First subjects dosed in Australian phase I study of denosumab biosimilar

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First subjects dosed in Australian phase I study of denosumab biosimilar

Biosimilars/Research | Posted 12/06/2020 0 Post your comment

Taiwan-based JHL Biotech announced on 18 May 2020 that the first group of subjects has been randomized and dosed in the week of 11 May 2020 in the company’s Australian phase I clinical trial of its candidate denosumab biosimilar (JHL1266) in healthy subjects.

The phase I study of JHL1266 is being carried out in Australia. It is a three-arm, randomized, double-blind, multicentre, parallel-group, single-dose study. It will compare the pharmacokinetic (PK) similarity of JHL1266 versus the originator, Amgen’s Prolia, sourced from the EU and the US after a single subcutaneous injection in healthy human subjects. The secondary objective is to assess the safety, tolerability, and immunogenicity and pharmacodynamics (PD) of JHL1266 as compared to Prolia.

JHL Biotech says that this study is one of the pivotal studies for registration with the ultimate objective to evaluate the similarity in PK, PD and immunogenicity.

The study will enrol 225 healthy subjects aged between 25 to 55 (males) or 25 to 45 (females) years old. The enrolled subjects will be randomized into 3 cohorts, JHL1266, Prolia-EU, or Prolia-US. A single 60 mg dose of JHL1266, Prolia-EU or Prolia-US will be administered subcutaneously on Day 1, and subjects will be observed for safety and tolerability and PK and PD blood samples will be collected for 20 weeks.

Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone.

James Huang, CEO of JHL Biotech said that ‘denosumab is an important biological for the treatment of post-menopausal osteoporosis and other common bone related diseases. Because it’s unfortunately very expensive for patients and healthcare payers, JHL1266 would provide an affordable treatment for these patients’. He added that he was ‘very proud of this achievement especially considering the COVID-19 pandemic. This is a significant milestone for JHL and a tremendous step forward in our mission to increasing public access to safe, effective, and high-quality biologics’.

JHL Biotech is also working on biosimilars of breast cancer treatment pertuzumab (JHL1199) [1] and leukaemia treatment rituximab (JHL1101) [2]. The company has also made a deal with Sanofi giving Sanofi rights to commercialize JHL1101 in China [3].

Biosimilars of denosumab

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pertuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pertuzumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-rituximab
3. GaBI Online - Generics and Biosimilars Initiative. Strategic biologicals alliance between Sanofi and JHL Biotech in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 12]. Available from: www.gabionline.net/Pharma-News/Strategic-biologicals-alliance-between-Sanofi-and-JHL-Biotech-in-China

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Source: ANZCTR, JHL Biotech