TG Therapeutics, Rhizen to collaborate on PI3K delta inhibitor
NEW YORK—Biopharmaceutical company TG Therapeutics and Rhizen Pharmaceuticals S A (Rhizen), a company specializing in therapeutics for cancer and immune disorders, have announced an exclusive global agreement. The companies will collaborate to develop and commercialize Rhizen's lead drug candidate, TGR-1202 (previously known as RP5264), a novel PI3K delta inhibitor. TG Therapeutics and Rhizen will develop the product jointly worldwide, with the exclusion of India, and will initially focus on indications in hematologic malignancies and autoimmune diseases. Beyond the candidate compound, Rhizen would contribute backup molecules offering opportunities for TG Therapeutics to develop therapies against the same indications.
"We are excited to enter into this collaboration with Rhizen Pharmaceuticals, whose innovative pre-clinical development program has yielded an impressive portfolio of PI3K delta inhibitors that we are eager to advance into development," Michael S. Weiss, executive chairman and interim CEO of TG Therapeutics, said in a press release. "TGR-1202 has already demonstrated encouraging pre-clinical activity, and will serve to expand our pipeline as we seek to develop much needed therapies for patients suffering from hematologic malignancies."
Per the terms of the agreement, TG Therapeutics will pay Rhizen both upfront licensing and milestone payments based on early clinical development, and will handle clinical development costs for the products through Phase II. Following Phase II, both companies will be jointly responsible for all development costs. TG Therapeutics and Rhizen will each retain an exclusive option that can be exercised at specific times during product development, for TG Therapeutics to license the rights to TGR- 1202. if TG Therapeutics exercises that option, Rhizen will be eligible for upfront, development and commercialization milestone payments in addition to milestone payments and royalties based on net sales of the product, with all told could total more than $250 million. Rhizen will maintain rights to manufacture and supply the product to TG Therapeutics, who will be responsible for clinical and regulatory development for the compound worldwide.
TGR-1202 is a highly specific PI3K delta inhibitor which targets the delta isoform with nanomolar potency as well as several fold selectivity over the alpha, beta and gamma isoforms of PI3K. the phosphoinositide-3-kinases (PI3Ks) are a family of enzymes known to be involved in a variety of cellular functions, including cell proliferation and survival, cell differentiation, intracellular trafficking and immunity. In particular, the delta isoform of PI3K is implicated in B-cell related lymphomas, and inhibitors of the PI3K delta pathway are presumed to be effective against the proliferation and survival of B-cell lymphocyes. Inhibition of PI3K delta signaling by use of TGR-1202 has demonstrated significant activity in preclinical xenograft models as well as primary cells from patients with hematologic cancers. It is expected that an Investigational New Drug application will be filed for the compound by the end of this year.
"The deep clinical and regulatory development knowledge and experience of the team at TG Therapeutics, and the existing clinical program focused on B-cell malignancies, makes TG an ideal partner with which to collaborate on development of TGR-1202," Swaroop Vakkalanka, president of Rhizen, said in a press release regarding the deal.
SOURCE: TG Therapeutics press release