Anti Interlukin-6 Receptor mAB
Tiziana's Anti IL-6R 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 of TZLS-501 and potentially other antiviral drugs such as remdesivir directly into the lungs by 2Q 2021.
In light of the coronavirus pandemic the Company is accelerating GMP manufacturing of its anti-IL-6R mAb concurrently with developing an inhalation technology for direct delivery of the antibody into the lungs using a handheld inhaler or nebulizer for treatment of patients with COVID-19.
Manufacturing of clinical supplies for a Phase 1 study is anticipated to be completed in 1H 2021 and we plan to submit an IND in 4Q 2021.