Israeli cell therapy biotech Pluristem Therapeutics has secured up to €50M in non-dilutive funding from the European Investment Bank to progress its coronavirus-targeting cell therapy to phase III.
The partners plan to sign the funding agreement at the end of April and Pluristem will initially receive €20M followed by two further installments totaling up to €30M. The later payments will depend on the achievement of agreed milestones relating to clinical development, regulatory approval, and scaling up of production.
Pluristem focuses on developing placenta-cell based therapies targeting a range of diseases. Its most advanced candidates are cell therapies to combat critical limb ischemia, where reduced blood flow often leads to amputation or death, and to rebuild muscle after hip fracture.
The company has a wholly-owned subsidiary branch in Berlin. It also announced in March that it planned to work with the Charité University of Medicine in Berlin to develop a cell therapy treatment to target the respiratory and inflammatory complications that affect some patients infected with the Covid-19 coronavirus.
Pluristem’s ‘PLX’ cell therapies are ‘off the shelf’, meaning that they are not taken from the people being treated and can be given to patients without specific tissue or genetic matching. The cells the company is using to treat Covid-19 are designed to activate immune system cells — regulatory T cells and M2 macrophages — that can help reduce the excessive immune response seen in some patients with the virus.
“In serious cases of Covid-19, patients may experience a cytokine storm, which can result in acute respiratory distress syndrome, and other serious and potentially fatal complications,” Michael Lehmicke, Director of Science and Industry Affairs at the Alliance for Regenerative Medicine, told me.
He added that, while there are currently no approved therapies for Covid-19, there is some evidence that cells with properties like that of Pluristem’s cell therapy “may mitigate a severe inflammatory response like that experienced by patients with severe cases of Covid-19.”
Since March, Pluristem reports it has treated seven patients with Covid-19-induced acute respiratory distress syndrome in Israel and one in the US as part of a ‘compassionate use’ program. While the numbers are too small to be conclusive, the initial results seem promising, with more than half of the Israeli group showing positive signs of recovery after a week. The company now plans to start a multinational phase III trial of its therapy.
“As we move forward into a multinational clinical trial for PLX cells to treat patients suffering from complications associated with Covid-19, we expect this EIB financing will accelerate our path to approval and to making a potentially effective Covid-19 treatment available worldwide,” Pluristem CEO and President, Yaky Yanay, said in a public statement.
Pluristem is not the only company hoping to treat Covid-19 using cell therapy. Australian biotech Mesoblast also has an allogeneic cell therapy targeting patients with acute respiratory distress syndrome. In a small recent study in the US, 75% of patients given two infusions of the therapy came off ventilator support within 10 days. US biotech Athersys has also recently had the go-ahead from the US FDA to start a trial of its cell therapy, also designed to treat respiratory complications of Covid-19.
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