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Pfizer Partners with Nona Biosciences for Heavy Chain-Only Antibody Discovery Platform

Monoclonal AntibodyCAR-T
  • Pfizer has entered a non-exclusive license agreement with Nona Biosciences to access their proprietary HCAb platform for generating fully human heavy chain-only antibodies across multiple disease indications.
  • The collaboration leverages Nona's Harbour Mice® platform, described as the world's first fully human HCAb transgenic mouse with clinical validation, offering versatility for diverse therapeutic applications.
  • Under the agreement terms, Nona will receive upfront payments and be eligible for regulatory, clinical, and commercial milestone payments while potentially collaborating on antibody discovery and development.
  • The HCAb platform enables development of various therapeutic modalities including bispecific antibodies, CAR-T therapies, antibody-drug conjugates, and mRNA-based therapeutics using fully human VH single-domain antibodies.

Radiopharm Theranostics Receives Ethics Approval for First-in-Human Trial of RAD 402 in Advanced Prostate Cancer

Monoclonal Antibody
  • Radiopharm Theranostics has received Bellberry Human Research Ethics Committee approval in Australia to initiate a first-in-human Phase 1 clinical trial of RAD 402 for metastatic or locally advanced prostate cancer.
  • RAD 402 is an anti-KLK3 monoclonal antibody radiolabeled with terbium-161, representing what the company believes is the first company-sponsored therapeutic trial using this radionuclide.
  • Preclinical biodistribution studies in mouse xenografts demonstrated strong tumor targeting, limited bone and marrow uptake, and appropriate hepatic excretion profile for the monoclonal antibody.
  • The therapy targets KLK3, which encodes prostate specific antigen and is expressed in prostate adenocarcinomas and their metastases, offering a novel mechanism of action through dual emission of beta particles and Auger electrons.

Mabloc and Instituto Butantan Partner to Develop First-in-Class Monoclonal Antibody Therapy for Yellow Fever

Monoclonal Antibody
  • Mabloc and Instituto Butantan announced a strategic partnership to co-develop MBL-YFV-01, a breakthrough monoclonal antibody therapy for yellow fever virus infection, addressing an urgent unmet medical need.
  • Primate studies published in Science Translational Medicine showed a single 50mg/kg dose of MBL-YFV-01 fully controlled viremia and prevented severe disease and death in 100% of treated primates.
  • The partnership comes amid escalating yellow fever outbreaks in Brazil, with confirmed human cases in São Paulo, Minas Gerais, and Espírito Santo, where millions remain at risk despite vaccine availability.
  • Instituto Butantan will manufacture MBL-YFV-01 and lead clinical studies to support regulatory submission to ANVISA, potentially delivering one of the world's first post-exposure therapies for yellow fever.

European Commission Approves World's First Liquid Formulation of IV Infliximab, Promising Significant Cost Savings

Monoclonal AntibodyDrug Approval
  • The European Commission has granted marketing authorization for Remsima™ IV liquid formulation, the world's first liquid formulation of intravenous infliximab, approved for all indications matching existing powder formulations.
  • The new liquid formulation eliminates reconstitution requirements and reduces drug preparation time by 51% while cutting preparation costs by 20%, with projected annual savings of up to €2.6 million across seven European countries.
  • Available in 100 mg and 350 mg vials, the formulation reduces storage space requirements by 50-70% and decreases contamination risks, supporting improved workflow efficiency in hospital settings.
  • The approval is based on comprehensive comparability data demonstrating equivalent stability and efficacy between the liquid and powder formulations of infliximab.

Acumen Pharmaceuticals Initiates Open-Label Extension Study for Alzheimer's Drug Sabirnetug

Monoclonal Antibody
  • Acumen Pharmaceuticals has dosed the first participant in the open-label extension portion of its Phase 2 ALTITUDE-AD trial for sabirnetug (ACU193) in early Alzheimer's disease.
  • The extension study will provide all 542 participants who completed the 18-month placebo-controlled trial with access to sabirnetug at 35 mg/kg intravenously for an additional 52 weeks.
  • Sabirnetug is the first humanized monoclonal antibody to demonstrate selective target engagement of toxic soluble amyloid beta oligomers in Alzheimer's patients.
  • The company expects to report topline results from the main ALTITUDE-AD study in late 2026, with the extension providing valuable long-term safety and efficacy data.

