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Clinical Trial News

Fred Hutch Launches National Vanguard Study to Evaluate Multi-Cancer Detection Blood Tests

  • Fred Hutch Cancer Center is leading the newly launched Vanguard Study, the first national trial of multi-cancer detection blood tests for adults ages 45-75.
  • The study will evaluate two MCD tests that screen for ten different cancers including bladder, breast, colorectal, esophageal, stomach, liver, lung, ovarian, pancreatic and prostate cancers.
  • Nearly half of all cancers diagnosed annually lack recommended screening tests and are often found at later stages when treatment is more difficult.
  • The randomized trial will compare control groups with participants receiving either the Avantect MCD Test by ClearNote Health or the Shield MCD Test by Guardant Health.

FDA Grants Orphan Drug Designation to SH-110 Oral Liquid Therapy for Glioma Treatment

Rare Disease
  • The FDA has granted orphan drug designation to SH-110, an oral liquid formulation specifically designed to treat glioma patients who experience difficulty swallowing.
  • SH-110 addresses a critical unmet need for approximately 15,000 patients diagnosed annually with glioma in the US, offering a safer alternative to capsule-based treatments that often require hazardous compounding.
  • The designation provides Shorla Oncology with significant regulatory incentives including tax credits, user fee waivers, and seven years of market exclusivity upon approval.
  • This development represents part of Shorla's broader mission to create more accessible, patient-centric oncology treatments, following their recent FDA approval of Tepylute for breast and ovarian cancer.

Researchers Identify Stromal Immunosuppressive Barrier in Gastric Cancer That Drives Treatment Resistance

  • Researchers have identified a stromal immunosuppressive barrier in gastric cancer composed of SPP1+ and C1QC+ macrophages along with exhausted CD8+ T cells that contributes to immune checkpoint inhibitor resistance.
  • The study used single-cell RNA sequencing and spatial transcriptomics to map immune cell interactions, revealing that MIF signaling from macrophages drives T cell exhaustion and immunotherapy resistance.
  • Based on barrier-associated features, the team developed a four-subtype classification system for gastric cancer patients that could guide personalized immunotherapy strategies and predict treatment outcomes.

Acumen Pharmaceuticals Partners with JCR to Develop Enhanced Brain Delivery Therapy for Alzheimer's Disease

Monoclonal Antibody
  • Acumen Pharmaceuticals and JCR Pharmaceuticals have entered a strategic collaboration to combine Acumen's amyloid beta oligomer-selective antibody expertise with JCR's blood-brain barrier-penetrating J-Brain Cargo® technology for Alzheimer's disease treatment.
  • The partnership aims to develop Enhanced Brain Delivery therapy using sabirnetug or other novel antibodies, with preclinical candidate data expected in early 2026 and exclusive option rights for up to two development candidates.
  • Acumen's lead program sabirnetug is currently in Phase 2 ALTITUDE-AD trial with 542 enrolled patients, having demonstrated selective target engagement and statistically significant amyloid plaque reduction in Phase 1 studies.
  • JCR's transferrin receptor-targeting platform has already produced an approved therapy in Japan for lysosomal storage disorders, providing validated safety profile for the blood-brain barrier delivery technology.

A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

NCT06335173Active, Not RecruitingPhase 2
Acumen Pharmaceuticals
Posted 2/29/2024

4TEEN4's Procizumab Shows First-in-Human Evidence of Shock Reversal in Terminally Ill Patients

Monoclonal Antibody
  • 4TEEN4 Pharmaceuticals published first-in-human data showing procizumab, a monoclonal antibody targeting circulating dipeptidyl peptidase 3 (cDPP3), successfully reversed cardiogenic shock in three terminally ill patients within 48 hours.
  • The first-in-class antibody demonstrated safety and efficacy by blocking cDPP3 activity, restoring cardiovascular function and normalizing organ systems without adverse events in patients with multi-organ failure.
  • The company plans to initiate a Phase 2a clinical trial (PROCARD1) in mid-2025 across 11 European centers, followed by a global pivotal Phase 2/3 study in the second half of 2026.
  • Cardiogenic shock affects approximately one in three ICU patients and has mortality rates exceeding 50%, with no approved causal therapies currently available for this life-threatening condition.

