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BMS-986365 Shows Promise in Phase 3 Trial for Advanced Prostate Cancer Resistant to Standard Therapies

Oncology
  • BMS-986365, a dual androgen receptor degrader and antagonist, demonstrated well-tolerated safety profile and promising anti-tumor activity in heavily pretreated metastatic castration-resistant prostate cancer patients.
  • The novel oral drug showed potential to overcome resistance to current androgen receptor pathway inhibitors regardless of AR genomic status in first-in-human studies.
  • A Phase 3 trial (rechARge) is now recruiting at 230 sites across 24 countries, comparing BMS-986365 to investigator's choice of standard therapies.
  • Preclinical data suggests BMS-986365 is 100-fold more potent than enzalutamide at inhibiting androgen-stimulated transcription and 10-120 fold more potent at inhibiting AR-dependent proliferation.

Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT04428788Active, Not RecruitingPhase 1
Celgene
Posted 6/22/2020

Cellectis Advances Gene Editing with Non-Viral TALEN Technology and TALE Base Editors at ASGCT 2025

Gene EditingCAR-TOncology
  • Cellectis presents breakthrough research on TALEN-mediated non-viral transgene insertion technology that addresses manufacturing constraints and genomic toxicity risks associated with traditional viral methods.
  • The company's TALE base editors (TALEB) demonstrate high-fidelity C-to-T editing with no detectable off-target effects in primary cells, enhancing specificity for therapeutic applications.
  • Research shows circular single-stranded DNA templates maintain better hematopoietic stem cell fitness and provide more stable gene editing compared to viral donor templates.
  • These innovations expand Cellectis' gene editing toolbox for developing next-generation therapies targeting cancer, autoimmune diseases, and monogenic disorders.

ImmVira Reports Favorable Safety Profile for Oncolytic Virus MVR-C5252 in Phase I Glioma Trial

OncologyRare Disease
  • ImmVira presented Phase I clinical results for MVR-C5252, an oncolytic herpes simplex virus therapy targeting malignant glioma, at the 2025 AACR annual meeting.
  • The study demonstrated a favorable safety profile with no serious adverse events or dose-limiting toxicities in three patients who received treatment via convection-enhanced delivery.
  • MVR-C5252 is engineered with PD-1 antibody and IL-12 to combine oncolytic effects with immune activation, addressing a cancer with less than 5% five-year survival rate.
  • The therapy has received Investigational New Drug approval in both the U.S. and China, plus FDA Orphan Drug Designation for this rare indication.

Monte Rosa Presents Promising Preclinical Data for CDK2 Molecular Glue Degrader in HR-Positive Breast Cancer at AACR 2025

Oncology
  • Monte Rosa Therapeutics presented preclinical data at AACR 2025 showing their CDK2-directed molecular glue degrader MRT-51443 achieved superior tumor regression compared to standard care in HR-positive/HER2-negative breast cancer models.
  • The combination of MRT-51443 with CDK4/6 inhibitor and anti-estrogen therapy demonstrated median tumor growth of -77% versus -3% for standard care in MCF7 models.
  • MRT-51443 showed highly selective CDK2 degradation with no detectable off-target activity and delayed resistance to CDK4/6 inhibition in vitro studies.
  • The company anticipates submitting an IND application for their cell cycle program in 2026, potentially offering improved treatment for patients who develop resistance to current therapies.

Y-mAbs Presents Preclinical Pharmacokinetics Data for CD38-SADA Pretargeted Radioimmunotherapy at AACR 2025

Oncology
  • Y-mAbs Therapeutics presented preclinical pharmacokinetics data for CD38-SADA at the 2025 AACR Annual Meeting, demonstrating key insights into the protein's behavior in animal models.
  • The study revealed that CD38-SADA monomers clear from plasma 20 times faster than tetramers, supporting the pretargeted radioimmunotherapy approach for improved tumor-to-normal tissue dose ratios.
  • These preclinical findings informed the design and dosing regimen for the ongoing first-in-human Phase 1 Trial 1201 in patients with relapsed/refractory non-Hodgkin lymphoma.
  • The company has already dosed the first patient in Trial 1201, marking a significant milestone for the CD38-SADA pretargeted radioimmunotherapy platform.

Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma

NCT05994157RecruitingPhase 1
Y-mAbs Therapeutics
Posted 2/1/2025

City of Hope to Present Groundbreaking Cancer Research at AACR Annual Meeting 2025

AIOncologyMonoclonal AntibodyPrecision Medicine
  • City of Hope researchers will present over 74 sessions at the AACR Annual Meeting 2025, showcasing innovative work in AI, precision medicine, and immunotherapies for various cancers.
  • A phase 3 clinical trial led by Dr. Aditya Shreenivas demonstrated that penpulimab combined with chemotherapy significantly improved progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma.
  • Novel AI tools and spatial transcriptomic technologies developed at City of Hope are advancing precision medicine approaches and revealing unique genetic changes in early-onset colorectal cancer among Hispanic and Latino patients.

CDR-Life's Novel T Cell Engagers Show Superior Potency Against Solid Tumors in Preclinical Studies

Oncology
  • CDR-Life presented promising preclinical data for its antibody-based T cell engager CDR404, demonstrating superior potency and durability compared to TCR-based approaches in MAGE-A4-positive tumors.
  • The company's lead candidate CDR404 is currently in Phase 1 trials showing early signals of immunological activity and anti-tumor effects, with data from early trial stages expected later this year.
  • A second T cell engager, CDR505, targeting KK-LC-1-positive tumors, demonstrated potent and selective killing of cancer cells with high specificity for the KK-LC-1 peptide/HLA-A*01:01 complex.

First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors

NCT06402201RecruitingPhase 1
CDR-Life AG
Posted 5/24/2024

CatalYm's Visugromab Shows Promise in Enhancing Antibody-Drug Conjugate Efficacy by Blocking GDF-15

Monoclonal AntibodyOncology
  • New preclinical data reveals that visugromab, CatalYm's GDF-15-neutralizing antibody, significantly enhances the anti-tumor activity of antibody-drug conjugates (ADCs) in multiple solid tumor models.
  • Research demonstrates that ADC treatment triggers GDF-15 expression as a potential resistance mechanism, which visugromab effectively counteracts by improving immune cell infiltration and activation in the tumor microenvironment.
  • These findings build on CatalYm's previous clinical evidence showing visugromab's ability to induce durable responses in relapsed/refractory solid tumors and mitigate cancer-associated cachexia.

First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER)

NCT04725474Active, Not RecruitingPhase 1
CatalYm GmbH
Posted 12/9/2020

Syncromune to Present Phase 1 Data on Novel SYNC-T Therapy for Metastatic Prostate Cancer at ASCO 2025

Oncology
  • Syncromune will present Phase 1 clinical data on its SYNC-T Therapy SV-102 for metastatic castration-resistant prostate cancer at the ASCO Annual Meeting on May 31, 2025.
  • SYNC-T is a potentially first-in-class platform immunotherapy that synchronizes tumor antigens, immune cells, and a multi-target biologic drug directly in the tumor microenvironment.
  • The therapy employs a proprietary device delivery system that lyses tumor cells to release antigens and then infuses a biologic drug, aiming to activate T cells against cancer throughout the body.

Phase 1 Trial of SYNC-T - Immunotherapy for Advanced/Metastatic Castration-Resistant Prostate Cancer

NCT05544227CompletedPhase 1
Williams Cancer Foundation
Posted 2/1/2023

A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT06533644RecruitingPhase 2
Syncromune, Inc.
Posted 5/29/2025

Avidicure Launches with $50M to Develop Novel Multifunctional Antibody Platform for Cancer

Monoclonal AntibodyOncology
  • Netherlands-based Avidicure has secured $50 million in seed financing to develop its AVC-Boosters platform, a novel multifunctional antibody modality designed to harness both innate and adaptive immune responses against cancer.
  • The company's lead product, AVC-S-101, targets Trop2 protein and is being developed for non-small cell lung cancer and other indications, with potential to deliver targeted and potent cancer monotherapy with reduced toxicity.
  • Avidicure's platform leverages decades of antibody engineering expertise and offers plug-and-play functionality for multiple product development, positioning it to potentially surpass first-generation antibodies, checkpoint inhibitors, and ADCs.

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