A little over three and a half years since coming out of stealth, OncoImmune is back with a new fundraise.
The Maryland-based biotech announced a $56 million Series B early Wednesday morning, seeking to support two Phase III trials for its lead program CD24Fc. The candidate is being tested in the treatment of severe Covid-19 cases in one study and leukemia patients prone to acute GVHD in the other.
OncoImmune’s existing investors, 3E Bioventures Capital and Kaitai Capital, led the round and were joined by new investors, GBA Fund and GF Xinde.
The CD24Fc compound is a recombinant fusion protein regulating inflammatory responses that OncoImmune hopes will have broad applications in cancer, autoimmune diseases, metabolic syndrome and GvHD. The biotech’s Phase IIa study in aGvHD showed a significant improvement in survival after 180 days, which is also serving as the Phase III primary endpoint.
That indication had been OncoImmune’s main target before the Covid-19 pandemic reared its ugly head. Given the CD24Fc program’s function as an inflammatory dampener, the biotech initiated its Phase III for severe Covid-19 in late April aiming to target the cytokine storm caused by the virus. OncoImmune is testing a single dose of its candidate — 480 mg by IV infusion.
OncoImmune’s Phase III Covid-19 trial is expected to enroll 270 patients, and the company announced the first 70 had been randomized for CD24Fc or placebo around mid-June. Those being evaluated in the study either require supplemental oxygen support or high flow oxygen non-invasive ventilation, in addition to ICU patients requiring invasive mechanical ventilation. Topline results are expected “soon,” the company said Wednesday.
Since CD24Fc works via a mechanism that does not duplicate that of other experimental therapeutics, OncoImmune is optimistic that, should it be authorized or approved in Covid-19, the candidate can be used in addition to other treatments like remdesivir.
Currently, remdesivir is the only drug proven to have any marked effect in Covid-19 cases following FDA authorization earlier this year. US regulators had previously authorized hydroxychloroquine for emergency use, but were forced to undo that action following the retraction of two major studies into the drug’s effectiveness.
The FDA also recently granted similar designation to convalescent plasma treatments, though commissioner Stephen Hahn has come under fire for overstating its potential benefits, among other things. There has been increasing worry among the American public that Covid-19 treatment and vaccine approval have been driven by politics instead of science, and a recent Endpoints News poll of industry insiders reflected a majority thought a EUA for plasma should not have been issued at all.
Social image: Yang Liu, Oncoimmune