TG Therapeutics (New York, USA) and Novimmune SA (Geneva, Switzerland) announced that the companies have entered into an exclusive global agreement to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701).
The companies will jointly develop the product on a worldwide basis, focusing on indications in the area of hematologic B-cell malignancies.
TG Therapeutics will make up-front and milestones payments based on early clinical development, and will be responsible for the costs of clinical development of the products through the end of Phase II, after which TG Therapeutics and Novimmune will be jointly responsible for all development and commercialization costs of the product. TG Therapeutics and Novimmune will each maintain an exclusive option, exercisable at specific times during development, for TG Therapeutics to license the rights to TG-1801, in which case Novimmune will be eligible to receive additional payments contingent on certain clinical, regulatory and commercial milestones, totaling approximately $185MM as well as tiered royalties on net sales.
TG-1801, a fully-human IgG1, designed to target and deplete B-cells via multiple mechanisms, is based on Novimmune’s kappa-lambda -body format which allows preservation of all favorable properties of a conventional monoclonal antibody while adding bispecific functionalities. One mechanism unique to this bispecific antibody involves blocking of CD47 referred to as the “do not eat me” signal for the body’s phagocytic cells specifically directed to CD19 positive cells. The net effect is highly targeted, potent anti-B-cell tumor phagocytic activity, while avoiding the general toxicity concerns associated with earlier agents targeting the CD47 pathway. Moreover, the co-targeting of CD19 is not only expected to enhance safety but by retaining its IgG1 Fc functionality, this agent is designed to provide a secondary mechanism of anti-tumor activity through the induction of antibody dependent cellular cytotoxicity (ADCC).
TG-1801 is expected to be the first anti-CD47 bispecific antibody worldwide that will go into clinical trials, which are expected to commence later this year or early in 2019.