RB-164 / CSPC Pharma, Radiance Biopharma - LARVOL DELTA

Evaluation of SYS6005 in Patients With Advanced Malignant Tumor (clinicaltrials.gov) - P1 | N=132 | Recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P1 trial • Hematological Malignancies • Oncology • Solid Tumor

Radiance Announces First Patient Dosing in Phase 1 Clinical Trial of its Next Generation ROR-1 Targeted ADC for Hematologic and Solid Malignancies (GlobeNewswire) - "Radiance Biopharma, Inc...today announced that the first patient in China has been dosed in the Phase 1 clinical trial of RB-164 (SYS6005), a next-generation antibody-drug-conjugate (ADC) targeting ROR-1....The Phase 1 portion of the open label study which will be conducted by Radiance in the U.S., Australia and Europe will evaluate the safety, efficacy and pharmacokinetics (PK) of RB-164 in participants with hematologic cancers such as lymphoma and advanced solid tumors that are associated with high ROR-1 expression."

Trial status • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Radiance Announces FDA Clearance of IND Application for a Phase 1 Clinical Trial of RB-164, an ROR-1 Targeted ADC, for Hematologic and Solid Malignancies (GlobeNewswire) - "Radiance Biopharma...announced that the U.S. Food and Drug Administration ('FDA') has cleared its Investigational New Drug ('IND') application for RB-164, an ROR-1 targeted ADC for hematologic and solid malignancies. The IND supports the initiation of a Phase 1 dose escalation and expansion clinical trial of RB-164 in patients with ROR-1 positive hematologic and solid cancers in the United States of America....The Phase 1 clinical trial is expected to be an open-label, dose escalation and expansion study to evaluate the safety and efficacy of RB-164 in subjects with ROR-1 positive hematologic cancers such as lymphoma, and various solid tumors. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability, and pharmacokinetics as well as anti-tumor activity defined by overall response rate, duration of response, and disease control rate."

IND • New P1 trial • Hematological Malignancies • Solid Tumor

CSPC launches clinical trial of its eighth ADC drug [Google translation] (bydrug.pharmcube.com) - "On February 16, CSPC Pharmaceutical Group registered a ROR1 ADC drug SYS6005 on the CDE Drug Clinical Trial Registration and Information Disclosure Platform website, and initiated a Phase I clinical trial CTR20250511 in patients with various advanced malignant tumors...In the patient exclusion criteria for inclusion, SYS6005 will exclude patients who have participated in other studies involving ROR1-targeted treatment or have previously received MMAE-loaded ADC treatment, indicating that it is an MMAE-loaded ROR ADC drug with a planned clinical dosing cycle of Q3W."

New molecule • New P1 trial • Solid Tumor

Radiance Biopharma Enters Exclusive License For ROR-1 Targeted Antibody Drug Conjugate (GlobeNewswire) - "Radiance Biopharma, Inc...announced that it has entered into an exclusive License agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093) for development and commercialization of RB-164 (SYS6005): a novel clinical stage antibody drug conjugate (ADC) targeting ROR-1. The agreement covers exclusive commercialization rights to RB-164 in the United States of America (USA), Canada, the European Union, the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein, Albania, Montenegro, North Macedonia, Serbia, and Australia. CSPC will retain all rights to SYS6005 in the remaining global markets....Under the terms of the Exclusive License, Radiance will pay CSPC an upfront payment of $15 million, and up to $150 million in potential development and regulatory milestone payments and over $1 Billion in potential commercial milestone payments, as well as potential tiered royalties based on annual net sales."

Licensing / partnership • Oncology