Tiziana Life Sciences Ltd (NASDAQ:TLSA) reported promising in-depth findings on the utility of its lead candidate, intranasal foralumab, which is the only fully human anti-CD3 monoclonal antibody (mAb), in the treatment of intracerebral hemorrhage (ICH), a subtype of stroke.
The New York-based biopharmaceutical company said the data using a mouse model of collagenase-induced ICH was shared in a presentation at the Annual American Academy of Neurology conference.
“Intracerebral hemorrhages are the deadliest form of acute stroke with early mortality ranging from 30% to 40%,” said Dr Howard L Weiner, chairman of Tiziana's Scientific Advisory Board and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital.
“It has been well demonstrated that microglial activation and edema play a critical role in the morbidity and mortality of this devastating event.”
The presentation was made at the AAN conference by Saef Izzy, from the Neurocritical Care faculty at Brigham and Women’s Hospital. He is also the assistant professor of neurology at Harvard Medical School.
“Currently, there are no effective interventions for ICH. Our research studied the effect of an intranasal anti-CD3 antibody in a mouse model of induced ICH,” said Izzy. “I believe that intranasal anti-CD3 represents a novel therapeutic approach for treating ICH as well as potentially other types of acute brain injury.”
Specifically, the study showed that intranasal anti-CD3 antibody reduced ICH injury severity, improved motor coordination recovery, boosted memory retention and functional recovery, accelerated hematoma resolution at seven days after ICH, reduced neuronal cell death at seven days after ICH, and reduced blood-brain barrier (BBB) leakage at three days after ICH.
The company also highlighted the following findings from the study:
- Reduced microgliosis at seven days after ICH
- Reduced astrocytosis at seven days after ICH
- Increased CD4+FoxP3+ and FoxP3+ IL10+ dependent Tregs at the site of hematoma at seven days after ICH
- Increased anti-inflammatory and reduced pro-inflammatory cytokines at the site of hematoma at seven days after ICH
- Upregulated microglial phagocytic transcriptomic profile at seven days after ICH
- Modulated microglial and astrocyte transcriptomic inflammatory profile after ICH
“The comprehensive and consistent findings of Dr Izzy’s research strongly supports the promising role of intranasal foralumab…and its potential for broad applications in neuroinflammation, including the treatment of acute ICH,” said Tiziana founder and interim CEO Gabriele Cerrone.
“These exciting findings may allow Tiziana to explore additional intranasal foralumab neuroinflammatory indications to help patients with unmet needs and create further shareholder value”.
Activated T cells play an important role in the inflammatory process. Foralumab, binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets.
Tiziana is developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive