HBM7020 / Harbour BioMed, Hualan Biological Engineering, Otsuka - LARVOL DELTA

Harbour BioMed Enters Global Strategic Collaboration with Otsuka to Advance BCMAxCD3 Bispecific T-Cell Engagers (PRNewswire) - "Harbour BioMed...announced a global strategic collaboration with Otsuka Pharmaceutical Co., Ltd. ('Otsuka') to advance BCMAxCD3 bispecific T-cell engagers for the treatment of autoimmune diseases. Under the terms of the agreement, Otsuka is granted an exclusive license to develop, manufacture, and commercialize HBM7020, a BCMAxCD3 bispecific T-cell engager globally, excluding Greater China (Mainland China, Hong Kong, Macau and Taiwan). In return, Harbour BioMed will receive a total of $47 million in upfront and near-term payments. The company is also eligible for additional payments of up to $623 million upon the achievement of specified development and commercial milestones, as well as tiered royalties on future net sales."

Licensing / partnership • Immunology

Harbour BioMed Reports 2021 Interim Results (PRNewswire) - "HBM7020, HBM1029 and HBM7015:...After completing the technology transfer, the two companies have jointly worked on the development of these three innovative products. It is expected that IND applications for these products will be submitted in 2022."

IND • Oncology

A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531 (clinicaltrials.gov) - P1; N=46; Active, not recruiting; Sponsor: Hoffmann-La Roche; Recruiting ➔ Active, not recruiting; N=157 ➔ 46

Enrollment change • Enrollment closed • Hepatitis B • Hepatology • Infectious Disease • IL10 • IL6 • TNFA

[VIRTUAL] Influence of TLR7 polymorphism and sex on pharmacodynamic response to TLR7 agonist (RO7020531) (APASL 2021) - No abstract available

PK/PD data

A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - P2; N=210; Recruiting; Sponsor: Hoffmann-La Roche; N=60 ➔ 210; Trial completion date: Mar 2023 ➔ Aug 2023; Trial primary completion date: Dec 2021 ➔ Mar 2023

Clinical • Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease

A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Jul 2022 ➔ Mar 2023

Clinical • Combination therapy • Trial completion date • Hepatitis B • Hepatology • Infectious Disease

Impact of type 2 diabetes variants identified through genome-wide association studies in early-onset type 2 diabetes from South Indian population. (PubMed, Genomics Inform) - "For CDKN2A/2B variant rs7020996, the heterozygous and homozygous carriers of allele 'C' were protective with odds ratios of 0.65 (95% CI, 0.51 to 0.83; p = 0.0004) and 0.62 (95% CI, 0.27 to 1.39; p = 0.24) respectively, relative to TT homozygote. This is the first study to report on the association of HHEX variant rs1111875 with EOT2D in this population."

Clinical • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CDKN2A • TCF7L2

A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Apr 2022 ➔ Jul 2022

Clinical • Combination therapy • Trial completion date • Hepatitis B • Hepatology • Infectious Disease

Harbour BioMed Presented Its Newly Discovered BCMA x CD3 Bispecific Antibody at Cell Engager Summit 2020 (PRNewswire) - "Harbour BioMed...presented its newly discovered Bispecific Antibody - BCMA x CD3 (HBM7020) at the Cell engager Summit. HBM7020 was developed using HBM's own HBICETM (HCAb Based Bispecific Immune Cell Engager) platform and has shown remarkable tumor killing with minimal cytokine response, which could translate in to a relatively efficacious and safe therapeutic....BCMA targeted therapies are still limited by their unresponsiveness in some patients, fast relapse, toxicity due to cytokine release syndrome (CRS), and short half-life etc. The off-shelf HBICETM BCMA x CD3 may overcome some of the limitations and become the new generation of therapeutics for multiple myeloma."

Cytokine release syndrome • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology