Tiziana Life Sciences Receives FDA Fast Track

Tiziana Life Sciences, Ltd. (Nasdaq: TLSA), a biotechnology firm focused on innovative immunomodulation therapies, announced a major milestone on July 24, 2024. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its intranasal formulation of foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS). This designation is intended to expedite the development and review process of drugs that address serious conditions with unmet medical needs.

Fast Track designation offers several advantages, including more frequent meetings with the FDA to discuss the drug's development plan, eligibility for Accelerated Approval and Priority Review if specific criteria are met, and a potential Rolling Review of the New Drug Application (NDA).

Expressing his excitement, Gabriele Cerrone, Chairman, acting CEO, and founder of Tiziana Life Sciences, noted that the designation highlights the potential of foralumab in addressing critical unmet needs in treating neurodegenerative diseases. Dr. William Clementi, Chief Development Officer of Tiziana Life Sciences, also emphasized the innovative approach of intranasal delivery, which aims to effectively target neuroinflammation, a key factor in the progression of neurodegenerative diseases such as Multiple Sclerosis, Alzheimer’s Disease, and Amyotrophic Lateral Sclerosis (ALS).

Intranasal foralumab is designed to modulate the immune system and reduce neuroinflammation. Early clinical data have shown promising therapeutic benefits and a favorable safety profile. Currently, 10 patients with na-SPMS have participated in an open-label intermediate-sized Expanded Access (EA) Program, with either improvement or stability of the disease observed within six months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. Additionally, intranasal foralumab is being examined in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with na-SPMS (NCT06292923).

In another development, Tiziana Life Sciences received a written notice from The Nasdaq Stock Market LLC on July 19, 2024, stating that the company failed to maintain a minimum bid price of at least $1.00 for a minimum of ten consecutive business days before the end of the Nasdaq grace period. Consequently, the company's ordinary shares will be subject to delisting from The Nasdaq Capital Market on July 29, 2024, unless the company requests a hearing before the Nasdaq Hearings Panel. Tiziana Life Sciences intends to request a hearing and present its plan to comply with the minimum bid price requirement, thereby staying any delisting action pending the Panel’s decision and any additional extension period granted.

Foralumab, the only fully human anti-CD3 monoclonal antibody, plays a significant role in modulating T cell function and dampening inflammation. This effect has been demonstrated in patients with COVID, multiple sclerosis, and healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial began screening patients in November 2023. Immunomodulation by nasal anti-CD3 monoclonal antibody represents a novel treatment avenue for neuroinflammatory and neurodegenerative diseases.

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies. Their innovative nasal approach aims to improve efficacy, safety, and tolerability compared to intravenous delivery. The company’s lead candidate, intranasal foralumab, has shown a favorable safety profile and clinical response in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending, expected to support a broad pipeline of applications.