Candidate: Foralumab (TZLS-401)

Category: ANTIBODY

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.

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: 200 Candidates and Counting

To navigate through the >200 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: