Immunoglobulin G

argenx Delivers on Promise to Transform Patient Expectations in Autoimmunity at American Academy of Neurology 2024 Annual Meeting

Retrieved on: 
星期四, 三月 7, 2024

“We are opening a new chapter for the VYVGART portfolio,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.

Key Points: 
  • “We are opening a new chapter for the VYVGART portfolio,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.
  • These positive data from the ADHERE study have been submitted to the FDA for potential approval of VYVGART Hytrulo in CIDP with a PDUFA target action date of June 21, 2024.
  • Achievement of MSE enables significant quality of life improvements: ADAPT/ADAPT+ demonstrate that >40% of patients achieve minimal symptom expression (MSE) across both studies.
  • Patients achieving MSE experience quality of life outcomes comparable to healthy populations, suggesting MSE could be a primary goal of gMG treatment.

Kamada Issues 2024 CEO Letter to Shareholders

Retrieved on: 
星期三, 三月 6, 2024

The recently completed 2023 was another successful period in our commercial journey as a global leader in the specialty plasma-derived field.

Key Points: 
  • The recently completed 2023 was another successful period in our commercial journey as a global leader in the specialty plasma-derived field.
  • Looking ahead, we expect the momentum from 2023 to extend throughout 2024, with profitability to be further increased as compared to last year.
  • These significant catalysts are propelling our continued annual double-digit profitable growth with substantial upside potential and limited downside risk.
  • On behalf of the entire Kamada team, we look forward to continuing to support patients and clinicians with the important lifesaving products that we develop, manufacture, and commercialize.

Tonix Pharmaceuticals Announces Translation of Preclinical Pharmacokinetic Parameters of TNX-1500 (Fc-modified humanized anti-CD40L mAb) Supports Monthly i.v. Dosing in Humans

Retrieved on: 
星期二, 三月 5, 2024

CHATHAM, N.J., March 05, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the results of modeling key human pharmacokinetic (PK) properties for TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* from animal studies. TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplantation and for the treatment of autoimmune disorders.

Key Points: 
  • TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplantation and for the treatment of autoimmune disorders.
  • “Preclinical studies in non-human primates have shown that TNX-1500 maintains the activity of first generation mAbs, with reduced risk of thrombotic complications.3-5 Today we are announcing that modeling studies from animal PK data3, predict that a half-life of approximately three weeks for TNX-1500 in humans6,7, which supports monthly dosing.
  • or biweekly s.c. dosing regimens.2 Based on its results in multiple sclerosis, Sanofi projects that frexalimab will exceed €5B per year in peak sales1.
  • TNX-1500 was designed to reduce binding to the Fc-receptor for IgG type 2a, or FcγR2a, which has been shown to play a role in the thrombosis associated with first-generation anti-CD40L mAbs, similar to frexalimab.

Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma

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星期五, 三月 1, 2024

CAMBRIDGE, Mass., March 01, 2024 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLN-619 in relapsed/refractory multiple myeloma. CLN-619 is a potential first-in-class humanized IgG1 monoclonal antibody that binds to stress-induced ligands, MICA and MICB, which are expressed on a wide variety of solid tumors and hematologic malignancies. The company will commence a Phase 1 dose-escalation and dose-expansion trial of CLN-619.

Key Points: 
  • The company will commence a Phase 1 dose-escalation and dose-expansion trial of CLN-619.
  • “Multiple myeloma remains incurable, and most patients experience sequential relapses.
  • The response to treatment is typically shorter with each relapse, so novel treatments are still needed,” said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology.
  • “Multiple myeloma is another example of a malignancy where MICA/B shedding from tumor cells allows for immune evasion.

Independent Lab Confirms Immunogenicity and Protection with IMUNON’s IMNN-101 in a Live Virus Challenge Against SARS-CoV-2 Variant XBB.1.5

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星期四, 二月 29, 2024

LAWRENCEVILLE, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces positive results from a live virus challenge study conducted for IMUNON by the Wistar Institute with IMNN-101 against the SARS-CoV-2 variant XBB.1.5. This study was conducted using the clinical vector that IMUNON intends to bring into its Phase 1 study during the second quarter and showed IMNN-101 immunogenicity and protective activity in a live viral mouse challenge.

Key Points: 
  • The SARS-CoV-2 XBB.1.5 variant was declared as the variant of concern for the 2023-2024 vaccine by the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee.
  • IMUNON has reported that intramuscular administration of a single dose of IMNN-101 in mice produced IgG neutralizing antibody and T-cell responses.
  • Challenging the mice with live virus 21 days after the second vaccination showed complete protection.
  • Protection in non-human primates was greater than 95%, which is comparable to mRNA.

Intrommune Therapeutics Presents Supporting Data Introducing a New Form of Food Allergy Treatment

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星期四, 二月 22, 2024

NEW YORK, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Intrommune Therapeutics , Inc., a biotechnology company committed to developing a patient-friendly treatment platform for people with peanut and other food allergies, announces data in a late-breaking poster presentation at this year’s American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting in Washington, D.C. supporting Oral Mucosal Immunotherapy (OMIT) as a potential new form of food allergy treatment.

