LUND, SWEDEN and SEATTLE, WA - Alligator Bioscience AB (NASDAQ Stockholm: ATORX) and Aptevo Therapeutics Inc . (NASDAQ:APVO) have announced interim data from an ongoing Phase 1 trial for their investigational cancer drug, ALG.APV-527, showing favorable drug exposure and signs of biological activity. The trial targets solid tumors likely to express the tumor antigen 5T4.
The dose-escalation study has enrolled over 50% of its participants, with the drug being well-tolerated thus far, and no maximum tolerated dose has been reached. The trial is continuing to explore higher-dose cohorts. ALG.APV-527 was measurable in all patients, with plasma concentrations aligning with the administered doses. Moreover, biomarker analyses confirmed the expression of the drug's targets, 4-1BB and 5T4, in tumor biopsies, indicating the drug's biological activity.
Notably, two patients with heavily pre-treated breast cancer who are part of the study showed measurable pharmacokinetic and pharmacodynamic responses, with both achieving stable disease as their best overall response. One patient has been on the study for seven months, and the other for over nine months.
Dirk Huebner, MD, Chief Medical Officer at Aptevo, expressed optimism about progressing into higher dose ranges based on preclinical models and the potential for increased signs of clinical activity. The trial includes patients with various tumor types such as breast, pancreatic, non-small cell lung, and colorectal cancers.
Sumeet Ambarkhane, MD, CMO at Alligator Bioscience, highlighted the encouraging findings of target presence in tumor biopsies and the potential of ALG.APV-527 to treat multiple cancer indications. The collaboration between Alligator and Aptevo aims to make a significant impact in cancer treatment.
The Phase 1 trial of ALG.APV-527 is being conducted at up to 10 U.S. sites and includes six cohorts in a 3+3 design, with the drug administered intravenously every two weeks. The trial's objectives are to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of the drug.
ALG.APV-527 is a bispecific antibody designed to stimulate immune cells for tumor control by targeting 4-1BB and 5T4. The drug's differentiated design aims to minimize systemic immune activation while allowing for potent tumor-specific responses.
The interim data is based on a press release statement, and further results are expected in the second half of 2024.
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