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CMS Secures Exclusive Rights to Two Breakthrough Antibody Therapies for Tetanus and Rabies Prevention

Monoclonal Antibody
  • China Medical System Holdings Limited has secured exclusive commercialization rights for two innovative monoclonal antibody therapies, Vecantoxatug for tetanus prevention and Silevimig for rabies prevention, through collaboration agreements with Genrix Bio.
  • Vecantoxatug, which received Breakthrough Therapy designation from China's NMPA in May 2024, demonstrated superior protection compared to human tetanus immunoglobulin in Phase III trials and has its New Drug Application under review.
  • Silevimig represents the world's first recombinant, fully human bispecific antibody for rabies prevention, designed according to WHO recommendations and showing non-inferior efficacy to current treatments in Phase III trials.
  • Both therapies address significant unmet medical needs in China, where tetanus has a 30-50% mortality rate and only 15% of high-risk rabies exposure cases receive passive immunization despite 16 million annual Category III exposures.

Percheron Therapeutics Appoints CMO and CTO to Advance HMBD-002 Cancer Immunotherapy Toward Phase II Trial

Monoclonal AntibodyOncology
  • Percheron Therapeutics has appointed Dr Eugene Kennedy as Chief Medical Officer and Valentina Dubljevic as Chief Technology Officer to strengthen leadership ahead of HMBD-002's phase II trial.
  • HMBD-002 is a monoclonal antibody targeting the immune checkpoint regulator VISTA that has completed phase I testing with favorable safety and tolerability data.
  • The company plans to commence recruitment for the phase II trial of HMBD-002 in calendar year 2026, marking a critical advancement in the oncology program.
  • Dr Kennedy brings over a decade of immuno-oncology experience from roles at Johns Hopkins and Carisma Therapeutics, while Dubljevic will focus on manufacturing and regulatory compliance.

Aurobindo Pharma Advances Denosumab Biosimilar Following Phase 3 Success, Eyes $7 Billion Market Entry

Monoclonal AntibodyOncology
  • Aurobindo Pharma completed successful Phase 3 clinical trials for its denosumab biosimilar, targeting osteoporosis and cancer-related bone treatments in a $7 billion global market.
  • The company plans regulatory filings in the US, EU, and other key markets starting January 2026, with European approval expected by end of 2026 and US approval by 2027.
  • Biosimilars are projected to capture 30-50% of the innovator market by 2030, representing initial sales potential of $1.5-1.6 billion across five to six major players.

CatalYm Initiates Phase 2b Trial of Visugromab in First-Line Metastatic NSCLC

Monoclonal Antibody
  • CatalYm has dosed the first patient in a randomized Phase 2b trial evaluating visugromab combined with chemoimmunotherapy as first-line treatment for metastatic non-squamous NSCLC.
  • The anti-GDF-15 antibody visugromab targets a tumor-derived cytokine that drives immune suppression and anti-PD-(L)-1 resistance, with previous trials showing deep and durable responses.
  • The GDFATHER-NSCLC-01 trial will enroll approximately 107 patients across multiple sites in the US, EU, and Switzerland, with objective response rate as the primary endpoint.
  • Results from a separate Phase 2 neoadjuvant bladder cancer trial combining visugromab with nivolumab will be presented at ESMO 2025 as a late-breaking oral presentation.

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

A multi-center Phase 2 study of neoadjuvant immunotherapy in combination with the anti-GDF-15 antibody visugromab (CTL-002) for the treatment of muscle invasive bladder cancer

2024-513957-55-00Active, Not RecruitingPhase 2
CatalYm GmbH
Posted 9/6/2023

Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC

NCT07098988RecruitingNot Applicable
CatalYm GmbH
Posted 8/1/2025

Visugromab in Cachexia International Trial

NCT07112196Not Yet RecruitingNot Applicable
CatalYm GmbH
Posted 2/1/2026

Alkem Laboratories Launches Affordable Pertuzumab Biosimilar for HER2-Positive Breast Cancer in India

Monoclonal AntibodyOncology
  • Alkem Laboratories has launched Pertuza injection 420mg/14mL, an indigenously developed pertuzumab biosimilar for HER2-positive breast cancer treatment in India.
  • The biosimilar demonstrated equivalence in efficacy, safety, and immunogenicity to the reference product in pivotal phase 3 clinical trials conducted by Alkem's biotech subsidiary.
  • The launch addresses significant accessibility challenges for pertuzumab therapy in India, where cost barriers have limited treatment options for HER2-positive breast cancer patients.
  • Alkem aims to make this critical therapy available to thousands of women annually who would otherwise be excluded from treatment due to financial constraints.

