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Clinical Trial News

ImmuneOncia's CD47 Antibody IMC-002 Shows 30% Response Rate in Advanced Hepatocellular Carcinoma Trial

Monoclonal Antibody
  • ImmuneOncia's next-generation CD47-targeting antibody IMC-002 demonstrated a 30% partial response rate when combined with lenvatinib in advanced hepatocellular carcinoma patients, significantly higher than the typical 10% seen with current second-line therapies.
  • The Phase 1b trial showed a favorable safety profile with 96% of adverse events being Grade 1-2, no neutropenia or thrombocytopenia, and median progression-free survival of 8.3 months.
  • AI-powered digital pathology analysis revealed a 60% objective response rate in patients with high CD47 expression versus no response in low-expression patients (p=0.018), supporting CD47 as a predictive biomarker.
  • Two patients have remained on treatment for over one year, with two of three partial responders being resistant to first-line immunotherapy, suggesting potential for sustained benefit in treatment-resistant cases.

Merck Explores $3+ Billion Acquisition of Swiss Biotech MoonLake Immunotherapeutics

  • Merck has held acquisition talks with Swiss biotech MoonLake Immunotherapeutics for more than $3 billion, according to Financial Times reports citing three people familiar with the matter.
  • The pharmaceutical giant submitted a nonbinding offer earlier this year which was initially rejected, though discussions could potentially be revived as Merck seeks to rebuild its pipeline.
  • The acquisition interest comes as Merck faces the looming patent expiration of its blockbuster cancer drug Keytruda beginning in 2028, creating urgency to diversify its revenue streams.
  • MoonLake's shares surged 19% in extended trading following the acquisition reports, while the biotech's position ahead of late-stage clinical data strengthens its negotiating position.

atai Life Sciences and Beckley Psytech Announce $390 Million Merger to Create Psychedelic Mental Health Leader

  • atai Life Sciences and Beckley Psytech have agreed to merge in an all-share transaction valued at $390 million, creating a market-leading mental health company focused on rapid-acting psychedelic therapies.
  • The combined entity, operating as atai Beckley, will feature a synergistic pipeline of proprietary psychedelic compounds differentiated by convenient administration routes and short clinic times.
  • A key near-term catalyst is the anticipated mid-2025 topline data from Beckley's Phase 2b trial of BPL-003 for treatment-resistant depression, representing the largest controlled trial of mebufotenin.
  • The merger is contingent on achieving pre-agreed success criteria in the ongoing BPL-003 Phase 2b study, with transaction closure expected in the second half of 2025.

BPL-003 Efficacy and Safety in Treatment Resistant Depression

NCT05870540CompletedPhase 2
Beckley Psytech Limited
Posted 9/14/2023

Novel Antibody-Drug Conjugate Achieves 85% Response Rate in Rare Blood Cancer Trial

Targeted TherapyPrecision Medicine
  • Pivekimab sunirine (PVEK), a first-in-class antibody-drug conjugate, demonstrated an 85% overall response rate and 70% complete response rate as frontline treatment for newly diagnosed BPDCN patients.
  • The Phase I/II CADENZA trial enrolled 84 patients with CD123-positive blastic plasmacytoid dendritic cell neoplasm, showing a median overall survival of 16.6 months in the frontline cohort.
  • PVEK targets CD123 receptors highly expressed on BPDCN cells and showed manageable safety profile with peripheral edema as the most common reversible side effect.
  • Researchers suggest PVEK should be considered as a new standard-of-care treatment for this rare, aggressive blood cancer that affects bone marrow, skin, and lymph nodes.

Allogeneic Cell Therapies Emerge as Next-Generation Cancer Treatment to Address Manufacturing and Cost Challenges

CAR-T
  • Allogeneic "off-the-shelf" cell therapies are being developed to overcome the complex manufacturing and supply chain limitations of current autologous CAR-T treatments, which require 9-14 days to produce individualized therapies.
  • TC Biopharm's allogeneic gamma-delta T-cell platform has demonstrated lower-cost and efficacy data in acute lymphoblastic leukemia, with the ability to treat broader patient populations using healthy donor cells rather than compromised patient cells.
  • The cell and gene therapy pipeline includes 147 late-stage trials with multiple allogeneic approaches nearing commercialization, while the overall field shows 36% annual growth projected through 2030 with 10-20 new approvals expected yearly.

Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults with Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)

NCT04416984Active, Not RecruitingPhase 1
Allogene Therapeutics
Posted 5/21/2020

Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma

NCT03939026Active, Not RecruitingPhase 1
Allogene Therapeutics
Posted 5/1/2019

Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

NCT06500273RecruitingPhase 2
Allogene Therapeutics
Posted 6/18/2024

Jenscare Reports Positive Clinical Outcomes for Tricuspid and Mitral Valve Interventions at EuroPCR 2025

  • Jenscare's LuX-Valve Plus TTVR system demonstrated a 97% device success rate with 95.7% of patients showing no above moderate tricuspid regurgitation at 30 days in the global TRINITY trial.
  • The JensClip TMVr system achieved durable results at one year with 96.29% of patients maintaining no above moderate mitral regurgitation and significant quality of life improvements.
  • Both devices showed favorable safety profiles with low mortality rates and minimal major complications in high-risk surgical patients.
  • The LuX-Valve Plus features innovative interventricular septum anchoring designed to prevent AV block, while JensClip offers a self-locking mechanism for enhanced procedural safety.

Bayer Submits Low-Dose MRI Contrast Agent Gadoquatrane for Global Regulatory Approval

Drug Approval
  • Bayer has submitted marketing authorization applications for gadoquatrane, an investigational MRI contrast agent that delivers 60% lower gadolinium dosing compared to standard agents while maintaining diagnostic efficacy.
  • The pivotal Phase III QUANTI studies involving 808 patients across 15 countries demonstrated non-inferior efficacy to comparator agents in visualization parameters and lesion detection with similar safety profiles.
  • Gadoquatrane represents the first low-dose macrocyclic contrast agent targeting the $3.5 billion global MRI contrast market, with particular benefits for pediatric patients and those requiring multiple lifetime scans.
  • Japan's submission marks the first regulatory application, with further global submissions planned as Bayer positions the agent to address growing safety concerns about gadolinium retention in tissues.

Freenome's Blood-Based Colorectal Cancer Test Achieves Landmark Results in Largest Prospective Study

AI
  • Freenome's PREEMPT CRC study, involving 48,995 participants, represents the largest prospective study of a blood-based colorectal cancer screening test and met all primary efficacy endpoints.
  • The test demonstrated 100% sensitivity for colorectal cancer and 94.8% specificity for advanced colorectal neoplasia in adults aged 45-49, a population with only 20% screening compliance.
  • FDA premarket approval submission is underway with completion anticipated by mid-2025, potentially offering a non-invasive alternative to address screening barriers affecting over 40% of eligible U.S. adults.

Prevention of Colorectal Cancer Through Multiomics Blood Testing

NCT04369053Completed
Freenome Holdings Inc.
Posted 5/20/2020

Biocartis Achieves First IVDR Class C Companion Diagnostic Certification for EGFR Mutation Test in Europe

Precision Medicine
  • Biocartis' Idylla™ EGFR Mutation Test becomes the first test in the company's portfolio to receive IVDR Class C companion diagnostic certification in Europe.
  • The test detects 44 EGFR mutations in under 3 hours with 99.2% sensitivity and 99.0% specificity for key biomarkers guiding NSCLC treatment decisions.
  • The certification enables European availability of the automated diagnostic platform, while US development continues in partnership with AstraZeneca for Tagrisso treatment selection.

Vantive Announces $1 Billion Investment in Digital Kidney Care Technologies Over Five Years

  • Vantive, a vital organ therapy company with 70 years of kidney care innovation, announced a five-year investment exceeding $1 billion to expand R&D and manufacturing capacity for digitally-enabled therapies.
  • The investment targets chronic kidney disease, which costs Europe over €140 billion annually and is projected to become the fifth leading cause of death globally by 2040.
  • Vantive's Sharesource Connectivity Platform has supported over 100 million home dialysis treatments worldwide and demonstrates improved patient adherence, reduced mortality, and lower hospitalization rates.
  • The company showcased its digital health portfolio at the 62nd European Renal Association Congress, including the PrisMax System for critical care and virtual reality training solutions.

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