BC3402 / Wuxi Biocity - LARVOL DELTA

An Open-Label, Multicenter, Phase Ib Study of the Anti-TIM3 Monoclonal Antibody BC3402 in Combination with Azacitidine in Patients with Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) (ASH 2024) - P1b | "Given the CR rate of ~16% with AZA monotherapy in this patient population, the current data supports further evaluation of BC3402 in combination with AZA for pts with treatment naïve MDS and CMML. Clinical trial information : NCT05970822."

Clinical • Combination therapy • P1 data • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Oncology • Solid Tumor • CD4 • CD8 • HAVCR2 • IFNG

A phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BC3402 in advanced solid malignancies (AACR 2024) - "BC3402 exhibited favorable safety profile and PK characteristics when administered as single infusion at doses ranging from 0.02 mg/kg to 30 mg/kg Q3W in pts with advanced solid cancers, and its safety profile supports further disease-directed studies in combination with other immune checkpoint inhibitors and/or rational therapeutic modalities."

Clinical • Metastases • P1 data • PK/PD data • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTLA4 • HAVCR2 • PD-1

BioCity announces the first patient dosed with its anti-TIM-3 mAb BC3402 in Combination with IMFINZI for the Treatment of Advanced Hepatocellular Carcinoma in a Phase Ib/II Trial (PRNewswire) - "BioCity Biopharma today announced dosing of the first patient in a Phase Ib/II clinical trial of its anti-TIM-3 monoclonal antibody (mAb) BC3402 in combination with IMFINZI (durvalumab) for the treatment of advanced hepatocellular carcinoma (HCC) in China. The study is being conducted at Zhongshan Hospital with Prof. Jia Fan as the principal investigator....BioCity and AstraZeneca will work closely with the investigators to advance this clinical study."

Trial status • Hepatocellular Cancer

BC3402 in Combination With Durvalumab in Patients With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2 | N=83 | Not yet recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

BioCity Signs Collaboration Agreement with AstraZeneca on BC3402, a monoclonal antibody targeting anti-TIM-3, in Combination with IMFINZI (durvalumab) for the Treatment of Advanced Hepatocellular Carcinoma in China (PRNewswire) - "BioCity Biopharma and AstraZeneca signed an agreement to collaborate on a Phase Ib/II clinical study to evaluate the safety and efficacy of BioCity's BC3402, a monoclonal antibody (mAb) targeting the T cell immunoglobulin and mucin domain-containing protein 3, also known as TIM-3, in combination with AstraZeneca's anti-PD-L1 mAb IMFINZI (durvalumab) for the treatment of advanced hepatocellular carcinoma (HCC）in China. BioCity will lead the trial, which has received IND approval by the National Medical Products Administration (NMPA)."

Licensing / partnership • New P1/2 trial • Hepatocellular Cancer

Study of BC3402 in Combination With Azacitidine in Patients With MDS and CMML (clinicaltrials.gov) - P1b | N=32 | Recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd.

Combination therapy • New P1 trial • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Phase I Study of BC3402 as a Single Agent in Patients With MDS and CMML (clinicaltrials.gov) - P1 | N=13 | Recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2023 ➔ Jul 2023

Enrollment open • Trial initiation date • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Phase I Study of BC3402 as a Single Agent in Patients With MDS and CMML (clinicaltrials.gov) - P1 | N=13 | Not yet recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd.

New P1 trial • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology