DUNP19 Earns ODD for Osteosarcoma

Osteosarcoma is genomically complex, which means that – sometimes – it can also be difficult to treat. Treatment and management, however, are crucial to ensuring positive patient outcomes. Doctors and researchers are working to create more effective care and management options. One of these options being explored is DUNP19. 

Developed by Radiopharm Theranostics, DUNP19 is a first-in-class therapy with antitumor properties. DUNP19 is a LRRC15-targeted monoclonal antibody that targets tumors. Healthy cells don’t express LRRC15. However, cancer cells do express LRRC15 – and higher amounts also signify more aggressive or difficult-to-treat cancers. DUNP19 is designed to find, target, and kill cancer cells, disrupting the tumor microenvironment.

According to Targeted Oncology, the U.S. Food and Drug Administration (FDA) recently granted Orphan Drug designation to DUNP19. Orphan Drug designation is granted to drugs and biologics intended to treat, prevent, or diagnose rare conditions. These are conditions affecting fewer than 200,000 people within the United States. Drug developers – in this case, Radiopharm Theranostics – also receive benefits with this designation. These include fee waivers, increased regulatory assistance, tax credits, and seven years of market exclusivity upon drug approval. 

Outside of Orphan Drug designation, DUNP19 has also received Rare Pediatric Disease designation.

About Osteosarcoma

Osteosarcoma, or osteogenic sarcoma, is a type of bone cancer which manifests in osteoblast cells which form bones. This cancer occurs most often in teenagers and young adults, though it can affect those who are younger or older. Risk factors include previous radiation therapy, certain inherited conditions, or other bone disorders. Osteosarcoma often occurs in areas like the femur, shinbone, or upper arm bone where the bone is growing quickly. It is more common in males than females. Symptoms can include:

  • Bone pain
  • Limping
  • Joint motion limitations
  • Bone fracture or break with no clear cause
  • Swelling or redness near the affected bone
  • A mass or lump