Key Points: 
  • NEW YORK, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Intrommune Therapeutics , Inc., a biotechnology company committed to developing a patient-friendly treatment platform for people with peanut and other food allergies, announces data in a late-breaking poster presentation at this year’s American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting in Washington, D.C. supporting Oral Mucosal Immunotherapy (OMIT) as a potential new form of food allergy treatment.
  • This data demonstrates that OMIT, an investigational treatment, which delivers allergenic proteins utilizing an innovative, specially formulated toothpaste, can safely be used to treat patients with food allergies in a more convenient way than food allergy therapies currently available.
  • The results of this study suggest OMIT as a new approach for the management of food allergy, providing a strong foundation for further research in the pediatric population.
  • The addition of OMIT as a new, safe and convenient option for both patients and physicians, marks an important advancement in the treatment of food allergies.

argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy

Retrieved on: 
星期二, 二月 20, 2024

“Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx.

Key Points: 
  • “Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx.
  • We chose to use a priority review voucher to accelerate review of our submission because CIDP patients have long been waiting for new treatment options.
  • In the open-label Stage A of the study, 67% of patients showed evidence of clinical improvement (ECI) following treatment with VYVGART Hytrulo.
  • VYVGART Hytrulo was well-tolerated with a safety profile that is consistent with prior clinical trials and the known profile of VYVGART®.

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Retrieved on: 
星期二, 三月 12, 2024

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      Guideline on allergen products development for
      immunotherapy and allergy diagnosis in moderate to lowsized study populations

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      Table of contents

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      Executive summary ..................................................................................... 3

      19

      1.

    • Specific effects ................................................................................................. 17

      14
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      12.

    • Management for allergies may involve avoidance of the allergen, medications to relieve

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      symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.

    • 71

      Recommendations are made on the clinical development, potential study designs and safety

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      considerations for allergen products within the scope of the guideline.

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      While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

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      there is no such treatment available for type IV allergies.

    • 93

      Several guidelines applicable for allergen products are available (see section 3) and provide advice on

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      quality and clinical development according to the current knowledge.

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      However, this guideline does not cover the indication of atopic dermatitis or asthma as these

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      conditions will require separate clinical trials (see Section 6).

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      In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

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      DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ

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      substantially to the allergen products as discussed above.

    • 1

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      ?

      Guideline on the clinical development of products for specific immunotherapy for the treatment

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      of allergic diseases - CHMP/EWP/18504/2006
      ?

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      Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

      ?

      Guideline on process validation for finished products - information and data to be provided in
      regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1

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      in moderate to low-sized study populations
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      ?

      Recommendations on common regulatory approaches for allergen products - CMDh/399/2019

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      4.

    • In any

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      case, a reduced validation should include all relevant manufacturing process steps that are considered
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      product specific.

    • 290

      Diagnostic allergen products (Type I allergy)

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      A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,

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      intracutaneous or provocation testing.

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      7.1.

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      8.

    • Clinical development of products for AIT: Study design,
      efficacy and safety

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      In general, the clinical development should be performed according to current guidelines.

    • In such single trial, the suitability as a test allergen as well as the

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      dose finding for the therapeutic allergen could be investigated.

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      8.2.1.

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      In general, sensitivity and specificity of the product should be determined.

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      10.2.

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      4.

    • Allergol Immunopathol, 1989;

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      17(2):53-65

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Seismic Therapeutic to Present Preclinical Data for Novel Immunoglobulin Sculpting Enzyme at AAN Annual Meeting

Retrieved on: 
星期五, 三月 8, 2024

Seismic Therapeutic, Inc ., the machine learning immunology company, today announced that the company will present preclinical data for its pan-immunoglobulin G (IgG) sculpting enzyme candidate, S-1117, at the American Academy of Neurology (AAN) annual meeting taking place on April 13-18 in Denver.

Key Points: 
  • Seismic Therapeutic, Inc ., the machine learning immunology company, today announced that the company will present preclinical data for its pan-immunoglobulin G (IgG) sculpting enzyme candidate, S-1117, at the American Academy of Neurology (AAN) annual meeting taking place on April 13-18 in Denver.
  • S-1117 is a novel engineered pan-IgG protease for the potential treatment of a range of chronic and acute autoantibody mediated diseases, including the chronic neuromuscular autoimmune disorder, myasthenia gravis.
  • The presentation at the AAN annual meeting will outline key preclinical in vitro and in vivo results supporting the differentiated profile of S-1117 compared to therapeutic benchmarks in chronic autoantibody mediated diseases.
  • Title: Preclinical Pharmacology of S-1117, a Novel Engineered Fc-fused IgG Cleaving Enzyme, for Chronic Treatment of Autoantibody-mediated Diseases

Non-Small-Cell Lung Cancer (NSCLC) Pipeline Landscape Report 2024: Comprehensive Insights About 100+ Companies and 120+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
星期三, 三月 6, 2024

This report provides comprehensive insights about 100+ companies and 120+ pipeline drugs in Non-Small-Cell Lung cancer (NSCLC) pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 100+ companies and 120+ pipeline drugs in Non-Small-Cell Lung cancer (NSCLC) pipeline landscape.
  • A detailed picture of the Non-Small-Cell Lung cancer (NSCLC) pipeline landscape is provided which includes the disease overview and Non-Small-Cell Lung cancer (NSCLC) treatment guidelines.
  • The assessment part of the report embraces, in depth Non-Small-Cell Lung cancer (NSCLC) commercial assessment and clinical assessment of the pipeline products under development.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Non-Small-Cell Lung cancer (NSCLC) R&D.