Promising Interim Phase 1 Results for ALG.APV-527 in Solid Tumors with 5T4 Antigen

Encouraging interim results have emerged from the Phase 1 clinical trial of ALG.APV-527, a drug developed by Alligator Bioscience AB and Aptevo Therapeutics, targeting solid tumors with the 5T4 antigen. The drug has shown positive drug exposure levels and biological activity, with the trial over 50% enrolled. Notably, patients with heavily pre-treated breast cancer demonstrated clinical activity, with stable disease as the best overall response observed.
The treatment has been well-tolerated, and no maximum tolerated dose has been established as the trial continues to escalate doses. Plasma concentrations of ALG.APV-527 in patients align with the administered dosage, and biomarker analysis confirms the drug's biological activity by showing target expression in tumor biopsies.
Dirk Huebner, MD, Chief Medical Officer at Aptevo, highlighted the ongoing dosing in the fourth cohort and the anticipation of increased clinical activity at higher doses. The trial includes patients with various tumor types, aiming to gain insights for later-stage development. Patient enthusiasm for the study is reflected in a growing waiting list.
Sumeet Ambarkhane, MD, CMO at Alligator Bioscience, expressed excitement over the interim data, emphasizing the potential of ALG.APV-527 as a novel bispecific antibody for multiple indications. The trial design involves six cohorts with a 3+3 structure, assessing ALG.APV-527's safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity.
ALG.APV-527 is a bispecific conditional 4-1BB agonist designed to be active only when bound to both 4-1BB and 5T4, a strategy that could minimize systemic immune activation while promoting tumor-specific immune responses. The drug's preclinical studies, indicating its differentiated design and efficacy, were published in Molecular Cancer Therapeutics.
Alligator Bioscience is a clinical-stage biotech company focused on developing immuno-oncology antibody drugs, with mitazalimab as a key asset. Aptevo Therapeutics is a clinical-stage company developing bispecific immunotherapies to improve cancer treatment outcomes. Both companies are committed to advancing ALG.APV-527's development and look forward to sharing more data later in the year.

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