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Fusion Pharmaceuticals to Acquire Prostate Cancer Radiopharmaceutical Program From RadioMedix

NEW YORK – Fusion Pharmaceuticals said on Monday that it will acquire a Phase II targeted radiopharmaceutical program from RadioMedix.

In the deal, Fusion will own the investigational new drug application for 225Ac-PSMA I&T, a prostate-specific membrane antigen-targeted alpha-emitting radiotherapy, which RadioMedix has been studying as a treatment for metastatic castration-resistant prostate cancer (mCRPC). Fusion will rename the agent FPI-2265.

In the Phase II trial underway, dubbed TATCIST, researchers are assessing 225Ac-PSMA I&T in 100 mCRPC patients whose tumors express PSMA as determined by Novartis' PET imaging agent Locametz (68Ga-PSMA-11). Patients are eligible regardless of whether they've received prior treatment with Novartis' targeted radiopharmaceutical Pluvicto (177Lu-PSMA-617). Fusion will open additional trial sites and report initial data from TATCIST during Q1 2024.

In addition to exploring the potential of actinium-based therapies with this latest deal, Fusion is conducting clinical trials for alpha-emitting radiopharmaceuticals, which it calls targeted alpha therapies or TATs, in advanced solid tumors expressing FGFR3 or NTSR1, among other settings.

"Fusion has recognized the potential opportunity for actinium-based therapies to address unmet needs in cancer given the power and potency of alpha radiation," Fusion CEO John Valliant said in a statement. "We believe that with Fusion's TAT development expertise and early investments that provide us with our actinium supply advantage, we are uniquely positioned to be first-to-market with an actinium-based PSMA agent."

In tandem with the closing of the RadioMedix deal, Fusion said it will sell approximately 17.6 million of its common shares at $3.40 per share to institutional investors through a private placement. The offering is expected to raise about $60 million for Fusion minus placement agent fees and other expenses. Fusion expects to have $248 million in cash and cash equivalents once the deal closes on Feb. 16. The Hamilton, Canada- and Boston-based firm said the available funds will cover operational costs and capital expenditures through the first quarter of 2025.

Avidity Partners, Federated Hermes Kaufmann Funds, Invus, Perceptive Advisors, and Woodline Master Fund LP are participating as new and existing investors. Morgan Stanley and Jefferies are the co-placement agents for the offering.