Where did this news come from?

RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, today announced significant progress in the clinical development of its lead product candidate, RYZ101. RYZ101 is an investigational, targeted radiopharmaceutical drug designed to deliver Actinium-225 (Ac225), a highly potent alpha-emitting radioisotope, to solid tumors expressing the somatostatin receptor (SSTR).

Headlines points for busy people:

— The company is enrolling in ACTION-1 study, a Phase 1b/3 trial of RYZ101, for treatment of neuroendocrine tumors (see details below)

— The RayzeBio received Investigational New Drug Application (IND) clearance from the U.S. Food and Drug Administration (FDA) to investigate RYZ101 for first-line treatment of patients with SSTR+ extensive-stage small cell lung cancer (ES-SCLC) in combination with standard of care.  This is a type of Lung Neuroendocrine Carcinoma. 

— The company say that RYZ101 is positioned to be the first approved Actinium-225 radiopharmaceutical therapy for the industry. 

The Company is enrolling patients in the Phase 1b portion of the ACTION-1 Phase 1b/3 trial of RYZ101 (NCT05477576). Safety, tolerability, and pharmacokinetics of RYZ101 will be evaluated in patients SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who have progressed on Lu-177 labelled somatostatin analogue therapy. Enrollment is progressing as planned and RayzeBio expects to announce data from the trial in 2023.

A statement from the company and leading US nuclear radiologists

“Clinicians and patients are very excited about the mechanism of action of RYZ101 and the advantages it offers. Significant interest is growing to explore Ac225, a highly potent radioisotope, for treatment of solid tumors. We believe RYZ101 has strong scientific rationale for treatment of both GEP-NETs and small cell lung cancer. We are very encouraged with the level of interest we have seen in the program and look forward to reporting results from RYZ101 in due course,” said Susan Moran, M.D., M.S.C.E., Chief Medical Officer of RayzeBio.

“Ac225 has the potential to provided increased efficacy compared to existing beta particle therapy, and we are excited to see the first randomized phase 3 trial evaluating an actinium labeled compound (RYZ101). ACTION-1 will study this treatment in patients with advanced neuroendocrine tumors of the GI tract and pancreas, who have limited effective treatment options. This trial will be the next step forward in improving treatment of these patients,” said Dr. Thomas Hope, M.D., Vice Chair of Clinical Operations and Strategy in the Department of Radiology. Dr. Hope is the chair of the steering committee for the phase 3 portion of ACTION-1 study.

As referenced in another press release issued today, RayzeBio has raised $418 million in equity capital since inception in 2020, including $160 million raised in a Series D financing, to advance targeted radiopharmaceutical therapies for cancer.

Who is RayzeBio?

RayzeBio is a biotechnology company focused on improving outcomes for people with cancer by harnessing the power of targeted radioisotopes. With a focus on clinically validated solid tumor targets, RayzeBio is developing novel drug conjugates to deliver potent therapeutic radioisotopes such as Actinium-225, an alpha-emitter. The company is backed by a syndicate of sophisticated healthcare investors and was established in 2020. For additional information, please visit www.rayzebio.com