Israel-based clinical-stage biopharmaceutical firm BioLineRx has entered into a collaboration with Taiwanese firm JHL Biotech for the joint development and commercialisation of BL-9020, a new monoclonal antibody intended for the treatment of type 1 diabetes.

As part of the deal, JHL Biotech will take care of all process development and manufacturing of BL-9020 during its pre-clinical and clinical development stages, while BioLineRx will oversee all pre-clinical development of BL-9020.

On a regional basis, responsibility for clinical development of BL-9020 will be shared by both the companies.

BL-9020 is designed to prevent destruction of insulin-producing beta cells in the pancreas and is developed to treat type 1 diabetes in early stage patients.

Data from the pre-clinical studies carried out in mouse models of type 1 diabetes suggests that BL-9020 can preserve surviving cells, thus preventing full maturation of the disease.

The company said that this effect is expected to delay and prevent the need for chronic insulin use by type 1 diabetes patients.

In addition to the development and commercialisation rights in China and South East Asia, JHL Biotech will also have global manufacturing rights to BL-9020, while BioLineRx will have development and commercialisation rights in the rest of the world.

JHL Biotech will adhere to US FDA guidelines and regulations in all development and manufacturing of BL-9020.

BioLineRx CEO Kinneret Savitsky said type 1 diabetes is a highly prevalent autoimmune disease affecting millions around worldwide.

"Currently, there is no cure for the disease. Patients with diabetes need to administer insulin on a daily basis."

"Currently, there is no cure for the disease, and patients with diabetes need to administer insulin on a daily basis throughout their lifetime," Savitsky said.

"Often, when the disease is diagnosed, patients experience a ‘honeymoon period’ that may last up to a year, during which there are still some insulin producing cells in the pancreas.

"Based on promising preclinical results, we have high hopes that BL-9020 may slow down or halt progression of the disease at this stage, which could be a significant step towards curing diabetes."

Both firms will have rights to all development and regulatory data generated under the deal to commercialise BL-9020 in its respective territory.

Each firm will also be entitled to single-digit royalties on the sale of BL-9020 in the other party’s respective territory.

Type 1 diabetes results from auto-immune destruction of the pancreatic beta cells producing insulin. It affects more than 20 million people worldwide, yet its treatment is currently limited to lifetime administration of insulin injections.

Image: A high-resolution model of six insulin molecules assembled in a hexamer. Photo: courtesy of Ras67.