rns19 Jun 2020 08:06
Tiziana Life Sciences plc
("Tiziana" or the "Company")
Tiziana Granted First-Ever Patent on a Transformational Technology for Oral Delivery of all Anti-CD3 Monoclonal Antibodies for Treatment of Human Diseases
· First-ever granted patent on oral administration of anti-CD3 monoclonal antibodies for immunotherapies
· Transformational oral formulation technologies applicable to other antibodies
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
New York/London, 19 June 2020 - Tiziana Life Sciences plc (Nasdaq: TLSA; AIM: TILS) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that the United States Patent and Trademark Office ("USPTO") has granted a patent covering its proprietary platform technology for the oral administration of 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 regulation of immune system. The patent will be issued by the USPTO on 23 June 2020.
"The issuance of this first-ever patent on formulation for oral administration of mAbs is a very exciting and timely development, as it facilitates a transformational avenue for immunotherapies" commented Dr. Howard L. Weiner, Chairman of Tiziana's Scientific Advisory Board, Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham and Women's Hospital. "We also recently successfully demonstrated that nasally-administered Foralumab is not only well tolerated but also produced desirable immunological responses. In addition, both oral and nasal administration routes are physiologic approaches to stimulate the mucosal immune system to induce disease modifying benefits, while minimizing the severe toxicities commonly associated with the traditional intravenous administration of anti-CD3 mAbs."
"The granting of this patent on first-in-class formulation technology allows us to work on bringing patients the first non-intravenous or subcutaneous treatment with antibodies to treat major gastrointestinal and neurodegenerative diseases such as Crohn's Disease, pro-MS and Alzheimer's disease. We believe development of the alternative administration routes of antibodies such as oral, nasal and inhalation could potentially be transformational for immunotherapies," added Gabriele Cerrone, chairman and founder of Tiziana.
The patent titled "Anti-CD3 formulations; patent No. 10,688,186, Inventor: Kunwar Shailubhai", is the first-ever to be granted on anti-CD3 formulations and covers oral administration with lyophilized and stabilized free-flowing powder of Foralumab or any other an