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BioInvent to Present Phase 1 Data for BI-1910 TNFR2 Agonist at SITC Despite Pausing Development

Monoclonal Antibody
  • BioInvent will present preliminary Phase 1 clinical data for BI-1910, a TNFR2 agonist for solid tumors, at the SITC Annual Meeting in November 2025.
  • The Phase 1 dose escalation study was completed without notable adverse events, with six of 12 evaluable patients showing stable disease.
  • Despite positive safety results, BioInvent has paused BI-1910 development to focus resources on its more advanced BI-1808 program following a strategic review.
  • BI-1910 demonstrated favorable pharmacokinetics and robust target engagement, with evidence of T cell proliferation induction in patients within the target dose range.

BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors

NCT06205706Active, Not RecruitingPhase 1
BioInvent International AB
Posted 12/4/2023

Igyxos Biotherapeutics Secures €5.7 Million French Government Grant to Advance First-in-Class Infertility Treatment

Monoclonal Antibody
  • Igyxos Biotherapeutics received €5.7 million in non-dilutive funding from the French government's France 2030 programme to support Phase 2 clinical trials of IGX12.
  • IGX12 is a first-in-class potentiating monoclonal antibody designed to enhance follicle stimulating hormone efficacy for treating both male and female infertility.
  • The company addresses a significant unmet medical need, as male infertility accounts for nearly half of all infertility cases but currently has no approved treatment options.
  • Phase 1 clinical trial results are expected in Q4 2025, with interim data showing good safety and tolerability in both men and women.

Incendia's PRTH-101 Shows Promise in Rare Thymic Cancers with 7.9-Month Median PFS

Monoclonal Antibody
  • Incendia Therapeutics reported encouraging Phase 1 results for PRTH-101, a first-in-class DDR1-targeted antibody, achieving 7.9 months median progression-free survival in thymic epithelial carcinoma patients.
  • The therapy demonstrated particular efficacy in patients with high DDR1 expression, with two confirmed partial responses and multiple patients showing prolonged stable disease beyond published expectations.
  • A pivotal Phase 2 registrational trial comparing PRTH-101 plus pembrolizumab to pembrolizumab alone is planned for 2026, targeting patients with recurrent or metastatic thymic epithelial carcinoma.
  • PRTH-101 works by disrupting tumor-associated collagen barriers to enable immune cell penetration into the tumor core, potentially transforming treatment for immune-excluded solid tumors.

A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies

NCT05753722RecruitingPhase 1
Incendia Therapeutics
Posted 3/3/2023

Calico's ABBV-CLS-628 Receives FDA Fast Track Designation for Autosomal Dominant Polycystic Kidney Disease

Monoclonal AntibodyRare Disease
  • The U.S. FDA has granted Fast Track Designation to ABBV-CLS-628, an investigational anti-PAPP-A monoclonal antibody developed by Calico and AbbVie for treating ADPKD.
  • ADPKD is the most common inherited kidney disease worldwide, leading to kidney failure in more than 50% of patients by age 60.
  • The therapy is currently being evaluated in a global Phase 2 clinical trial across approximately 95 sites, with participants receiving intravenous treatment every 4 weeks for 92 weeks.
  • Fast Track Designation facilitates development and expedites FDA review for drugs addressing serious conditions with unmet medical needs.

A Study to Assess Adverse Events and Effectiveness of IntraVenous Infusions of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT06902558RecruitingPhase 2
AbbVie
Posted 6/9/2025

Amgen's Repatha Becomes First PCSK9 Inhibitor to Demonstrate Primary Prevention of Cardiovascular Events in Landmark 12,000-Patient Trial

Monoclonal Antibody
  • Amgen's Phase 3 VESALIUS-CV trial demonstrated that Repatha significantly reduced major adverse cardiovascular events in over 12,000 high-risk patients without prior heart attack or stroke history.
  • The study met both primary endpoints, showing statistically and clinically significant reductions in coronary heart disease death, heart attack, ischemic stroke, and arterial revascularization procedures.
  • Repatha becomes the first and only PCSK9 inhibitor proven effective for both primary and secondary cardiovascular prevention, potentially expanding treatment to tens of millions more patients.
  • Approximately 85% of enrolled patients were maintained on high-intensity or moderate LDL-cholesterol reducing therapy, with median follow-up of 4.5 years showing no new safety signals.

