MedPath

Tagged News

Innate Pharma Advances Key Pipeline Assets While Implementing Strategic Restructuring

Monoclonal Antibody
  • Innate Pharma received FDA Breakthrough Therapy Designation for lacutamab in Sézary syndrome and is nearing completion of Phase 3 trial protocol preparation following regulatory discussions.
  • The company's Nectin-4 ADC IPH4502 is progressing through Phase 1 enrollment with first patient data expected in H1 2026, while AstraZeneca's PACIFIC-9 trial with monalizumab completed enrollment.
  • Innate plans to reduce staffing by approximately 30% and focus resources on three highest-value assets: IPH4502, lacutamab, and monalizumab, with cash runway extending to Q3 2026.
  • Sanofi invested €15 million in new equity while the company reported €70.4 million in cash position as of June 30, 2025.

A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)

NCT05839626TerminatedPhase 1
Sanofi
Posted 5/15/2023

Tonix Pharmaceuticals Licenses Long-Acting Monoclonal Antibody TNX-4800 for Seasonal Lyme Disease Prevention

Monoclonal Antibody
  • Tonix Pharmaceuticals has licensed worldwide rights to TNX-4800, a long-acting human monoclonal antibody developed by UMass Chan Medical School for seasonal prevention of Lyme disease.
  • The single-dose antibody targets outer-surface protein A (OspA) on Borrelia burgdorferi bacteria, blocking their maturation in infected deer ticks and providing immediate protection throughout the entire tick season.
  • TNX-4800 completed a positive Phase 1 study demonstrating safety, tolerability, and a linear pharmacokinetic-pharmacodynamic-efficacy relationship, with Tonix planning an adaptive Phase 2/3 study.
  • Approximately 70 million people in the United States live in Lyme disease-endemic areas and could potentially benefit from this prophylactic treatment, as no FDA-approved vaccines or preventive therapies currently exist.

Eisai's Tau Antibody Etalanetug Receives FDA Fast Track Designation for Alzheimer's Disease

Monoclonal Antibody
  • Eisai's investigational anti-MTBR tau antibody etalanetug (E2814) has been granted FDA Fast Track designation to expedite development for Alzheimer's disease treatment.
  • Phase I/II clinical trial results showed target engagement with MTBR-tau species in cerebrospinal fluid and reduction in CSF MTBR-tau243 biomarker in patients with Dominantly Inherited Alzheimer's Disease.
  • The antibody is currently being evaluated in combination with lecanemab in two ongoing clinical trials targeting both inherited and sporadic early Alzheimer's disease.
  • Fast Track designation enables more frequent FDA interactions and potential eligibility for accelerated approval pathways if clinical data supports efficacy.

A Study to Assess Safety and Target Engagement of E2814 in Participants With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's Disease

NCT04971733CompletedPhase 1
Eisai Inc.
Posted 6/28/2021

A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease

NCT06602258Active, Not RecruitingPhase 2
Eisai Inc.
Posted 9/30/2024

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)

NCT05269394Active, Not RecruitingPhase 2
Washington University School of Medicine
Posted 12/22/2021

Lilly Commits $5 Billion to Virginia Manufacturing Facility for Bioconjugate and ADC Production

Monoclonal AntibodyOncology
  • Eli Lilly announces plans to build a $5 billion manufacturing facility in Virginia's Goochland County, marking the company's first dedicated bioconjugate platform and monoclonal antibody production site.
  • The facility will focus on manufacturing antibody-drug conjugates (ADCs) and active pharmaceutical ingredients for cancer, autoimmune, and other advanced therapies.
  • The project will create 650 high-paying manufacturing jobs and 1,800 construction positions, representing the first of four new U.S. manufacturing sites Lilly plans to announce this year.
  • Expected completion within five years, the facility is part of Lilly's $50 billion U.S. capital expansion commitment since 2020 and will incorporate advanced technologies including AI and machine learning.

CatalYm Strengthens Leadership Team to Advance Visugromab Through Late-Stage Development

Monoclonal AntibodyOncologyLeadership Change
  • CatalYm appointed four experienced executives to accelerate visugromab's progression into late-stage clinical development following promising Phase 2a results.
  • The company's GDFATHER-2 trial demonstrated that visugromab combined with anti-PD-1 inhibitor produced deep and durable responses across multiple solid tumor types with favorable safety.
  • CatalYm is advancing visugromab into multiple Phase 2b studies including first-line metastatic NSCLC and cachexia indications based on Nature-published data.
  • The leadership changes position the GDF-15-targeting therapy developer for potential regulatory approval and commercial success in oncology and cachexia markets.

