OncoImmune Raises $56 Million to Advance Anti-Inflammatory and Oncology Pipeline

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Rockville, Maryland-based OncoImmune closed on a Series B round worth $56 million. The round was co-led by HM Capital and a blue-chip investor. Existing investors, 3E Bioventures Capital and Kaitai Capital, in addition to new investors GBA Fund and GF Xinde, also joined.

The company is currently running two Phase III clinical programs of its lead candidate, CD24Fc, a first-in-class biologic. One is in COVID-19 patients and the other is in leukemia patients prone to acute graft-versus-host disease (GVHD) after receiving allogeneic hematopoietic stem cell transplant. The company plans to use the proceeds to support the trials and to expand its pipeline.

“We are grateful to our investors for their confidence and continued support,” said Yang Liu, founder, chief executive officer and chairman of OncoImmune.

“We are delighted to see the significant progress OncoImmune has made in the past few years,” added Karen Liu, Partner at 3E BioVentures. “It exemplifies how great scientific discovery can be turned into potential novel therapeutics benefiting patients.”

CD24Fc regulates host inflammatory response to tissue injuries. As such, it has potential for a broad range of diseases, including cancer, autoimmune disease, metabolic syndrome and GVHD. It is a first-in-class biologic that fortifies an innate immune checkpoint against excessive inflammation. In the context of COVID-19, it is being evaluated to see if it can control the cytokine storms associated with severe disease.

The company has four other products in preclinical development, all for oncology indications: Onc-392, echinomycin, ONC-781 Bispecific and ONC-781 CAR-T.

On June 14, 2020, the company announced it had hit an important milestone in its Phase III trial of CD24Fc for severe and critical COVID-19 patients. The first 70 patients had been randomized and been treated with wither CD24Fc or placebo. The Institutional Review Board analyzed the safety data and granted approval to continue enrollment.

The study had been opened at 10 medical centers around the country. The plan was to enroll a total of 230 patients. The company indicated today that topline results were expected soon.

CD24Fc’s mechanism of action does not duplicate any other experimental therapies, so the company hopes it will be approved or granted emergency use authorization (EUA) to be used with other therapies, such as Gilead’s remdesivir.

At the time of the June announcement, Pan Zheng, the company’s chief medical officer, noted, “We have seen neither infusion reactions nor other drug-related adverse events associated with the trial in first 70 patients. The mortality rate so far is 5%, which is considered low among severe and critical COVID-19 patients. The preliminary results show that the safety of the drug is outstanding for this indication.”

CD24Fc completed a Phase IIa trial for prophylactic treatment of acute GVHD in leukemia patients receiving hematopoietic stem cell transplantation. It also demonstrated a significant improvement in 180 Day Grade III-IV acute GVHD Free Survival, which was the Phase III primary endpoint. CD24Fc prophylaxis also demonstrated decreased relapse and, compared to match controls, showed improvement in overall survival, non-relapse mortality and relapse-free survival. The drug also showed a dose-dependent decrease in severe—meaning greater than Grade 3—mucositis. Currently a 20-patient open-label dose expansion cohort at the recommended clinical dose is fully enrolled.

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