AZD2068 / AstraZeneca - LARVOL DELTA

A First-in-Human Study of the Radiopharmaceutical [225Ac]-FPI-2068 in Patients (pts) with Advanced Solid Tumors (ASTRO 2024) - P1 | "[225Ac]-FPI-2068 (FPI-2068) is an EGFR/c-MET targeting bispecific antibody (FPI-2053) linked to the alpha emitting radioisotope actinium-225 which has shown to have promising efficacy in preclinical tumor models. TBD"

Clinical • Metastases • P1 data • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • MET

A Phase 1, First-in-human, Multicentre, Open-label, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumors (SNMMI 2024) - P1 | "[225Ac]-FPI-2068 is an EGFR/c-MET targeting bispecific antibody (FPI-2053) linked to the alpha emitting radioisotope actinium-225 which has been shown to have promising efficacy in a range of preclinical tumor models. This is a Trial in Progress."

Clinical • Metastases • P1 data • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • MET

A Phase 1, First-in-human, Multicentre, Open-label, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumors (SNMMI 2024) - P1 | "[225Ac]-FPI-2068 is an EGFR/c-MET targeting bispecific antibody (FPI-2053) linked to the alpha emitting radioisotope actinium-225 which has been shown to have promising efficacy in a range of preclinical tumor models. This is a Trial in Progress."

Clinical • Metastases • P1 data • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • MET

A Phase 1, First-in-human, Multicentre, Open-label, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumors (SNMMI 2024) - P1 | "[225Ac]-FPI-2068 is an EGFR/c-MET targeting bispecific antibody (FPI-2053) linked to the alpha emitting radioisotope actinium-225 which has been shown to have promising efficacy in a range of preclinical tumor models. This is a Trial in Progress."

Clinical • Metastases • P1 data • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • MET

A Phase 1, First-in-human, Multicentre, Open-label, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumors (SNMMI 2024) - P1 | "[225Ac]-FPI-2068 is an EGFR/c-MET targeting bispecific antibody (FPI-2053) linked to the alpha emitting radioisotope actinium-225 which has been shown to have promising efficacy in a range of preclinical tumor models. This is a Trial in Progress."

Clinical • Metastases • P1 data • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • MET

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Fusion Pharmaceuticals Inc. | Initiation date: Feb 2024 ➔ Jun 2024

Metastases • Trial initiation date • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Fusion Pharmaceuticals Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=110 | Not yet recruiting | Sponsor: Fusion Pharmaceuticals Inc.

New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Fusion Pharmaceuticals Announces Presentation of Preclinical Data Supporting FPI-2068, a Novel Targeted Alpha Therapy for EGFR-cMET Expressing Cancers (PRNewswire) - "Fusion Pharmaceuticals Inc...today announced the presentation of preclinical data for FPI-2068, a clinical stage bispecific IgG-based targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that co-express EGFR-cMET....The data are being presented in a poster presentation at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held October 11-15 in Boston, Massachusetts....In the preclinical study, FPI-2068 demonstrated anti-tumor efficacy in colorectal and lung tumor xenograft mouse models, and single dose administration of FPI-2068 led to prolonged tumor regression. Further, FPI-2068 caused activation of the DNA damage response (DDR) pathway as well as apoptosis, suggesting an inability of the cellular machinery to repair the DNA damage induced by the alpha radiation, consistent with the proposed primary mechanism of action."

Preclinical • Oncology • Solid Tumor

FPI-2068: A novel anti-EGFR/cMET, alpha-particle emitting, radioimmunoconjugate for cancer therapy. (AACR-NCI-EORTC 2023) - No abstract available

Oncology

Fusion Pharmaceuticals Announces Second Quarter 2023 Financial Results and Clinical Program Updates (Canada Newswire) - "FPI-1434...Fusion has discontinued the hot-only dosing portion of the study and is currently enrolling Cohort 2 in the cold/hot dosing regimen at 25 kBq/kg. The Company expects to report data from this cohort around year-end 2023....Fusion plans to provide guidance on timing for pharmacokinetic, imaging and safety data following early experience with FPI-2059 patient screening and enrollment....Fusion plans to provide additional guidance on timelines for the FPI-2068 program following initial experience with patient screening to better predict the cadence of patient enrollment."

P1 data • P1/2 data • Trial status • Adrenal Cortex Carcinoma • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Eye Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Melanoma • Ocular Melanoma • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Uveal Melanoma

Fusion Pharmaceuticals Announces IND Clearance for FPI-2068, a Jointly Developed Novel Targeted Alpha Therapy (PRNewswire) - "Fusion Pharmaceuticals...announced the clearance of investigational new drug (IND) applications for [225Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [111In]-FPI-2107 (FPI-2107) to the U.S. Food and Drug Administration (FDA). Fusion is jointly developing FPI-2068 with AstraZeneca....under the companies' multi-asset collaboration agreement. FPI-2068 is a targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that express EGFR and cMET...Fusion will be operationally responsible for the Phase 1 study, while AstraZeneca will be responsible for subsequent clinical development."

IND • Oncology • Solid Tumor

"$FUSN $AZN Fusion Pharmaceuticals Announces IND Clearance for FPI-2068, a Jointly Developed Novel Targeted Alpha Therapy https://t.co/KkaGykx5y8" (@stock_titan)

Fusion Pharmaceuticals Reports Progress and Provides Recent Corporate Highlights (Canada Newswire) - "...'we expect to file an investigational new drug application (IND) for FPI-2068, our first novel TAT being developed in collaboration with AstraZeneca, in the first quarter of 2023.'....The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3 is intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Patient enrollment and dosing is ongoing. The first cohort of the Phase 1 portion of this study is designed to evaluate various doses of vofatamb ('cold antibody') to assess the impact of pre-dosing on tumor uptake and will inform the dosing regimen for the remainder of the study. The Company anticipates providing a clinical data update in 2024."

Enrollment status • IND • P1 data • Oncology • Solid Tumor