• The authors conclude that “nasal anti-CD3 has the potential to be a non-toxic novel immunotherapeutic approach for the treatment of Alzheimer’s disease (AD)”

• FDA has cleared the IND for intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for human study in mild to moderate Alzheimer’s Disease

• The publication shows anti-CD3 monoclonal antibody (mAb) administered intranasally, ameliorates disease in a 3xTg model of Alzheimer’s disease by targeting microglial activation in the brain, while expanding regulatory T cells in the periphery

• Remarkably, this reduced microglial activation and improved cognition occurs independent of amyloid beta disposition.

• The full publication can be found HERE 

Tiziana’s Foralumab Is A Promising  Treatment With Potential To Treat Multiple Neurological Diseases

“The anti-CD3 target is established and it’s validated,” said Tiziana COO and CMO Mathew Davis at a recent conference. “We are the only company that is delivering this intranasally. We are the only company that is in the clinic with a fully human anti-CD3 antibody.”

The anti-CD3 monoclonal antibody used in Tiziana’s Foralumab binds to the CD3 receptor on the surface of T cells, typically used as a way to suppress the immune system to prevent transplant rejection or treat autoimmune disease. 

The challenge in treating these kinds of conditions has long been finding the balance between suppressing the immune response to protect the patient without harming the body’s ability to fight off actual threats like viral infections and bacteria. 

However, research shows that anti-CD3 antibodies can do just that. They are able to selectively dampen the autoimmune response – when the dysregulated immune system attacks the body’s own cells and tissue – without limiting its ability to detect and respond to external threats.  

Tiziana’s Foralumab is the only anti-CD3 monoclonal antibody treatment in clinical trials that is fully human — a significant differentiator as these tend to come with fewer adverse reactions than those that are genetically engineered.

It’s also the only one that’s delivered via an intranasal spray, making it less invasive than an infusion and allowing it to travel directly to the T cells in the patient’s lymph nodes. 

In the neurological diseases that Tiziana is focused on, this formulation has allowed its lead drug candidate to bind to regulatory T cells, then these T cells activate and create Tregs which are specifically tasked with maintaining homeostasis and preventing the immune system from attacking itself. Once Foralumab creates these Tregs, they can cross through the blood-brain barrier and help fight neuroinflammation at its source. 

Tiziana Highlights Past Results And Upcoming Milestones Across Foralumab Clinical Trials

During a recent investor conference, Davis focused on the exciting results Tiziana has seen so far from its clinical trials and highlighted some of the upcoming milestones and plans for the year ahead. 

In fact, Davis noted that all of the patients in its clinical trials had previously tried Ocrelizumab and discontinued it when their symptoms continued to progress. In its ongoing expanded access program, for example, the Tiziana COO and CMO spoke about a patient who had discontinued the anti-CD20 treatment in 2021 when his condition had become so bad that he could no longer walk more than 100 feet without assistance. 

The non-active SPMS patient enrolled in Tiziana’s expanded access program in January 2022. “By the end of 2022, he was able to walk without assistance,” Davis said. “He’s back in his job and, as of this recording, he continues to walk without assistance.”

In the biopharma’s most recent data readout, other patients from the expanded access program started to show similar improvement. Three of the four patients currently enrolled saw their fatigue scores decrease after three months. Meanwhile, a phase 1 trial found that microglia – a part of the innate immune system inside the brain – had significantly decreased activation in the brains of 5 out of 6 treated patients after three months.

Davis said another data readout is expected soon, detailing the results from the expanded access program after six months of treatment. Tiziana has begun clinical site selection and plans to start a phase 2a trial in non-active SPMS before the end of this year with topline data expected by the end of 2024. 

To learn more about Tiziana, click HERE

Featured photo by Jesse Orrico on Unsplash.

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