkpoints, showing 100-1000 fold greater sensitivity in cancer cells compared to normal cells.
  • The novel drug class targets cyclins A and B through a two-step mechanism that causes DNA damage and mitotic cell death specifically in cancers with elevated E2F activity, including small cell lung cancer and triple negative breast cancer.
  • A nationwide phase 1 clinical trial testing compound CID-078 is now open for patients with small cell lung cancer, triple negative breast cancer, and other cancers, marking the first clinical application of direct cyclin inhibition.
  • Preclinical studies demonstrated that patient-derived xenografts of small cell lung cancer stopped growing when treated with the drug, providing strong mechanistic evidence published in Nature to support human testing.

BeginNGS Newborn Genome Screening Program Expands to Qatar in First International Collaboration

Precision Medicine
  • Rady Children's Institute for Genomic Medicine announced a collaboration with Sidra Medicine in Qatar to implement the BeginNGS genome-based newborn screening program internationally.
  • The partnership aims to screen newborns for over 1,000 treatable genetic disorders, building on Qatar's existing NOOR project for large-scale newborn genome screening.
  • BeginNGS technology reduces false positives by 97 percent and benefits one in 13 infants, currently screening for 511 severe childhood genetic diseases across multiple US hospitals.
  • The collaboration supports the program's goal of implementing screening for 1,000 diseases in at least 10 countries by 2030.

Molecular Testing and Targeted Therapies Transform Treatment Landscape for Pediatric Low-Grade Gliomas

Targeted TherapyPrecision Medicine
  • Comprehensive molecular testing using NGS panels and methylation profiling has become foundational for accurately diagnosing pediatric low-grade gliomas and identifying actionable mutations like BRAF alterations.
  • Targeted therapies including BRAF and MEK inhibitors are emerging as compelling alternatives to traditional chemotherapy, offering oral administration and better tolerability for children.
  • The treatment approach has evolved from cytotoxic chemotherapy to precision medicine strategies that balance tumor control with quality of life over the chronic, multi-year treatment course.
  • Molecular diagnostics typically return within 2-4 weeks for full results, with initial pathology and specific mutations like BRAF V600E detectable within one week through targeted immunohistochemistry stains.

Atropos Health and Novartis Partner to Deploy AI for Faster Rare Disease Diagnosis in PNH Patients

AIRare DiseaseReal World EvidencePrecision Medicine
  • Atropos Health has partnered with Novartis to develop AI models that identify undiagnosed patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder affecting 10-20 people per million worldwide.
  • The collaboration addresses critical diagnostic delays in PNH, where many patients wait over a year for diagnosis and some wait more than five years due to the disease's rarity and varied symptoms.
  • The AI model, trained on real-world data from the Atropos Evidence Network, is now available for integration into health systems to accelerate appropriate diagnosis at the point of care.
  • The partnership aims to reduce time from initial symptoms to testing, diagnosis and treatment by implementing patient-finding models across health system members of the Atropos Evidence Network.

Oman Achieves Medical Milestone with First Successful CAR-T Cell Therapy Implementation

CAR-TPrecision Medicine
  • The University Medical City in Oman successfully implemented the first CAR-T cell therapy in the Sultanate, positioning the country among regional leaders in advanced blood cancer treatment.
  • The therapy has demonstrated remarkable response rates in patients with B-cell Acute Lymphoblastic Leukemia and Diffuse Large B-cell Lymphoma, particularly for those unresponsive to conventional treatments.
  • This achievement results from collaboration between national medical teams and international partners, marking a significant step toward medical self-sufficiency and reduced overseas treatment costs.
  • The implementation represents a pioneering milestone in localizing cutting-edge immunotherapy previously available only at select international centers.

ViewsML and iProcess Form Strategic Partnership to Accelerate AI-Powered Virtual Biomarker Testing

AIPrecision Medicine
  • ViewsML, a pioneer in AI-powered virtual immunohistochemistry staining, has partnered with iProcess Global Research to expand access to virtual biomarker technology across research institutions and pharmaceutical companies.
  • The collaboration enables customers to eliminate physical biomarker staining, dramatically accelerating turnaround times from days to seconds while preserving rare tissue samples for multiplex analysis.
  • ViewsML's platform predicts biomarker expression at the per-cell level using only a single H&E image, fitting seamlessly into existing pathology workflows for research and diagnostic applications.
  • The partnership addresses growing demand for faster, more scalable, and cost-effective biomarker analysis, particularly in early drug discovery and high-throughput settings.

Phase III IMvigor011 Trial Demonstrates Significant Survival Benefits for ctDNA-Guided Bladder Cancer Treatment

Precision Medicine
  • The randomized phase III IMvigor011 trial achieved positive topline results, showing statistically significant and clinically meaningful improvements in disease-free survival and overall survival for Signatera-positive muscle-invasive bladder cancer patients treated with atezolizumab.
  • This represents the first prospective phase III study in muscle-invasive bladder cancer to use a personalized, ctDNA molecular residual disease-guided approach for treatment selection.
  • Signatera-negative patients demonstrated excellent outcomes without adjuvant treatment, with 100% overall survival at 12 months and 98% at 18 months.
  • Natera plans to finalize its premarket approval application to the FDA for Signatera as a companion diagnostic for selecting MIBC patients for atezolizumab treatment after cystectomy.

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

NCT04660344Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 5/3/2021

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

NCT04008030Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 8/5/2019

Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)

NCT04886804RecruitingPhase 1
Boehringer Ingelheim
Posted 7/2/2021

Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)

NCT03377491CompletedPhase 3
NovoCure Ltd.
Posted 2/10/2018

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

NCT04145622RecruitingPhase 1
Daiichi Sankyo
Posted 11/3/2019

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