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OncoImmune Announces Completion of Phase II Trial

January 11, 2019 By americanpharmaceuticalreview

OncoImmune has completed its Phase IIa trial of CD24Fc for the Prevention of Acute GVHD Following Myeloablative Allogeneic HSCT.

The Phase IIa trial is a multicenter prospective randomized study designed to determine the MTD (Maximum Tolerated Dose) of CD24Fc for acute GVHD (Graft Versus Host Disease) prophylaxis. The last patient completed the study in December, 2018 and CD24Fc was found to be safe and very well tolerated. In addition, compared to both placebo and historical controls, CD24Fc treatment provided a statistically significant improvement in 180-day grade III-IV GVHD-free survival and 180-day grade III-IV GVHD and relapse-free survival. In addition, the benefit of including CD24Fc in standard GVHD prophylaxis regimens is further supported by the observed reduction in relapse and non-relapse mortality, better 1-year overall survival, and a dose-dependent reduction in severe mucositis.

CD24Fc targets the CD24-Siglec pathway that regulates host inflammatory response to tissue injuries, which has broad implications in the pathogenesis of autoimmune diseases, cancer and graft-versus-host disease (GvHD). OncoImmune will continue clinical development of CD24Fc for the prevention of acute GvHD, as well starting trials in additional clinical indications. CD24Fc has received orphan drug designation for GvHD in both the US and Europe.

The trial is funded in part by the National Cancer Institute and more recently by the FDA’s Orphan Products Clinical Trials Grant Program.

“We are very excited by our proof of concept clinical data for the prevention of GvHD and we are planning to initiate a Phase III trial in 2019,” said Yang Liu, OncoImmune CEO and co-founder.

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