RadioMedix Inc. Announces the Acquisition of its 225Ac-PSMA I&T program, a Targeted Alpha Therapy (TAT) for Metastatic Castration Resistant Prostate Cancer, by Fusion Pharmaceuticals Inc.
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- Published on Thursday, 16 February 2023 11:52
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HOUSTON, TX, USA I February 15, 2023 I RadioMedix, Inc. (“RadioMedix” or “Company”), a clinical-stage radiopharmaceutical company announced the acquisition of it’s 225Ac-PSMA-I&T asset by Fusion Pharmaceuticals. Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. 225Ac-PSMA-I&T is currently being evaluated under a phase 2 physician-sponsored investigational new drug (IND) under the acronym of TATCIST trial. RadioMedix will also provide manufacturing support to Fusion for the TATCIST trial and first pivotal clinical trial to evaluate the safety and efficacy of 225Ac-PSMA-I&T for metastatic castration-resistant prostate cancer (mCRPC). As currently designed, the trial is expected to evaluate approximately 100 patients with four treatment cycles per patient, occurring every eight weeks. Patients are initially dosed at 100 kBq/kg.
According to the World Health Organizations, in 2020, there were 1.41 million cases of prostate cancer. In the US, numbers from the National Cancer Institute and the American Cancer Society, suggest a 1/8 lifetime probability for men with an annual prevalence of 268,400 cases and 34,500 (11%) deaths. Of these, approximately 10–20% of cases progress after androgen deprivation therapy to the more aggressive disease stage of metastatic castration resistant prostate cancer (mCRPC).
“Having treated mCRPC patients for many years, we initiated the TATCIST trial to evaluate TAT in this group of patients with this catastrophic illness,” said Ebrahim Delpassand, M.D., Chairman and CEO of RadioMedix and Medical Director of Excel Diagnostics & Nuclear Oncology Center. “Given Fusion’s radiopharmaceutical development capabilities, leadership in actinium supply, and established infrastructure, this company is in the best position in developing 225Ac radiopharmaceuticals. This was one of our main incentives to partner with Fusion to advance this drug through clinical development in the most time-effective and practical way, so this drug becomes commercially available to patients, as soon as possible”; continued Dr. Delpassand.
“A growing body of clinical data, including more than 250 patients treated in various investigator-sponsored studies as well as preliminary results from the first ten patients in the TATCIST trial, demonstrates the power of targeted alpha therapies in prostate cancer where there is a significant unmet need for patients,” said Fusion President and Chief Business Officer Mohit Rawat. “We are pleased to partner with Dr. Delpassand and RadioMedix to advance this study efficiently through clinical development for the benefit of a growing number of patients who are not adequately treated with currently available therapies.”
RadioMedix, Inc. is a clinical-stage biotechnology company, focused on innovative radiopharmaceuticals for the diagnosis, monitoring, and Targeted Alpha Therapy (TAT) of cancer. The Company has also established facilities including a drug discovery center for the early probe development, a pre-clinical core facility for in vitro and in vivo evaluation of radiopharmaceuticals, and 27,500 SQF cGMP manufacturing and analytical suite for Phase I-III clinical trial, and large-scale post-approval commercial manufacturing, also known as the Spica Center. To learn more, visit www.radiomedix.com
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle-emitting isotopes to various targeting molecules to selectively deliver the alpha-emitting payloads to tumors. Fusion's first program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3, currently in a Phase 1 study; and FPI-2059, a small molecule targeting neurotensin receptor 1, which has received FDA IND clearance and will begin a Phase 1 study. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Response Inhibitors and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion's growing pipeline of TATs, the company has signed strategic agreements for actinium supply with TRIUMF, Niowave, Inc., and BWXT Medical Ltd.