FPI-1434 / AstraZeneca - LARVOL DELTA

A Phase 1/2 Study of [225Ac]-FPI-1434 Injection (clinicaltrials.gov) - P1/2 | N=253 | Recruiting | Sponsor: Fusion Pharmaceuticals Inc. | Trial primary completion date: Jun 2024 ➔ Jun 2025

Metastases • Trial primary completion date • Adrenal Cortex Carcinoma • Breast Cancer • Cervical Cancer • Endometrial Cancer • Eye Cancer • Genito-urinary Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Uveal Melanoma

Fusion Pharmaceuticals Announces Clinical Program and Manufacturing Updates (PRNewswire) - P1 | N=253 | NCT03746431 | Sponsor: Fusion Pharmaceuticals Inc. | "Fusion announced today encouraging early findings from Cohort 2 in the ongoing FPI-1434 Phase 1 clinical trial. No dose limiting toxicities (DLTs) were observed to date in the 25 kBq/kg dose cohort. Two out of three patients completed the DLT period, and one pancreatic cancer patient discontinued treatment due to disease progression...One heavily treated patient with Ewing sarcoma showed evidence of anti-tumor activity after a single 25 kBq/kg dose of FPI-1434...The Company plans to complete and further evaluate results from Cohort 2 and hold a Safety Review Committee (SRC) meeting to evaluate the emerging data. Fusion plans to share more details on the data and the FPI-1434 development program in mid-2024."

P1 data • Ewing Sarcoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Sarcoma • Solid Tumor

Fusion Pharmaceuticals Announces Third Quarter 2023 Financial Results and Clinical Program Updates (PRNewswire) - "The Phase 1, multi-center, open-label clinical trial is designed to investigate the safety, tolerability, and pharmacokinetics of FPI-1434 in patients with solid tumors expressing IGF-1R....Fusion 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....R&D Expenses: Research and development expenses for the third quarter of 2023 were $14.6 million, compared to $16.6 million for the same period in 2022. The decrease was primarily due to a decrease in FPI-1966 program-related activities as a result of the Company ceasing clinical development for the program and a decrease in manufacturing-related costs for our Phase 1 clinical trial of FPI-1434, partially offset by program expenses for our Phase 2 clinical trial of FPI-2265."

Commercial • Enrollment status • P1 data • Breast Cancer • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Phase 1/2 Study of [225Ac]-FPI-1434 Injection (clinicaltrials.gov) - P1/2 | N=253 | Recruiting | Sponsor: Fusion Pharmaceuticals Inc. | Trial primary completion date: Jun 2023 ➔ Jun 2024

Metastases • Trial primary completion date • Adrenal Cortex Carcinoma • Breast Cancer • Cervical Cancer • Endometrial Cancer • Eye Cancer • Genito-urinary Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Uveal Melanoma • IGF1 • IGFBP3

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 to Present Interim Data from Phase 1 Trial of FPI-1434 in Patients with Solid Tumors Expressing IGF-1R (PRNewswire) - P1/2 | N=253 | NCT03746431 | Sponsor: Fusion Pharmaceuticals Inc. | "Fusion Pharmaceuticals Inc...announced the presentation of interim data from the dose escalation portion of the Phase 1 trial of [225Ac]-FPI-1434 (FPI-1434) in patients with solid tumors expressing IGF-1R....Pre-administration of cold antibody demonstrated improved tumor uptake while also reducing hematological toxicity observed in the hot only dosing arm. When normalized to 15 kBq/kg, the average lesion absorbed dose and dose/volume in the cold/hot arm were nearly double the level compared to hot only....Two heavily pre-treated patients from the cold/hot dosing arm received three and five cycles of treatment, with both achieving durable stable disease as their best response....Fusion is currently enrolling Cohort 2 in the cold/hot dosing regimen at 25 kBq/kg and expects to report data from this cohort around year-end 2023."

P1 data • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Fusion Pharmaceuticals Announces First Quarter 2023 Financial Results and Clinical Program Updates (PRNewswire) - "FPI-1434...The Company anticipates reporting a clinical data update from the Phase 1 trial in a poster presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting on Tuesday, June 27th from 12:30 – 2:00pm CT, followed by a webcast investor presentation (details to be provided)....Fusion announced that it is discontinuing the Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3. As part of a portfolio prioritization decision to focus resources on the Company's lead program, FPI-2265, and assessment of the relative portfolio value contributions of our clinical assets, Fusion no longer plans to pursue development of FPI-1966."

Discontinued • P1 data • Adrenal Cortex Carcinoma • Bladder Cancer • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Eye Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Liver Cancer • Lung Cancer • Melanoma • Ocular Melanoma • Oncology • Ovarian Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer • Urothelial Cancer • Uterine Cancer • Uveal Melanoma

Fusion Pharmaceuticals Announces Fourth Quarter 2022 Financial Results and Clinical Program Updates (PRNewswire) - "FPI-2265...Fusion plans to expand the Phase 2 program to additional sites and expects to report data on approximately 20 to 30 patients in the first quarter of 2024....FPI-1434...The Company anticipates reporting safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, from the Phase 1 trial in the second quarter of 2023. Fusion continues to anticipate the initiation of a Phase 1 combination trial with FPI-1434 and KEYTRUDA^® (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy."