Hetero Healthcare and Enzene Launch Perzea, India's Most Affordable Pertuzumab Biosimilar for HER2-Positive Breast Cancer

Monoclonal AntibodyOncology
  • Hetero Healthcare Limited has launched Perzea, its most cost-effective biosimilar of pertuzumab, through a semi-exclusive collaboration with Enzene Biosciences Limited to expand affordable breast cancer treatment access in India.
  • The biosimilar targets HER2-positive breast cancer patients and aims to reduce economic barriers that have restricted access to this globally recognized monoclonal antibody therapy.
  • Perzea is designed to be used in combination with trastuzumab and chemotherapy, following the established standard of care for HER2-positive breast cancer treatment.
  • The launch aligns with the Government of India's healthcare vision to ensure equitable access to life-saving medications and represents a significant step toward democratizing advanced cancer therapies.

AstraZeneca's Tezspire Receives EU Regulatory Recommendation for Chronic Rhinosinusitis with Nasal Polyps

Monoclonal Antibody
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of AstraZeneca and Amgen's Tezspire (tezepelumab) for treating chronic rhinosinusitis with nasal polyps in adults.
  • The WAYPOINT Phase III trial demonstrated significant reductions in nasal polyp severity and congestion, with 98% elimination of surgery need and 89% reduction in systemic corticosteroid use compared to placebo.
  • This recommendation represents a potential breakthrough for the approximately 320 million people worldwide affected by this chronic inflammatory condition, where nearly half of European patients remain uncontrolled with current therapies.
  • Regulatory applications are currently under review in the US, China, Japan and several other countries based on the same trial results.

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

NCT05583227Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/10/2022

Tezepelumab COPD Exacerbation Study

NCT04039113CompletedPhase 2
AstraZeneca
Posted 7/30/2019

Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis

NCT04851964CompletedPhase 3
AstraZeneca
Posted 4/22/2021

POSITIVE Trial Shows Tildrakizumab Delivers Comprehensive Quality of Life Benefits in Psoriatic Disease

Monoclonal AntibodyReal World Evidence
  • The POSITIVE trial demonstrates that tildrakizumab significantly improves psychological wellbeing in psoriatic disease patients, with WHO-5 scores increasing from 53.7 at baseline to 70.43 at two years, surpassing European population norms.
  • Clinical outcomes showed sustained improvement with mean PASI scores decreasing from 12.9 at baseline to 1.3 at week 104, with 79.0% of patients maintaining PASI ≤2 at two years.
  • The study revealed that 29.5% of patients experienced "psycholag," a delay in psychological recovery despite rapid skin clearance, highlighting the complex relationship between physical and mental health outcomes.
  • Quality of life measures and family burden scores showed consistent improvement throughout the 24-month observation period, with favorable safety outcomes reported in 11.1% of patients experiencing treatment-related adverse events.

EMA Recommends Amgen's Uplizna for Rare Autoimmune Disease IgG4-RD

Monoclonal AntibodyRare Disease
  • The European Medicines Agency's human medicines committee has recommended expanding Amgen's Uplizna (inebilizumab) indication to treat adult patients with active immunoglobulin G4-related disease (IgG4-RD).
  • IgG4-RD is a rare, chronic autoimmune condition that can cause tissue scarring and inflammation in multiple organs, with no currently authorized medicines in the EU.
  • Phase 3 trial data showed 58.8% of Uplizna patients achieved corticosteroid-free, flare-free complete remission at week 52, compared to 22.4% receiving placebo.
  • The monoclonal antibody targets and destroys B cells, and is already approved for neuromyelitis optica spectrum disorders.

Precision Biologics Reports Promising Efficacy Data for Novel Ovarian Cancer ADC PB-vcMMAE-5

Monoclonal AntibodyTargeted Therapy
  • Precision Biologics' novel antibody-drug conjugate PB-vcMMAE-5 demonstrated significant anti-tumor activity in ovarian cancer models, achieving up to 92.51% cell killing in vitro and robust tumor volume reduction at higher doses.
  • The ADC targets truncated core 2 O-glycans specifically expressed by cancer cells using the improved monoclonal antibody PB-223, which shows 4-fold stronger binding affinity compared to its predecessor NEO-102.
  • Safety studies in mice showed the treatment was well-tolerated with no signs of distress or significant organ toxicity, supporting its potential for clinical development in ovarian and other cancers expressing core 2 O-glycans.

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