NoveCite has signed an exclusive licence with Novellus Therapeutics Limited to develop and commercialise NoveCite induced pluripotent stem cell (iPSC)-derived mesenchymal stem cells (NC-iMSCs) to treat acute respiratory conditions, with a near-term focus on COVID-19 associated Acute Respiratory Distress Syndrome (ARDS).

According to Citius Pharmaceuticals Inc. (NoveCite’s parent company), early clinical trials and emergency authorisation programmes using MSCs to treat ARDS have demonstrated that the cell therapies reduce inflammation, enhance clearance of pathogens and stimulate tissue repair in the lungs.

The company states that iMSCs are the next generation MSC therapies, believed to be differentiated and superior to donor-derived MSCs because they overcome several of the challenges associated with human donor-derived MSCs (eg, variable donor and tissue sources, limited supply, low potency, inefficient and expensive manufacturing). According to Citius, iMSCs are more potent and secrete exponentially higher levels of immunomodulatory proteins; have a practically unlimited supply; are cloned from a single donor to be economically produced at scale with consistent quality and potency; and as a result have significantly higher expansion capability.

Each year there are 3 million cases of ARDS globally, approximately 200,000 of these occur in the US. The COVID-19 pandemic has added significantly to the number of ARDS cases. When a COVID-19 patient develops ARDS, they are put on a mechanical ventilator. The death rate for patients on ventilators can be as high as 50 percent, depending on associated co-morbidities, because there is no approved treatments and the current standard of care only attempts to provide symptomatic relief.

“NoveCite iMSCs have the potential to be a breakthrough in the field of cellular therapy for acute respiratory conditions because of the high potency seen in Novellus’ pre-clinical studies and because iMSCs are iPSC-derived, and therefore overcome the manufacturing challenges associated with donor derived cells,” said Myron Holubiak, Chief Executive Officer of Citius.

“We are excited to be part of this effort because of the promise to save lives and reduce long term sequelae in patients with devastating respiratory diseases such as ARDS caused by COVID-19,” said Dr Matthew Angel, Chief Science Officer of Novellus.  “Our iMSC technology has multimodal immunomodulatory mechanisms of action that make it potentially promising therapy to treat acute respiratory diseases.”

NC-iMSC therapies

NoveCite’s mesenchymal stem cell therapy product is derived from a human iPSC line generated using a proprietary mRNA-based reprogramming process. The NC-iMSCs produced from this clonal technique are genetically homogeneous. In in vitro studies, NC-iMSCs exhibited superior potency and high cell viability compared to donor-derived MSCs, they also secreted more immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with ARDS in patients with COVID-19.