human monoclonal antibodies News
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Alloy Therapeutics becomes BaseLaunch’s first dedicated antibody discovery Domain Partner
“We are excited to partner with the BaseLaunch team and support their continued success developing a vibrant hub for biotechnology innovation in the Basel Area,” said Errik Anderson, chief executive and founder of Alloy Therapeutics. “At Alloy, we are singularly focused on supporting scientists developing new medicines for patients by democratizing access to foundational drug ...
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U.S. FDA Extends Review of Biologics License Application for REGEN-COV (casirivimab and imdevimab) for Treatment and Prophylaxis of COVID-19
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended by three months its review of the Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The extension is due to ongoing discussions with the FDA on pre-exposure ...
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New, late-breaking data at EADV highlights emerging clinical profile of amlitelimab (formerly KY1005) in adults with inadequately controlled moderate-to-severe atopic dermatitis
Low dose arm of the study met the co-primary endpoints of percent change in Eczema Area and Severity Index (EASI) score from baseline, and incidence of treatment-emergent adverse events, through week 16 First trial to assess the effects of blocking OX40-Ligand, a key immune system regulator, in patients with moderate-to-severe atopic dermatitis Data support amlitelimab as a potential ...
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Immune Biosolutions reports that its lead immunotherapy product IBIO123 neutralizes 100% of the SARS-CoV-2 variants of concern (VOCs), including Omicron
Immune Biosolutions Inc., a clinical-stage company, is pleased to announce that its leading biological drug candidate maintains a potent activity in neutralization assays. Recent results have confirmed that this drug, IBIO123, is capable of neutralizing SARS-CoV-2 (COVID-19) and all its current variants of concern (VOCs) that have emerged throughout the pandemic, including the latest Omicron ...
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MorphoSys’ Licensing Partner Roche Provides Update on Phase 3 GRADUATE Program for Gantenerumab in Early Alzheimer’s Disease
MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that its licensing partner Roche (SIX: RO, ROG; OTCQX: RHHBY) provided an update on the GRADUATE I and II studies evaluating gantenerumab in people with early Alzheimer’s disease (AD). The studies did not meet their primary endpoint of slowing clinical decline. The level of beta-amyloid removal, the protein that builds up to make plaques ...
By MorphoSys AG
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Kannalife, Inc. Receives Notice of Allowance from USPTO for Trademark of Atopidine
DOYLESTOWN, Pa., April 01, 2020 (GLOBE NEWSWIRE) — Kannalife, Inc. (“Kannalife” or the “Company”) (OTCQB: KLFE), a biopharmaceutical medchem company specializing in the research and development of potent novel monotherapeutics, announced today that the Company has been issued a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its ...
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Immune-Onc Therapeutics Enters into Clinical Collaboration with BeiGene in China
Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced it has entered into a clinical trial collaboration and supply agreement with to evaluate Immune-Onc’s first-in-class myeloid checkpoint inhibitors, IO-108 and IO-202, in combination with ...
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FDA Accepts Dupixent (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory ...
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Creative Diagnostics Launches Monkeypox Virus Antibodies and Antigens to Support MPXV Research
Creative Diagnostics, a global leader in offering raw materials, antibodies, and reagents for the bio-technology industry, announced the launch of several Monkeypox Virus Antibodies and Antigens that have been validated to work in various types of immunoassays and can be used as tools for the detection of Monkeypox viruses. Monkeypox virus (MPV or MPXV) is a double-stranded DNA virus that causes ...
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Dupixent (dupilumab) Approved by European Commission for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union. Dupixent is now also approved in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised ...
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AVEO Oncology Highlights Recent Progress and 2022 Outlook
AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, today highlighted its recent progress and outlook for 2022. “I am proud of the entire AVEO team this year, as we accomplished several key milestones in the face of what remains a challenging environment with the ongoing COVID-19 pandemic,” said Michael Bailey, President and Chief Executive ...
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Immune-Onc Therapeutics Doses First Patient in Phase 1 Clinical Trial of IO-108 in Patients with Advanced Solid Tumors in China
IO-108 is the first LILRB2-targeting antibody administered to Chinese patients Implementation of IO-108 program in China initiates Immune-Onc’s global clinical development plan; Phase 1 trial has completed dose escalation in the U.S. in solid tumor patients Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel ...
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AVEO Oncology Announces Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany to Evaluate Ficlatuzumab and ERBITUX® (cetuximab) in Patients with Recurrent or Metastatic HNSCC
AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, today announced that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany to evaluate ficlatuzumab in combination with ERBITUX® (cetuximab), an EGFR-targeted antibody, in patients with recurrent or metastatic head and neck squamous cell carcinoma ...
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AVEO Oncology Presents Three Posters for Tivozanib/Immunotherapy Combinations at the 2022 ASCO GI Cancers Symposium
First line cohort of the Phase 1b/2 DEDUCTIVE study demonstrates promising efficacy and tolerability of tivozanib plus durvalumab in first line HCC Two trials in progress posters presentations for the DEDUCTIVE HCC study and the recently initiated Phase 1b/2 IMMCO-1 study of tivozanib and atezolizumab in multiple immunologically cold tumors AVEO Oncology (Nasdaq: AVEO), a commercial stage, ...
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Immune-Onc Therapeutics Initiates Expansion Cohorts for IO-108 and Enters into Clinical Supply Agreement with Regeneron
IO-108 is being studied as a monotherapy and in combination with select anti-PD-1 antibodies in multiple expansion cohorts of solid tumors Clinical supply agreement with Regeneron accelerates Immune-Onc’s solid tumor clinical development program Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel ...
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Immune-Onc Therapeutics Announces Appointment of Christopher Whitmore as Chief Financial Officer and Provides Clinical Progress Update
Company announces completion of Phase 1 dose escalation ahead of schedule for IO-108, a first-in-class antibody targeting LILRB2 (ILT4) Signals of clinical activity observed in multiple tumor types for IO-108 as a single agent and in combination with an anti-PD-1 Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel ...
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