On September 13, 2024 Alligator Bioscience AB and Aptevo Therapeutics reported that positive interim data from the dose escalation portion of the companies’ Phase 1 study evaluating ALG.APV-527 will be presented at a poster on Saturday, September 14, 2024, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress, taking place September 13-17, 2024, in Barcelona, Spain (Press release, Alligator Bioscience, SEP 13, 2024, View Source [SID1234646560]).
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Information om presentationen
Posternummer: #668P
Titel: First-in-Human Phase I Dose Escalation Study of ALG.APV-527, a 5T4 Tumor Antigen-Conditional 4-1BB Bispecific Antibody, in Patients with Advanced Solid Tumors, Demonstrates Positive Safety, Signals of Biological Activity and Patients with Lasting Stable Disease
Presentatör: Thomas Marron, MD, PhD
Datum: Lördag, 14 september, 2024
About the study
The Phase 1 study with ALG.APV-527 is an open-label, multicenter study that will include six cohorts in a 3+3 design*. The study will be conducted in adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen, including (but not limited to) non-small cell lung cancer (NSCLC), gastric/gastroesophageal cancer, and head and neck cancer, in up to 10 clinics in the US. ALG.APV-527 will be administered intravenously every two weeks. The study will evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527.
*In a 3+3 design, cohorts of three patients are treated with increasing dose levels. If at least two out of three or six patients suffer a so-called Dose Limiting Toxicity (DLT), the dose escalation is stopped at the current dose level.
About ALG.APV-527
ALG.APV-527 is a bispecific 4-1BB agonist, which is active only upon simultaneous binding to 4-1BB and 5T4. The molecule has the potential to be of clinical utility as 4-1BB has the ability to stimulate the immune cells (anti-tumor-specific T cells) involved in tumor fighting, making 4-1BB a particularly attractive target for cancer immunotherapy. 5T4 is a tumor-associated antigen that is expressed during fetal development but is also overexpressed on a number of solid tumors, including non-small cell lung cancer (NSCLC), breast, head and neck, cervical, renal, gastric, colon and rectal cancers.
Preclinical studies have been published in the peer-reviewed publication Molecular Cancer Therapeutics , a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The study, which highlights the molecule’s differentiated design that minimizes systemic immune activation, while enabling highly effective tumor-specific responses, demonstrates the drug candidate’s potent activity in preclinical models.