Eosinophil

Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis

Retrieved on: 
Monday, March 11, 2024

The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.

Key Points: 
  • The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.
  • Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab withdrawal-arm and 66.7% for placebo.
  • TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab continuation, 5.5% amlitelimab withdrawal, 20% placebo).
  • Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Press Release: Dupixent® sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation

Retrieved on: 
Friday, February 23, 2024

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).

Key Points: 
  • The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).
  • The target action date for the FDA decision is June 27, 2024.
  • In both trials, Dupixent also rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.
  • Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

Revolo Biotherapeutics Receives Orphan Drug Designation from the U.S. FDA for its First-in-Class Peptide as a Potential Treatment for Eosinophilic Esophagitis

Retrieved on: 
Tuesday, January 30, 2024

Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.

Key Points: 
  • Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.
  • A statistically significant reduction in eosinophils, CD4+, and CD8+ cells from baseline as measured in esophageal tissue by flow cytometry.
  • A statistically significant increase in T regulatory cells in esophageal tissue and B regulatory cells in the blood, respectively.
  • The trial will evaluate higher dose levels of ‘1104 and a longer duration of therapy.

First Patient Dosed in Phase 2 Portion of Aulos Bioscience’s Phase 1/2 Clinical Trial for AU-007, a Computationally Designed IL-2 Antibody for Solid Tumor Cancers

Retrieved on: 
Thursday, January 25, 2024

AU-007 is a human IgG1 monoclonal antibody designed to harness the power of interleukin-2 (IL-2) to eradicate solid tumors, and the first AI-designed human monoclonal antibody to be tested in a clinical trial.

Key Points: 
  • AU-007 is a human IgG1 monoclonal antibody designed to harness the power of interleukin-2 (IL-2) to eradicate solid tumors, and the first AI-designed human monoclonal antibody to be tested in a clinical trial.
  • Phase 1 data demonstrate that AU-007 is currently the only IL-2 agent that can reduce regulatory T cells (Tregs), which suppress the immune system.
  • This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells.
  • To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626 ).

Allakos Announces Phase 2 Lirentelimab Trials in Atopic Dermatitis and Chronic Spontaneous Urticaria Did Not Meet Their Primary Endpoints

Retrieved on: 
Tuesday, January 16, 2024

SAN CARLOS, Calif., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, today announced topline data from its phase 2 clinical trial in patients with atopic dermatitis (ATLAS) and from its Phase 2b clinical trial in patients with chronic spontaneous urticaria (MAVERICK).

Key Points: 
  • In the ATLAS trial, lirentelimab-treated patients’ blood eosinophils decreased by 96% versus placebo-treated patients’ blood eosinophils which decreased by 15%.
  • In the MAVERICK trial, lirentelimab-treated patients’ blood eosinophils decreased by 95% versus placebo-treated patients’ blood eosinophils which increased by 9%.
  • Across both trials safety was similar to previous clinical trials of lirentelimab.
  • In the ATLAS trial, 18.5% of lirentelimab treated patients experienced IRRs versus 6.2% of placebo treated patients.

GSK Enters Agreement to Acquire Aiolos Bio

Retrieved on: 
Tuesday, January 9, 2024

GSK plc (LSE/NYSE: GSK) and Aiolos Bio, Inc. (Aiolos) today announced that they have entered into an agreement under which GSK will acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with certain respiratory and inflammatory conditions, for a $1 billion upfront payment and up to $400 million in certain success-based regulatory milestone payments.

Key Points: 
  • GSK plc (LSE/NYSE: GSK) and Aiolos Bio, Inc. (Aiolos) today announced that they have entered into an agreement under which GSK will acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with certain respiratory and inflammatory conditions, for a $1 billion upfront payment and up to $400 million in certain success-based regulatory milestone payments.
  • AIO-001 was exclusively licensed to Aiolos outside of Greater China by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui).
  • In addition, GSK will also be responsible for success-based milestone payments as well as tiered royalties owed to Hengrui.
  • This transaction is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US.

EsoCap reports positive topline results from ACESO Phase II trial investigating ESO-101 in eosinophilic esophagitis

Retrieved on: 
Tuesday, December 5, 2023

The ACESO study is a randomized, placebo-controlled, double-blind Phase II study to evaluate the efficacy, tolerability and safety of ESO-101 in patients with active eosinophilic esophagitis (EoE).

Key Points: 
  • The ACESO study is a randomized, placebo-controlled, double-blind Phase II study to evaluate the efficacy, tolerability and safety of ESO-101 in patients with active eosinophilic esophagitis (EoE).
  • "The ACESO study represents an important milestone in the development of our unique application platform for the treatment of esophageal diseases.
  • Following the successful results of this Phase II study, we now plan to initiate a Phase III program in eosinophilic esophagitis,” said Isabelle Racamier, CEO of EsoCap.
  • The detailed results from the ACESO study, including secondary endpoint data, will be submitted for presentation at a future scientific conference.

Aulos Bioscience Advances AU-007 to Phase 2 Portion of Phase 1/2 Study Evaluating Computationally Designed IL-2 Antibody for Treatment of Solid Tumors

Retrieved on: 
Monday, December 18, 2023

AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors.

Key Points: 
  • AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors.
  • This is encouraging as the anti-tumor activity has been observed in heavily pre-treated patients whose tumors had progressed through checkpoint inhibitors.
  • Clinical data from the Phase 1/2 study were presented at the 38th Society for Immunotherapy of Cancer (SITC) Annual Meeting in November.
  • Created by Biolojic Design, AU-007 is the first computationally designed monoclonal antibody to be tested in a clinical trial.

Bullous Pemphigoid Drug Pipeline Research Report 2023: Comprehensive Insights on 5+ Companies and 5+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Friday, November 10, 2023

The "Bullous Pemphigoid - Pipeline Insight, 2023" report offers comprehensive insights into the pipeline landscape for Bullous Pemphigoid, a skin disorder.

Key Points: 
  • The "Bullous Pemphigoid - Pipeline Insight, 2023" report offers comprehensive insights into the pipeline landscape for Bullous Pemphigoid, a skin disorder.
  • It covers information about more than 5 companies and over 5 pipeline drugs related to Bullous Pemphigoid.
  • Furthermore, the report offers a comprehensive overview of the current status and growth prospects within the Bullous Pemphigoid pipeline landscape.
  • Overall, this report offers a comprehensive and detailed analysis of the Bullous Pemphigoid pipeline landscape, providing valuable insights into the current status and future prospects of potential treatments for this skin disorder.

New Phase 1 Dose Escalation Data Show Well-Tolerated Safety Profile and Anti-Tumor Activity for Aulos Bioscience’s AU-007 at Society for Immunotherapy of Cancer (SITC) Annual Meeting

Retrieved on: 
Friday, November 3, 2023

The data also demonstrate early evidence of anti-tumor activity in patients with several solid tumor cancer types.

Key Points: 
  • The data also demonstrate early evidence of anti-tumor activity in patients with several solid tumor cancer types.
  • “These encouraging new data support AU-007’s distinct advantages in the IL-2 class,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer .
  • At this point, we are observing the greatest anti-tumor activity in patients with tumors known to be sensitive to immune-modulating drugs.
  • These data support our decision to focus our Phase 2 expansion cohorts in melanoma, renal cell carcinoma and non-small cell lung cancer.