TG Therapeutics and Novimmune Forge $185M Agreement

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TG Therapeutics and NovImmune SA struck a collaborative deal worth up to $185 million on the development and commercialization of a treatment for hematologic B-cell malignancies, such as non-Hodgkin’s Lymphoma and chronic lymphocytic leukemia.

The two companies will combine their resources to develop Novimmune's novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801, which was previously known as NI-1701. TG-1801 is a fully-human IgG1. It is designed to target and deplete B-cells via multiple mechanisms and is based on Novimmune's kappa-lambda -body format. That allows preservation of all favorable properties of a conventional monoclonal antibody while adding bispecific functionalities, the companies said in a statement.

TG-1801 is expected to be the first anti-CD47 bispecific antibody worldwide that will go into clinical trials. Those trials are expected to begin later this year or early in 2019, the companies said.

"We are delighted to see our first bispecific antibody move forward into the clinic with an experienced partner in the field of hematological malignancies, and to provide proof of principle for our completely novel approach," Novimmune Chairman and Chief Executive Eduard Holdener said in a statement. "We are excited about the potential benefit that this new approach could bring to B-cell lymphoma patients."

Michael Weiss, chief executive officer of TG Therapeutics, said Novimmune’s innovations in the field of CD47 bispecific antibodies have created a targeting approach that is safer and more effective. CD47 was recently validated as a “very promising pathway for tumor targeting,” Weiss said, especially in combination with anti-CD20 monoclonal antibodies.

“TG-1801 has demonstrated encouraging pre-clinical anti-tumor activity both as a single agent and in combination with anti-CD20 monoclonal antibodies. With the addition of TG-1801 to our pipeline, we now have three targeted immunotherapies in-house that can potentially be used together to create a novel non-chemo treatment option that uses the body's immune system to fight B-cell cancers, including NHL and CLL,” Weiss said in a statement.

Under terms of the agreement, 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. At that time, Novimmune will be eligible to receive additional payments contingent on certain clinical, regulatory and commercial milestones, totaling approximately $185 million as well as tiered royalties on net sales.

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. At the end of Phase II, TG Therapeutics and Novimmune will be jointly responsible for all development and commercialization costs of the product. 

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