225Ac-RYZ801 / PeptiDream, Ablaze Pharma, BMS, RayzeBio - LARVOL DELTA

Glypican-3 as a Theranostic Target in Hepatocellular Carcinoma. (PubMed, J Nucl Med) - "A clinical phase 1 trial with an 225Ac-labeled macrocyclic peptide ([225Ac]Ac-RAYZ-8009, RYZ801) using PET with [68Ga]Ga-RAYZ-8009 (RYZ811) for patient selection is currently ongoing. Furthermore, an 225Ac-labeled GPC3 antibody, BAY 3547926, is undergoing phase 1/2 clinical testing."

First-in-human • IO biomarker • Journal • Fibrosis • Hepatoblastoma • Hepatocellular Cancer • Immunology • Oncology • Solid Tumor • GPC3

A phase I/Ib study of the theranostic pair RYZ811 and RYZ801 to identify and treat patients (pts) with glypican-3-positive (GPC3+) unresectable hepatocellular carcinoma (HCC) (ESMO 2025) - P1 | "Secondary objectives are to assess PK, ADs to organs/tumors and preliminary antitumor activity. Enrollment for part 1 is ongoing in the USA."

Clinical • P1 data • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC (clinicaltrials.gov) - P1/2 | N=590 | Recruiting | Sponsor: RayzeBio, Inc. | Phase classification: P1 ➔ P1/2 | N=70 ➔ 590 | Trial completion date: Jan 2031 ➔ Jun 2031 | Trial primary completion date: Mar 2029 ➔ Jun 2030

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

GPC3-targeted radiopharmaceutical therapy for neuroendocrine prostate cancer (AACR 2024) - "Preclinical in vitro and in vivo data demonstrated the potential of the novel binder as a theranostic agent for the treatment of patients with GPC3+ NEPC."

Gastrointestinal Cancer • Genito-urinary Cancer • Genitourinary Neuroendocrine Carcinoma • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor • GPC3

A phase 1/1b study of the theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) in patients with glypican-3-positive (GPC3+) previously treated unresectable hepatocellular carcinoma. (ASCO-GI 2026) - P1 | "Secondary objectives are to assess PK, ADs to critical organs and tumors, and preliminary antitumor activity. Enrollment for Part 1 is ongoing in the USA."

Clinical • P1 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

Study of the Theranostic Pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to Identify and Treat Subjects with GPC3+ Unresectable HCC (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: RayzeBio, Inc.

New P1 trial • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

Bristol Myers Squibb Completes Acquisition of RayzeBio, Adding Differentiated Actinium-Based Radiopharmaceutical Platform (Businesswire) - "Bristol Myers Squibb...announced today that it has successfully completed its acquisition of RayzeBio, Inc...With the completion of the acquisition, RayzeBio shares have ceased trading on the NASDAQ Global Market and RayzeBio is now a wholly owned subsidiary of Bristol Myers Squibb...This transaction brings a promising pipeline of RPTs to Bristol Myers Squibb, including RayzeBio’s lead program RYZ101 (²²⁵Ac-DOTATATE), which targets somatostatin receptor 2 (SSTR2), over-expressed in GEP-NETs and extensive stage small cell lung cancer (ES-SCLC)...The platform has the potential to be a significant IND engine to generate a number of candidates and comes with a state-of-the-art RPT manufacturing facility, which is expected to begin operating in the first half of 2024....Bristol Myers Squibb’s previously announced tender offer to acquire all of the outstanding shares of RayzeBio common stock for a purchase price of $62.50 per share in..."

Commercial • M&A • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor

Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform with Acquisition of RayzeBio (Businesswire) - "Bristol Myers Squibb...and RayzeBio, Inc...announced a definitive merger agreement under which Bristol Myers Squibb will acquire RayzeBio for $62.50 per share in cash, for a total equity value of approximately $4.1 billion, or $3.6 billion net of estimated cash acquired. The transaction was unanimously approved by both the Bristol Myers Squibb and RayzeBio Boards of Directors....RayzeBio is completing construction of a state-of-the-art in-house manufacturing facility in Indianapolis, Indiana, and GMP drug production is expected to begin in the first half of 2024. The transaction is expected to be treated as a business combination and to be dilutive to Bristol Myers Squibb’s non-GAAP diluted earnings per share by approximately $0.13 in 2024. Bristol Myers Squibb expects to finance the acquisition with primarily new debt issuance."

M&A • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor

RayzeBio to Present at Upcoming Medical Conferences (Businesswire) - "RayzeBio...announced that the Company will be presenting data for its lead clinical program, RYZ101 (Ac225 DOTATATE) at two upcoming medical conferences as well as presentations on preclinical programs."

Clinical data • Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

RayzeBio Nominates Glypican-3 (GPC3) Targeted Radiopharmaceutical Therapy Drug Candidate for Treatment of Liver Cancer (Businesswire) - "RayzeBio, Inc...announced the nomination of a first-in-class novel peptide drug candidate against GPC3....Initial preclinical data will be presented at the EASL Liver Cancer Summit in Estoril, Portugal on April 20, 2023....RayzeBio is advancing the GPC3 drug candidate into IND enabling studies as a targeted radiopharmaceutical therapy and plans to provide additional details on the program’s progress at various scientific meetings throughout the year."

New molecule • Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology

Ablaze Pharmaceuticals Plans Development of Innovative GPC3 Targeted Radiopharmaceutical Therapy for Liver Cancer in Greater China (PRNewswire) - "Ablaze Pharmaceuticals...announced the development plans of a first-in-class novel peptide drug candidate against GPC3. The proprietary GPC3 targeting peptide is being licensed from RayzeBio pursuant to an existing license agreement. Upon in-license of product candidates by Ablaze from RayzeBio, Ablaze will be responsible for clinical development and commercialization of the product in the Greater China region. The strategic collaboration between Ablaze and RayzeBio leverages RayzeBio's strength in TRT discovery and Ablaze's expertise in therapeutic product clinical development and radiopharmaceutical infrastructure in China."

Licensing / partnership • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor