Tiziana Life Sci PLC - Article on Clinical Activity of OKT3
Newly Published Article Reporting Clinical Activity of Orally Administered OKT3, a Mouse Anti-CD3 Monoclonal Antibody, in Moderate to Severe Ulcerative Colitis Patients, Supports Tiziana's Oral Monoclonal Antibody Platform
Third party research conducted by leading
Tiziana's platform oral monoclonal antibody (mAb) technology applicable to mAb's on the market today which are currently available only through IV, addressing an enourmous market potential.
Tiziana's Foralumab is the first fully human anti-CD3 mAb which has not shown anti-drug antibody (immune reaction) in humans
Tiziana's Foralumab, the only fully human anti-CD3 mAb, exhibits potency and functionality similar to OKT3, which is a mouse anti-CD3 (2). Therapeutic use of intravenously administered OKT3 and other humanized anti-CD3 mAbs is limited due to significant adverse reactions, including life threatening cytokine release syndrome. The Company is pioneering oral delivery of mAb's for the treatment of autoimmune and inflammatory diseases that is applicable to the $100 billion market of mAb's that are currently only available through IV delivery.
"The safe and effective oral delivery of mAb's has the potential to transform the use of biologic medications. While the scientific community has long recognized oral delivery of proteins and peptides as a challenge, we believe our propeitary platform technology is a breakthrough in oral delivery of mAb's," stated
Foralumab is currently in a Phase 1 trial at the
The aim of this pilot study was to determine the immunologic effects and safety of orally delivered anti-CD3 antibody in patients with moderate-to-severe ulcerative colitis (UC). (1)
The primary endpoints were changes in immunologic parameters and evaluation for safety. Six subjects received oral OKT3. The biologic effects of oral anti-CD3 included significantly increased proliferation in response to anti-CD3 and anti-inflammatory gene expression profile in peripheral blood mononuclear cells. No serious treatment-related adverse events occurred.
(1).Boden, E. K., Canavan, J. B., Moran, C. J., McCann, K., Dunn, W. A., Farraye, F. A., Ananthakrishnan, A. N., Yajnik, V., Gandhi, R., Nguyen, D. D., Bhan, A. K., Weiner, H. L., Korzenik, J. R., Snapper, S. B. Immunologic alterations associated with oral delivery of anti-CD3 (OKT3) monoclonal antibodies in patients with moderate-to-severe ulcerative colitis. Crohn's & Colitis 360 (2019). 183: 240-246.
(2).Ogura M1, Deng S1,
Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, has shown reduced release of cytokines after IV administration in patients with Crohn's disease, with decreases in the classic side effects of cytokine release syndrome (CRS), and enhances the overall safety profile of Foralumab. In a humanized mouse model , it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances Tregs and thus has the potential to provide therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.
Muromonab-CD3 (Orthoclone OKT3) is a murine anti-human CD3 monoclonal antibody. OKT3 was developed by Johnson and Johnson and it was the first monoclonal antibody approved by the FDA in 1985 to be administered to humans via the intravenous route for the trearment of acute, glucocorticoid-resistant rejection of allogenic renal, heart and liver transplants. However, manufacture of OKT3 was voluntarily withdrawn from the market [should say why to be balanced].
For further enquiries:
+44 (0)20 7601 6125
This information is provided by RNS, the news service of the