Immix Biopharma, Inc. announced study data showing that ImmixBio's lead candidate IMX-110 produced a 50% response rate in a first-line-therapy-resistant cancer - soft tissue sarcoma (STS) mouse study, surpassing the STS standard of care doxorubicin's 0% response rate in the same mouse study. The responses were assessed by RECIST 1.1 criteria applied to mice, with progression assessed after one cycle of treatment in a study funded by ImmixBio and conducted by a major STS oncology treatment center. The U.S. Food and Drug Administration (“FDA”) has approved orphan drug designation (“ODD”) for IMX-110 for the treatment of soft tissue sarcoma.

The FDA has already approved rare pediatric disease (“RPD”) designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma. Soft tissue sarcoma is a cancer that begins in the tissues that connect, support, and surround body structures. The global STS market is estimated to reach approximately $6.5 billion by 2030 from the estimated $2.9 billion in 2019.

Globally, there are roughly 116,000 new cases of STSs each year, of which 21,500 are in the European Union and 40,500 are in China. According to the American Cancer Society, there were roughly 13,000 new cases of STS in the United States during 2020. Approximately 160,000 people live with soft tissue cancers in the United States.