Benzinga | Aug 18, 2020 05:36AM EDT

Tiziana Granted U.S. Patent on Methods and Use of Anti-CD3 Monoclonal Antibodies for Treatment of Crohn's Disease

Tiziana Life Sciences plc (NASDAQ:TLSA) announces that the United States Patent and Trademark Office ("USPTO") has granted a patent on use and methods of treatment of Crohn's disease with Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 monoclonal antibodies (mAb).The CD3 (cluster of differentiation 3) is a protein complex on T-cells, which is important for the regulation of the immune system. The patent will be published by the USPTO on 1 September, 2020 as Patent No. 10,759,858. Recently, Tiziana also announced the issuance of the first-ever patent on oral administration of anti-CD3 mAbs for treatment of human diseases (Patent No. 10,688,186). The grant of this additional composition-of-matter and use patent further strengthens the Company's intellectual property, consisting of proprietary technologies on oral and nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of human diseases.

Tiziana previously reported the successful completion of a Phase 1 trial utilizing oral administration of Foralumab on 9 January, 2020, which was designed to evaluate its safety and tolerability in healthy subjects. The trial was conducted at Brigham and Women's Hospital, Harvard Medical School, Boston, Mass., and indicated that oral administration of Foralumab was well-tolerated up to a 5 mg dose ( https://www.tizianalifesciences.com/news-item?s=2020-01-09-tiziana-reports-phase-1-clinical-data-demonstrating-oral-treatment-with-foralumab-a-fully-human-anti-cd3-monoclonal-antibody-is-well-tolerated-in-healthy-volunteers). The Company plans to move forward with a phase 2 trial in the 4th quarter of 2020 with orally administered Foralumab for the evaluation of moderate-to-severe patients with Crohn's Disease.

Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Lifesciences, commented, "We are delighted that this key patent on composition-of-matter and use for treatment of Crohn's Disease is granted. We are very excited about the continued development of the oral administration ofForalumab for the treatment of Crohn's disease because this alternative route of administration seems to minimize toxicity and we believe it would maximize clinical activity by acting topically in the gut to inhibit inflammation."

Additionally, Tiziana previously reported the successful completion of a Phase 1 study evaluating safety and analysis of biomarkers for clinical activity of nasally administered stabilized solution of Foralumab on 28 November, 2018 ( https://www.tizianalifesciences.com/news-item?s=2018-11-28-tiziana-announces-initiation-of-phase-1-clinical-trial-with-nasal-administration-of-foralumab-a-fully-human-anti-cluster-definition-3-monoclonal-antibody-anti-cd3-mab-in-healthy-volunteers).

Additionally, a Phase 2 trial in patients with progressive multiple sclerosis will commence in the 4th quarter. Importantly, in both clinical studies, the severe toxicities commonly associated with intravenous administration of anti-CD3 mAbs were not observed with oral or nasal administration of Foralumab.

The person who arranged for the release of this announcement on behalf of the Company was Dr. Kunwar Shailubhai, CEO & CSO of Tiziana.