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TG Therapeutics Initiates Phase 3 Trial for Subcutaneous BRIUMVI in Multiple Sclerosis

Monoclonal Antibody
  • TG Therapeutics has commenced enrollment in a Phase 3 trial evaluating subcutaneous BRIUMVI (ublituximab-xiiy) for relapsing forms of multiple sclerosis, marking a significant milestone in the company's subcutaneous development program.
  • The randomized, open-label study will compare subcutaneous BRIUMVI administered every 8 or 12 weeks against the currently approved intravenous formulation, with the primary endpoint being non-inferior drug exposure at week 24.
  • If successful, BRIUMVI would become the only anti-CD20 therapy offering both healthcare provider-administered IV and patient self-administered subcutaneous options, potentially capturing an estimated 40% of the RMS CD20 market that prefers self-injectable therapies.
  • The company projects that positive trial data could support regulatory approval by 2028, expanding treatment flexibility for multiple sclerosis patients while broadening BRIUMVI's market opportunity.

Knight Therapeutics Submits MINJUVI Supplemental Application for Follicular Lymphoma in Brazil

Monoclonal AntibodyOncology
  • Knight Therapeutics' Brazilian affiliate has submitted a supplemental application to ANVISA seeking approval for MINJUVI (tafasitamab) in combination with rituximab and lenalidomide for previously treated follicular lymphoma patients.
  • The submission is based on the pivotal Phase 3 inMIND trial results, which demonstrated a 57% reduction in disease progression risk with median progression-free survival of 22.4 months versus 13.9 months for placebo.
  • Follicular lymphoma represents 20-25% of adult non-Hodgkin lymphoma cases in Brazil, with limited treatment options available for relapsed or refractory disease.
  • The application was selected for review under Project Orbis, with Knight planning additional regulatory submissions across Latin America in the coming months.

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

Symbiosis Pharmaceutical Services Achieves Manufacturing Milestone with 1,000th Sterile Injectable Batch

Monoclonal Antibody
  • Symbiosis Pharmaceutical Services, a global contract manufacturing organization, has successfully completed its 1,000th sterile drug product batch since its founding in 2011.
  • The Scottish-based company has manufactured complex injectable products including monoclonal antibodies, antibody-drug conjugates, viral vectors, and advanced therapy medicinal products across clinical and commercial stages.
  • Symbiosis played a crucial role in COVID-19 vaccine development by manufacturing nearly one million doses of the Oxford University/AstraZeneca vaccine at its Stirling facility to support clinical trials.
  • The milestone reflects the company's growth from a startup to an internationally recognized sterile manufacturer supporting global pharmaceutical development and commercial supply chains.

Osteosarcoma Market Poised for Significant Growth Through 2034 as Novel Therapies Enter Pipeline

Monoclonal AntibodyOrphan DrugRare Disease
  • The osteosarcoma market in the 7MM is expected to grow significantly by 2034, driven by extensive R&D activities and the entry of novel therapies including OST-HER2, Naxitamab 15-096, and HALMB-0168.
  • OS Therapies plans to submit a Biologics License Application for OST-HER2 to the US FDA by 2025, with the potential to receive a Priority Review Voucher upon approval.
  • The market faces challenges including chemotherapy resistance in approximately half of patients and limited treatment options for relapsed or refractory cases.
  • Currently, MEPACT (mifamurtide) remains the only approved therapy specifically for osteosarcoma, highlighting significant unmet medical needs in this rare cancer.

Sensei Biotherapeutics to Present Phase 1 Data on Novel VISTA-Targeting Cancer Therapy at ESMO 2025

Monoclonal Antibody
  • Sensei Biotherapeutics will present clinical data from the Phase 1 dose expansion cohort of solnerstotug, a pH-selective anti-VISTA antibody, at ESMO Congress 2025 in Berlin.
  • The study evaluates solnerstotug alone and in combination with cemiplimab in patients with advanced solid tumors resistant to prior PD-(L)1 therapy.
  • Solnerstotug is designed to selectively block the VISTA checkpoint within the low pH tumor microenvironment to unleash T cells against tumors.
  • The presentation will be delivered by Dr. Kyriakos Papadopoulos on October 17, 2025, highlighting results from this novel immunotherapy approach.

