EUR 6 million grant for project led by Novimmune

Led by NovImmune, the FIGHT HLH Consortium includes leading institutions working to combat the impact of HLH, an orphan disease, on patients and their families. It includes Meyer University Children Hospital in Florence, Pediatric Hospital Bambino Gesù in Rome and Lonza Biologics Plc.

Cristina de Min, NovImmune Chief Medical Officer, noted, "Thanks to the excellent collaborative work of the FIGHT HLH Consortium members and support from the European Commission, we are poised to commence clinical study of NI-0501 in HLH patients. The program is designed to give a clear readout on the ability of the drug to affect disease course and benefit these high-need patients."

The Principal Investigator of the first clinical trial of the FIGHT HLH program, Prof. Maurizio Aricò, commented, "We are thrilled by the opportunity to collaborate with NovImmune to advance NI-0501 into clinical development as the evidence is compelling that interferon-gamma (IFNγ) is a primary driver of the disease and dramatic results in preclinical models have been demonstrated."

The development program for NI-0501 in HLH has been designed with the participation of key experts in both Europe and the USA.

"NovImmune is delighted to have been selected by the European Commission for such a prestigious grant, as NI-0501 holds the potential to become the first approved and targeted therapy to fight HLH," noted Jack Barbut, CEO of NovImmune.

About HLH

Hemophagocytic lymphohistiocytosis (HLH) is a severe immune system disorder, the genetic underpinnings of which are becoming clear. HLH is caused by a severe impairment of cytotoxic T cell function that triggers aberrant activation of the immune system. This is mediated to a large degree by dramatic increase in levels of IFNγ — the target of NI-0501. The primary form of the disease typically arises in pediatric patients, is lethal if untreated, and has a 40% mortality rate with current best available care. The secondary form of the disease typically arises later in life, and is also associated with significant mortality. HLH is an orphan disease for which no drugs have been approved, representing a high-unmet-need.