Benzinga | Jul 16, 2020 05:54AM EDT

Tiziana Announces Submission of Patent Application on Use of Foralumab, the Only Fully Human Anti-CD3 Monoclonal Antibody, to Enhance Success of CAR-T Therapy

Tiziana Life Sciences plc (NASDAQ:TLSA) is pleased to announce that it has submitted a patent application on potential use of Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), to improve success of CAR-T therapy for cancer and other human diseases. The patent application conveys inventions related to improving CAR-T expansion and/or survival using anti-CD-3 mAbs administered either alone or in combination with other co-stimulatory molecules, such as an anti-IL-6 receptor monoclonal antibody, an anti-CD28 monoclonal antibody or specific inhibitors of signaling pathways of phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR).

Foralumab treatment could potentially enhance expansion and survival of chimeric antigen receptor T cells (CAR-T) therapy for cancers and other human diseases

Foralumab may be co-administered either alone or in combination with other drugs to improve success of CAR-T therapy"The CAR-T is one of the most promising therapies utilizing T cells from your own immune system, which are genetically engineered and supercharged to hunt down and destroy cancer cells. In this context, we are developing oral and nasal administrations of Foralumab for the treatment of Crohn's Disease and progressive multiple sclerosis, respectively. The common underlying approaches in these programs are to strengthen your own body defenses to fight against these diseases. Being a fully human anti-CD3 mAb, Foralumab is most suitable for CAR-T therapy as it does not produce an immune response unlike other humanized anti-CD3 mAbs," commented Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.

Typically, CAR-T cell therapies are created using a patients' own T cells that have been engineered to express a chimeric antigen receptor (CAR) to reprogram the T cells to kill cancer cells. The CAR combines the specificity of a mAb with the cytotoxic and memory functions of T cells. CAR-T cell therapy has shown tremendous promise in the treatment of a variety of hematological and solid cancers, and potentially for patients with autoimmune diseases. Despite encouraging clinical success, relapse rates following CAR-T therapy are high, limiting the utility of this promising cancer therapy. An improved CAR-T therapy can be achieved through more efficient production processes by optimizing the ex vivo expansion conditions and/or providing concomitant therapies utilizing anti-CD3 mAbs, either alone or in combination with other co-stimulatory molecules such as an anti-IL-6 receptor mAbs, an anti-CD28 mAbs or specific inhibitors of signaling pathways of phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR).

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 ("MAR"), encompassing information relating to the Placing as described above, and is disclosed in accordance with the Company's obligations under Article 17 of MAR.

The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Exectuive Officer and Chief Scientific Officer of the Company.