Tiziana Life Sciences PLC (LON:TILS) (NASDAQ:TLS) has announced that the US 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 biotechnology company, which is focused on innovative therapeutics for oncology, inflammation and infectious diseases, noted that the CD3 (cluster of differentiation 3) is a protein complex on T-cells, which is important for the regulation of the immune system. It said the patent will be published by the USPTO on September 1, 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 group said 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, Massachusetts, and indicated that oral administration of Foralumab was well-tolerated up to a 5 mg dose. 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.
In a statement, 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 of Foralamab 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 November 28, 2018. And a Phase 2 trial in patients with progressive multiple sclerosis will commence in the fourth quarter of 2020.
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.