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French Biotech Kyron.bio Raises €5.5M to Advance Glycan-Controlled Antibody Therapeutics

Monoclonal Antibody
  • Paris-based kyron.bio secured €5.5M in funding led by HCVC to develop its glycan-engineering platform that addresses immune response challenges in antibody therapeutics.
  • The company's breakthrough technology achieves over 97% consistency in glycan structures, enabling precise control of sugar molecules on drug surfaces to prevent unwanted immune attacks.
  • The platform combines engineered Chinese Hamster Ovary cell lines with proprietary glycan-engineering tools to improve drug safety and efficacy in chronic disease treatments.
  • Funding will accelerate platform development, team expansion, and preclinical studies while supporting the launch of an EIC Transition project backed by the European Innovation Council.

FDA Grants Fast Track Designation to Teva's TEV-53408 for Celiac Disease Treatment

Monoclonal Antibody
  • The FDA has granted Fast Track designation to Teva's investigational anti-IL-15 antibody TEV-53408 for treating celiac disease patients on gluten-free diets.
  • TEV-53408 is currently undergoing Phase 2a clinical trials to evaluate its efficacy and safety in adults with celiac disease.
  • The designation reflects the urgent unmet medical need for celiac disease patients, as current treatment is limited to strict gluten-free diets.
  • Celiac disease affects approximately 1% of the global population and represents a significant autoimmune disorder with limited therapeutic options.

A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease

NCT06807463RecruitingPhase 2
Teva Branded Pharmaceutical Products R&D LLC
Posted 3/31/2025

KU Leuven Spin-off Hemastatx Develops First Therapy Targeting Root Cause of Severe Bleeding Disorder

Monoclonal AntibodyRare Disease
  • Hemastatx, a new KU Leuven spin-off, has developed the first therapy to address the underlying mechanism of von Willebrand factor defects, a severe bleeding disorder affecting 100,000 hospitalized patients annually worldwide.
  • The company's novel antibody therapy targets ADAMTS13, a molecular scissor that excessively degrades von Willebrand factor in affected patients, restoring blood clotting function and halting bleeding episodes.
  • The spin-off secured seed funding from international investors including Swiss accelerator BaseLaunch, the Butterfly Fund, and KU Leuven's Gemma Frisius Fund to advance preclinical development and prepare for clinical trials.

Invivyd's PEMGARDA Shows 84% COVID-19 Prevention Efficacy in Landmark Phase 3 Trial

Monoclonal Antibody
  • Invivyd's CANOPY Phase 3 trial demonstrated that PEMGARDA (pemivibart) achieved an 84% relative risk reduction in symptomatic COVID-19 compared to placebo over six months (nominal p <0.0001).
  • The study represents the first placebo-controlled trial of an authorized COVID-19 monoclonal antibody conducted in a contemporary U.S. population already seropositive from prior infection or vaccination.
  • PEMGARDA was generally well-tolerated with infusion-related reactions occurring in 3.6% of immunocompromised patients and 2.2% of immunocompetent participants.
  • The trial results support the FDA's emergency use authorization of PEMGARDA for pre-exposure prophylaxis in moderate-to-severe immunocompromised patients.

Phanes Therapeutics Doses First Patient with Anti-CD73 Antibody Mavrostobart in Combination Therapy Trial

Monoclonal AntibodyOncology
  • Phanes Therapeutics has dosed the first patient in a clinical study evaluating mavrostobart (PT199), an anti-CD73 monoclonal antibody, in combination with chemotherapy.
  • Mavrostobart demonstrates complete inhibition of both soluble and membrane-bound CD73 enzyme activities without hook effect at higher concentrations, addressing limitations of current CD73 inhibitors.
  • The multi-center Phase I/II MORNINGSTAR study is evaluating mavrostobart's safety, tolerability, pharmacokinetics and preliminary efficacy alone and in combination with PD-1 inhibitors or chemotherapy.
  • The company is leveraging proprietary technology platforms to develop novel biologics addressing unmet medical needs in cancer treatment.

