AP 402 / AP Biosciences - LARVOL DELTA

AP402, a bispecific antibody targets p95HER2 and CD137, shows a potent antitumor activity in p95HER2-expressing cancers (AACR 2025) - "Due to the lack of extracellular domain, p95HER2 has been recognized as the potential mechanism of trastuzumab-resistance. Nonclinical studies demonstrated that AP402 is efficacious in triggering the effector functions of NK and T cells in vitro and blocking the growth of p95HER2-positive breast and lung tumors in vivo. AP402 was well tolerated in repeat doses up to 100 mg/kg in monkeys."

IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Solid Tumor • TNFRSF9

AP Biosciences Presents Preclinical Data on p95HER/CD137 T-Cell Engager at American Association of Cancer Research Annual Meeting (GlobeNewswire) - "Specificity for p95HER2: AP402 demonstrates high-affinity binding to p95HER2, confirming its selectivity for the truncated isoform over full-length HER2; T-cell Activation: In co-culture assays, AP402 promoted robust IFN-γ secretion from T cells, with activity correlating to p95HER2 expression on target cells. Compared to combination treatments with individual parental antibodies, AP402 showed synergistic T-cell activation; Activation Across Multiple Cell Lines: AP402 induced strong IFN-γ responses in multiple p95HER2-expressing cancer cell lines (e.g., SK-OV-3), demonstrating its potential applicability across tumor types; Efficacy in Cell Line-Derived and Patient-Derived Xenograft Models: In both CDX and p95HER2-positive breast cancer PDX models, AP402 treatment resulted in significant tumor regression."

Preclinical • Breast Cancer • HER2 Positive Breast Cancer

AP Biosciences Doses First Patient in Phase 1/2 Clinical Trials of AP402 for HER2+ Cancer Patients (GlobeNewswire) - "AP Biosciences...today announced that it has dosed the first patient in its Phase 1 study evaluating AP402, a potential first-in-class, next generation T cell engager targeting CD137 and p95HER2 in patients relapsed/refractory to anti-HER2 treatment. The Phase 1 clinical trial, currently taking place in Australia, is designed to evaluate the safety, tolerability, and preliminary efficacy of AP402 in HER2+ patients with advanced solid tumors, including breast cancer. The following dose expansion phase of the study may include clinical sites in Taiwan, South Korea and the United States."

Trial status • Breast Cancer • HER2 Positive Breast Cancer

AP Bioscience to Present New Preclinical Data at American Association of Cancer Research Annual Meeting (GlobeNewswire) - "AP Biosciences...today announced that it will present a preclinical abstract in a poster presentation at the upcoming American Association for Cancer Research (AACR) Association Annual Meeting, taking place in Chicago, IL, April 25- 30, 2025....The data will showcase the potential of AP402, a first-in-class, next generation T cell engager targeting CD137 and p95HER2 in in-vivo and in vitro studies."

Preclinical • Solid Tumor

A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=85 | Recruiting | Sponsor: AP Biosciences Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2026 ➔ Dec 2027 | Initiation date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Solid Tumor