P1 data • P2 data • Trial status • Breast Cancer • Cervical Cancer • Endometrial Cancer • Eye Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Melanoma • Ocular Melanoma • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Uveal Melanoma

Current and future targeted alpha particle therapies for osteosarcoma: Radium-223, actinium-225, and thorium-227. (PubMed, Front Med (Lausanne)) - P1, P1/2 | "This review will detail experience using the alpha emitter radium-223 (Ra, tradename Xofigo), that targets bone formation, in osteosarcoma, specifically related to patient selection, use of gemcitabine for radio-sensitization, and using denosumab to increasing the osteoblastic phenotype of these cancers. A case of an inoperable left upper lobe vertebral-paraspinal-mediastinal osteoblastic lesion treated successfully with Ra combined with gemcitabine is described. Because not all areas of osteosarcoma lesions are osteoblastic, but nearly all osteosarcoma cells overexpress IGF1R, and some subsets expressing Her-2, the anti-IGF1R antibody FPI-1434 linked to actinium-225 (Ac) or the Her-2 antibody linked to thorium-227 (Th) may become other means to provide targeted alpha particle therapy against osteosarcoma (NCT03746431 and NCT04147819)."

Journal • Review • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • IGF1R

A Phase 1/2 Study of [225Ac]-FPI-1434 Injection (clinicaltrials.gov) - P1/2 | N=227 | Recruiting | Sponsor: Fusion Pharmaceuticals Inc. | Trial primary completion date: Jun 2022 ➔ Jun 2023

Trial primary completion date • Breast Cancer • Endometrial Cancer • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • IGF1 • IGFBP3

Fusion Pharmaceuticals Announces Second Quarter 2022 Financial Results and Clinical Program Updates (PRNewswire) - "FPI-1434: The Company anticipates reporting Phase 1 safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing regimen, in the first half of 2023. Fusion continues to anticipate the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy; FPI-1966: Fusion expects to dose the first patient in the second half of 2022 and plans to provide updated guidance for preliminary pharmacokinetic, imaging and safety data from the first patient cohort following initial experience with patient screening in order to better predict the cadence of patient enrollment."

P1 data • P1/2 data • Trial status • Oncology • Solid Tumor

Fusion Pharmaceuticals Provides Updates on FPI-1434 and FPI-1966 Clinical Programs (PRNewswire) - "Fusion Pharmaceuticals Inc...announced updates on its Phase 1 clinical trial evaluating FPI-1434 as a monotherapy for the treatment of solid tumors expressing IGF-1R and its Phase 1 clinical trial evaluating FPI-1966 for the treatment of solid tumors expressing FGFR3. In the FPI-1434 trial, the Company now expects to report Phase 1 safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing regimen, in the first half of 2023, rather than in the second half of 2022. Fusion is also updating guidance for FPI-1966 and expects to dose the first patient in this study in the second half of 2022, rather than in the second quarter of 2022."

P1 data • Trial status • Oncology • Solid Tumor

"$FUSN FPI-1434 Phase 1 data delayed from 2H'22 to 1H'23. FPI-1966 dosing delayed from Q2 to 2H'22." (@BioStocks)

P1 data

Fusion Pharmaceuticals Presents Imaging Data from Cold Antibody Sub-Study in the Phase 1 Study of FPI-1434 (PRNewswire) - P1 | N=227 | NCT03746431 | Sponsor: Fusion Pharmaceuticals Inc | "Fusion Pharmaceuticals Inc...announced the presentation of imaging data from the 'cold antibody sub-study' evaluating pre-administration of cold antibody (naked antibody without the isotope) prior to administration of the imaging agent (antibody with the isotope) in the Phase 1 study of FPI-1434 for the treatment of solid tumors expressing IGF-1R. ...Imaging data from the study demonstrate a favorable gain in [111In]-FPI-1547 tumor lesion uptake versus normal tissue when FPI-1175 was pre-administered and compared to dosing with FPI-1547 alone. Importantly, sites of improved tumor lesion uptake were independent of anatomic location of disease and included bone, lung, liver, and lymph nodes. Administration of FPI-1547 with and without pre-administration of FPI-1175 was safe without any drug-related Serious Adverse Events or Dose Limiting Toxicities."

P1 data • Oncology • Solid Tumor

FPI-1434: Data from P1 portion of P1/2 trial (NCT03746431) for advanced solid tumors in H2 2022 (Fusion Pharma) - Corporate Presentation: RP2D data from P1 portion of P1/2 trial for advanced solid tumors in H2 2022

P1 data • Trial status • Oncology • Solid Tumor

A Phase 1/2 Study of [225Ac]-FPI-1434 Injection (clinicaltrials.gov) - P1/2; N=227; Recruiting; Sponsor: Fusion Pharmaceuticals Inc.; Phase classification: P1 ➔ P1/2; N=38 ➔ 227; Trial completion date: Dec 2022 ➔ Jun 2026

Clinical • Enrollment change • Phase classification • Trial completion date • Breast Cancer • Endometrial Cancer • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • IGF1 • IGFBP3

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

Fusion Pharmaceuticals Announces Second Quarter 2021 Financial Results and Business Update (Canada Newswire) - “FPI-1966…The Company anticipates initiating the Phase 1 study around the end of 2021 and reporting interim data from the first patient cohort around the end of 2022…R&D Expenses: Research and development expenses for the second quarter of 2021 were $21.1 million, compared to $3.3 million for the same period in 2020. The increase was primarily related to increased platform development and research activities, clinical activities related to the ongoing Phase 1 clinical trial of FPI-1434, asset purchase agreements and preclinical research and manufacturing costs.”

Commercial • New P1 trial • P1 data • Bladder Cancer • Genito-urinary Cancer • Head and Neck Cancer • Oncology

Fusion Pharmaceuticals Announces Preliminary Safety and Dosimetry Results from its Single-Dose Portion of the Phase 1 Study of FPI-1434 (PRNewswire) - "Fusion Pharmaceuticals...announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting. The presentations and posters highlight the potential of Fusion's targeted alpha therapies (TATs) to enable delivery of alpha particle emitting isotopes (225Ac) to targeted tumor cells."

P1 data • Preclinical • Oncology • Solid Tumor

[VIRTUAL] Combination of IGF-1R targeted alpha therapy with Olaparib results in synergistic efficacy against colorectal and lung cancer xenografts. (AACR 2021) - "Olaparib co-dosing enhanced FPI-1434 efficacy which supports consideration of this combination for clinical use. Ineffective single-agent doses, when combined, resulted in synergistic efficacy in both Colo-205 and A549 models suggesting that the mechanism can be applied to multiple cancer types where predisposing mutations in DNA repair are lacking. The strongest combination effect appeared to occur at the low single-agent doses suggesting that PARP inhibition may potentiate efficacy at lower clinical doses of FPI-1434."

Clinical • Late-breaking abstract • Colorectal Cancer • Lung Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • CASP3

Fusion Pharmaceuticals Announces First Quarter 2021 Financial Results and Business Update (PRNewswire) - "'We continue to advance our Phase 1 study of FPI-1434...In anticipation of data and determination of a recommended Phase 2 dose in the first half of 2022, we are amending the study protocol to define tumor-specific cohorts based upon IGF-1R expression and tumor uptake as seen to date in the Phase 1 study...In parallel, we are building a diverse pipeline of alpha-emitting radiopharmaceuticals. We expect to file our investigational new drug (IND) application for FPI-1966 in the second quarter of this year.'"

Clinical protocol • IND • P1 data • Oncology • Solid Tumor

Fusion Pharmaceuticals Announces Clinical Collaboration with Merck to Evaluate Fusion's Targeted Alpha Therapy (TAT) in Combination with Merck's KEYTRUDA (pembrolizumab) in Patients With Solid Tumors Expressing IGF-1R (PRNewswire) - “Fusion Pharmaceuticals Inc…announced that it has entered into a clinical trial collaboration with a subsidiary of Merck (known as MSD outside the U.S. and Canada) to evaluate Fusion's lead candidate, [225Ac]-FPI-1434 (FPI-1434), in combination with Merck's anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab), in patients with solid tumors expressing insulin-like growth factor 1 receptor (IGF-1R)…The planned Phase 1/2 combination trial…expected to initiate approximately six to nine months after achieving the recommended Phase 2 dose in the ongoing Phase 1 study of FPI-1434 monotherapy. Under the terms of the agreement, Fusion will sponsor the study and Merck will supply KEYTRUDA.”

Licensing / partnership • New P1/2 trial • Oncology • Solid Tumor

Fusion Pharmaceuticals Announces Preclinical Combination Data Demonstrating Enhanced Efficacy in Multiple Preclinical Tumor Models (Canada Newswire) - "Product candidate FPI-1434, when administered with olaparib, resulted in enhanced efficacy against colorectal and lung cancer xenografts; Combination of IGF-1R targeted alpha therapy with immune checkpoint inhibitors demonstrated enhanced efficacy in colorectal cancer models."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology

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 Initiates Multi-Dose Portion of Phase 1 Trial of FPI-1434 in Patients with Advanced Solid Tumors (Canada Newswire) - "Fusion Pharmaceuticals...announced that the first patient has been dosed in the multi-dose portion of the Phase 1 study evaluating [225Ac]-FPI-1434 (FPI-1434) in patients with advanced solid tumors. FPI-1434 is a radioimmunoconjugate that utilizes Fusion's proprietary Fast-Clear™ linker to connect a humanized monoclonal antibody targeting the insulin-like growth factor 1 receptor (IGF-1R), with the alpha-emitting isotope actinium-225, creating a targeted alpha therapy (TAT)."

Trial status • Oncology • Solid Tumor