Cytokine

Molecular Templates, Inc. Provides Interim Update

Retrieved on: 
Monday, March 4, 2024
Therapy, Head, Neoplasm, Neck, CLS, AML, Part, TME, Sale, Pembrolizumab, Multiple myeloma, Bristol Myers Squibb, Symantec Endpoint Protection, TPS, Hyponatremia, Cytokine, Hypertension, Tumor microenvironment, Patient, Immunoglobulin A, MD Anderson Cancer Center, Hyperlipidemia, Disease, Biology, HNSCC, Hypercholesterolemia, CPS, PD-L1, Cancer, Pharmaceutical industry

Unique pharmacodynamic effects demonstrating potent Treg clearance and IL-2 increases were observed at the first dose level.

Key Points: 
  • Unique pharmacodynamic effects demonstrating potent Treg clearance and IL-2 increases were observed at the first dose level.
  • MTEM intends to initiate a study of MT-0169 in CD38+ acute leukemias in collaboration with MD Anderson Cancer Center.
  • Additional details on each of these participant’s clinical profile and response to the investigational treatment are provided below.
  • MTEM plans on initiating an investigator sponsored trial with MD Anderson Cancer Center to evaluate MT-0169 in relapsed or refractory CD38+ AML patients.

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

16

Key Points: 
    • 16

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

      17

      Table of contents

      18

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

      19

      1.

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

      14
      15

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

      Page 2/18

      53

      12.

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

      66

      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

      72

      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

      Page 3/18

      88

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

      89

      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

      94

      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

      Page 4/18

      127

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

      128

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

    • 129

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

      130

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

      131

      substantially to the allergen products as discussed above.

    • 1

      156

      ?

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

      157
      158

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

      159
      160
      161

      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

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

      Page 5/18

      162

      ?

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

      163

      4.

    • In any

      199

      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

      Page 6/18

      200

      product specific.

    • 290

      Diagnostic allergen products (Type I allergy)

      291

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

      292

      intracutaneous or provocation testing.

    • 298

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

      Page 9/18

      305
      306

      7.1.

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

      Page 11/18

      377

      8.

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

      378

      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

      376

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

      Page 12/18

      415

      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

      Page 13/18

      454
      455

      8.2.1.

    • 493

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

      Page 15/18

      527

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

    • 540

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

      Page 16/18

      561

      10.2.

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

      Page 17/18

      595

      4.

    • Allergol Immunopathol, 1989;

      602

      17(2):53-65

      603

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

      Page 18/18

Global Psoriatic Arthritis Drug Landscape Research Report 2024: Comprehensive Insights About 20+ Companies and 25+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 6, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Therapy, Acquisition, Arthritis, Psoriasis, Psoriatic arthritis, TEM, Inflammation, Malignancy, News, Atopic dermatitis, Route, Phase II, JAK1, KCNA3, JAK3, Discovery, Cell, Bristol Myers Squibb, Multiple sclerosis, Administration, Cytokine, Rheumatoid arthritis, TYK2, Clinical trial, NDA, Lluís Companys, Immune system, JAK2, Pharmaceutical industry

This report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Psoriatic Arthritis pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Psoriatic Arthritis pipeline landscape.
  • A detailed picture of the Psoriatic Arthritis pipeline landscape is provided which includes the disease overview and Psoriatic Arthritis treatment guidelines.
  • The assessment part of the report embraces, in depth Psoriatic Arthritis commercial assessment and clinical assessment of the pipeline products under development.
  • Psoriatic Arthritis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Bonum Therapeutics to Present Poster on Lead Program at AACR 2024

Retrieved on: 
Tuesday, March 5, 2024
Biotechnology, Health Technology, Pharmaceutical, Health, Therapy, Acquisition, Engineering, IL-12, Doctor of Philosophy, Roche, Safety, AACR, Cell, IL2, Cytokine, Patient, Poster, Biology, TGF, Pharmaceutical industry

Scientists from Bonum will present these data in a poster at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2024, taking place April 5-10 in San Diego, CA.

Key Points: 
  • Scientists from Bonum will present these data in a poster at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2024, taking place April 5-10 in San Diego, CA.
  • The in vivo safety and efficacy data described in the poster demonstrate that this program is suitable for progressing into the clinic.
  • John Mulligan, PhD, Bonum Therapeutics’ CEO, commented, “We are excited with the progress of our lead program, cLAG3-IL2, and are eager to make the first public presentation about the program at AACR.”
    The poster will be available on the Bonum website on the day of the presentation.
  • The merits of the platform were validated by the Roche acquisition of Good Therapeutics and its PD-1-regulated IL-2 program in September 2022.

