Tiziana’s patented oral formulation of fully human anti-CD3 mAb, Foralumab is a game changer for the treatment of Crohn’s Disease and other autoimmune diseases by potentially improving efficacy and reduced toxicity. Foralumab modulates the immune response, reducing inflammation locally and systemically, through interaction with the mucosal immune system. Tiziana anticipates the initiation of a Phase 2 trial with nasally administered Foralumab in progressive multiple sclerosis (pro-MS) in Q4 2020. Phase 2 trial with orally administered Foralumab for Crohn’s indication is anticipated to be initiated soon.
Tiziana's Anti IL-6R, an mAb, binds to both membrane-bound and soluble forms of IL-6R, 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 anti-inflammatory and anti-infective agents as therapy for COVID-19, multiple myeloma, arthritis, lupus and oncology indications. Excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with severe lung damage observed with COVID-19 infections and acute respiratory illness. China’s National Health Commission has recommended the use of anti-IL6-R mAbs for treatment of inflammation and elevated cytokine levels (“cytokine storm”) in COVID-19 patients. A recent study also reported that COVID-19 infection caused clusters of severe respiratory illness like ARDS. Tiziana aims to complete the development of inhalation technology to deliver stable aerosols directly into the lungs by Q2 2021.
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 1 and 2 studies and shown indications of efficacy. In two, completed, Phase 2 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. Tiziana intends to initiate Phase 2b in HCC patients with Milciclib in combination with a TKI in Q2 2021.
Tiziana's StemPrintER is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, estrogen receptor-positive HER2-negative breast cancer patients, based on the detection of 20 cancer stem cell markers. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer. Tiziana announced to demerge StemPrintER and SPARE (together "StemPrintER") personalized medicine businesses into a separate company.