Tiziana Life Sciences PLC   | AIM:TILS


Autoimmune diseases are primarily due to a malfunction when the immune system attacks certain cells in the body as foreign invaders. This can result in irreparable damage to critical organs and tissues eventually resulting in autoimmune diseases (1-4).

Tiziana Life Sciences has recently acquired foralumab, a unique asset which we are investigating for orally administered treatment of autoimmune diseases. Foralumab is a fully human anti-CD3 monoclonal antibody which has been shown to modulate immune response and has potential applications for inflammatory bowel diseases, type I diabetes and lupus. We anticipate filing an IND in 2016.


The therapeutic use of anti-CD3 remains an attractive strategy for broader applications in chronic inflammatory and autoimmune diseases with high unmet medical needs such as ulcerative colitis, inflammatory bowel diseases, multiple sclerosis, lupus, non-alcoholic steatohepatitis (NASH) and type 1 diabetes.


The mucosal immune system in particular, has evolved mechanisms that enable establishment of tolerance to foreign molecules. Using similar mechanisms to induce tolerance to autoimmune inflammatory diseases is an attractive approach for treatment as it is a clinically applicable in a physiologic manner. Lack of toxicity and ease of administration are also important features desired for an effective immunotherapy. One of the mechanisms that are used by the mucosal immune system involves the induction of regulatory T cells(7). Several studies have demonstrated that oral (or nasal) administration of anti-CD3 monoclonal antibodies can be used to induce immune tolerance and this treatment strategy seems effective in the treatment of animal models of autoimmune diseases. Oral administration of anti-CD3 antibodies represents a new avenue for the treatment of autoimmune diseases (8-10).


  1. 1.Chatenoud L. CD3-specific antibody-induced active tolerance: from bench to bedside. Nat Rev Immunol. 2003;3(2):123–132.

  2. 2.Herold KC, Hagopian W, Auger JA, Poumian-Ruiz E, Taylor L, Donaldson D, et al. Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus. N Engl J Med. 2002; 346(22):1692–1698.

  3. 3.da Cunha AP, Weiner HL. Induction of immunological tolerance by oral anti-CD3. Clin Dev Immunol. 2012;2012:425021. doi: 10.1155/2012/425021. Epub 2011 Nov 14

  4. 4.Chatenoud L. Immune therapy for type 1 diabetes mellitus-what is unique about anti-CD3 antibodies? Nat Rev Endocrinol. 2010 Mar;6(3):149-57. doi: 10.1038/nrendo.2009.275

  5. 5.Ochi H, Abraham M, Ishikawa H, Frenkel D, Yang K, Basso A, Wu H, Chen ML, Gandhi R, Miller A, Maron R, Weiner HL. New immunosuppressive approaches: oral administration of CD3-specific antibody to treat autoimmunity. J Neurol Sci. 2008 Nov 15;274(1-2):9-12.

  6. 6.Herold KC, Taylor L. Treatment of Type 1 diabetes with anti-CD3 monoclonal antibody: induction of immune regulation? Immunol Res. 2003;28(2):141-50.

  7. 7.Oral tolerance. Weiner HL, da Cunha AP, Quintana F, Wu H. Immunol Rev. 2011 May;241(1):241-59

  8. 8.Ishikawa H, Ochi H, Chen ML, Frenkel D, Maron R, Weiner HL. Inhibition of autoimmune diabetes by oral administration of anti-CD3 monoclonal antibody. Diabetes. 2007, 56(8):2103-9.

  9. 9.Ilan Y, Zigmond E, Lalazar G, Dembinsky A, Ben Ya'acov A, Hemed N, Kasis I, Axelrod E, Zolotarov L, Klein A, El Haj M, Gandhi R, Baecher-Allan C, Wu H, Murugaiyan G, Kivisakk P, Farez MF, Quintana FJ, Khoury SJ, Weiner HL. Oral administration of OKT3 monoclonal antibody to human subjects induces a dose-dependent immunologic effect in T cells and dendritic cells.

  10. 10.Lalazar G, Mizrahi M, Turgeman I, Adar T, Ben Ya'acov A, Shabat Y, Nimer A, Hemed N, Zolotarovya L, Lichtenstein Y, Lisovoder N, Samira S, Shalit I, Ellis R, Ilan Y. Oral Administration of OKT3 MAb to Patients with NASH, Promotes Regulatory T-cell Induction, and Alleviates Insulin Resistance: Results of a Phase IIa Blinded Placebo-Controlled Trial. J Clin Immunol. 2015 May;35(4):399-407. doi: 10.1007/s10875-015-0160-6



  1. Current treatments for patients with autoimmune diseases include immune suppressive drugs that inhibit the cells of the immune system.

  2. These cells are also normally responsible for our protective responses to foreign invaders and tumors, and therefore, inhibiting them can often have severe side effects.

  3. Immune tolerance therapies are increasingly becoming attractive approaches to reprogram the immune system to stop the immune attack on self-tissue while still continue to maintain immune surveillance to fight infection(5,6).


AutoImmune Disease


We have acquired foralumab, a fully human anti-CD3 antibody a unique asset for treatment of autoimmune diseases such as ulcerative colitis, inflammatory bowel diseases, type I diabetes, lupus and others. We anticipate filing an IND in 2016.

We anticipate filing an IND in 2016.