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

Additional Clinical Stage Product Candidates (Businesswire) - "...Zura is continuing its evaluation of potential development approaches for torudokimab (ZB‑880) and crebankitug (ZB‑168), informed by current clinical and translational evidence and ongoing assessment of the evolving competitive landscape."

Clinical • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Ulcerative Colitis

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