Dose Escalation/Expansion Study of Mavrostobart (PT199), an Anti-CD73 MAb, Administered Alone and in Combination with a PD-1 Inhibitor or Chemotherapy (the MORNINGSTAR Study)

NCT05431270RecruitingPhase 1
Phanes Therapeutics
Posted 8/11/2022

Lupin Partners with SteinCares to Commercialize Ranibizumab Biosimilar Across Latin America

Monoclonal Antibody
  • Lupin Limited has signed a license and supply agreement with SteinCares for the commercialization of its biosimilar ranibizumab across Latin American markets, excluding Mexico and Argentina.
  • The partnership designates SteinCares to handle regulatory filings and commercialization activities while Lupin retains manufacturing responsibilities for the VEGF-A inhibitor.
  • Ranibizumab biosimilar is indicated for multiple retinal disorders including wet AMD, diabetic macular edema, and diabetic retinopathy, potentially expanding treatment access in the region.
  • The collaboration leverages SteinCares' regional expertise and established presence as a biosimilar leader in Latin America to transform retinal care accessibility.

Abbisko's FGFR4 Inhibitor Irpagratinib Receives China's Breakthrough Therapy Designation for Hepatocellular Carcinoma

Precision MedicineOncologyMonoclonal AntibodyTargeted Therapy
  • Abbisko Therapeutics' irpagratinib (ABSK011) has received Breakthrough Therapy Designation from China's NMPA for treating hepatocellular carcinoma, marking the first precision-targeted therapy using molecularly defined biomarkers for this indication.
  • The highly selective FGFR4 inhibitor targets FGF19 overexpression, which affects approximately 30% of HCC patients worldwide and is associated with significantly worse prognosis.
  • Clinical data from the 2024 ESMO GI Congress showed irpagratinib combined with atezolizumab achieved a 50% objective response rate in FGF19-positive HCC patients previously treated with immune checkpoint inhibitors.
  • The designation will expedite regulatory approval processes, potentially making irpagratinib the first globally approved FGFR4 inhibitor for HCC treatment.

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)

NCT04524871RecruitingPhase 1
Hoffmann-La Roche
Posted 11/1/2020

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152)

NCT05904886Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 9/14/2023

Protein Therapeutics Market Surges to $400 Billion as 20 New Drugs Gain Approval in 2023

Monoclonal AntibodyDrug Approval
  • The global protein therapeutics market reached an estimated $400 billion in value, driven by increasing pharmaceutical company investment in advanced protein-based drug development strategies.
  • Nearly 20 protein-based drugs received regulatory approval in 2023 for treating various diseases including cancer and metabolic disorders, demonstrating accelerated development in this therapeutic area.
  • Monoclonal antibodies dominate the protein therapeutics sector with an estimated market value of $48.5 billion by 2011, representing the largest segment ahead of insulin therapies.
  • The protein therapeutics market is projected to grow at a compound annual growth rate of approximately 13% during 2012-2014, significantly outpacing overall pharmaceutical market growth.

Prothena Discontinues Birtamimab Development After Phase 3 Failure in AL Amyloidosis

Rare DiseaseMonoclonal Antibody
  • Prothena's Phase 3 AFFIRM-AL trial of birtamimab for AL amyloidosis failed to meet its primary endpoint of time to all-cause mortality (HR=0.915, p-value=0.7680).
  • The company has announced complete discontinuation of birtamimab development, including stopping the open-label extension trial, following the disappointing clinical results.
  • Prothena plans substantial organizational restructuring with workforce reductions and will provide detailed plans to decrease operating expenses in June 2025.

GV20 Therapeutics to Present AI-Designed Immune Checkpoint Inhibitor Data for Advanced Melanoma at ASCO 2025

Monoclonal AntibodyOncology
  • GV20 Therapeutics will present updated Phase 1 data on GV20-0251, the first AI-designed antibody targeting the novel immune checkpoint IGSF8, at ASCO 2025.
  • The presentation will showcase clinical and translational findings from patients with advanced solid tumors resistant to anti-PD(L)1 therapies, with a focus on melanoma patients showing primary resistance.
  • GV20-0251 represents a significant advancement in AI-driven drug discovery, having progressed from target identification to IND filing in just three years with promising early efficacy data.

A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies

NCT05669430RecruitingPhase 1
GV20 Therapeutics
Posted 3/23/2023

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