foralumab oral (TZLS-401 oral) / Tiziana Life Sci, Light Chain Biosci - LARVOL DELTA

Tiziana Life Sciences Ltd Reports Annual Results for the Twelve Months Ended December 31, 2022, and Corporate Update (GlobeNewswire) - "Tiziana Life Sciences, Ltd...announced financial results for the twelve months ended December 31, 2022, and provided a corporate update on its lead programs in development....Research and development (R&D) expenses decreased to $13.0 million compared to $13.2 million in the twelve months ended 31 December 2021. The decrease is primarily related to the focus on the Company’s proprietary programs, foralumab and to a lower extent, IL6-R."

Commercial • Alzheimer's Disease • CNS Disorders • Crohn's disease • Immunology • Inflammatory Bowel Disease

Tiziana Life Sciences Ltd (“Tiziana” or “the Company”) - Updated Interim Results for the Six Months Ended 30 June 2022 (GlobeNewswire) - "Initiated a Phase 1b clinical trial in Crohn’s disease patients to evaluate oral capsules of foralumab, a fully human anti-cd3 monoclonal antibody. The revised protocol allowed for the study of a broader patient population and a shorter dosing period. These protocol amendments or revisions were intended to expedite patient enrollment with study completion targeted for the fourth quarter of 2022. This study was the first multiple-dose study with orally administered enteric-coated capsules of foralumab in patients with Crohn’s disease. Due to the refocus of the company subsequent to the first six months of 2022, this study has been placed on hold."

Trial suspension • Crohn's disease • Immunology • Inflammatory Bowel Disease

A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Tiziana Life Sciences, PLC | N=16 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Tiziana Life Sciences to Present at the 2022 Biotechnology Innovation Organization Annual Convention to Discuss Recent Updates to Ongoing Clinical Programs (GlobeNewswire) - "Tiziana Life Sciences Ltd...announced that its Chief Executive Officer and Chief Scientific Officer, Kunwar Shailubhai, Ph.D., will present at the Biotechnology Innovation Organization (BIO) Annual Convention taking place at the San Diego Convention Center, Monday June 13 - Thursday, June 16, 2022....He will also provide an update on the initiation of Phase 1b trial with ‘first-ever’ oral capsules of foralumab for treatment of patients with mild-to-moderately active Crohn’s Disease. Company management will also be participating in one-on-one meetings throughout the conference."

Clinical • Crohn's disease • Inflammatory Bowel Disease

A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Tiziana Life Sciences, PLC | Initiation date: Oct 2021 ➔ May 2022

Trial initiation date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Tiziana Announces Initiation of Phase 1b Clinical Trial in Crohn’s Disease Patients to Evaluate Oral Capsules of Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody (GlobeNewswire) - "Tiziana Life Sciences...announced initiation of a Phase 1b clinical trial to evaluate orally administered enteric-coated capsules of foralumab in patients with mild-to-moderate Crohn's Disease (CD). This revised protocol, as previously outlined in the Company’s announcement on February 4, 2022, allows for the study of a broader patient population and a shorter dosing period. These protocol amendments or revisions are intended to expedite patient enrollment with study completion targeted for the fourth quarter of 2022."

Trial completion date • Trial status • Crohn's disease • Inflammatory Bowel Disease

Tiziana Announces Submission of Amendment to Investigational New Drug Application to Advance Oral Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Patients with Crohn’s Disease (GlobeNewswire) - "Tiziana Life Sciences Ltd...announced submission of an amendment to an Investigational New Drug (IND) application for evaluation of orally administered capsules of foralumab, which it believes would be the first 'take home' immunotherapy, in patients with mild-to-moderately active Crohn’s Disease. If accepted by the U.S. Food and Drug Administration (FDA), the amendment is expected to expedite patient enrollment and completion of the foralumab Phase 1b study by the fourth quarter of 2022."

IND • New P1 trial • Crohn's disease • Inflammatory Bowel Disease

A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Tiziana Life Sciences, PLC

Clinical • New P1 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease