Potential Ulcerative Colitis Therapy Advancing in Clinical Development

Potential Ulcerative Colitis Therapy Advancing in Clinical Development

Tiziana Life Sciences recently announced its plan for further development of foralumab, the company’s fully human anti-CD3 antibody, with a first evaluation of the compound in two clinical indications: graft vs. host disease, and ulcerative colitis, an inflammatory bowel disease (IBD).

Foralumab is the only fully human engineered anti-CD3 antibody currently in clinical development, the company reports. The compound is being tested in Phase 2 studies and has potential applications in a wide array of autoimmune and inflammatory diseases like IBD and ulcerative colitis, as well as for type 1 diabetes, rheumatoid arthritis, psoriasis, and multiple sclerosis.

Tiziana also announced the addition of two new members to its Scientific Advisory Board team, Professors Howard Weiner, MD, and Kevan Herold, MD, who will focus on a clinical development plan for foralumab.

Dr. Weiner is the co-director of the Ann Romney Center for Neurologic Diseases at Brigham & Women’s Hospital in Boston, and a professor of Neurology at the Harvard Medical School. He has investigated the mucosal immune system for the treatment of autoimmune diseases, and pioneered the use of anti-CD3 to induce regulatory immune T cells for the treatment of such diseases. Dr. Weiner was also one of the pioneers in immunotherapy for MS treatment and has done significant research on immune mechanisms in nervous system diseases like Alzheimer’s and amyotrophic lateral sclerosis (ALS), and in strokes and brain tumors, according to a press release.

Dr. Herold is a professor of Immunobiology and Endocrinology at Yale University, and deputy director, Yale Center for Clinical Investigation, director of the Yale Diabetes Center, and director of the TrialNet Center at Yale. His work has concentrated on the development of new ways to prevent and treat autoimmune diseases using translational, immunologic, and metabolic approaches, with a particular focus on anti-CD3 monoclonal antibody therapy. Dr. Herold’s clinical interests surround the management of endocrine diseases, and he is involved in many national and international clinical studies, the release states.

“The addition of Professors Herold and Weiner to Tiziana’s Scientific Advisory Board marks a vital step for the company,” Tiziana’s executive chairman, Gabriele Cerrone, said in the release. “Prof. Herold’s previous experience in CD3 antibody research will be invaluable in planning the clinical strategy for foralumab, and he will take on a major role in its further development. In addition, Prof. Weiner brings a wealth of expertise in the field of immunology and regulation of processes that govern cancer and autoimmune disease, which will also be critical as we build out our anti-CD3 clinical strategy and the development of our fully human antibody asset, foralumab.”