Obsidian Therapeutics Announces Clinical & Preclinical Presentations at the American Association of Cancer Research Annual Meeting

Retrieved on: 
Tuesday, March 5, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Obsidian, TIL, University, ICI, AACR, Annual general meeting, Safety, MD Anderson Cancer Center, DRD, Therapy, Cytokine, Patient, Pharmaceutical industry

Obsidian Therapeutics, Inc. , a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced presentations reporting initial clinical data from the ongoing first-in-human study of OBX-115 and preclinical data from our cytoDRiVE® platform demonstrating regulatable cytoTIL15 signal transduction in cis and trans, as well as the ability of a single drug-responsive domain (DRD) to coregulate two cytokines, LIGHT and mbIL15, in tumor-infiltrating lymphocytes (TIL) during the American Association of Cancer Research (AACR) Annual Meeting, which will be held April 5-10, 2024 in San Diego, CA.

Key Points: 
  • Obsidian Therapeutics, Inc. , a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced presentations reporting initial clinical data from the ongoing first-in-human study of OBX-115 and preclinical data from our cytoDRiVE® platform demonstrating regulatable cytoTIL15 signal transduction in cis and trans, as well as the ability of a single drug-responsive domain (DRD) to coregulate two cytokines, LIGHT and mbIL15, in tumor-infiltrating lymphocytes (TIL) during the American Association of Cancer Research (AACR) Annual Meeting, which will be held April 5-10, 2024 in San Diego, CA.
  • These data follow the announcement of positive top-line results from the ongoing first-in-human, Phase 1 clinical trial evaluating the safety and efficacy of OBX-115, Obsidian’s lead engineered TIL cell therapy candidate, in patients with metastatic melanoma that has relapsed and/or is refractory to prior immune checkpoint inhibitor (ICI) therapy ( NCT05470283 ).
  • The details of these posters are as follows:
    Presenting Author: Rodabe N Amaria, The University of Texas MD Anderson Cancer Center, Houston, TX

Indapta Therapeutics Receives U.S. FDA Fast Track Designation for Lead Clinical Drug Candidate IDP-023 for Non-Hodgkin’s Lymphoma and Myeloma

Retrieved on: 
Thursday, February 29, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Fast Track, CMV, BLA, Cell, Biologics license application, Cytomegalovirus, Interleukin, Safety, Therapy, Cytokine, Accelerated approval (FDA), Patient, NK, Clinical trial, Multiple myeloma, Rituximab, Lymphoma, Cancer, Priority review, Pharmaceutical industry

Companies granted Fast Track designation may be eligible for more frequent interactions with the FDA, Accelerated Approval and Priority Review, and Rolling Review of a Biologic License Application (BLA).

Key Points: 
  • Companies granted Fast Track designation may be eligible for more frequent interactions with the FDA, Accelerated Approval and Priority Review, and Rolling Review of a Biologic License Application (BLA).
  • “This designation highlights the promise of Indapta’s highly potent NK cell platform and will further accelerate clinical development of our lead drug candidate, IDP-023, for two of the largest unmet needs in B-cell driven blood cancers, non-Hodgkin’s lymphoma and multiple myeloma,” said Dr. Mark Frohlich, CEO of Indapta.
  • Patients being enrolled now in Indapta’s Phase 1 clinical trial are receiving up to three planned doses of IDP-023 with or without interleukin-2.
  • To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors with increased numbers of g-NK cells, with low donor-to-donor variability.

Xencor to Host Webcast to Review Fourth Quarter and Full Year 2023 Financial Results and Provide Vudalimab Clinical Update

Retrieved on: 
Tuesday, February 20, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Cancer, Telephone, Cytokine, Webcast, Antibody

Xencor management will host a webcast and conference call the same day at 4:30 p.m.

Key Points: 
  • Xencor management will host a webcast and conference call the same day at 4:30 p.m.
  • ET (1:30 p.m. PT) to discuss financial results, provide a corporate update and provide a clinical update of vudalimab (PD-1 x CTLA-4) in metastatic castration-resistant prostate cancer (mCRPC).
  • The live webcast may be accessed through “Events & Presentations” in the Investors section of the Company’s website, located at investors.xencor.com .
  • Telephone participants may register to receive a dial-in number and unique passcode that can be used to access the conference call.

