RevImmune Announces Phase II Trial of the T-Cell Growth Factor CYT107 for COVID-19

Under Way in Europe Since May,In Preparation in the U.S.

Designated As An Urgent Public Health National Priority In U.K.

BETHESDA,Maryland,June 29,2020 -- RevImmune,a privately held biotechnology company developing CYT107 immune therapy for infectious diseases and cancer,announced today that it has launched the "ILIAD" Phase II trial for treatment of COVID-19.

Many COVID-19 clinical trials have focused on decreasing the hyper-inflammatory phase that often occurs in COVID-19 patients and can cause substantial damage. However,there is a growing recognition that the hyper-inflammatory phase is generally temporary,and is often followed by a stage of immune exhaustion and T cell loss. Therapy with CYT107 is designed to substantially increase the number of immune T cells and correct the immune exhaustion.

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 "ILIAD" Phase II trial of CYT107 for COVID-19 was selected by the U.K. National Health System for designation as an "urgent public health national priority." The trial opened in the U.K. in mid-May and is enrolling patients at 10 sites across the U.K. The trial opened in France and Belgium in early June. Preparations for the trial are under way in the U.S.

In addition to the clinical trial in COVID-19,RevImmune has also treated 12 COVID-19 patients on a compassionate use basis. The data from the compassionate use cases support the ILIAD trial design and are in the process of peer reviewed publication.

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 seen within days of beginning administration of CYT107,and have been seen to continue for up to a year after the 2-4 week administration. This lasting effect of CYT107 to maintain the increase in immune cells over time is important in preventing late infections that are a 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 inCOVID-19 and other infectious diseases by safely strengthening the patient's own immune system.

RevImmune is collaborating with a team of leading experts in critical care and immunology,including: Dr. Manu Shankar-Hari,the Principal Investigator leading the U.K. trial cohort,Dr. Bruno Francois,the Principal Investigator leading the trial cohort in France and Belgium,as well as Drs. Richard Hotchkiss and Ken Remy at Washington University in St. Louis,Drs. Lyle Moldawer and Scott Brakenridge at the University of Florida Gainesville,and Dr. Martin A. "Mac" Cheever,Director of the Cancer Immunotherapy Trials Network (CITN) at the Fred Hutchinson Cancer Research Center.

Dr. Remy commented: "data over the past few months from China,Italy,and the US have demonstrated that patients with COVID-19 infections have a sustained and severe loss of lymphocytes with a profound immune suppression. Patients who succumb to COVID-19 have the most severe loss of lymphocytes and have a 50% incidence of developing secondary hospital-acquired infections."

Dr. Hotchkiss explained that "IL-7 has well documented anti-viral activity in immuno-suppressed patients with HIV,hepatitis C,and JC virus. In addition,in a multi-center Phase II trial that we conducted with RevImmune,CYT107 also reversed lymphopenia (low levels of T cells) and improved immunity in patients with life threatening sepsis. We believe that IL-7/CYT107 represents an important new approach for treating immune-suppressed patients with a variety of infectious diseases."

About RevImmune

RevImmune is a privately held biotech company based in France,the U.S. and the U.K. RevImmune is in multiple Phase II trials with CYT107 for treatment of sepsis,certain infectious diseases and certain cancers. Over 440 patients have been treated with CYT107 in RevImmune's prior trials for multiple different viral diseases and sepsis. CYT107 showed an excellent safety profile and encouraging results in those trials.

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