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TG Therapeutics to develop Checkpoint’s antibodies in hematological malignancies

TG Therapeutics, Inc. will develop and commercialise Checkpoint Therapeutics’ fully human anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies, as part of an agreement signed between the two companies.

Under the terms of the agreement, TG Therapeutics will make an up-front payment as well as make development and sales-based milestone payments and will pay a tiered single digit royalty on net sales.

Checkpoint, a newly formed subsidiary of Coronado Biosciences, Inc. will develop and commercialise Anti-PD-L1 and Anti-GITR Antibodies in Hematological Malignancies in solid tumors, which were generated at the Department of Cancer Immunology and AIDs at Dana-Farber Cancer Institute (Dana-Farber).

Anti-PD-L1 antibodies target programmed cell death ligand 1 (PD-L1) signals from activating tumor specific effector T-cells. Anti-PD-L1 antibodies are designed to block that signal permitting effector T-cells to attack the cancer.

Anti-GITR antibodies target glucocorticoid-induced tumor necrosis factor receptor related protein (GITR), which is regularly expressed on the surface of regulatory T-cells (Tregs) and is expressed on the surface of effector T-cells after their activation.

Modulation of GITR with agonistic antibodies has been shown to amplify the antitumor immune responses in animal models via multiple mechanisms. Anti-GITR antibodies are designed to activate the GITR receptor thereby increasing the proliferation and function of effector T cells.

Mr. Michael S. Weiss, executive chairman, Interim CEO and president said: "Checkpoint inhibitors and other immuno-oncology targeted agents have already demonstrated the ability to transform the way we treat cancer by unlocking the immune system, offering the promise of deep and durable remissions.

"While the recent introduction of novel targeted agents has already revolutionized the way we treat hematological malignancies, we at TG believe that incorporation of immuno-therapy will prove to be a second paradigm-shift in the treatment of these diseases, and it is our goal to be at the forefront leading this charge.

"As we’ve said previously, we will continue to build our portfolio to optimize our combination approach to provide the best possible outcomes to patients with B-cell malignancies without the need to use harsh chemotherapy, ideally pushing toward a cure. It is believed that these two antibodies can work synergistically together and we believe that adding them to the already marked activity we are seeing with our proprietary combination of TG-1101 and TGR-1202 across CLL and NHL could greatly enhance the therapeutic benefit to patients with hematological malignancies. Our goal is to advance both of these antibodies into the clinic in the second half of next year."

Both programmes are currently in pre-clinical development and are expected to enter the clinical stage in 2016.