Biopharma investors were recently wowed by data from a pipeline drug from Provention Bio which could delay the onset of type 1 diabetes in at-risk patients – and now UK biotech Tiziana is promoting its own contender in the field.
The share price of Provention Bio doubled last month after it released data which showed its immunotherapy PRV-031 (teplizumab) could delay the onset of of type 1 diabetes in children and adults by a median of two years. Teplizumab is a mouse derived anti-CD3 mAb, and is administered intravenously. It is being evaluated in the treatment of a range of autoimmune diseases, including type 1 diabetes among others.
The rise in share price followed a study published in The New England Journal of Medicine, which contained results from Provention’s phase 2 trial in 76 patients at risk of developing Type 1 diabetes (T1D)who were given teplizumab. These results showed a significant delay in the onset and diagnosis of Type 1 diabetes when compared to placebo, by a median of 2 years in high-risk children and adults. The results were even more impressive for a subgroup of patients, around 60%, who did not develop the condition at all in the study period.
Now Tiziana is looking to rival Provention with the development of its own anti-CD3 mAB foralumab, which it says is the only entirely human anti-CD3 mAb. According to Tiziana, foralumab has potential benefits over Provention’s teplizumab because it is not mouse derived, which offers safety and efficacy advantages.
Tiziana have also cited the benefits of foralumab’s administration when compared to teplizumab, which is administered by injection. Comparably, foralumab is administered orally or nasally, which the UK biotech sees as an extra advantage – it potentially could provide clinical benefits, as patients are more likely to comply with the treatment.
Kunwar Shailubhai
Kunwar Shailubhai, CEO & CSO of Tiziana said “Children and adults at high risk of developing Type 1 diabetes may benefit from safe and effective prophylactic use of anti-CD3 mAb’s. We congratulate Prof. Kevan Herold, a member of Tiziana’s Scientific Advisory Board, and the research team that conducted the published study. Tiziana’s proprietary technology for the oral and nasal delivery of mAb’s in general, and foralumab specifically, have strong potential indications in autoimmune diseases including Type 1 diabetes.
The phase 2 compound of foralumab has potential applications in a variety of autoimmune and inflammatory diseases, which Tiziana has based on promising animal studies. These show that when nasally or orally introduced, the drug has the potential for the immunotherapy of autoimmune and inflammatory diseases safely by the induction of regulatory T cells that play a key role in the prevention of autoimmunity.
Currently, Foralumab is in a phase 1 trial at the Harvard Medical School to study its effects on neurodegenerative disease through nasal delivery. Tiziana have also planned an upcoming phase 1 trial which will evaluate the use of foralumab’s use in Crohn’s disease and nonalcoholic steatohepatitis (NASH), with a phase 2 trial expected to start next year.