The Company’s lead compound, milciclib, is a molecule which blocks the action of specific enzymes called cyclin-dependent kinases (CDKs) involved in cell division as well as a number of other protein kinases.
Milciclib has successfully completed two phase II clinical trials for epithelial thymic carcinoma and/or thymoma in patients previously treated with chemotherapy. In both of these trials, the treatment with milciclib met primary (progression free survival at 3 months; PFS-3) and secondary endpoint overall survival (OS). Seven patients from these studies have been continuing treatment with milciclib for more than 2 years and some up to 6 years, demonstrating tolerability of milciclib. In addition, oral treatment with milciclib is also being evaluated in a phase 2a trial in sorafenib-resistant HCC patients. Topline data from this ongoing trial will be reported in the 2Q, 2019.
Foralumab (TZLS-401) has significant potential as the only fully human engineered anti-human CD3 antibody in clinical development with advantages of short duration of treatment regimen, reduced immunogenicity and prevention of the life-threatening cytokine release syndrome. We have also developed a novel proprietary oral formulation of foralumab for the treatment of autoimmune and inflammatory diseases based on the concept of oral tolerance. This proprietary oral formulation of foralumab may potentially have broader applications for all anti-CD3 and other monoclonal antibodies. Administration via the oral and nasal routes is expected to mitigate side effects (primarily infusion related reactions) observed when foralumab was administered intravenously.
With Phase II studies for Crohn’s Disease using foralumab administered intravenously, the observed modulation of T-cell responses provides the potential extension into a wide range of other autoimmune and inflammatory diseases, such as; NASH, PBC, ulcerative colitis, progressive multiple sclerosis and autoimmune Type-1 diabetes. Based on the concepts of mucosal tolerance, foralumab is being developed as both an immunosuppressive and immunomodulatory agent, with therapeutic benefits of rendering T-cells unable to orchestrate an immune response and induction of immune tolerance via maintenance of regulatory T-cells administered via the oral and nasal routes of administration.
TZLS-501 is a fully human anti IL-6R monoclonal antibody with a novel mechanism of action. The mAb possesses a high affinity for IL-6R and the IL-6/IL-6R complex and effectively blocks the complex even at high IL-6 circulating levels, showing superiority and overcoming the limitations of other IL-6 pathway drugs. Therefore, TZLS-501 demonstrates a decreased potential for adverse events with improved efficacy in patients with high circulating levels of IL-6 and controlling chronic inflammation in diseases such as multiple myeloma, rheumatoid arthritis and other autoimmune diseases.