Procizumab (PCZ; AK1967) in Critical Cardiovascular Care

NCT06832722RecruitingPhase 1
4TEEN4 Pharmaceuticals GmbH
Posted 7/13/2025

Oncomatryx Secures €12.5 Million EIC Accelerator Funding to Advance Novel ADC Platform for Hard-to-Treat Cancers

Oncology
  • Oncomatryx Biopharma received €12.5 million in EIC Accelerator funding, comprising €2.5 million in grants and €10 million in equity investment, making it the only oncology company selected among 40 recipients from 959 applications.
  • The company's lead ADC candidate OMTX705 demonstrated outstanding safety with no dose-limiting toxicity and showed long responses in 95 patients with metastatic immune-cold solid tumors expressing FAP.
  • Funding will support expansion cohorts of ongoing Phase I trials in pancreatic, colorectal, and lung cancer, with randomized clinical trials currently underway for these indications.

Follicular Lymphoma Market Poised for 6% CAGR Growth Through 2034 as Novel Therapies Advance

CAR-TDrug Approval
  • The follicular lymphoma market is projected to grow at a 6% CAGR during 2025-2034, driven by increased disease awareness and rising number of clinical trials focused on this slow-growing B-cell malignancy.
  • Recent regulatory approvals include Japan's approval of EPKINLY (epcoritamab) as the first subcutaneous T-cell engaging bispecific antibody for relapsed/refractory follicular lymphoma, and FDA approval of tafasitamab-cxix combination therapy.
  • The market was valued at approximately $1.082 billion in 2024, with the United States representing the largest market and approximately 35,000 new cases diagnosed across seven major markets.
  • Over 45 companies are developing 50+ therapies in the pipeline, including innovative approaches like CAR-T cell treatments, bispecific antibodies, and targeted therapies from companies such as Regeneron, AstraZeneca, and Bristol Myers Squibb.

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

NCT04680052Active, Not RecruitingPhase 3
Incyte Corporation
Posted 4/15/2021

Korean Researchers Develop Precision Nanobody Therapy for Lung Adenocarcinoma with 90% Tumor Reduction

Targeted TherapyPrecision Medicine
  • Researchers at Korea Research Institute of Bioscience and Biotechnology developed the A5 nanobody that specifically targets CD155 protein overexpressed in lung adenocarcinoma cells.
  • The A5-LNP-DOX delivery system achieved 2-3 fold higher drug uptake in cancer cells and demonstrated 70-90% tumor burden reduction in animal models.
  • The nanobody therapy suppressed cancer cell migration and invasion by over 50% while showing no major organ toxicity in preclinical studies.
  • Clinical analysis revealed that patients with high CD155 and PXN expression levels had significantly worse survival outcomes, validating the therapeutic target.

Oxford BioDynamics' EpiSwitch Biomarkers Show Promise in Pfizer Bladder Cancer Trial

Precision Medicine
  • Oxford BioDynamics' EpiSwitch blood-based biomarkers demonstrated strong correlation with immune profiles of patient tumors in Pfizer's JAVELIN Bladder 100 trial involving 496 bladder cancer patients.
  • The liquid biopsy technology effectively determined tumor immune activity levels in a less invasive manner than traditional tissue biopsies, supporting treatment decision-making.
  • The study validated EpiSwitch as an accurate method for evaluating cancer patient immune responses, building on its existing 94% accuracy in prostate cancer detection compared to standard PSA testing's 55%.
  • Results support expanding EpiSwitch technology beyond prostate cancer to revolutionize cancer detection and monitoring across various cancer types.

Synendos Therapeutics Names Dr. George Garibaldi as CMO to Lead Phase 2 Development of Novel Neuropsychiatric Therapy

  • Synendos Therapeutics has appointed Dr. George Garibaldi as Chief Medical Officer as the company transitions from Phase 1 to Phase 2 clinical development of its lead drug candidate SYT-510.
  • Dr. Garibaldi brings over 30 years of CNS drug development experience from leadership roles at Roche, Novartis, and Janssen, where he oversaw breakthrough treatments including Ocrevus for multiple sclerosis and Exelon for Alzheimer's disease.
  • SYT-510 represents a first-in-class Selective Endocannabinoid Re-uptake Inhibitor (SERI) targeting neuropsychiatric disorders through novel endocannabinoid system modulation.
  • The appointment positions Synendos to advance its innovative approach to treating anxiety disorders, PTSD, and other CNS conditions with potentially improved chronic tolerability profiles.

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