AMY109 / Roche - LARVOL DELTA

Phase I study of the safety and clinical activity of the interleukin-8 inhibitor AMY109 combined with atezolizumab in patients with advanced solid cancers. (PubMed, J Immunother Cancer) - "With no DLTs, AMY109 plus atezolizumab was well tolerated in patients with advanced solid tumors, with no new safety signals. AMY109 showed a dose-proportional increase in exposure. The PRs in two patients were durable."

IO biomarker • Journal • Metastases • P1 data • Cervical Cancer • Fibrosis • Gastrointestinal Cancer • Hepatology • Immunology • Oncology • Pancreatic Cancer • Solid Tumor • CXCL8

Phase I study of IL-8 inhibitor AMY109 plus atezolizumab (atezo) in patients (pts) with advanced solid tumours (ESMO 2023) - "With no DLTs, AMY109 plus atezo was well tolerated in pts with advanced solid tumours, with no new safety signals. The partial responses were durable."

Clinical • IO biomarker • Metastases • P1 data • Cervical Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CXCL8

Phase 1 study of AMY109, a novel humanized anti-IL-8 monoclonal antibody, in healthy volunteers and patients with endometriosis (WCE 2023) - No abstract available

Clinical • P1 data • Endometriosis • Gynecology • Women's Health • CXCL8

Non-clinical efficacy study of AMY109 (long-acting anti-IL-8 antibody) to develop a new treatment of endometriosis (WCE 2023) - No abstract available

Clinical • Endometriosis • Gynecology • Women's Health • CXCL8

Chugai and Biofourmis Enter into New Partnership Focused on Data-Driven Virtual Care for Endometriosis-Related Pain (PRNewswire) - "Chugai Pharmaceutical Co., Ltd...and Biofourmis...announced that they have entered into a new partnership agreement for the continued development and real-world use of digital solutions to objectively measure pain in patients with endometriosis....Continued development of objective measurement technology for pain associated with endometriosis; Advancing progress on a technology platform for a real-world data driven pain measurement and supporting patient care; Virtual specialty care delivery by Biofourmis for endometriosis patients in the U.S.; Utilization of data collected during research and development and post-marketing of Chugai's investigational product for the treatment of endometriosis pain, AMY109..."

Licensing / partnership • Endometriosis • Women's Health

Chugai’s Anti-IL-8 Recycling Antibody AMY109, Improves Inflammation and Fibrosis in Endometriosis in an Industry-Government-Academia Non-Clinical Study Published in Science Translational Medicine (Chugai Press Release) - "Chugai Pharmaceutical Co., Ltd...announced that AMY109, an anti-IL-8 recycling antibody® under development for the treatment of endometriosis, has been published in the U.S. scientific journal, Science Translational Medicine on February 22, 2023 (local time), with results from nonclinical studies in monkeys showing improvement in inflammation and fibrosis in endometriosis....While the monkey r-ASRM score increased (worsened) in the vehicle group compared to pre-treatment, both the AMY109 low and high-dose groups showed suppression (improvement); Nodular lesion volume increased in the vehicle group compared with baseline, while it decreased in both the AMY109 low and high-dose groups; Pathological fibrosis was not changed in the vehicle group, but was attenuated in the AMY109 low and high-dose groups..."

Preclinical • Endometriosis • Oncology • Women's Health

A long-acting anti-IL-8 antibody improves inflammation and fibrosis in endometriosis. (PubMed, Sci Transl Med) - "In addition, experiments using cells derived from human endometriosis revealed that AMY109 inhibited the recruitment of neutrophils to endometriotic lesions and the production of monocyte chemoattractant protein-1 from neutrophils. Thus, AMY109 may represent a disease-modifying therapy for patients with endometriosis."

Journal • Developmental Disorders • Endometriosis • Fibrosis • Gynecology • Immunology • Inflammation • Pain • Women's Health • CCL2 • CXCL8