Tiziana Life Sciences: Expanding the pipeline, unlocking value
Tiziana Life Sciences PLC (LON:TILS, NASDAQ:TLSA) has expanded the range of indications — which include severe inflammatory and autoimmune diseases — of its lead therapy fully human anti-CD3 monoclonal antibody Foralumab, signing a new collaboration in Brazil to develop the nasal formulation of Foralumab to treat respiratory failure in COVID-19 patients. Nasally administered Foralumab would offer a first in class immunotherapeutic approach, designed to strengthen immune defence and to directly address the primary site of inflammation, i.e. the nasal passage and respiratory tract. The acceleration of the demerger and listing plans for the genomics risk assessment business including StemPrintER and SPARE, set for completion in 2020, can help unlock very buoyant commercial prospects, and crystallise the value of both the therapeutic and genomics arms of the business.
Tiziana has expanded the pipeline of indications for the nasal formulation of Foralumab, its fully human anti-CD3 monoclonal antibody (mAb), having signed an agreement to cover collaboration between its team of scientists at the Harvard Medical School and those at the Santa Casa de Misericórdia de Santos hospital in Sao Paulo, to conduct a clinical study to investigate the mAb for treating respiratory failure in COVID-19 patients. The clinical study will include patients, treated either with nasally administered Foralumab alone, or combined with the orally-administered antiviral drug dexamethasone, and is scheduled to start imminently, with clinical data anticipated to be reported by the end of 2020.
The scientific basis for the use of Foralumab for treatment of COVID-19 is to modulate the human immune system via the stimulation of regulatory T cells (Tregs) and downregulation of CD8+ cytotoxic cells in the respiratory system. This is an innovative strategy based on suppressing the over-reaction of the immune system seen in severe respiratory inflammation known as a cytokine storm, to reduce the resulting hyperinflammation and potentially fatal lung damage and/or respiratory failure in COVID-19 patients. Recent studies have also shown that Tregs are depleted in patients with severe COVID-19 disease. So, Tiziana’s strategy aims to target the potential underlying causes of severe complications and mortality based on evidence that comprised immunity plays a role in respiratory infections such as those caused by COVID-19.
The rationale is supported by data from a Phase I clinical study of nasal Foralumab tested in healthy volunteers, which showed the treatment was well tolerated and that it stimulated the production of Tregs. Furthermore, animal studies conducted at the Harvard Medical School by Dr Howard Weiner (chair of the company’s scientific advisory board) established that nasally administered Foralumab suppressed cytotoxic CD8+ T cell responses, identified as one of the main causes of severe lung damage in COVID-19. Also, data from a Phase 1 clinical study showed that nasally administered Foralumab stimulated Tregs, induced IL-10 and suppressed production CD8+ cells. These recent studies also provided evidence that nasal administration of Foralumab induces favourable immune mechanisms and stimulates the production of Tregs that suppress inflammation and help resolve immune-mediated disease. The delivery approach can enable a direct route to the respiratory tract that is the main site of COVID-19 inflammation.
EXAS estimates that Breast Cancer diagnostic market opportunity is worth around US$1bn globally
In 2020, more than 300,000 women are expected to be diagnosed with breast cancer in the United States according to the American Cancer Society, and worldwide it is estimated that there were around 2mln newly diagnosed cases of breast cancer in 2018. So, while the strategy remains to be clarified by the future management team, the clinical and commercial prospects for StemPrintER look buoyant given the size of the unmet need, the projected addressable market, as well as its superiority to a market standard, if ongoing validation studies confirm this promise.
Industry metrics suggest that the current market valuation of Tiziana does not fully reflect its underlying therapeutic pipeline and attributes no value to Accustem Sciences, even at a discount to the takeover multiple paid by EXAS. We suggest a target valuation of up to £700mln for its therapeutic programmes on executing milestones over the next 12-18 months, with Accustem providing pure upside to the current market valuation