KUR-503 / Baylor College of Medicine, Athenex - LARVOL DELTA

Athenex Provides Fourth Quarter and Full Year 2022 Financial Results and Business Update (GlobeNewswire) - "Recent FDA-imposed clinical hold of the KUR-501 Investigational New Drug Application (IND) following the death of a young heavily pretreated male patient with R/R HRNB treated at the fifth dose level of 300 million cells/m2 approximately three weeks after CAR-NKT cell therapy product administration....Anticipated Upcoming Milestones: Targeting Phase 1 GINAKIT2 study of KUR-501 reopening mid-2023, pending FDA potentially lifting clinical hold; Phase 1 GINAKIT2 dose escalation study safety and preliminary efficacy data update anticipated in 2H 2023....Next clinical trial data update from the ongoing ANCHOR and ANCHOR2 studies anticipated in 2H 2023....KUR-503: Allogeneic GPC3 CAR-NKT cell therapy for previously treated advanced GPC3-expressing hepatocellular carcinoma...IND application filing for the investigational treatment of adults with previously treated advanced GPC3-expressing hepatocellular carcinoma planned in 2024."

IND • P1 data • Trial suspension • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Leukemia • Liver Cancer • Lymphoma • Neuroblastoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Athenex Provides Second Quarter 2022 Financial Results and Business Update (GlobeNewswire) - "Key Anticipated Milestones: Oral Paclitaxel: Phase 2 data from I-SPY 2 trial evaluating Oral Paclitaxel in combination with dostarlimab in neoadjuvant breast cancer expected in 2H 2022. Regulatory interactions with UK MHRA for Oral Paclitaxel in advanced breast cancer in UK remain on track with responses to questions expected later this quarter. KUR-501: autologous GD2 CAR-NKT cell therapy for relapsed/refractory high-risk neuroblastoma...Next data update from the ongoing GINAKIT2 study expected in 2023. KUR-502: allogeneic CD19 CAR-NKT cell therapy for relapsed/refractory B-cell malignancies. Ongoing multicenter expansion of Phase 1 dose escalation ANCHOR study. Next clinical trial data update from the ongoing ANCHOR study anticipated in 4Q 2022 or 1Q 2023. KUR-503: IND filing for KUR-503 in GPC3-expressing hepatocellular carcinoma planned in 2023."

European regulatory • IND • P1 data • P2 data • Breast Cancer • Diffuse Large B Cell Lymphoma • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Neuroblastoma • Oncology

Athenex Provides First Quarter 2022 Financial Results and Business Update (GlobeNewswire) - "Online presentation of KUR-503 preclinical data, our allogeneic GPC3 CAR-NKT cell program in liver cancer, at the American Society of Clinical Oncology (ASCO) on June 3-7, 2022"

Preclinical • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Athenex Provides Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update (GlobeNewswire) - "Key Anticipated Milestones: Data from I-SPY 2 trial of Oral Paclitaxel in combination with dostarlimab in neoadjuvant breast cancer expected in 2H22; IND filing for KUR-503, our allogeneic CAR-NKT program in liver cancer in 1H23."

IND • P2 data • Breast Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology