Although many COVID-19 clinical trials have focused on decreasing the hyper-inflammatory phase that often occurs in patients and can cause substantial damage, there is a growing recognition that this phase is generally temporary. Often this is followed by a stage of immune exhaustion and T cell loss. In this clinical trial, sponsor Revlmmune will investigate the use of CYT107 for immune therapy: specifically to increase the number of immune T cells and correct immune exhaustion, part of its “ILIAD” Phase 2 treatment for COVID-19.
What is CYT107?
CYT107 is a therapeutic form of the master growth factor for human T cells: Interleukin-7 (IL-7). CYT107 has been administered to over 440 patients in clinical trials and is known to substantially increase the number and diversity of T cells, including in patients in the ICU with low and exhausted T cell levels from overwhelming infections CYT107 has an excellent safety profile, even in very sick patients.
The sponsor reports that the effects of CYT107/IL-7 in restoring immune levels are both rapid and durable. The treatment involves just two administrations per week for 2-4 weeks. In clinical trials to date, the effects have been observed within days of commencing administration of CT&107, and have been seen to continue for up to a years after the 2-4 week administration. The sponsor posits that this lasting effect of the investigational therapy, to maintain the increase in immune cells over time is important in preventing late infections that are frequent cause of patient relapse and hospital readmission.
CYT107/IL-7 can readily be combined with other treatments as well. For example, CYT107/IL-7 can be combined with treatments such as Remdesivir, other anti-viral treatments and/or anti-inflammatory treatments. Thus, CYT107 offers a novel means of improving outcomes in COVID-19 and other infectious diseases by safely strengthening the patient’s own immune system.
Relevant Data for COVID-19 Cases
Sponsor Revlmmune reports that based on data being generated from China and Italy to America, patients who are passing due to COVID-19 have significant loss of lymphocytes and face a 50% incidence of developing a secondary-hotel infections reports Dr. Ken Remy, Washington University St. Louis. Moreover the research from a multi-center Phase 2 clinical trial involving Revlmmune and Dr. Richard Hotchkiss, Washington University St. Louis suggests that CYT107 can reverse lymphopenia (low levels of T cells) and boost immunity in subjects with dangerous sepsis. Hence the doctor commented “We believe that IL-7C/CYT107 represents an important new approach for treating immune-suppressed patients with a variety of diseases.”
Part of the “ILIAD” Phase 2 trial for treatment of COVID-19, was selected by the UK National Health System for designation as an “urgent public health national priority.” The trial opened in the UK in mid-May and is enrolling patients at 10 sites across the UK. The trial opened in France and Belgium in early June. Preparation for the trial are under way in America.
The sponsor has also treated 12 COVID-19 patients on a compassionate use basis. The data derived from this effort supports the ILIAD trial design and are in the process of peer reviewed publication.
The biotech sponsor is collaborating with a team of leading experts in critical care and immunology including:
· Dr. Manu Shankar-Hari, Principal Investigator leading the UK trial cohort
· Dr. Bruno Francois, Principal Investigator, leading the France and Belgium trial cohort
· Dr. Richard Hotchkiss, Washington University St. Louis
· Ken Remy, Washington University St. Louis
· Lyle Moldawar, University of Florida, Gainesville
· Scott Brakenridge, University of Florida, Gainesville
· Dr. Martin A. “Mac” Cheever, Director of the Cancer Immunotherapy Trials Network (Fred Hutchinson Cancer Research Center)
A privately held biotech firm based in France, the U.S. and the UK, Revlmmune is in multiple Phase 2 clinical trials with CYT107 for treatment of sepsis, certain infectious diseases and certain cancers. Over 440 patients have been treated with CYT107 in Revlmmune’s prior trails for multiple different viral diseases and sepsis. The investigational product has exhibited a good safety profile and encouraging results in those trials.
The company was founded in France in the 2000s and resumed by investors in 2013 the United States. The company’s headquarters is now in Bethesda, MD, with an operational office in France. The company’s pipeline can be seen here.