Compugen to Present Data Reflecting its Diversified Immuno-Oncology Pipeline at AACR 2024

Retrieved on: 
Wednesday, March 6, 2024
Immunotherapy, AACR, Cytokine, Tumor microenvironment, Abstract, TIGIT, PVRIG, Biology, Compugen, Pharmaceutical industry

HOLON, Israel, March 6, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that it will present data from its differentiated immuno-oncology preclinical and clinical pipeline, in two poster presentations at the American Association for Cancer Research (AACR) annual meeting on April 5-11, 2024, in San Diego, California.

Key Points: 
  • HOLON, Israel, March 6, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that it will present data from its differentiated immuno-oncology preclinical and clinical pipeline, in two poster presentations at the American Association for Cancer Research (AACR) annual meeting on April 5-11, 2024, in San Diego, California.
  • "It is exciting that the progress we have made to potentially address immunotherapy resistance from diverse angles will be reflected at AACR this year," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen.
  • Eran Ophir, Ph.D., Chief Scientific Officer at Compugen, added, "At ACCR we will present data supporting the unique biology of PVRIG suggesting its role in sensitizing tumors to other immune checkpoints TIGIT and PD-(L)1.
  • The data will be published in the online Proceedings supplement to the AACR journal Cancer Research prior to the meeting on Friday, March 22, 2024.

Pusan National University Researchers Reveal How Diabetes Weakens Gum Defense

Retrieved on: 
Friday, February 16, 2024
Diabetes, PD, Translation, Assistant, Type, Blood, Inflammation, South Korea, Cell, Risk, RNA, Cytokine, B cell, Clinical, Patient, NK, Monocyte, Insulin resistance, Pusan National University, Periodontal disease, Research, Vaccine

BUSAN, South Korea, Feb. 16, 2024 /PRNewswire/ -- Periodontitis (PD) is a common complication in individuals with diabetes mellitus (DM). Despite the profound implications for overall health, the complex bidirectional relationship between them lacks a comprehensive understanding so far, leaving the precise nature of their immunological connection inadequately understood. Prior studies focusing on local immune responses in gingival tissue fall short in capturing the systemic immunological relationship.

Key Points: 
  • BUSAN, South Korea, Feb. 16, 2024 /PRNewswire/ -- Periodontitis (PD) is a common complication in individuals with diabetes mellitus (DM).
  • In an innovative study, researchers from the Republic of Korea have investigated the relationship between periodontitis (PD) and diabetes mellitus (DM).
  • Led by Assistant Professor Yun Hak Kim from Pusan National University, the study employs pioneering single-cell RNA analysis and digs into the immune dynamics at the cellular level.
  • In conclusion, this groundbreaking research provides a first-of-its-kind immunological explanation for the complex association between periodontitis and type 2 diabetes mellitus.

Shamir Medical Center Reveals New Long-Term Results from Long COVID Study to Highlight Positive Impact on Symptoms Resulting from Hyperbaric Oxygen Therapy

Retrieved on: 
Thursday, February 15, 2024
Regeneration, Metabolism, Research, Randomized controlled trial, Tel Aviv University, Inflammation, Hyperbaric medicine, Quality of life, Neuron, Sleep, Psychiatry, Thrombosis, Shamir Medical Center, Cytokine, Fatigue, COVID, Patient, Gene, HBOT, Tissue, Pressure, Pharmaceutical industry

In a previous randomized controlled trial, significant improvements in cognitive, psychiatric, fatigue, sleep, and pain symptoms among long COVID patients who underwent a unique protocol of hyperbaric oxygen therapy were documented.

Key Points: 
  • In a previous randomized controlled trial, significant improvements in cognitive, psychiatric, fatigue, sleep, and pain symptoms among long COVID patients who underwent a unique protocol of hyperbaric oxygen therapy were documented.
  • This longitudinal follow-up included 31 patients from the original study, who were treated with 40 daily sessions of HBOT.
  • The results indicate HBOT can improve the quality of life, quality of sleep, psychiatric and pain symptoms of patients suffering from long COVID.
  • By delivering high oxygen concentrations, HBOT can enhance oxygen delivery to tissues, resulting in recovery of injured tissues permanent improvement.