To best address the needs of patients with rare diseases and rare cancers, additional treatment options are necessary. But developing these treatment options can be time-consuming and sometimes difficult. The FDA developed the Orphan Drug program to incentivize drug developers and facilitate the development and review of drugs and biologics intended to treat, diagnose, or prevent rare conditions. These are those which affect under 200,000 Americans. According to a September 30 press release from biotechnology company Immix Biopharma, Inc. (“Immix”), the company’s candidate IMX-110, intended to treat soft tissue sarcoma (STS), recently earned Orphan Drug designation.
So what is IMX-110, and why did it receive this status? The treatment uses Immix’s TME NormalizationTM Technology to enhance circulation within the body and destroy the tumor microenvironment (TME) to prevent the tumor from growing. IMX-110 is a Tissue-Specific TherapeuticTM which helps promote cell death (apoptosis) within the tumor microenvironment.
In particular, IMX-110 attacks and destroys cancer-associated fibroblasts, the actual cancer, and tumor-associated macrophages. Through this, the treatment creates a hostile environment in which the tumor cannot survive and the cancer cannot proliferate. To learn more about IMX-110 and its therapeutic benefits, take a look at the Immix pipeline.
For receiving Orphan Drug designation, Immix was also given fee waivers, tax credits, increased regulatory assistance, and 7 years market exclusivity upon approval.
Soft Tissue Sarcoma (STS)
As the name suggests, soft tissue sarcoma, a form of rare cancer, manifests in the body’s soft tissues (muscle, fat, joint linings, blood vessels, etc.). Radiation exposure increases the risk of developing soft tissue sarcoma. Altogether, over 50 forms of soft tissue sarcoma exist. Each has its own age of onset and may affect various parts of the body. Some symptoms associated with soft tissue sarcoma include:
- A noticeable lump or swollen area
- Pain (if the tumor presses on nerves or muscles)
- Abdominal pain and cramping (if the tumor is in the abdomen)