Immunoglobulin G

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

Retrieved on:

Thursday, February 29, 2024

Wistar Institute, SARS-CoV-2, Messenger, FDA, Food, Vaccine, Vaccination, Immunoglobulin G, Bangladesh Technical Education Board, Primate, DNA, Mouse

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

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.

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

Retrieved on:

Tuesday, February 20, 2024

Neonatal Fc receptor, Chronic inflammatory demyelinating polyneuropathy, Autoimmune disease, CIDP, FDA, Food, ECI, PDUFA, Euronext, Risk, Autoantibody, Safety, Immunoglobulin G, Patient, Clinical trial, Biology, Pharmaceutical industry

“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:

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

Retrieved on:

Friday, March 8, 2024

Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, AAN, Myasthenia gravis, Immunoglobulin G, Autoimmunity, Outline, Novel, Pharmacology, BCR, American Academy, Vaccine

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:

Wednesday, March 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.

BeiGene to Present Clinical and Preclinical Data from Broad Portfolio and Pipeline at AACR Annual Meeting 2024

Retrieved on:

Wednesday, March 6, 2024

It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

Key Points:

It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide.
With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations.
We are committed to radically improving access to medicines for far more patients who need them.

Tubulis to Present Preclinical Proof-of-Concept Data for Two Lead ADC Candidates Targeting Solid Tumors at the AACR Annual Meeting 2024

Retrieved on:

Tuesday, March 5, 2024

Both ADC candidates are optimized for long-lasting, durable tumor engagement and minimal off-target toxicity.

Key Points:

Both ADC candidates are optimized for long-lasting, durable tumor engagement and minimal off-target toxicity.
The results we will present at the AACR Annual Meeting will highlight the preclinical differentiation of our two lead candidates, TUB-030 and TUB-040.
The full abstracts will be published on March 22, 2024, in an online-only proceedings supplement to the AACR journal, Cancer Research.
The company will issue a press release detailing the full preclinical data following the presentation at AACR.

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.

Viridian Therapeutics Highlights Recent Progress and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on:

Tuesday, February 27, 2024

Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the fourth quarter and full year ended December 31, 2023.

Key Points:

Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the fourth quarter and full year ended December 31, 2023.
“Throughout 2023, we delivered important clinical results across our TED portfolio, marking significant progress for the company,” said Steve Mahoney, Viridian President and Chief Executive Officer.
Two ongoing registrational Phase 3 clinical trials, THRIVE and THRIVE-2, are continuing to enroll patients with active and chronic TED, respectively.
In October 2023, Viridian unveiled its development of a portfolio of engineered FcRn inhibitors, including VRDN-006 and VRDN-008.