Candidate: TZLS-501

Category: ANTIBODY

Type: Fully-human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb) for treatment of patients infected with SARS-CoV-2, delivered directly into the lungs using a handheld inhaler or nebulizer.

Status: Tiziana said August 24 it has been granted U.S. Patent No. 10,759,862, to be published September 1, for methods and use of fully human monoclonal antibody (mAb; TZLS-501) that recognizes both IL-6 receptor (IL-6R) and IL-6 receptor complex with IL-6 (IL-6R/IL-6) for prophylactic and therapeutic intervention for human diseases.

Tiziana said it was expediting clinical development of TZLS-501, as well as GMP manufacturing by simultaneously developing inhalation delivery directly to the lungs using a nebulizer and conducting an inhalation safety toxicology studies in Cynomolgus monkeys. “Completion of these studies will enable us to file an IND and initiate a clinical trial in COVID-19 patients by Q1 2021,” said Kunwar Shailubhai, PhD, MBA, CEO and CSO of Tiziana.

He added that Tiziana plans to use TZLS-501 with the same inhalation delivery technology for the treatment of patients with acute respiratory distress syndrome (ARDS).

Tiziana submitted a provisional patent application for the delivery technology in April. The application covered treatment with the monoclonal antibody, as well as prophylactic intervention with a vaccine candidate, designed from Spike (S) protein of COVID-19.

Tiziana acquired TZLS-501, formerly called NI-1201, from Novimmune in 2017 for undisclosed upfront, milestone, and future royalty payments: “We view NI-1201 as a potential game-changer for addressing the high unmet need of autoimmune and inflammatory diseases,” Tiziana Executive Chairman Gabriele Cerrone stated at the time. The license is now maintained by Bristol-Myers Squibb.


COVID-19: 200 Candidates and Counting

To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:

● ANTIVIRAL
● VAX
● ANTIBODY
● RNA