Entry ID | 609 |
INN | None |
Status | Clinical |
Drug code(s) | ES102, INBRX-106 |
Brand name | None |
mAb sequence source | mAb humanized |
General Molecular Category | Naked monospecific |
Format, general category | Fragment-Fc |
Format details | (VHH-VHH-VHH)2-Fc |
Isotype (Fc) | IgG1 |
Light chain isotype | None |
Linker | None |
Ave. DAR | None |
Conjugated/fused moiety | None |
Discovery method/technology | None |
Target(s) | OX40 |
Indications of clinical studies | Non-small cell lung cancer, Head and neck cancer, solid tumors |
Primary therapeutic area | Cancer |
Most advanced stage of development (global) | Phase 2/3 |
Status | Active |
Start of clinical phase (IND filing or first Phase 1) | December 12, 2019 |
Start of Phase 2 | |
Start of Phase 3 | May 14, 2024 |
Date BLA/NDA submitted to FDA | |
Year of first approval (global) | None |
Date of first US approval | |
INN, US product name | None |
US or EU approved indications | None |
Company | Inhibrx Biosciences Inc. |
Licensee/Partner | Elpiscience Biopharma Ltd. |
Comments about company or candidate | NCT06623136 Phase 2 in NSCLC due to start in Oct 2024. NCT06295731 Phase 2/3 in head and neck cancer started in May 2024 Jan 2024: all non-101 assets and liabilities, including INBRX-105, INBRX-106, INBRX-109, Inhibrx's non-101 discovery pipeline and its corporate infrastructure, will be spun out from the Company into a new publicly traded company, Inhibrx Biosciences, Inc. Aug 2023 Inhibrx presentation: Promising clinical activity in ongoing phase 1/2; Randomized, Phase 2 study in CPI r/r NSCLCSA and in combo with IO; update in Q4 ’23 with data expected 2H ‘24. https://inhibrx.com/wp-content/uploads/2023/08/Inhibrx-Presentation-August-2023.pdf NCT04991506 Phase 1 started in Oct 2021 still recruiting as of last update in Dec 2022. NCT04730843 Phase 1 in solid tumors started in March 2021. Elpiscience has in-licensed ES102/ INBRX-106 from Inhibrx, and possesses greater China rights. ES102 has shown impressive monotherapy efficacy in pre-clinical animal models and has the potential to translate clinically. ES102 is currently being evaluated in dose escalation study in the US, while Elpiscience also received IND approval from CDE in August 2020. NCT04198766 Phase 1 started recruiting in Dec 2019; changed to Phase 1/2 as per title: An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors. |
Full address of company | La Jolla, CA 92037 North America United States of America https://inhibrx.com/ |
Immune check point target. Hexavalent OX40 agonist antibody. Wild type IgG1 Fc.
Anticipated events | None |
Factor(s) contributing to discontinuation | None |