Tiziana’s Foralumab is the world’s first and only, fully human anti-CD3 antibody and can be delivered orally, making it a potential game changer in the treatment of NASH, Crohn’s Disease and other autoimmune diseases through higher efficacy and reduced toxicity. Foralumab modulates the immune response, reducing inflammation locally and systemically, through interaction with the mucosal immune system. Proof of concept was demonstrated in Phase II clinical trials with orally-dosed, mouse anti-CD3 mAB for treatment of NASH. Phase 1 clinical trials for nasally-administered foralumb are ongoing and a Phase I study of orally-dosed foralumab is being planned in 2019.
Tiziana’s Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomycin receptor kinases and Src family kinases controlling cell growth and malignant progression of cancer. Milciclib has demonstrated safety in 316 patients with advanced solid cancers in Phase I and II studies and shown indications of efficacy. In two, completed, Phase II thymic cancer trials, Milciclib successfully increased overall survival and met both primary and secondary endpoints. While the current standard of care for hepatocellular carcinoma (HCC), the most common liver cancer, is only effective in a small percentage of patients, Milcilib has the potential to be broadly effective because it targets the underlying cause of disease. A unique feature of Milciclib is its ability to reduce microRNAs, miR-221 and miR-222, that promote the formation of blood vessels (angiogenesis) to facilitate the spread of cancer cells Levels of these microRNAs are consistently increased in HCC patients and may contribute towards resistance to treatment with Sorafenib. Phase II results from a current HCC trial are expected in July 2019.
Pre-Clinical Pipeline Assets
Tiziana has two pre-clinical assets in development:
- Anti IL-6r mAb binds to membrane-bound and soluble forms of IL-6, an inflammatory cytokine driving chronic inflammation associated with autoimmune disease and cancer, reducing circulating levels of the cytokine. Anti IL-6r antibody can potentially be used in combination with Foralumab or other agents as therapy for multiple myeloma, arthritis, lupus and oncology indications.
- StemPrintER™ is a multi-gene signature diagnositic assay intended for early diagnosis of estrogren receptor positive ER+/HER2 negative breast cancer patients, based on the detection of cancer stem cell markers. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2400 patients with breast cancer.