Tiziana Life Sciences Has Only Fully Human Anti-CD3 mAB In Clinical Studies, Could Be Poised To Improve Care For Patients With Severe Multiple Sclerosis

Tiziana Life Sciences TLSA, a London-based biotechnology company, is developing a first-in-class drug, Foralumab. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) at the clinical stage.

It is important to note that Tiziana has the world's first and only fully human anti-CD3 monoclonal antibody in clinical development and is gaining attention after Sanofi's SNY recent acquisition of Provention Bio PRVB for $2.9 billion for the Company’s Humanized CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes.

To this day, there is no drug on the market that is a fully human, anti-CD3 monoclonal antibody, and this opens up a blockbuster potential  opportunity for Tiziana and other notable biotech companies like Theravance Biopharma, Inc. TBPH, Innate Pharma SA IPHA, Edgewise Therapeutics, Inc., EWTX and Seagen Inc. SGEN    

A study recently monitored Foralumab’s immunological mutations in SARS-CoV-2 patients who had received the drug intranasally. The study’s results were published in the prestigious scientific journal Proceedings of the National Academy of Sciences (PNAS) and the story was picked up by multiple outlets, including Forbes. 

The results of the study were that Foralumab was able to reduce inflammation by affecting CD3+ T-cell inflammatory responses. Because it has shown deregulatory activity in inflammatory pathways, it has demonstrated a unique mechanism that positions it both as an adjuvant therapy for SARS-CoV-2 patients and those with certain immune disorders.

A Fully Human mAB Drug For Immune Disorders

Drugs using mAbs are increasingly common, and the global market for mAbs in 2022 was $210.06 billion. Fully human mAb therapies are the least likely to produce an immune response in the patient, but up until this point there was no fully human anti-CD3 mAb at the clinical trial stage. 

Now Tiziana Life Sciences has successfully completed phase 1 trials for Foralumab, a fully human anti-CD3 mAb for treating patients with non-active secondary progressive multiple sclerosis (SPMS). Though the drug has the potential to treat multiple diseases, the company is focusing its attention on non-active SMPS, as there are currently no other Food and Drug Administration (FDA)-approved treatments for this condition.

Because Foralumab is an anti-CD3 drug targeting the immune system, it is important it doesn’t activate an immunogenic response. As a fully human mAB, it is less likely to activate the response than either mouse or chimeric mAB therapies. This could give Foralumab a significant advantage as an immunomodulator for treating autoimmune disorders, such as non-active SPMS.

Foralumab aims at suppressing inflammation in the immune system, by improving the production of and enhancing the function of regulatory t-cells (Tregs). The drug is able to pass the blood-brain barrier (BBB) and suppress effector T-cells which are causing neuroinflammatory activity.

After a 13-week toxicology report, the drug demonstrated a robust safety profile and hasn’t caused any serious adverse events in either pre-clinical or human studies. An open-label expanded access (EA) program saw favorable results, including one patient (EA2) whose expanded disability status scale (EDSS) score fell by a whole point from 6.0 to 5.0. This indicated a regression of the SPMS, where a change in .5 would have been statistically significant. 

Tiziana was excited with these results and will be beginning the phase 2 trial in Q3 2023. The trial will last three months and will be randomized and placebo-controlled.

Learn more about what Tiziana Life Sciences is doing to change monoclonal antibody therapies.

Featured photo by Chokniti Khongchum on Pexels 

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