On November 7, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the third quarter ended September 30, 2023 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, NOV 7, 2023, View Source [SID1234637136]).
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Chief Executive Officer John Valliant, Ph.D., commented, "In 2023, Fusion has focused on transitioning to a later stage company leading the development of next-generation radiopharmaceuticals that leverage the potency and precision of alpha-emitting particles. We believe in the potential of our diversified pipeline of targeted alpha therapy (TAT) programs, our AstraZeneca collaboration, multiple actinium supply partnerships and our proprietary, state-of-the-art radiopharmaceutical manufacturing facility to produce innovative therapies for patients with multiple cancer types and create significant value.
Dr. Valliant continued, "In the third quarter, we advanced patient enrollment in our Phase 2 clinical trial of FPI-2265, a small molecule-based TAT targeting prostate specific membrane antigen (PSMA) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) which is positioned to be the first actinium-based PSMA TAT to market. We are on track to report data on approximately 20 to 30 patients in the first quarter of 2024. Following encouraging recently reported data and continued momentum in the PSMA-targeted radiopharmaceuticals space, we are increasingly excited about the substantial market and patient need that FPI-2265 could address. We are also on track to share data from the second cohort in our Phase 1 study of FPI-1434 in patients with solid tumors expressing IGF-1R around the end of this year. In addition, we were pleased to share preclinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on FPI-2068, a jointly developed TAT with AstraZeneca targeting solid tumors expressing EGFR-cMET, which showed anti-tumor efficacy and confirmatory evidence of FPI-2068’s mechanism of action. These data were the basis for our investigational new drug (IND) clearance earlier this year, and we look forward to progressing the program into the previously announced Phase 1 clinical study.
"Finally, with manufacturing and supply chain expertise as a core foundation of Fusion, we are pleased with the progress in validation of our proprietary GMP radiopharmaceutical manufacturing facility, which we expect will be capable of producing up to 100,000 doses of drug per year. We look forward to beginning to produce clinical doses early in 2024 and are confident in the diversified supply chain we have invested in which supports our ability to deliver therapies to patients in need."
Portfolio Update
FPI-2265
In February 2023, Fusion acquired an IND for an ongoing Phase 2 clinical trial (the "TATCIST" trial) evaluating 225Ac-PSMA I&T, a small molecule targeting PSMA expressed on prostate cancers. The alpha-emitting radiopharmaceutical being evaluated in the TATCIST trial is now known as FPI-2265.
The TATCIST trial is designed to evaluate patients with mCRPC with progressive disease, including patients who are naïve to PSMA-targeted radiopharmaceuticals and those who have been pre-treated with 177Lu-based PSMA radiopharmaceuticals such as PLUVICTO. Fusion expects to report data on approximately 20 to 30 patients in the first quarter of 2024 including safety and efficacy results (PSA50 responses, ORR, and rPFS).
FPI-1434
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. The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose. Interim Phase 1 data were presented at the SNMMI Annual Meeting in June 2023. Three patients were dosed in Cohort 1 at a dose of 15 kBq/kg following pre-administration of cold antibody. In this first cohort, cold/hot dosing was observed to be safe with no treatment-related serious adverse events (SAEs) or dose limiting toxicities (DLTs). Results demonstrated pre-administration of cold antibody improved tumor uptake while also reducing hematological toxicity observed in the hot only dosing arm, potentially enhancing the therapeutic index. 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. Further, the 15 kBq/kg cold/hot dosing arm showed comparable systemic exposure to approximately 40 kBq/kg of a hot only dose but with an improved hematological profile as measured by changes in platelet count.
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.
FPI-2059
The Phase 1, multi-center, open-label clinical trial is 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. Patient enrollment and dosing are ongoing. Fusion plans to provide guidance on timing for pharmacokinetic, imaging and safety data following early experience with FPI-2059 patient screening and enrollment.
FPI-2068
Fusion announced FDA clearance of IND applications for [225Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [111In]-FPI-2107 (FPI-2107). Fusion is jointly developing FPI-2068 with AstraZeneca under the companies’ multi-asset collaboration agreement. FPI-2068 is a bispecific IgG-based TAT designed to deliver actinium-225 to various solid tumors that express EGFR and cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.
Recent News
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In October, Fusion announced the appointment of Jeremy Bender, Ph.D., M.B.A., Teresa Bitetti, M.B.A. and David Meek to its Board of Directors.
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In October, Fusion presented preclinical data on FPI-2068 at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held October 11-15 in Boston.
Third Quarter 2023 Financial Results
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Cash and Investments: As of September 30, 2023, Fusion held cash, cash equivalents and investments of $207.3 million, compared to cash, cash equivalents and investments of $186.6 million as of December 31, 2022. Fusion expects its existing cash, cash equivalents and investments as of September 30, 2023 will be sufficient to fund operations into the second quarter of 2025.
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Collaboration Revenue: For the third quarter of 2023, Fusion recorded $2.0 million of revenue under the AstraZeneca collaboration agreement, compared to $0.2 million for the same period in 2022.
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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.
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G&A Expenses: General and administrative expenses for the third quarter of 2023 were $6.8 million, compared to $7.4 million for the same period in 2022. The decrease was primarily due to a decrease in corporate and patent related legal expenses.
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Net Loss: For the third quarter of 2023, Fusion reported a net loss of $17.3 million, or $0.25 per share, compared with a net loss of $24.0 million, or $0.55 per share, for the same period in 2022.