BioLineRx's EDP-14 to Enter the Company's Main Therapeutic Pipeline as BL-9010

BioLineRx has announced that following promising pre-clinical data, EDP-14, for the treatment of severe and persistent asthma, has been added to the Company's main therapeutic pipeline.

The project is now named BL-9010. Previously, the project was developed under BioLineRx’s Early Development Program.

BL-9010, a novel bi-specific antibody treatment for severe and persistent asthma, targets and links together two immunological modulators - IgE and CD300a.

Allergen-bound IgE activates cells involved in allergic responses, such as mast cells, while CD300a inhibits immune responses.

Professor Francesca Levi-Schaffer from the Hebrew University of Jerusalem, the inventor of BL-9010, found that CD300a is expressed on mast cells and that linking IgE with CD300a using a bi-specific antibody leads to potent inhibition of allergic reactions characteristic of asthma.

In murine models of experimental asthma, BL-9010 significantly blocked allergic responses. Importantly, this could be reproduced in human mast cells, where BL-9010 was shown to inhibit the allergic reaction of these cells in-vitro.

The human mast cells were activated by IgE molecules from allergic patients and by specific allergens, mimicking the human disease, while BL-9010 prevented the release of allergy-mediating substances by the cells.

"Asthma is a highly prevalent disease with no satisfactory cure that affects millions of people around the world," said Dr. Kinneret Savitsky, CEO of BioLineRx. "The results of the pre-clinical trials were extremely impressive and convincing, and raise hopes that BL-9010 will be an effective treatment. As a result, the project is now being advanced to our main product pipeline and will be further developed at an accelerated pace. Due to its unique mechanism of action, promising in-vivo results and the true unmet medical need, this project, although still in pre-clinical stages of development, is already attracting the interest of potential partners."

BL-9010 was developed to treat severe and persistent asthma patients, but may also potentially treat chronic urticaria as well as additional allergic conditions.