NBL-015 / CSPC Pharma, Cypherpunk Technologies, NovaRock Biotherapeutics, Leap Therapeutics - LARVOL DELTA

Phase 1/2a Study to Evaluate FL-301 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Flame Biosciences | N=115 ➔ 0 | Trial completion date: Feb 2024 ➔ Jan 2022 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Feb 2024 ➔ Jan 2022

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Evaluation of the Safety and Efficacy of NBL-015 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=410; Not yet recruiting; Sponsor: NovaRock Biotherapeutics, Ltd

Clinical • New P1 trial • Oncology • Solid Tumor • CLDN18

NovaRock Biotherapeutics Announces Exclusive License Agreement and Strategic Partnership with Flame BioSciences (PRNewswire) - "NovaRock Biotherapeutics Limited...announced that they have entered into an exclusive license agreement and strategic partnership with Flame Biosciences....Under the terms of the Agreement, NovaRock has granted Flame Biosciences the exclusive rights to NBL-015 outside of Greater China (including mainland China, Hong Kong, Macau, and Taiwan). Flame shall be responsible for the development, regulatory approval, and commercialization of NBL-015.... The lead product candidates from this collaboration are expected to enter clinical development in late 2023."

Licensing / partnership • New trial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

CSPC’s CDK9 inhibitor and Claudin 18.2 mAb nodded for trials in China and US respectively (GBI Health) - "China-based CSPC Pharmaceutical Group Ltd (01093.HK) announced clinical trial approvals for its CDK9 inhibitor SYHX1903 and Claudin 18.2 monoclonal antibody (mAb) NBL-015 in China and the United States respectively. SYHX1903, a highly selective CDK9 inhibitor, can now enter a clinical study in malignant hematological tumors. NBL-015...can now be assessed in solid tumors in Phase I clinical trials in the US, including for pancreatic cancer and gastroesophageal cancer."

Non-US regulatory • Esophageal Cancer • Gastric Cancer • GastroEsophageal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Pancreatic Cancer

CSPC Pharma’s CLDN18.2 mAb granted additional ODD status in US (GBI Health) - "China-based CSPC Pharmaceutical Group Limited (01093.HK) picked up a second orphan drug designation (ODD) from the US FDA for its in-house developed Claudin18.2 (CLDN18.2) monoclonal antibody (mAb) NBL-015. The indications in question are gastric cancer and gastroesophageal junction cancer."

Orphan drug • Gastric Cancer • GastroEsophageal Cancer • Gastrointestinal Cancer • Oncology