efineptakin alfa

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Ligands
efineptakin alfa

GtoPdb Ligand ID: 11097

Comment: Efineptakin alfa is a long-acting immunoglobulin (Ig) fusion protein composed of recombinant human IL-7 fused to a hybrid Fc (hyFc) region of a human antibody. It comprises two disulphide bond-linked peptide chains. Efineptakin alfa has hematopoietic and immunopotentiating activities. In the oncology setting IL-7 enhances T-cell-mediated anti-tumour immune responses. Efineptakin alfa is being developed by Genexine (in-licensed to I-MAB Biopharma) and NeoImmuneTech. The peptide sequence of efineptakin alfa is claimed in Genexine's patent WO2016200219A1 as sequence 24 and would appear to be referred to as MGM-IL-7-hyFc therein [3].

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Summary of Clinical Use
Efineptakin alfa has advanced to early stage clinical trials in advanced cancers; for example, in combination with chemoradiotherapy (in glioma) and checkpoint inhibitors (in melanoma and triple negative breast cancer). Preclinical investigations are ongoing as a monotherapy, and as a combination strategy in additional cancer types and immunology-focused indications. Click here to link to ClinicalTrials.gov's full list of efineptakin alfa trials. Both the EMA and FDA have granted orphan drug designation status to efineptakin alfa (designated as rhIL-7-hyFc) as a treatment for idiopathic CD4⁺ lymphocytopenia (in 2017 [1] and 2019 [2] respectively).

Summary of Clinical Use

Efineptakin alfa has advanced to early stage clinical trials in advanced cancers; for example, in combination with chemoradiotherapy (in glioma) and checkpoint inhibitors (in melanoma and triple negative breast cancer). Preclinical investigations are ongoing as a monotherapy, and as a combination strategy in additional cancer types and immunology-focused indications. Click here to link to ClinicalTrials.gov's full list of efineptakin alfa trials. Both the EMA and FDA have granted orphan drug designation status to efineptakin alfa (designated as rhIL-7-hyFc) as a treatment for idiopathic CD4⁺ lymphocytopenia (in 2017 [1] and 2019 [2] respectively).

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT02860715	Clinical Trial of GX-I7 in Healthy Volunteers	Phase 1 Interventional	Genexine, Inc.
NCT04332653	NT-I7 (Hyleukin-7) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors	Phase 1/Phase 2 Interventional	NeoImmuneTech
NCT03901573	High-Risk Skin Cancers With Atezolizumab Plus NT-I7	Phase 1/Phase 2 Interventional	NeoImmuneTech