Amgen Settles Denosumab Biosimilar Patent Dispute with Accord BioPharma

Monoclonal Antibody
  • Amgen and Accord BioPharma reached a settlement agreement on July 16, 2025, resolving patent litigation over Accord's denosumab biosimilar INTP23, with Accord agreeing to delay U.S. market entry until October 1, 2025.
  • The settlement represents the fourth resolved denosumab biosimilar litigation for Amgen, which has filed eight total BPCIA cases to protect its Prolia® and Xgeva® franchises worth over $4.3 billion in annual U.S. sales.
  • Three denosumab biosimilars from Sandoz, Fresenius Kabi, and Celltrion have already launched in the U.S. market following their respective settlements with Amgen in 2025.

GSK's TIM-3 Inhibitor Cobolimab Fails Phase III Trial in Advanced Lung Cancer

Monoclonal Antibody
  • GSK's anti-TIM-3 monoclonal antibody cobolimab failed to improve overall survival in the Phase III COSTAR trial for advanced non-small cell lung cancer patients previously treated with immunotherapy.
  • The study tested both triple therapy (cobolimab plus Jemperli and docetaxel) and double combination (Jemperli plus docetaxel) against docetaxel alone, with neither meeting the primary efficacy endpoint.
  • This setback adds to a growing list of failed TIM-3 checkpoint inhibitor programs from major pharmaceutical companies including Novartis, Roche, and Bristol Myers Squibb.
  • Despite the failure, cobolimab remains in Phase II studies for liver cancer, cervical cancer, and melanoma, though GSK has not confirmed its development plans.

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy

NCT04655976Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 12/8/2020

Viridian Therapeutics Secures $385 Million Deal with Kissei for Thyroid Eye Disease Therapies in Japan

Monoclonal AntibodyRare Disease
  • Viridian Therapeutics has entered into an exclusive licensing agreement with Kissei Pharmaceutical for veligrotug and VRDN-003 in Japan, receiving $70 million upfront with potential milestone payments up to $315 million.
  • Both drug candidates are anti-IGF-1R antibodies targeting thyroid eye disease, with veligrotug having demonstrated positive results in phase 3 THRIVE trials and VRDN-003 being a subcutaneous, half-life extended formulation.
  • The collaboration leverages Kissei's expertise in rare disease development and commercialization in Japan to address significant unmet medical needs for TED patients.
  • Viridian will also receive tiered royalties ranging from the 20s to mid-30s percent on net sales in Japan, while Kissei assumes all development and commercialization responsibilities.

An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED)

NCT06625398Active, Not RecruitingPhase 3
Viridian Therapeutics, Inc.
Posted 8/27/2024

A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

NCT06812325RecruitingPhase 3
Viridian Therapeutics, Inc.
Posted 2/3/2025

Sanofi's SAR446523 Receives FDA Orphan Drug Designation for Relapsed/Refractory Multiple Myeloma

Monoclonal Antibody
  • The FDA has granted orphan drug designation to SAR446523, Sanofi's investigational GPRC5D-targeting monoclonal antibody for treating relapsed or refractory multiple myeloma.
  • SAR446523 is an IgG1-based antibody with enhanced ADCC activity that targets GPRC5D, a receptor highly expressed on plasma cells in multiple myeloma patients.
  • The drug is currently being evaluated in a phase 1 first-in-human study as a subcutaneous treatment for patients with relapsed or refractory multiple myeloma.
  • Multiple myeloma affects more than 180,000 people globally each year and remains incurable with a 62% five-year survival rate for newly diagnosed patients.

A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma

NCT06630806RecruitingPhase 1
Sanofi
Posted 10/30/2024

Harbour BioMed to Present Phase II Data on Novel Anti-CTLA-4 Antibody Combination for Treatment-Resistant Colorectal Cancer at ESMO 2025

Monoclonal Antibody
  • Harbour BioMed will present Phase II clinical data on porustobart (HBM4003), a next-generation anti-CTLA-4 antibody, combined with tislelizumab for microsatellite stable metastatic colorectal cancer at ESMO Congress 2025.
  • The multicenter study enrolled heavily pretreated patients with non-liver metastatic MSS colorectal cancer, a population with limited response to current immune checkpoint inhibitors.
  • Porustobart represents the first fully human heavy-chain-only antibody in clinical development globally, featuring enhanced Treg cell depletion and improved safety profile compared to conventional CTLA-4 antibodies.
  • The combination therapy addresses a significant therapeutic challenge, as MSS metastatic colorectal cancer remains resistant to standard immunotherapy approaches.

HBM4003 Combine With Toripalimab in Patients With Advanced NEN and Other Solid Tumors Study

NCT05167071Active, Not RecruitingPhase 1
Harbour BioMed (Guangzhou) Co. Ltd.
Posted 12/28/2021

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