EAACI

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

Retrieved on: 
Tuesday, March 12, 2024

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Key Points: 
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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

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      1.

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

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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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.

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      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.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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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.

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      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.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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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

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      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

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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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
      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      product specific.

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      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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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      7.1.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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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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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      dose finding for the therapeutic allergen could be investigated.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      8.2.1.

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      10.2.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
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      4.

    • Allergol Immunopathol, 1989;

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      17(2):53-65

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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BioCryst Announces Publication of Data from Open-label Extension of the APeX-2 Pivotal Trial of ORLADEYO® (berotralstat)

Retrieved on: 
Tuesday, December 19, 2023

“We are pleased to share long-term efficacy and safety data from APeX-2 as published in JACI: In Practice.

Key Points: 
  • “We are pleased to share long-term efficacy and safety data from APeX-2 as published in JACI: In Practice.
  • These data further illustrate the potential lasting outcomes that can be appreciated by patients who are treated with oral, once-daily ORLADEYO.
  • In part 3 of the study (weeks 49-96), all patients (n=81) were treated with open-label ORLADEYO at 150 mg.
  • JACI: In Practice is an official journal of the American Academy of Allergy, Asthma, and Immunology (AAAAI).

EAACI Pediatric Allergy and Asthma Meeting 2023: Shaping the Future of Pediatric Allergy and Asthma Care

Retrieved on: 
Tuesday, October 17, 2023

ZURICH, Oct. 17, 2023 /PRNewswire/ -- The Organizing Committee is thrilled to announce the eagerly anticipated EAACI Pediatric Allergy and Asthma Meeting (PAAM) 2023, scheduled to take place from 2nd to 4th November 2023.

Key Points: 
  • ZURICH, Oct. 17, 2023 /PRNewswire/ -- The Organizing Committee is thrilled to announce the eagerly anticipated EAACI Pediatric Allergy and Asthma Meeting (PAAM) 2023, scheduled to take place from 2nd to 4th November 2023.
  • This event will bring together esteemed experts from around the world to address the pressing challenges and advancements in the field of pediatric allergy and asthma.
  • Allergy often manifests as a multi-system disorder in children with co-existing conditions such as allergic rhinitis, eczema, and food allergies.
  • These conditions can significantly impact a child's daily life, affecting their school performance, travel, dietary choices, sleep patterns, and social interactions.

EAACI Pediatric Allergy and Asthma Meeting 2023: Shaping the Future of Pediatric Allergy and Asthma Care

Retrieved on: 
Tuesday, October 17, 2023

ZURICH, Oct. 17, 2023 /PRNewswire/ -- The Organizing Committee is thrilled to announce the eagerly anticipated EAACI Pediatric Allergy and Asthma Meeting (PAAM) 2023, scheduled to take place from 2nd to 4th November 2023.

Key Points: 
  • ZURICH, Oct. 17, 2023 /PRNewswire/ -- The Organizing Committee is thrilled to announce the eagerly anticipated EAACI Pediatric Allergy and Asthma Meeting (PAAM) 2023, scheduled to take place from 2nd to 4th November 2023.
  • This event will bring together esteemed experts from around the world to address the pressing challenges and advancements in the field of pediatric allergy and asthma.
  • Allergy often manifests as a multi-system disorder in children with co-existing conditions such as allergic rhinitis, eczema, and food allergies.
  • These conditions can significantly impact a child's daily life, affecting their school performance, travel, dietary choices, sleep patterns, and social interactions.

Novel classification of allergic disorders published by the European Academy of Allergy and Clinical Immunology: SIAF

Retrieved on: 
Tuesday, October 10, 2023

DAVOS, Switzerland, Oct. 10, 2023 /PRNewswire/ -- The revision of the current allergic disease nomenclature based on symptoms and organ dysfunction has been long-awaited at the time of modern patient-tailored treatments and precision medicine. The new classification is based on disease mechanisms, thus facilitating targeted and personalised disease management.

