Immunoglobulin E

VIDEO: AXIM Biotechnologies CEO Presents at Benzinga Virtual Healthcare Summit 2024

Retrieved on:

Wednesday, March 27, 2024

SAN, Research, Allergy, Interview, Telecanthus, FDA, Immunoglobulin E, Lactoferrin, Pharmaceutical industry

SAN DIEGO, CA, March 27, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire –AXIM Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare diagnostic solutions development company, today released a fireside chat interview conducted with its CEO John Huemoeller II and Tony Noto at the 2024 Benzinga Virtual Healthcare Summit. During the presentation, Mr. Huemoeller shares insights into the Company’s work with its two FDA-cleared ophthalmological diagnostic assays currently being marketed to clinicians throughout the country as well as research being conducted in its Parkinson’s diagnostic program.

Key Points:

SAN DIEGO, CA, March 27, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – AXIM Biotechnologies, Inc .
( OTCQB: AXIM ) (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare diagnostic solutions development company, today released a fireside chat interview conducted with its CEO John Huemoeller II and Tony Noto at the 2024 Benzinga Virtual Healthcare Summit .
The presentation can be viewed here: https://aximbiotech.com/presentations/
“We’re in the diagnostic solutions segment using teardrops and have mastered a couple of tests already, Lactoferrin which is for dry eye disease, and IgE which is for allergies,” said John Huemoeller II, CEO of AXIM Biotechnologies during the presentation.
So now that we've been able to master that, it's allowed us to move into other places, such as Parkinson's,” added Huemoeller.

TLI Investigator Dr. Nicholas Jenzjowsky Receives NIH/NIAID Grant to Investigate the Neural Regulation of Asthma

Retrieved on:

Wednesday, March 20, 2024

TLI, Asthma, Research, Hope, Doctor of Philosophy, Allergy, Neuron, Immunoglobulin E, Infection, Pharmaceutical industry

The grant will fund the innovative project "Asthmatic inflammation requires neuronal upregulation of B-cells," which commenced this month and will run until January 2025.

Key Points:

The grant will fund the innovative project "Asthmatic inflammation requires neuronal upregulation of B-cells," which commenced this month and will run until January 2025.
This groundbreaking research aims to delve into the complexities of asthma and its symptoms, a major global health concern that requires a deeper understanding of its underlying mechanisms.
The innovative nature of this project underscores TLI's commitment to cutting-edge science and the potential impact of the research.
It aims to uncover potential drug targets and inform new strategies to mitigate the growing problem of allergic asthma.

Kymera Therapeutics Presents Preclinical Data for STAT6 and TYK2 First-In-Class, Oral Degrader Immunology Programs at the American Academy of Dermatology Annual Meeting

Retrieved on:

Friday, March 8, 2024

WATERTOWN, Mass., March 08, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that its preclinical data demonstrating the therapeutic potential of its potent and selective heterobifunctional degraders of STAT6 (KT-621) and TYK2 (KT-294) are being presented in the poster session at the American Academy of Dermatology’s Annual Meeting in San Diego, California. Kymera’s oral STAT6 and TYK2 degraders have the potential to address multiple immune-mediated diseases and overcome the limitations of existing technologies and agents. Today’s poster presentations mark the first time that data from a STAT6 targeted agent and a TYK2 degrader have been shared at a major medical meeting. Based on the results generated to date, Kymera intends to initiate Phase 1 testing for KT-621 and KT-294 in the in the second half of 2024 and the first half of 2025, respectively. Data from both Phase 1 trials are expected to be reported in 2025.

Key Points:

Kymera’s oral STAT6 and TYK2 degraders have the potential to address multiple immune-mediated diseases and overcome the limitations of existing technologies and agents.
Today’s poster presentations mark the first time that data from a STAT6 targeted agent and a TYK2 degrader have been shared at a major medical meeting.
“Our differentiated strategy to targeted protein degradation has resulted in an industry-leading immunology pipeline of oral degrader medicines, each with the potential to treat multiple complex immuno-inflammatory diseases.
At low daily oral doses, preclinical studies with KT-621 demonstrated near full in vivo STAT6 degradation in disease-relevant tissues that was well-tolerated.

Allakos Presents Preclinical Data Highlighting Inhibition of MRGPRX2-Mediated Mast Cell Activation with AK006 at AAAAI 2024

Retrieved on:

Monday, February 26, 2024

SAN CARLOS, Calif., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (Nasdaq: ALLK), a clinical-stage biotechnology company developing therapeutics that target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases, today announced a poster presentation at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The poster highlights preclinical data detailing AK006’s mechanism of action and ability to reduce MRGPRX2-induced skin inflammation.

Key Points:

The poster highlights preclinical data detailing AK006’s mechanism of action and ability to reduce MRGPRX2-induced skin inflammation.
Inappropriate mast cell activation, via IgE-dependent and IgE-independent pathways, has been implicated in the pathogenesis of multiple inflammatory skin diseases.
IgE-dependent mast cell activation has been identified as a pathogenic driver of chronic spontaneous urticaria and food allergy and agents which target this pathway have demonstrated therapeutic activity.
More recently, mast cell activation through MRGPRX2, an IgE independent mast cell activation pathway, has been implicated in the pathogenesis of chronic spontaneous urticaria, atopic dermatitis and prurigo nodularis.

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

Retrieved on:

Thursday, February 22, 2024

AAAAI, Food allergy, MD, Ara, Physician, Food, Immunoglobulin E, H2, Therapy, Patient, Immunoglobulin G, Asthma, Peanut, Research, American Academy, Pharmaceutical industry

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.

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

Retrieved on:

Tuesday, March 12, 2024

Filtration, Vespula, Toxicity, Histamine, EAACI, Immunotherapy, Asthma, Report, Allergy, Skin, Pregnancy, PR, EEC, MITES, RNA, Criterion, History, CMR, Contraindication, HEP, Draft, Guideline, Patient, Ames test, Diagnosis, Dermatitis, Venom, Literature, Trial of the century, Reproduction, Silicon–germanium, SPT, Food allergy, Cosmetics, EECS, Absorption, Marketing, Safety, Data collection, Directive 2001/83/EC, GMP, ID50, Antibody, Documentation, European, Type IV hypersensitivity, Genotoxicity, Applicant (sketch), Aeroallergen, CHMP, PRIME, Immunoglobulin G, Type, Publication, Biology, Pollen, DNA, Environment, Immune system, Toolbox, NLN, AIT, Atopic dermatitis, Fatality, Chapter, Anaphylaxis, Process validation, ICH, Antigen, Rhinitis, Clinical trial, Erythema, Knowledge, Prescription, Human, Network, Medication, Scope, VIT, ICT, EMA, Collection, Macrophage, Outline, Metabolism, Registry, Inflammation, Immunoglobulin E, Nature, European Pharmacopoeia, Food, Risk, Prevalence, Mastocytosis, Observation, Cytokine, NPP, Patient safety, Disease, Finished, Medical device

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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
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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.
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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.
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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.
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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

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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.
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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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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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Epsilogen and Lonza Announce Successful Large-Scale GMP Manufacturing of MOv18, an IgE Antibody Targeting Ovarian Cancer

Retrieved on:

Tuesday, March 5, 2024

Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, today announced successful completion of Good Manufacturing Practice (“GMP”) manufacturing of MOv18 IgE, Epsilogen’s lead IgE antibody drug candidate.

Key Points:

Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, today announced successful completion of Good Manufacturing Practice (“GMP”) manufacturing of MOv18 IgE, Epsilogen’s lead IgE antibody drug candidate.
Current research and monitoring indicate that this is the first time GMP manufacturing of a therapeutic IgE antibody has been completed at scale.
Epsilogen intends to use this new material for its upcoming Phase Ib study in platinum-resistant ovarian cancer (PROC) patients, scheduled to start later in 2024.
Lonza and Epsilogen have worked together to apply Lonza’s knowledge and experience to MOv18 IgE.

New England Journal of Medicine Publishes Phase III Data Showing Xolair Significantly Reduced Allergic Reactions Across Multiple Foods in People With Food Allergies

Retrieved on:

Sunday, February 25, 2024

Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials.

Key Points:

Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials.
The U.S. Food and Drug Administration (FDA) recently approved the expanded use of Xolair in children and adults with IgE-mediated food allergies based on the OUtMATCH data.
“While allergic reactions to exposures are common and often severe, there have been limited treatment advancements for food allergy.
“The OUtMATCH study demonstrated that anti-IgE therapy increased most patients’ threshold for an allergic reaction.

New England Journal of Medicine publishes Phase III data showing Xolair® (omalizumab) significantly reduced allergic reactions across multiple foods in people with food allergies

Retrieved on:

Sunday, February 25, 2024

Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials4.

Key Points:

Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials4.
The US Food and Drug Administration (FDA) recently approved the expanded use of Xolair in children and adults with IgE-mediated food allergies based on the OUtMATCH data.
"While allergic reactions to exposures are common and often severe, there have been limited treatment advancements for food allergy.
The results of the OUtMATCH study showed that anti-IgE therapy could significantly reduce the occurrence of allergic reactions across multiple foods in the event of an accidental exposure."

Omalizumab Increases the Reaction Threshold for Peanut and Other Common Food Allergies

Retrieved on:

Sunday, February 25, 2024

WASHINGTON, Feb. 25, 2024 /PRNewswire-PRWeb/ -- Sixteen weeks of omalizumab results in a higher tolerated threshold for multiple food allergies according to new research presented today at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting and published in the New England Journal of Medicine.

Key Points:

"Food allergies affect millions of individuals in the U.S., and those impacted face a daily threat of life-threatening reactions.
To remain safe, constant vigilance is required and even then, accidental exposures are very common," said Dr. Robert A.
"The OUtMATCH study demonstrated that omalizumab (Xolair) significantly increased the threshold for reaction in most patients for peanut and the six other foods studied, enough to provide real protection against small, accidental exposures.
As food allergies are common, this study highlights a valuable option for safe and effective food allergy treatment.