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Clinical Trial News

Vizgen and Hamamatsu Form Strategic Partnership to Advance Spatial Biology Workflows for Cancer Research

  • Vizgen and Hamamatsu Photonics announced a strategic partnership integrating MoxiePlex™ multiplex immunofluorescence imaging with InSituPlex® assays for streamlined biomarker detection.
  • The collaboration combines 9-color imaging capabilities with high throughput capacity of up to 60 slides per run, designed for high-volume laboratory applications.
  • Initial deployment focuses on multiplex immunofluorescence panels for non-small cell lung cancer research, with plans to expand into broader translational pathology applications.
  • The integrated solution aims to eliminate common barriers in multiplex assay development while facilitating the transition from research to clinical impact.

Merck KGaA's ADC Precemtabart Tocentecan Shows Promising Safety and Efficacy in Metastatic Colorectal Cancer Trial

  • Merck KGaA's antibody-drug conjugate precemtabart tocentecan demonstrated safety and tolerability in a Phase Ib trial for metastatic colorectal cancer patients.
  • The PROCEADE-CRC-01 study showed a median progression-free survival of 6.9 months and 72% disease control rate at week 12.
  • The ADC targets CEACAM5 and delivers a topoisomerase 1 inhibitor payload, with plans to advance the 2.8mg/kg dose.
  • Investigators noted the therapy compares favorably to current third-line treatments where response rates are typically in single digits.

Phase 1b/2 Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced NSCLC (Substudy NSCLC)

2024-517818-15-00RecruitingPhase 1/2
Merck Healthcare KGaA
Posted 1/29/2025

Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)

NCT05464030RecruitingPhase 1
EMD Serono Research & Development Institute, Inc.
Posted 8/4/2022

Mapmygenome Acquires Microbiome Insights to Expand Global Genomics and Microbiome Research Capabilities

  • Hyderabad-based Mapmygenome has strategically acquired Canadian microbiome sequencing leader Microbiome Insights, including its CAP-accredited laboratory and intellectual property portfolio.
  • The acquisition enhances Mapmygenome's scientific capabilities in metagenomics, transcriptomics, and targeted metabolomics while expanding its North American footprint.
  • Microbiome Insights brings over 1,000 completed studies for 600+ global clients and will continue operating as a premier contract research organization.
  • The partnership aims to deliver integrated genomics and microbiome testing services across borders, combining AI-driven genomics with deep microbiome expertise.

CAR-T Cell Therapy Shows Promise for Severe Autoimmune Neurological Diseases in Pioneering European Studies

CAR-T
  • German physicians at Ruhr-University Bochum successfully treated two patients with chronic inflammatory demyelinating polyneuropathy (CIDP) using CAR-T cell therapy, achieving over 200% improvement in clinical scores and neurophysiological tests.
  • The treatment specifically targets pathogenic B-cells responsible for autoimmune attacks on the peripheral nervous system, with patients regaining mobility within days and requiring no further immune therapy after a single treatment.
  • Dutch researchers at LUMC became the first in the Netherlands to treat an autoimmune disease patient with CAR-T therapy, successfully eliminating autoantibodies in a neurological lupus case and enabling discontinuation of immunosuppressive treatment.
  • Both studies represent groundbreaking applications of cancer immunotherapy to severe autoimmune neurological conditions, offering new hope for treatment-resistant patients who have exhausted conventional therapeutic options.

Novel CAR T-Cell Therapy ALLO-316 Shows 33% Response Rate in Advanced Renal Cell Carcinoma

CAR-T
  • ALLO-316, a novel CAR T-cell therapy targeting CD70, demonstrated a 33% confirmed objective response rate in patients with advanced clear cell renal cell carcinoma whose tumors expressed CD70 in at least 50% of cells.
  • The TRAVERSE first-in-human trial enrolled 44 patients who underwent lymphodepletion, with 39 receiving ALLO-316 infusion, targeting patients who had failed checkpoint inhibitors and tyrosine kinase inhibitors.
  • Safety profile showed manageable toxicity with 25 patients developing cytokine-release syndrome and only 2 patients experiencing dose-limiting toxicities, with no cases of graft-versus-host disease observed.
  • The therapy addresses a significant unmet medical need for metastatic clear cell renal cell carcinoma patients with limited alternative treatment options after standard therapies fail.

Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

NCT04696731Active, Not RecruitingPhase 1
Allogene Therapeutics
Posted 2/24/2021

A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)

NCT04438083TerminatedPhase 1
CRISPR Therapeutics AG
Posted 6/16/2020

Cofactor Genomics' AI-Powered RNA Platform Shows 300-400% Improvement in Predicting Cancer Immunotherapy Response

AIPrecision Medicine
  • Cofactor Genomics' OncoPrism platform demonstrates 300-400% improvement in predicting patient responses to cancer immunotherapies compared to other clinical tests using AI and RNA expression data.
  • The company presented first-time validation results for OncoPrism-NSCLC, showing superior performance over PD-L1 testing with higher sensitivity and specificity in non-small cell lung cancer patients.
  • OncoPrism-HNSCC and OncoPrism-NSCLC are now available for clinical use from Cofactor's CAP-accredited, CLIA-certified laboratory, with Medicare reimbursement approval secured for the head and neck cancer version.

Universal CAR-T Cell Therapy Achieves 91% Response Rate in Aggressive T Cell Cancers

CAR-T
  • An international Phase I/II trial of WU-CART-007, a universal CAR-T cell therapy, demonstrated a 91% overall response rate in patients with relapsed or refractory T cell acute lymphoblastic leukemia and T cell lymphoblastic lymphoma.
  • The therapy achieved complete remission in 72.7% of evaluable patients who received the full dose, significantly outperforming standard-of-care treatments that typically achieve only 20%-40% remission rates.
  • Using CRISPR gene editing technology, this "off-the-shelf" therapy can be manufactured from healthy donor cells and made readily available, eliminating the 3-6 week manufacturing delay of traditional CAR-T therapies.
  • Most patients experienced manageable cytokine release syndrome, with 88.5% having mild to moderate cases and only 19% experiencing more severe reactions.

Coherus BioSciences Rebrands as Coherus Oncology, Advances Immuno-Oncology Pipeline with Novel Combination Therapies

Monoclonal Antibody
  • Coherus BioSciences has completed its strategic transformation to Coherus Oncology, reflecting its exclusive focus on proprietary innovative immuno-oncology medicines.
  • The company's pipeline centers on LOQTORZI (toripalimab-tpzi), the only FDA-approved PD-1 inhibitor indicated in combination with chemotherapy for recurrent or metastatic nasopharyngeal carcinoma.
  • Two novel candidates are advancing through clinical trials: CHS-114, a selective CCR8 antibody targeting regulatory T cells, and casdozokitug, a first-in-class IL-27 antagonist showing activity across multiple cancer types.
  • A randomized Phase 2 study is evaluating casdozokitug combined with toripalimab and bevacizumab versus standard combination therapy in first-line advanced metastatic hepatocellular carcinoma.

Bambusa Therapeutics Doses First Patient with BBT002 Bispecific Antibody and Receives FDA Clearance for BBT001

  • Bambusa Therapeutics has initiated dosing in its Phase 1 clinical trial for BBT002, a novel bispecific antibody designed as a "platform in a molecule" for treating respiratory, dermatology, and gastroenterology conditions.
  • The company received FDA clearance for its BBT001 Investigational New Drug application, expanding clinical development of this atopic dermatitis treatment from Australia to the United States.
  • Both BBT001 and BBT002 represent half-life extended bispecific antibodies with preclinical data suggesting enhanced efficacy and improved dosing convenience compared to approved biologics.
  • The rapid advancement of two differentiated bispecific programs into clinical trials within 12 months of company founding demonstrates Bambusa's execution capabilities in inflammatory disease therapeutics.

A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT06944925RecruitingPhase 1
Bambusa Therapeutics
Posted 5/8/2025

A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)

NCT06808477RecruitingPhase 1
Bambusa Therapeutics
Posted 2/27/2025

PolyActiva Secures $40M Series C to Advance Revolutionary Glaucoma Implant Technology

  • Melbourne-based PolyActiva raised $40 million in Series C funding, including $27 million from Australia's National Reconstruction Fund, to advance its biodegradable glaucoma treatment implant.
  • The company's innovative two-millimeter polymer implant delivers medication directly into the eye over six months, potentially eliminating daily eye drops for glaucoma patients.
  • With Phase 2B clinical trials underway, PolyActiva aims to commercialize the technology by 2029 while maintaining its Australian headquarters and expanding local manufacturing capabilities.
  • The funding addresses a critical need for the 80 million people globally affected by glaucoma, a number expected to reach 111 million by 2040.

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