Candidate: Foralumab (Formerly TZLS-401)
Type: Fully human anti-CD3 monoclonal antibody (mAb) in-licensed from Novimmune in December 2014. Foralumab is designed to bind to the T cell receptor complex, modulating levels of regulatory and effector T cells and the inflammatory response.
2021 Status: Tiziana said June 23 that it signed an agreement with FHI Clinical, a global clinical contract research organization (CRO), to conduct a Phase II proof-of-concept study in Brazil to evaluate the safety, tolerability and efficacy of intranasal Foralumab in hospitalized patients with severe COVID-19 and pulmonary inflammation. The randomized, placebo-controlled, double-blind, proof-of-concept study is designed to expand on preliminary findings of safety, tolerability and efficacy of intranasal administration of Foralumab seen in mild to moderate non-hospitalized COVID-19 patients, and announced in February. Foralumab will be delivered intranasally through a metered-dose nasal atomization device.
On February 2, Tiziana reported positive data from an exploratory randomized clinical study in Brazil investigating nasally administered Foralumab alone and in combination with orally administered dexamethasone in COVID-19 patients. The study was completed in collaboration with scientific teams at Harvard Medical School and INTRIALS, a full-service CRO based in São Paulo, Brazil. Of the study’s 39 patients, the 10 randomized to Forelumab showed the highest percentage of lung CT scan improvement—80%, compared with 75 in 12 patients treated with Foralumab and dexamethasone, and 43% for the 14 control patients receiving no treatment.
2020 Status: Tiziana said July 31 it submitted a patent application for the potential use of nasally administered Foralumab for the treatment of COVID-19 either alone or in combination with other anti-viral drugs. Tiziana reasons that nasal administration with Foralumab could potentially modulate or stimulate the immune system to suppress cytokine storm and reduce respiratory failure in COVID-19 patients.
Tiziana has a worldwide exclusive license for nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of neurodegenerative and other diseases. In 2018, Tiziana announced the development of a robust formulation and delivery of Foralumab using a nasal spray device, as well as the successful completion of a Phase I trial showing that the treatment was well-tolerated and showed positive immunomodulatory effects as measured by biomarker analysis. In January 2020, Tiziana announced the successful completion of a Phase I trial with oral administration of Foralumab, demonstrating that the treatment was well-tolerated up to a 5 mg dose.
Tiziana plans to launch Phase 2 studies with an oral formulation of Foralumab for Crohn’s Disease, and with nasally administered Foralumab for progressive multiple sclerosis. The company said Foralumab has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn’s Disease, multiple sclerosis, type 1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis, and rheumatoid arthritis.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: