TG Therapeutics and Novimmune SA Announce Global Agreement for Development and Commercialization of a Novel Anti-CD47/ Anti-CD19 Bispecific Antibody
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.
“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,” said Chairman and Chief Executive
“We are excited to enter into this collaboration with
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought its anti-PD-L1 monoclonal antibody into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future. TG Therapeutics is headquartered in New York City.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially are the following: our ability to successfully and cost effectively complete preclinical and clinical trials; the risk that early clinical trial results, that may have influenced our decision to proceed with additional clinical trials, will not be reproduced in future studies; the risk that TG-1801 will not be the first anti-CD47 bispecific antibody worldwide that will go into clinical development; the risk that the company will not move forward with the development of TG-1801, formerly known as NI-1701. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
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Source: TG Therapeutics, Inc.