Key Points: 
  • The new classification is based on disease mechanisms, thus facilitating targeted and personalised disease management.
  • The world's key opinion leaders gathered around the initiative of the European Academy of Allergy and Clinical Immunology (EAACI) to present a new classification of allergic disorders based on the mechanisms of diseases.
  • Published online today in Allergy, the position paper reveals the new way allergic diseases are perceived.
  • We expect the new classification to  profoundly change the healthcare professionals' approach to managing allergic diseases since it provides key solutions to a personalised approach.

Novel classification of allergic disorders published by the European Academy of Allergy and Clinical Immunology: SIAF

Retrieved on: 
Tuesday, October 10, 2023

DAVOS, Switzerland, Oct. 10, 2023 /PRNewswire/ -- The revision of the current allergic disease nomenclature based on symptoms and organ dysfunction has been long-awaited at the time of modern patient-tailored treatments and precision medicine. The new classification is based on disease mechanisms, thus facilitating targeted and personalised disease management.

Key Points: 
  • The new classification is based on disease mechanisms, thus facilitating targeted and personalised disease management.
  • The world's key opinion leaders gathered around the initiative of the European Academy of Allergy and Clinical Immunology (EAACI) to present a new classification of allergic disorders based on the mechanisms of diseases.
  • Published online today in Allergy, the position paper reveals the new way allergic diseases are perceived.
  • We expect the new classification to  profoundly change the healthcare professionals' approach to managing allergic diseases since it provides key solutions to a personalised approach.

EAACI International Severe Asthma Forum (ISAF) Hybrid 2023: Advancing Severe Asthma Care

Retrieved on: 
Tuesday, October 3, 2023

This event will unite global experts and emerging professionals to address the challenges of severe asthma and enhance patient care.

Key Points: 
  • This event will unite global experts and emerging professionals to address the challenges of severe asthma and enhance patient care.
  • "We believe that by combining our diverse knowledge and expertise, we can significantly impact on the treatment and management of severe asthma."
  • Patient-Centric Focus: Patient care is a central theme, emphasizing the event's commitment to improving the lives of severe asthma patients.
  • Cutting-Edge Insights: ISAF 2023 will feature plenary talks, workshops, and sessions highlighting the latest severe asthma research and clinical advancements.

Celldex Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, August 8, 2023

HAMPTON, N.J., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.

Key Points: 
  • - Phase 2 CSU enrollment completed; topline data by YE 2023 -
    HAMPTON, N.J., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.
  • In July 2023, Celldex announced that enrollment to the CSU study had been completed.
  • CSU EAACI 2023 Data Summary:
    At EAACI 2023 , data were presented on the complete 24 week experience for all patients.
  • In May 2023, Celldex announced that the first patient had been dosed in the Phase 1 study of CDX-585.

Pharvaris Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, August 7, 2023

Pharvaris anticipates submitting the results of this nonclinical study to the FDA by the end of 2023.

Key Points: 
  • Pharvaris anticipates submitting the results of this nonclinical study to the FDA by the end of 2023.
  • R&D expenses were €14.7 million for the quarter ended June 30, 2023, compared to €13.7 million for the quarter ended June 30, 2022.
  • G&A expenses were €7.8 million for the quarter ended June 30, 2023, compared to €7.7 million for the quarter ended June 30, 2022.
  • Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board.

Intellia Therapeutics Announces Second Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Thursday, August 3, 2023

The Company plans to present additional data from the ATTRv-PN arm of the Phase 1 study by year-end 2023.

Key Points: 
  • The Company plans to present additional data from the ATTRv-PN arm of the Phase 1 study by year-end 2023.
  • Collaboration Revenue: Collaboration revenue decreased by $0.4 million to $13.6 million during the second quarter of 2023, compared to $14.0 million during the second quarter of 2022.
  • G&A Expenses: General and administrative expenses increased by $8.5 million to $30.7 million during the second quarter of 2023, compared to $22.1 million during the second quarter of 2022.
  • Net Loss: The Company’s net loss was $123.7 million for the second quarter of 2023, compared to $100.7 million during the second quarter of 2022.