ABY-271 / Affibody - LARVOL DELTA

First-in-Human Safety and Biodistribution Phase 1 Study of [¹⁷⁷Lu]Lu-ABY-271 in Subjects with HER2-Positive Metastatic Breast Cancer (NCT07081555) (SNMMI 2026) - P1 | "Info Purpose/Background: HER2-positive metastatic breast cancer remains a major clinical challenge, as many patients ultimately develop resistance to current therapies, e.g., monoclonal antibodies, tyrosine kinase inhibitors, and antibody-drug conjugates such as trastuzumab deruxtecan. Preclinical dosimetry modelling demonstrated strong concordance with observed normal organ absorbed doses in humans. [177Lu]Lu-ABY-271 was well tolerated and shows promising potential for further clinical development so that the study will be pursued. Additional clinical and dosimetry data will be presented at the conference."

Clinical • First-in-human • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

First-in-Human Safety and Biodistribution Phase 1 Study of [¹⁷⁷Lu]Lu-ABY-271 in Subjects with HER2-Positive Metastatic Breast Cancer (NCT07081555) (SNMMI 2026) - P1 | "Info Purpose/Background: HER2-positive metastatic breast cancer remains a major clinical challenge, as many patients ultimately develop resistance to current therapies, e.g., monoclonal antibodies, tyrosine kinase inhibitors, and antibody-drug conjugates such as trastuzumab deruxtecan. Preclinical dosimetry modelling demonstrated strong concordance with observed normal organ absorbed doses in humans. [177Lu]Lu-ABY-271 was well tolerated and shows promising potential for further clinical development so that the study will be pursued. Additional clinical and dosimetry data will be presented at the conference."

Clinical • First-in-human • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

First-in-Human Safety and Biodistribution Phase 1 Study of [¹⁷⁷Lu]Lu-ABY-271 in Subjects with HER2-Positive Metastatic Breast Cancer (NCT07081555) (SNMMI 2026) - P1 | "Info Purpose/Background: HER2-positive metastatic breast cancer remains a major clinical challenge, as many patients ultimately develop resistance to current therapies, e.g., monoclonal antibodies, tyrosine kinase inhibitors, and antibody-drug conjugates such as trastuzumab deruxtecan. Preclinical dosimetry modelling demonstrated strong concordance with observed normal organ absorbed doses in humans. [177Lu]Lu-ABY-271 was well tolerated and shows promising potential for further clinical development so that the study will be pursued. Additional clinical and dosimetry data will be presented at the conference."

Clinical • First-in-human • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Development of a cGMP-compliant automated synthesis of the radiotherapeutic [ 177 Lu]Lu-ABY-271: Enabling reliable radiolabelling for a first-in-human phase I study (EANM 2025) - P1, P2 | "Conclusion This study presents an automated cGMP-compliant radiolabeling protocol for [ 177 Lu]Lu-ABY-271, the radiosynthesis was established for clinical use in a Phase I trial in HER2 positive metastatic breast cancer patients (NCT07081555). Critical parameters impacting the yield and product stability were determined manually and supported the GMP translation of this protocol."

First-in-human • P1 data • Breast Cancer • Esophageal Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Solid Tumor • HER-2

A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Affibody

New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Theranostic Pair of Affibody Molecules Targeting HER2 Expressing Cancer (SNMMI 2025) - "The theranostic pair targets a different HER2 epitope compared to trastuzumab or pertuzumab, allowing them to be administered concomitantly. Tezatabep matraxetan has demonstrated clinical utility in early trials with breast cancer patients, underscoring the unmet need for improved diagnostics that overcome the limitations of biopsy-based HER2 analysis. In preclinical studies, [177Lu]Lu-ABY-271 demonstrated a favorable biodistribution profile and potent antitumor effect, which was further enhanced when combined with trastuzumab. A first-in-human study of [177Lu]Lu-ABY-271 is currently under way with early results anticipated during 2025."

Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Theranostic Pair of Affibody Molecules Targeting HER2 Expressing Cancer (SNMMI 2025) - "The theranostic pair targets a different HER2 epitope compared to trastuzumab or pertuzumab, allowing them to be administered concomitantly. Tezatabep matraxetan has demonstrated clinical utility in early trials with breast cancer patients, underscoring the unmet need for improved diagnostics that overcome the limitations of biopsy-based HER2 analysis. In preclinical studies, [177Lu]Lu-ABY-271 demonstrated a favorable biodistribution profile and potent antitumor effect, which was further enhanced when combined with trastuzumab. A first-in-human study of [177Lu]Lu-ABY-271 is currently under way with early results anticipated during 2025."

Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2