Fusion Pharmaceuticals Announces Clinical Program and Manufacturing Updates

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Fusion Pharmaceuticals Announces Clinical Program and Manufacturing Updates

Fusion Pharmaceuticals, a clinical-stage oncology company specializing in next-generation radiopharmaceuticals as precision medicines, shared significant advancements in its FPI-2265 development program, provided updates on FPI-1434 Phase 1 Cohort 2 data, and reported successful production at its proprietary manufacturing facility.

The company, listed on Nasdaq under the symbol FUSN, announced the achievements on January 4, 2024.

FPI-2265 Phase 2/3 Development Plan in mCRPC

Fusion Pharmaceuticals revealed successful alignment with the U.S. Food and Drug Administration (FDA) on a Phase 2/3 protocol for FPI-2265, a targeted alpha therapy (TAT) designed for the treatment of metastatic castration-resistant prostate cancer (mCRPC) patients with progressive disease. The development plan includes a Phase 2 dose optimization lead-in, estimated to complete enrollment by the end of 2024, and a Phase 3 registrational trial set to commence in 2025.

In the Phase 2 portion, FPI-2265’s safety and efficacy across three dosing regimens will be assessed in approximately 60 mCRPC patients. The primary endpoints are safety and the proportion of patients with a ≥50% decline in PSA level. Fusion plans to explore alternate regimens with higher dosing frequency while maintaining the same cumulative dose and total treatment duration. The Phase 3 trial, a registration-enabling global trial, is expected to evaluate the efficacy and safety of FPI-2265 in around 550 mCRPC patients and is scheduled to initiate in 2025.

FPI-1434 Cohort 2 Data & Next Steps

Encouraging findings were reported from Cohort 2 in the ongoing FPI-1434 Phase 1 clinical trial. Notably, no dose-limiting toxicities were observed at the 25 kBq/kg dose level. The data showed a promising safety profile, with evidence of anti-tumor activity observed in a heavily treated patient with Ewing sarcoma. Fusion plans to conduct further evaluations of Cohort 2 results and convene a Safety Review Committee (SRC) meeting to assess emerging data. Additional details on the data and the FPI-1434 development program are expected to be shared in mid-2024.

Manufacturing Facility Update

Fusion announced the completion of validation for its state-of-the-art good manufacturing practice (GMP) manufacturing facility. The facility is now fully operational, with the successful production of the first clinical dose of a TAT. This accomplishment positions Fusion for execution on multiple clinical programs, providing additional capacity and flexibility in manufacturing programs.

The facility, located on the McMaster University campus in Hamilton, Ontario, has clinical and commercial scale manufacturing capabilities. Fusion expects it to produce up to 100,000 doses per year, supporting various programs, including FPI-2265 manufacturing.

Financials

As of September 30, 2023, Fusion’s cash, cash equivalents, and investments on a pro forma basis were approximately $287 million. Subsequent proceeds of approximately $65 million from sales under the at-the-market equity offering program and an expected $15 million drawdown under the existing debt facility enhance the company’s financial position. Fusion anticipates its cash resources will be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2025.

About Fusion Pharmaceuticals

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. The company’s portfolio includes FPI-2265, currently in a Phase 2 trial targeting prostate-specific membrane antigen (PSMA) for metastatic castration-resistant prostate cancer. Fusion’s collaboration with AstraZeneca involves jointly developing novel targeted alpha therapies (TATs) and combination programs, expanding its potential impact in the field.

Forward-Looking Statements: This press release contains forward-looking statements regarding Fusion Pharmaceuticals’ business and financial performance. Actual results may differ materially from these statements due to various factors, as outlined in the Company’s filings with the Securities and Exchange Commission (SEC). Fusion disclaims any obligation to update forward-looking statements.