A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

NCT06335173Active, Not RecruitingPhase 2
Acumen Pharmaceuticals
Posted 2/29/2024

Sandoz Launches First FDA-Approved Multiple Sclerosis Biosimilar TYRUKO in US Market

Monoclonal AntibodyDrug ApprovalNeurology
  • Sandoz has launched TYRUKO (natalizumab-sztn) as the first and only FDA-approved biosimilar for multiple sclerosis treatment in the United States, developed by Polpharma Biologics.
  • The biosimilar is approved for all indications of reference medicine Tysabri, including relapsing forms of MS and Crohn's disease, offering a more cost-effective treatment option for patients.
  • TYRUKO is available through a Risk Evaluation and Mitigation Strategy (REMS) program due to progressive multifocal leukoencephalopathy (PML) risks, with Sandoz partnering with Labcorp for free JCV antibody testing.
  • The launch represents a strategic milestone for Sandoz's biosimilar leadership ambitions in the US market, with the product already available in 14 European countries.

European Regulators Recommend Approval of Incyte's Minjuvi for Relapsed Follicular Lymphoma

Monoclonal AntibodyDrug ApprovalOncology
  • The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for relapsed or refractory follicular lymphoma after at least one prior therapy.
  • Phase 3 inMIND trial results demonstrated statistically significant improvement in progression-free survival, with patients achieving median PFS of 22.4 months compared to 13.9 months in the control arm (HR: 0.43, P<0.0001).
  • If approved by the European Commission, Minjuvi would represent the first CD19- and CD20-dual-targeted immunotherapy for European patients with relapsed or refractory follicular lymphoma.
  • The treatment was well tolerated with a manageable safety profile, offering a chemotherapy-free alternative for second-line treatment in a disease affecting 2-4 out of every 100,000 people in Western countries.

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

Formycon Achieves Technical Proof of Similarity for Dupilumab Biosimilar FYB208, Targeting $20 Billion Market

Monoclonal Antibody
  • Formycon AG successfully completed the Technical Proof of Similarity (TPoS) for FYB208, demonstrating high analytical comparability to Dupixent (dupilumab).
  • The biosimilar candidate targets chronic inflammatory diseases including COPD, asthma, and atopic dermatitis in a market expected to reach over $20 billion by 2030.
  • Strong preclinical data may enable FYB208 to proceed without a Phase III comparative efficacy study, potentially accelerating development timelines.
  • The achievement adds another growth driver to Formycon's biosimilar portfolio, which already includes two marketed products and one recently approved candidate.

Gates Foundation Awards $13.5 Million to Slash Monoclonal Antibody Costs from $100 to $10 Per Gram

Monoclonal Antibody
  • The Gates Foundation has awarded $13.5 million across multiple projects to reduce monoclonal antibody manufacturing costs from the current $50-100 per gram to just $10 per gram, making these life-saving treatments accessible in low-resource settings.
  • Seven innovative projects are exploring breakthrough approaches including fungal expression systems, continuous flow platforms, and membrane-based purification technologies to replace expensive traditional manufacturing methods.
  • The initiative targets critical global health needs, with the first application focusing on antimalarial antibodies to address a disease that kills over 500,000 people annually, primarily in Africa.
  • These cost reduction efforts could transform global access to monoclonal antibody treatments, particularly in low- and middle-income countries where Africa currently holds only 1% of the global mAb market despite high disease burden.

Lundbeck Seeks Asian Market Approval for Vyepti Migraine Prevention Therapy

Monoclonal Antibody
  • Lundbeck has filed marketing authorization applications for Vyepti (eptinezumab) in Japan, China, and South Korea, marking the company's first regulatory submissions for this migraine prevention therapy in Asia.
  • The applications are supported by Phase 3 SUNRISE trial data demonstrating eptinezumab's efficacy in predominantly Asian patients with chronic migraine, addressing a significant unmet medical need in the region.
  • If approved, this would represent Lundbeck's first marketing authorization in Japan and the first biologic launch by the company in China and South Korea, expanding access to CGRP-targeted migraine prevention.

Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan

NCT05064371CompletedPhase 3
H. Lundbeck A/S
Posted 9/21/2021

Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

NCT04921384CompletedPhase 3
H. Lundbeck A/S
Posted 5/29/2021

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