actinium-225 zalsenertant tetraxetan (225Ac-FPI-2059) / 3B Pharma, AstraZeneca - LARVOL DELTA

A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Fusion Pharmaceuticals Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Ewing Sarcoma • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Fusion Pharmaceuticals Reports First Quarter 2024 Financial Results and Announces Clinical Program Updates (Canada Newswire) - "Patient enrollment and dosing is ongoing in the Phase 1, multi-center, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-2059 as well as preliminary anti-tumor activity in participants with NTSR1 expressing advanced metastatic solid tumors....R&D Expenses: Research and development expenses for the first quarter of 2024 were $21.3 million, compared to $15.9 million for the same period in 2023. The increase was primarily due to an increase in FPI-2265 program-related costs for our Phase 2 clinical trial of FPI-2265 in patients with mCRPC, and an increase in manufacturing-related costs."

Commercial • Trial status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

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

NTSR1-targeted alpha therapeutic [Ac-225]-FPI-2059 induces growth inhibition in a preclinical colorectal tumor model (AACR 2023) - "These results demonstrate that targeted delivery of [225Ac]-FPI-2059 to NTSR1 expressing tumors results in significant growth inhibition and enhanced survival, thereby providing promising preclinical evidence to support the clinical development of [225Ac]-FPI-2059."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Fusion Pharmaceuticals Announces Presentation of Preclinical Data Supporting FPI-2059 and Leading Targeted Alpha Therapy Platform at AACR Annual Meeting (PRNewswire) - 'Fusion Pharmaceuticals...announced the presentation of preclinical data that provide further support of its clinical stage FPI-2059, a neurotensin receptor 1 (NTSR1) targeted alpha therapy (TAT), and additional preclinical development programs. The Company presented these data in three poster presentations at the American Association for Cancer Research (AACR) Annual Meeting....Outcomes of the study demonstrate robust FPI-2059 tumor uptake and dose-dependent tumor growth inhibition and therapeutic efficacy in a preclinical colorectal tumor model."

Preclinical • Oncology • Solid Tumor

A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Fusion Pharmaceuticals Inc. | Initiation date: Nov 2022 ➔ Feb 2023

Trial initiation date • Colorectal Cancer • Ewing Sarcoma • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Fusion Pharmaceuticals Announces First Patient Dosed in Phase 1 Study of FPI-2059, a Targeted Alpha Therapy (TAT) for the Treatment of Solid Tumors Expressing NTSR1 (PRNewswire) - "Fusion Pharmaceuticals...announced that the first patient has been dosed in the Phase 1 study evaluating [225Ac]-FPI-2059 (FPI-2059). FPI-2059 is a small molecule targeted alpha therapy (TAT) designed to deliver actinium-225 to tumor sites expressing neurotensin receptor 1 (NTSR1), a protein that is overexpressed in gastrointestinal, prostate, pancreatic ductal adenocarcinoma (PDAC) and multiple other cancers."

Trial status • Ewing Sarcoma • Gastric Cancer • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor

A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Fusion Pharmaceuticals Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Ewing Sarcoma • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Fusion Pharmaceuticals Inc.

New P1 trial • Colorectal Cancer • Ewing Sarcoma • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Fusion Pharmaceuticals Announces FDA Clearance of IND for FPI-2059, an Investigational Small Molecule-Based Radiopharmaceutical Targeting Solid Tumors Expressing NTSR1 (PRNewswire) - "Fusion Pharmaceuticals Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) applications for [225Ac]-FPI-2059 (FPI-2059) and the corresponding imaging analogue [111In]-FPI-2058 (FPI-2058)....Fusion plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing NTSR1, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. The study will prioritize six solid tumor indications, including head and neck squamous cell carcinoma, pancreatic, neuroendocrine prostate, colorectal, gastric and Ewing sarcoma."

IND • Colorectal Cancer • Ewing Sarcoma • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Fusion Pharmaceuticals Announces Third Quarter 2021 Financial Results and Clinical Program Update (PRNewswire) - "FPI-1434 Phase 1 multi-dose data now expected in 2H 2022; [for FPI-1966] Fusion expects to dose the first patient in the first quarter of 2022 and expects interim data from the first patient cohort in the first quarter of 2023. FPI-2059 investigational new drug application (IND) on track for first half 2022."

IND • New P1 trial • P1 data • Oncology • Solid Tumor

"#NTSR1 Targeted #AlphaTherapeutic [#225Ac] #FPI2059 Induces Regression in Preclinical #Colorectal #XenograftModel https://t.co/aAVXN5A4ib" (@1stOncology)

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Solid Tumor

Fusion Pharmaceuticals Announces Presentation of Preclinical Data Supporting its FPI-1966 and FPI-2059 Targeted Alpha Therapies (PRNewswire) - "Fusion Pharmaceuticals...announced the presentation of preclinical data that provide further support of its FPI-1966 and FPI-2059 targeted alpha therapies (TATs) at the 34th Annual European Association of Nuclear Medicine Congress. These data reinforce the clinical dosing regimen of FPI-1966 and highlight the potential of FPI-2059 as an actinium-225 labelled precision medicine targeting NTSR1....We are pleased to be advancing further preclinical studies of FPI-2059 as we approach an investigational new drug (IND) filing in the first half of 2022."

IND • Preclinical • Oncology • Solid Tumor

Fusion Pharmaceuticals Announces Closing of Acquisition of IPN-1087, a Small Molecule Targeting NTSR1, from Ipsen (PRNewswire) - "Fusion Pharmaceuticals...announced it has completed the acquisition of Ipsen's (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087. IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. Fusion intends to use IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1."

M&A • Oncology • Solid Tumor

Fusion Pharmaceuticals Announces Fourth Quarter 2020 Financial Results and Business Update (Canada Newswire) - "Fusion intends to utilize its expertise and IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1. The Company expects to submit an investigational new drug application in the first half of 2022; FPI-1434 Monotherapy: Fusion anticipates reporting Phase 1 multi-dose safety and imaging data, and the recommended Phase 2 dose/schedule, in the first half of 2022; Fusion anticipates the initiation of a Phase 1 combination study with FPI-1434 to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy; FPI-1966: Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 in the second quarter of 2021."

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

Fusion Pharmaceuticals to Expand Pipeline with Acquisition of IPN-1087, a Small Molecule Targeting NTSR1, from Ipsen (Canada Newswire) - "Fusion Pharmaceuticals Inc...announced it has entered into an asset purchase agreement (APA) to acquire Ipsen's (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087. IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. Fusion intends to use IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1....Under the terms of the APA, Fusion will issue to Ipsen 400,000 shares of its common stock upon closing and an additional 200,000 shares upon the achievement of a patent-related milestone."

M&A • Oncology • Solid Tumor