Lundbeck Advances Innovative Phase 3 Trial Design for Amlenetug in Multiple System Atrophy

Monoclonal AntibodyOrphan DrugRare Disease
  • Lundbeck will present details of its Phase 3 MASCOT trial for amlenetug, a first-in-class monoclonal antibody targeting α-synuclein aggregation in Multiple System Atrophy patients.
  • The innovative trial design employs Bayesian progression modeling methods to address unique challenges in rare disease drug development with limited patient populations.
  • Multiple System Atrophy is a rapidly progressing neurodegenerative disease with no approved treatments, affecting patients who typically live 6-9 years after symptom onset.
  • Amlenetug has received Orphan Drug Designation from FDA and EMA, plus SAKIGAKE designation in Japan, highlighting its potential therapeutic significance.

A Study of Lu AF82422 in Participants With Multiple System Atrophy

NCT05104476Active, Not RecruitingPhase 2
H. Lundbeck A/S
Posted 11/16/2021

A Trial of Lu AF82422 in Participants With Multiple System Atrophy (MSA)

NCT06706622RecruitingPhase 3
H. Lundbeck A/S
Posted 12/3/2024

Bristol Myers Squibb's Anti-Tau Antibody BMS-986446 Receives FDA Fast Track Designation for Alzheimer's Disease

Monoclonal Antibody
  • The FDA has granted Fast Track Designation to BMS-986446, Bristol Myers Squibb's anti-microtubule binding region-tau antibody currently in Phase 2 development for early Alzheimer's disease.
  • BMS-986446 targets pathological tau protein fragments to prevent cell-to-cell spread and promote clearance through microglial activation, aiming to modify disease progression.
  • The designation recognizes the potential of this investigational therapy to address the urgent unmet medical need for disease-modifying treatments in Alzheimer's disease.
  • The ongoing TargetTau-1 Phase 2 trial is fully enrolled and evaluates multiple doses using comprehensive biomarker strategies to assess tau and amyloid-beta biology.

Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease

NCT06268886Active, Not RecruitingPhase 2
Bristol-Myers Squibb
Posted 3/20/2024

Star Therapeutics Secures $125 Million Series D to Advance VGA039 Phase 3 Trial for von Willebrand Disease

Monoclonal Antibody
  • Star Therapeutics raised an oversubscribed $125 million Series D financing co-led by Sanofi Ventures and Viking Global Investors to advance its bleeding disorder pipeline.
  • The funding supports VGA039, a first-in-class monoclonal antibody targeting Protein S, which has initiated a pivotal Phase 3 trial for von Willebrand disease treatment.
  • VGA039 offers a once-monthly subcutaneous dosing regimen compared to current factor replacement therapies requiring two to three IV infusions per week.
  • The therapy has received FDA Fast Track and orphan drug designations and could address all types of von Willebrand disease affecting over 50,000 U.S. patients.

Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)

NCT07115004RecruitingNot Applicable
Vega Therapeutics, Inc
Posted 9/1/2025

Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)

NCT05776069RecruitingPhase 1
Vega Therapeutics, Inc
Posted 3/16/2023

Star Therapeutics Secures $125M Series D to Advance Von Willebrand Disease Drug VGA039 Through Phase 3 Testing

Monoclonal Antibody
  • Star Therapeutics raised $125 million in Series D funding co-led by Sanofi Ventures and Viking Global Investors to advance its Von Willebrand disease drug VGA039 through late-stage clinical testing.
  • VGA039 is a preventive antibody therapy targeting protein S to boost thrombin generation, designed as a subcutaneous injection that could treat all types of Von Willebrand disease patients.
  • The company initiated a Phase 3 trial in September 2024 for VGA039, positioning it to compete in the Von Willebrand disease market alongside Roche's Hemlibra and Takeda's recently expanded therapy.
  • Von Willebrand disease affects up to 1% of the U.S. population as the most common bleeding disorder, with current treatments requiring frequent infusions or injections of replacement clotting factors.

Novartis Launches Direct-to-Patient Platform for Cosentyx with 55% Discount in US

Monoclonal Antibody
  • Novartis will launch a direct-to-patient platform on November 1, 2025, offering Cosentyx at a 55% discount off list price to cash-paying patients in the US.
  • The initiative follows President Trump's September 29 deadline for pharmaceutical companies to implement drug price cuts, joining other major pharma companies in offering significant discounts.
  • Cosentyx, Novartis' top-selling US product, treats multiple immune-mediated inflammatory diseases and has been used by over 1.8 million patients globally since its 2015 launch.
  • The platform represents a proof-of-concept for direct-selling specialty medicines and may expand to additional Novartis products and direct-to-employer models.

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