MS Society, TG Therapeutics Partner to Advance Potential Oral Therapy for Progressive MS

Fast Forward, a non-profit subsidiary of the National Multiple Sclerosis Society, will give financial support to TG Therapeutics to advance TGR-1202 (umbralisib) into preclinical testing as a potential oral therapy for progressive forms of multiple sclerosis.

The support, whose value was not specified, is part of a Sponsored Research Agreement between Fast Forward and the company. Research work will be led by Lawrence Steinman, MD, a professor of pediatrics, neurology, and neurological sciences at Stanford University.

“We are extremely pleased to announce this research collaboration with the National Multiple Sclerosis Society and Dr. Lawrence Steinman to explore the use of TGR-1202 in pre-clinical models of progressive forms of MS,” Michael S. Weiss, executive chairman and chief executive officer of TG Therapeutics, said in a press release.

“Our long-term vision has always included developing TGR-1202 in auto-immune diseases and it is research collaborations like this one that will help us identify the most appropriate targets for clinical evaluation,” Weiss added.

TGR-1202 is an orally administrated inhibitor that blocks a signaling enzyme called PI3K delta. Immune cells such as B-cells have high levels of this enzyme, which is thought to be important for cell proliferation and survival.

“We look forward to evaluating umbralisib [TGR-1202]’s effect on our preclinical progressive MS models in hopes to move umbralisib closer to clinical development in MS,” Steinman said.

The approval of Ocrevus (ocrelizumab), by Genentech, to treat primary progressive and relapsing multiple sclerosis underscored the potential of B-cell-targeted therapies for MS patients. As a result, investigative drugs that also aim to bolster B-cell survival or activity, such as those being developed by TG Therapeutics, are an attractive approach to potentially treating patients.

Another potential treatment by the company — an engineered antibody, TG-1101 (ublituximab) — targets a specific sequence on the CD20 protein found on immune B-cells. This infusion therapy is now in two Phase 3 clinical studies for relapsing multiple sclerosis, ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248). Both are currently enrolling patients at sites in Kentucky, Tennessee, and New York.

“TG Therapeutics is clearly committed to finding solutions for people with MS and we are pleased to work with a partner with the credibility and experience to carry this project forward,” said Mark Allegretta, associate vice president of commercial research at the National MS Society. “This exemplifies our effort to identify clinic-ready drug candidates to expand the pipeline of therapies being tested for use in MS.”