crebankitug (ZB-168) / Pfizer, Zura Bio - LARVOL DELTA

Zura Bio Announces Two Immunology Abstracts Presented at the World Allergy Congress in Bangkok (Businesswire) - "Zura Bio Limited....today announced two abstracts were accepted and presented at World Allergy Congress (WAC), held December 1 – 3, 2023 in Bangkok, Thailand. The abstracts highlight Zura Bio’s informative research for ZB-168, an anti-IL-7Rα monoclonal antibody with potential across a broad set of indications where the IL-7 or TSLP pathways may be involved, and ZB-880 (torudokimab), a fully human, high affinity monoclonal antibody that neutralizes IL-33 and also has potential for a broad range of indications."

Biomarker • Clinical data • Atopic Dermatitis • Immunology

Zura Bio Reports Third Quarter 2023 Financial Results and Recent Business Highlights (BioSpace) - "ZB-168: Initiate Phase 2 trial of ZB-168, an anti-IL-7Rα inhibitor, in 2024. Pending Phase 2 IL-7R external catalysts in ulcerative colitis, atopic dermatitis and additional TSLP driven catalysts."

New P2 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Zura Bio Enters into Sponsored Research Agreement with Benaroya Research Institute (Businesswire) - "Zura Bio Limited...announced that they have entered into a sponsored research agreement focused on further characterizing the pivotal role of Interleukin-7 receptor alpha (IL-7Rα) in Thymic Stromal Lymphopoietin (TSLP) and Interleukin-7 (IL-7) signaling pathways. Zura Bio is currently advancing ZB-168, a monoclonal antibody targeting IL-7Rα, for the treatment of immune and inflammatory disorders."

Licensing / partnership • Immunology • Metabolic Disorders

Zura Bio Reports Second Quarter 2023 Financial Results and Recent Business Highlights (Businesswire) - "Research and Development (R&D) expenses: R&D expenses were $28.2 million for the second quarter ended June 30, 2023, compared to $0.1 million for the second quarter ended June 30, 2022. The increase was primarily due to expenses related to the acquisition of ZB-106 from Eli Lilly and Company....ZB-106 (tibulizumab): Initiate Phase 2 trials of ZB-106, an anti-IL-17 and anti-BAFF dual antagonist, for the treatment of systemic sclerosis and hidradenitis suppurativa in 2H-2024. ZB-168: Initiate Phase 2 trial of ZB-168, an anti-IL-7Rα inhibitor, in 2024. Pending Phase 2 external catalysts in ulcerative colitis, atopic dermatitis and additional TSLP driven catalysts."

Commercial • New P2 trial • Immunology • Inflammatory Bowel Disease • Systemic Sclerosis • Ulcerative Colitis

Immunomodulatory activity of humanized anti-IL-7R monoclonal antibody RN168 in subjects with type 1 diabetes. (PubMed, JCI Insight) - P1 | "This trial shows that, at dosages of 1-3 mg/kg, RN168 selectively inhibits the survival and activity of memory T cells while preserving naive T cells and Tregs. These immunologic effects may serve to eliminate pathologic T cells in autoimmune diseases."

Clinical • IO Biomarker • Journal • Diabetes • Immune Modulation • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Tetanus • Type 1 Diabetes Mellitus

A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS) (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: Pfizer; Trial completion date: May 2017 ->Jun 2017

Trial completion date • Biosimilar • Immunology • Multiple Sclerosis

Novel Combined Immune Deficiency and Radiation Sensitivity Blended Phenotype in an Adult with Biallelic Variations in ZAP70 and RNF168. (PubMed, Front Immunol) - "Thus, the patient was found to have a novel blended phenotype associated with multilocus genomic variation: i.e., separate and distinct genetic defects. These findings further illustrate the clinical utility of applying genomic testing in patients with primary immunodeficiency diseases."

Journal • Biosimilar • Immunology

Autophagy Regulates Chromatin Ubiquitination in DNA Damage Response through Elimination of SQSTM1/p62. (PubMed) - Mol Cell - "Moreover, nuclear-localized p62 increased the sensitivity of tumor cells to radiation both in vitro and in vivo, and this required its interaction with RNF168. Our findings indicate that autophagy-deficiency-induced p62 accumulation results in inhibition of histone ubiquitination and highlight the complex relationship between autophagy and the DNA damage response."

Journal • Biosimilar

A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Pfizer; Not yet recruiting -> Recruiting

Enrollment open • Biosimilar • Diabetes • Immunology

Model-Based Characterization of the Pharmacokinetics, Target Engagement Biomarkers, and Immunomodulatory Activity of PF-06342674, a Humanized mAb Against IL-7 Receptor-α, in Adults with Type 1 Diabetes. (PubMed, AAPS J) - "The results provide important insight into the mechanism of IL-7Rα blockade and immunomodulatory activity of PF-06342674 and establish a rational framework for dose selection for subsequent clinical trials of PF-06342674. Furthermore, this analysis serves as an example of mechanistic modeling to support dose selection of a drug candidate in the early phases of development."

Biomarker • Clinical • Journal • PK/PD data • IL7