Tiziana Life Sciences (NASDAQ: TLSA) Announces Positive Data In Its Secondary-Progressive Multiple Sclerosis Trial, What Could This Mean For The Company?

Company Moves Ahead With Drug Development

Tiziana Life Sciences recently announced positive data of reduction in microglial activation as seen in 3-month Positron Emission Tomography (PET) scans. This has now been seen in a total of 5 of the 6 patients with non-active secondary-progressive multiple sclerosis (na-SPMS) treated with intranasal foralumab in its Expanded Access program. Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory diseases including multiple sclerosis, Alzheimer’s disease and amyotrophic lateral sclerosis (ALS). Results confirm the positive signal previously reported in the first two Expanded Access patients who both subsequently demonstrated clinical improvements. The company is going to move forward with clinical development with a Phase 2a trial to begin in Q3 2023. 

Tiziana hosted a KOL webinar to review the results, and Howard L. Weiner, M.D., Chairman of Tiziana's Scientific Advisory Board and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, explained the significance of the results HERE.

Tiziana’s drug Foralumab has already been singled out for its unique and novel potential as an immunomodulating therapy. There are no drugs currently approved by the Food and Drug Administration (FDA) for non-active SPMS, and its regulatory T-cell (Treg)-enhancing activity has been shown to dampen inflammatory responses in a subset of immune cells.

Tiziana’s First-In-Class Drug Product 

Tiziana Life Sciences TLSA is developing the first fully human, anti-CD3 mAb. The drug, Foralumab, will treat patients suffering from non-active, secondary progressive multiple sclerosis (SPMS), though it could also have applications in other CNS diseases. 

Fully human mAb’s are the latest generation of mAb technology. Fully human mAb’s have a lower incidence rate of anti-drug antibodies (ADAs) than either humanized or chimeric drugs. This means they are less likely to be identified by the host immune system as a foreign antigen and cause an immunogenic response in the patient, though some immune responses to fully human mAb’s have been reported. 

Sanofi (NASDAQ) Acquires Provention Bio for $2.9 Billion

Sanofi SNY has just agreed to purchase Provention Bio PRVB at $25 per share – over three times the biotech’s stock price – for around $2.9 billion. As a leading international pharmaceutical and healthcare company with a market cap of over $140 billion, this is Sanofi’s second-largest acquisition ever. 

The acquisition will boost Sanofi’s drug portfolio by adding a first-in-class type 1 diabetes therapy – Provention’s anti-CD3 monoclonal antibody (mAb) drug Teplizumab – to it. Adding this drug aligns strategically with Sanofi’s long-term position at the intersection of immune-mediated diseases and disease-modifying therapies in areas of unmet medical need. 

The multi-billion purchase of Provention by Sanofi Sofio suggests that there is serious interest in the medical market for immunosuppressive mAb therapies. This could put Tiziana in an exciting position as the developer of the first fully human anti-CD3 mAb, especially as this drug is an immunomodulator. 

The global market for mAb’s was $210.06 billion in 2022. Both Provention’s Teplizumab and Tiziana’s Foramulab are anti-CD3 mAb’s, meaning they are immunosuppressive drugs used to reduce inflammation in the body. mAb drugs are categorized as animal, chimeric, humanized or fully human based on whether the drugs use animal or human proteins. Teplizumab is classified as a humanized drug.

Click here to learn more about how Tiziana Life Sciences is tackling Multiple Sclerosis.

Featured photo by Ousa Chea on Unsplash

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