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Tiziana Life Sciences receives US patent protection for a potentially transformational oral delivery method for monoclonal antibody treatment

  • This is the first-ever granted patent on oral administration of anti-CD3 monoclonal antibodies for immunotherapies
  • The transformational oral formulation technologies are applicable to other antibodies as well
Tiziana Life Sciences PLC - Tiziana Life Sciences receives US patent protection for a potentially transformational oral delivery method for monoclonal antibody treatment

Tiziana Life Sciences PLC (LON:TILS) (NASDAQ:TLSA) has received a US patent for a breakthrough oral formulation of a monoclonal antibody that has been hailed as offering a “transformational avenue for immunotherapies”.

The patent protects the “lyophilised and stabilised free-flowing powder” of Foralumab contained in enteric-coated capsules for oral treatment of disease.

This first-in-class formulation allows Tiziana to work on drugs for Crohn’s, multiple sclerosis and Alzheimer’s disease that can be administered by mouth rather than requiring a painful intravenous line or injection.

The technology could also help eradicate many of the toxic side-effects of the intravenous use of mAbs such as Foralumab.

Adding to the potential of the drug, Tiziana has now successfully demonstrated that nasally-administered Foralumab is not only well-tolerated but also produces the “desirable immunological responses”.

Alzheimer’s grant

Indeed, Dr Howard Weiner, chairman of the company’s scientific board, has received a US research grant to investigate the nasal application for the treatment of Alzheimer’s disease.

The NIH award provided third-party validation of his work in an area of great unmet medical need, analysts said.

“We believe the development of alternative administration routes of antibodies such as oral, nasal, and inhalation could potentially be transformational for immunotherapies,” said Gabriele Cerrone, chairman and founder of Tiziana.

Anti-CD3s such as Foralumab bind to the surface of T-cells meaning they are immune-suppressive drugs.

Explaining the new mode of action, Weiner said: “Both oral and nasal administration routes are physiologic approaches to stimulate the mucosal immune system to induce disease-modifying benefits.”

The group has successfully completed two phase I trials – respectively for the oral and nasal indications.

Avoids toxicities

Crucially, in both clinical studies, the severe toxicities commonly associated with intravenous administration of anti-CD3 mAbs were not observed.

Foralumab is emerging as the jewel in the crown for Tiziana, which has clinical and pre-clinical assets spanning cancers, autoimmune and inflammatory diseases.

It also has a potentially best-in-class cancer diagnostic platform that it is spinning out into a separate company.

Eminent Wall Street analyst Raghuram Selvaraju, of H.C. Wainwright, recently flagged the huge potential value of the business, when he set a price target for the shares US$25, or £5 here in the UK. To put that in perspective, the US-listed American depository shares closed at $6.03 each and the LSE-quoted stock finished at 90p on Thursday.

Humira paves the way

Possibly overlooked by investors and touched on only briefly in Selvaraju’s note is the significant potential Foralumab, which is in the same class of medication as Humira, the world’s biggest-selling drug with sales of US$19.9bn in 2018.

Sold by AbbVie Inc (NYSE:ABBV), the monoclonal antibody treats ailments such as arthritis, Crohn’s, ulcerative colitis, and psoriasis.

With reference to Foralumab, Tiziana chairman Cerrone told Proactive: “Being able to deliver monoclonal antibodies orally for the first time is a game-changer. Most monoclonal antibody drugs such as AbbVie’s Humira are administered intravenously.”

In Friday morning trading, shares in Tiziana in London were 13.9% higher at 102.50p.

 -- Adds share price --

Quick facts: Tiziana Life Sciences PLC

Price: 114 GBX

Market: AIM
Market Cap: £189.71 m


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