FF21101 / Strategia Therap, Fujifilm Holdings - LARVOL DELTA

Preclinical evaluation of Cadherin 3 (CDH3) -targeted alpha radiopharmaceutical therapy, 225Ac-PPMX-T002 for the treatment of solid cancer (EANM 2024) - P1 | "A phase 1 clinical trial of a radiolabeled anti-CDH3 antibody, yttrium-90 (90Y)-PPMX-T002 (former called FF-21101) has demonstrated the safety profile of the RPT with some early signs of antitumor activity (NCT02454010)1... 225Ac-PPMX-T002 RPT exhibited high anti-tumor efficacy with tolerable toxicity in animal experiments, suggesting the potential human clinical application."

Preclinical • Gastrointestinal Cancer • Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CDH3

Dosimetry of a Novel Indium-Labeled Anti-P-Cadherin Monoclonal Antibody (FF-21101) in Non-Human Primates. (PubMed, Cancers (Basel)) - "FF-21101(In) exhibits favorable biodistribution in cynomolgus macaques and estimated human dosimetric characteristics. Data obtained in this study were used to support the filing of an investigational new drug application with the FDA for a Phase I clinical trial."

Journal • Oncology • CDH3

Phase 1 study of FF-21101(90Y), a radioimmunotherapeutic targeting P-cadherin, in advanced solid tumors (AACR 2017) - "Tumor P-cadherin overexpression provides an attractive target for radioimmunotherapy. FF-21101(111In/90Y) exhibits favorable dosimetry, good tolerability and preliminary evidence of reduction in tumor burden. Pre-treatment tumor P-cadherin expression may be an important biomarker for patient selection."

P1 data • Biosimilar • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Pancreatic Cancer • Sarcoma

A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer (clinicaltrials.gov) - P1 | N=73 | Completed | Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Oct 2021

Trial completion • Trial completion date • Cholangiocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Phase 1 study of FF-21101(90Y), a radioimmunotherapeutic (RIT) targeting P-cadherin, in advanced solid tumors (AACR 2018) - "Tumor P-cadherin overexpression provides an attractive target for RIT. Radiolabeled FF-21101 exhibits favorable dosimetry and biodistribution, good tolerability and preliminary evidence of anti-cancer activity. Pre-treatment tumor P-cadherin expression may be an important biomarker for patient selection."

IO Biomarker • P1 data • Biliary Cancer • Cholangiocarcinoma • Neuroendocrine Tumor • Ovarian Cancer • Pancreatic Cancer • Sarcoma

[VIRTUAL] Phase I expansion study of P-cadherin-targeted 90Y-FF-21101 antibody in advanced chemorefractory colorectal and pancreatic-biliary cancers. (ASCO-GI 2021) - "90Y-FF-21101 administered every 12 wks demonstrated expected toxicities and has been generally well-tolerated, with preliminary evidence of benefit demonstrated in heavily pre-treated pts with advanced CRC. The optimal dose and schedule for this radioimmunotherapeutic will continue to be explored, along with pre-treatment P-cadherin expression as a predictive biomarker for disease response."

IO biomarker • P1 data • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CDH3

A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer (clinicaltrials.gov) - P1; N=73; Active, not recruiting; Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.; Recruiting ➔ Active, not recruiting; N=123 ➔ 73

Enrollment change • Enrollment closed • Cholangiocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

ASCO GI 2021 | 90Y-FF-21101: a P-cadherin-targeting antibody in advanced CRC (VJHemOnc) - "Vivek Subbiah, MD...outlines the results of a Phase I expansion study of 90Y-FF-21101, a P-cadherin targeting monoclonal antibody in advanced chemorefractory colorectal (CRC) and pancreatic-biliary cancers....This novel antibody was well-tolerated and preliminary evidence suggests clinical benefit in heavily pre-treated patients with advanced colorectal cancer."

Interview • Video

Phase 1 Study of P-cadherin-Targeted Radioimmunotherapy with Y-FF-21101 Monoclonal Antibody in Solid Tumors. (PubMed, Clin Cancer Res) - "The favorable safety profile and initial antitumor activity observed for Y-FF-21101 warrant further evaluation of this radioimmunotherapeutic (RIT) approach and provide initial clinical data supporting P-cadherin as a potential target for cancer treatment."

IO Biomarker • Journal • P1 data • Oncology • Ovarian Cancer • Solid Tumor

A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer (clinicaltrials.gov) - P1; N=123; Recruiting; Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.; N=54 ➔ 123

Enrollment change • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Preclinical Characterization of Radioimmunoconjugate In/Y-FF-21101 Against P-cadherin Expressing Tumor in Mouse Xenograft Model and Non-Human Primate. (PubMed, J Nucl Med) - " FF-21101 radioimmunotherapy exhibited high antitumor affinity and antitumor efficacy in mouse xenograft models. Extrapolation of the pharmacokinetics in monkeys to humans suggests the potential for clinical application of FF-21101 for treating P-cadherin expressing tumor."

IO Biomarker • Journal • Preclinical • Oncology

A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.; Trial completion date: Dec 2020 ➔ Dec 2023; Trial primary completion date: Dec 2019 ➔ Dec 2021

Trial completion date • Trial primary completion date

A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.; Trial completion date: Dec 2019 ➔ Dec 2020; Trial primary completion date: May 2019 ➔ Dec 2019

Trial completion date • Trial primary completion date