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

Visugromab in Cachexia International Trial

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

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

NCT07098988RecruitingNot Applicable
CatalYm GmbH
Posted 8/1/2025

Novel PCSK9 Inhibitor Recaticimab Shows 54% LDL Cholesterol Reduction in Phase 3 Trial for Familial Hypercholesterolemia

Monoclonal Antibody
  • Recaticimab, a novel PCSK9 inhibitor, demonstrated a 54.4% reduction in LDL cholesterol levels compared to placebo in adults with heterozygous familial hypercholesterolemia.
  • The phase 3 REMAIN-3 trial enrolled 143 patients across 25 sites in China, with participants receiving 150 mg subcutaneous injections every 4 weeks for 12 weeks.
  • The treatment showed comparable safety profiles to placebo, with injection site reactions being the most common treatment-related adverse event at 8.4%.
  • The results provide a potential new treatment option for patients with inadequately controlled heterozygous familial hypercholesterolemia, a genetic condition causing dangerously high cholesterol levels.

SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research

NCT04844125CompletedPhase 3
Jiangsu HengRui Medicine Co., Ltd.
Posted 4/14/2021

Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia

NCT04885218CompletedPhase 3
Jiangsu HengRui Medicine Co., Ltd.
Posted 7/30/2021

Zoetis Receives EU Regulatory Nod for First Long-Acting Feline Osteoarthritis Pain Treatment

Monoclonal Antibody
  • The European Medicines Agency's Committee for Veterinary Medicinal Products has issued a positive opinion for Portela (relfovetmab), Zoetis' monoclonal antibody therapy for feline osteoarthritis pain relief.
  • Portela would be the first long-acting anti-nerve growth factor monoclonal antibody therapy for cats, providing three months of pain relief with a single injection.
  • The therapy addresses a significant unmet need, as up to 40% of cats show clinical signs of osteoarthritis but only 18% are diagnosed by veterinary professionals.
  • European Commission approval is expected in Q4 2025, with commercial availability anticipated in 2026, expanding Zoetis' existing feline pain management portfolio.

FibroBiologics Reports Breakthrough Results for Single-Dose Fibroblast Spheroid Therapy in Chronic Psoriasis

Monoclonal Antibody
  • FibroBiologics announced positive IND-enabling preclinical results showing that a single administration of human dermal fibroblast (HDF) spheroids matched the efficacy of multiple doses of anti-IL-23 monoclonal antibody in acute psoriasis models.
  • The same single HDF spheroid treatment demonstrated significant reduction in disease recurrence in chronic-relapse psoriasis models, potentially offering long-term protection against relapse.
  • The company is expanding research to include repeated dosing regimens, cytokine profiling, and histopathological assessments to strengthen the foundation for clinical advancement.
  • FibroBiologics holds over 270 patents and is developing this novel cell therapy approach for psoriasis, which affects over eight million adults in the United States.

Roivant Sciences Gains Orphan Drug Designation in Japan for Mosliciguat in Pulmonary Hypertension

Rare DiseaseMonoclonal Antibody
  • Roivant Sciences' subsidiary Pulmovant received orphan drug designation from Japan's Ministry of Health, Labour and Welfare for mosliciguat, an inhaled soluble guanylate cyclase activator.
  • The designation grants regulatory benefits and potential market exclusivity for treating pulmonary hypertension associated with interstitial lung disease, an underserved indication with limited treatment options.
  • Mosliciguat was originally licensed from Bayer after the pharmaceutical giant exited respiratory research, positioning Roivant to advance this promising therapeutic candidate.
  • The company's stock rose 9.4% following the positive regulatory news, reflecting investor optimism about the drug's commercial potential in Japan's orphan disease market.

TG Therapeutics to Present Six-Year BRIUMVI Data at ECTRIMS 2025, Showcasing Long-Term Multiple Sclerosis Treatment Outcomes

Monoclonal AntibodyReal World Evidence
  • TG Therapeutics will present six years of long-term efficacy and safety data for BRIUMVI (ublituximab-xiiy) from the ULTIMATE I and II open-label extension studies at the 2025 ECTRIMS meeting in Barcelona.
  • The presentations will include updates from the ENHANCE study on modified dosing regimens and real-world clinical experience from the first Phase 4 observational study ENABLE for relapsing multiple sclerosis patients.
  • BRIUMVI is a glycoengineered monoclonal antibody targeting CD20-expressing B-cells, approved in the U.S., EU, and UK for treating adults with relapsing forms of multiple sclerosis with demonstrated efficacy in pivotal trials involving 1,094 patients.

Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )

NCT03277261CompletedPhase 3
TG Therapeutics, Inc.
Posted 9/19/2017

Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)

NCT03277248CompletedPhase 3
TG Therapeutics, Inc.
Posted 8/25/2017

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.