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Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) is a clinical-stage oncology company based in Hamilton, Ontario, Canada, and Boston, focusing on the development of next-generation radioconjugates (RCs) for precision cancer treatments. The company specializes in targeted alpha therapy (TAT), leveraging their unique expertise in linking alpha particle-emitting isotopes to targeting molecules to create highly effective therapeutics.
Fusion’s lead program, FPI-2265, is designed specifically for metastatic castration-resistant prostate cancer (mCRPC). This innovative treatment targets the prostate-specific membrane antigen (PSMA) and is currently undergoing a Phase 2 clinical trial. FPI-2265 aims to improve patient outcomes by delivering a potent radioactive payload directly to cancer cells, minimizing damage to healthy tissues. The recent Phase 2 TATCIST trial results, presented at the AACR Annual Meeting 2024, demonstrated promising clinical activity and safety, with meaningful improvements in secondary endpoints for mCRPC patients.
Fusion’s pipeline includes several other promising candidates, such as FPI-1434, targeting the insulin growth factor 1 receptor (IGF1R), FPI-2059, targeting the neurotensin receptor 1 (NTSR1), and FPI-2068, a bispecific IgG-based RC targeting EGFR-cMET.
The recent acquisition of Fusion by AstraZeneca marks a significant milestone. AstraZeneca will acquire all of Fusion’s outstanding shares for $21.00 per share in cash, plus a non-transferable contingent value right of $3.00 per share, subject to achieving specific regulatory milestones. This acquisition, valued at approximately $2.4 billion, underscores Fusion's pivotal role in pioneering RCs and enhancing AstraZeneca's oncology portfolio.
Fusion operates a state-of-the-art Good Manufacturing Practice (GMP) compliant facility, ensuring the production of clinical doses for its expanding pipeline. The company has strategic actinium supply agreements with Niowave, Inc., and BWXT Medical to meet the growing demand for their therapies.
With a robust pipeline, strategic partnerships, and a strong balance sheet, Fusion is well-positioned to advance their mission of transforming cancer treatment through innovative alpha-emitting radioconjugates.
Fusion Pharmaceuticals Inc. (FUSN) announced Q1 2021 financial results and updates on its clinical pipeline, focusing on FPI-1434's Phase 1 study. The company is amending the study protocol to define tumor-specific cohorts and plans to submit an IND for FPI-1966 soon. Financially, Fusion reported a net loss of $17.5 million, or $0.42 per share, and R&D expenses rose to $10.7 million due to increased clinical activities. Cash reserves at $278.2 million are projected to fund operations until late 2023. COVID-19 caused moderate delays in patient recruitment for clinical trials.
Fusion Pharmaceuticals (Nasdaq: FUSN) announced a collaboration with Merck to assess FPI-1434, its lead radiopharmaceutical candidate, alongside Merck's KEYTRUDA therapy for solid tumors with IGF-1R expression. The collaboration aims to enhance tumor treatment efficacy, capitalizing on promising preclinical data. The Phase 1/2 trial will investigate FPI-1434's safety, tolerability, and pharmacokinetics, expected to start six to nine months after the ongoing Phase 1 study. Fusion will sponsor the study, while Merck will provide KEYTRUDA.
Fusion Pharmaceuticals (Nasdaq: FUSN), a clinical-stage oncology company, will present at the Bloom Burton & Co. Healthcare Investor Conference on April 20, 2021, at 10:30 AM EDT. The presentation will be led by CEO John Valliant, Ph.D. A live webcast will be available on the company’s website, with a replay to be archived for 90 days. Fusion specializes in developing next-generation radiopharmaceuticals for cancer treatment, focusing on its lead program, FPI-1434, currently in Phase 1 trials.
Fusion Pharmaceuticals (Nasdaq: FUSN) presented preclinical data at the 2021 AACR Virtual Annual Meeting, demonstrating enhanced efficacy of its product candidate FPI-1434 in combination therapies for colorectal and lung cancer. Results showed that FPI-1434, combined with olaparib, induced significant cancer cell apoptosis, requiring lower doses for efficacy. Additionally, IGF-1R targeted alpha therapy in combination with immune checkpoint inhibitors resulted in complete tumor eradication and an increase in antigen-specific CD8 positive T cells, highlighting the potential of FPI-1434 in advanced cancer treatment options.
Fusion Pharmaceuticals has successfully acquired Ipsen's intellectual property related to IPN-1087, a small molecule targeting neurotensin receptor 1 (NTSR1), to develop a new alpha-emitting radiopharmaceutical, FPI-2059.
The acquisition involved issuing 600,000 shares of common stock to Ipsen and potential milestone payments up to €67.5 million, plus royalties on future sales. This move signals Fusion's commitment to advancing targeted therapies for various solid tumors and enhancing its oncology pipeline.
Fusion Pharmaceuticals (Nasdaq: FUSN) has appointed Donald A. Bergstrom, M.D., Ph.D., to its Board of Directors. Dr. Bergstrom brings over 15 years of biopharmaceutical experience, currently serving as executive vice president at Relay Therapeutics. His expertise in precision oncology is expected to enhance Fusion's Targeted Alpha Therapies (TAT) platform and clinical pipeline. Dr. Bergstrom's leadership is anticipated to provide crucial strategic guidance during Fusion's growth phase, with the board expanding from eight to nine members.
Fusion Pharmaceuticals (Nasdaq: FUSN) reported financial results for Q4 2020, highlighting a net loss of $13.4 million, or $0.32 per share, an increase from $8.2 million, or $4.25 per share in Q4 2019. The company holds $299.5 million in cash as of December 31, 2020, sufficient to fund operations until 2023. The FPI-1434 Phase 1 study is progressing, with patient dosing ongoing. Recent partnerships with Ipsen and AstraZeneca aim to enhance Fusion’s pipeline of targeted alpha therapies. However, COVID-19 has caused delays in patient recruitment and enrollment.
Fusion Pharmaceuticals (Nasdaq: FUSN) announced an asset purchase agreement to acquire Ipsen's IPN-1087, targeting neurotensin receptor 1 (NTSR1) for creating FPI-2059, an alpha-emitting radiopharmaceutical aimed at solid tumors. The acquisition includes issuing 400,000 shares to Ipsen, with milestones involving additional shares and payments up to €67.5 million. Fusion's CEO highlighted significant potential for FPI-2059 in treating high-unmet need cancers, like colorectal and pancreatic cancers. This transaction aims to diversify and enhance Fusion’s pipeline of targeted alpha therapies.
Fusion Pharmaceuticals has announced an agreement to acquire Ipsen's IPN-1087, a small molecule targeting neurotensin receptor 1 (NTSR1) in solid tumors. This acquisition aims to develop FPI-2059, an alpha-emitting radiopharmaceutical designed to target tumors overexpressing NTSR1. Fusion will issue 400,000 shares to Ipsen upon closing and up to €67.5 million in development milestones. Ipsen will receive royalties on future net sales and further milestone payments totaling €350 million.
The acquisition is set to diversify Fusion's pipeline, potentially advancing treatments for colorectal cancer and pancreatic ductal adenocarcinoma.
Fusion Pharmaceuticals, a clinical-stage oncology firm, will participate in the "Novel Oncology Targets" panel at the Cowen 41st Annual Health Care Conference on March 1, 2021, at 1:20 PM EST. CEO John Valliant will represent the company, showcasing its innovative work in developing next-generation radiopharmaceuticals. Fusion's lead program, FPI-1434, is currently undergoing Phase 1 clinical trials, focusing on targeted therapies for various tumor types using proprietary alpha particle emitting isotopes.
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