Investigational Drug
AB248
TrialFetch AI Analysis
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Overview
Etakafusp alfa (AB248) is an investigational immunotherapy developed by Asher Biotherapeutics, designed to selectively activate CD8+ T cells for the treatment of solid tumors. (businesswire.com)
Mechanism of Action
AB248 is engineered by fusing a reduced potency interleukin-2 (IL-2) mutein to an anti-CD8β antibody. This design enables the selective activation of CD8+ T cells, which are crucial for anti-tumor responses, while avoiding activation of natural killer (NK) cells and regulatory T (Treg) cells. This selectivity aims to enhance therapeutic efficacy and reduce potential toxicities associated with broader IL-2 therapies. (businesswire.com)
Clinical Development
AB248 is currently being evaluated in a Phase 1a/1b clinical trial (AB248-101) to assess its safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity, both as a monotherapy and in combination with pembrolizumab, in patients with locally advanced or metastatic solid tumors. (businesswire.com)
Efficacy
Preclinical studies have demonstrated that AB248 promotes significant expansion and phenotypic enhancement of tumor-infiltrating CD8+ T cells, leading to potent anti-tumor activity. (asherbio.com)
Safety
Initial data from the ongoing Phase 1a/1b trial indicate that AB248 is generally well-tolerated, with a safety profile that supports its continued clinical development. (businesswire.com)
Further Reading
- Asher Bio Announces Dosing of First Patient in Phase 1a/1b Clinical Trial of AB248
- Asher Bio Announces Publications in Cancer Discovery Highlighting the Differentiated Profile of AB248
Last updated: Apr 2025
Active trials using AB248
Found 2 active trials using this drug:
TrialFetch AI summary: Adults with extensive-stage SCLC that has progressed after ≥1 prior systemic therapy, including those with controlled brain metastases, receive tarlatamab (DLL3-directed bispecific T‑cell engager) combined with AB248 (CD8-targeted IL‑2 mutein fusion designed to selectively activate CD8+ T cells) to assess safety, dose, and preliminary efficacy. Excludes prior DLL3- or IL‑2/7/15–directed therapies and symptomatic CNS disease.
ClinicalTrials.gov ID: NCT07037758
TrialFetch AI summary: This trial enrolls adults with previously untreated, stage IV NSCLC (squamous or non-squamous, PD-L1 TPS ≥ 1%, no actionable driver mutations) and evaluates combinations of rilvegostomig, a bispecific PD-1/TIGIT inhibitor, with AB248 (a CD8-targeted IL-2 variant) and/or standard therapies including platinum-based chemotherapy and ramucirumab. Patients with prior immunotherapy, actionable genomic alterations, or significant autoimmune disease are excluded.
ClinicalTrials.gov ID: NCT06996782
