Cases of multiple myeloma seem to be rising across the country and the globe. New and effective therapeutic interventions have the potential to significantly benefit this patient population. Ichnos Sciences Inc. (“Ichnos”) is working to create one of these therapies with its first-in-class treatment ISB 1442. In fact, shares Ichnos in a recent news release, ISB 1442 recently earned Orphan Drug designation from the FDA. 

Orphan Drug designation is granted to drugs or biologics intended to treat, prevent, or diagnose rare conditions (affecting fewer than 200,000 Americans). This status comes with incentives such as fee waivers, tax credits, increased regulatory assistance, and up to seven years of market exclusivity following drug approval. 

The National Cancer Institute describes ISB 1442 as:

a human bispecific antibody directed against the human cell surface glycoproteins CD38 and CD47, with potential immunostimulating, phagocytosis-inducing and antineoplastic activities.

Preclinical studies highlighted the therapy’s efficacy in combating tumors. Ichnos has also been evaluating ISB 1442 in a Phase 1 study; so far, patients have enrolled in Australia and the study is set to begin U.S.-based enrollment sometime this year. 

Outside of multiple myeloma, Ichnos is also developing ISB 1442 for acute myeloid leukemia (AML). 

What is Multiple Myeloma?

Multiple myeloma is a type of cancer that develops in plasma cells, a type of white blood cell that normally plays a role in immune function and infection fighting. The exact cause of multiple myeloma is unknown. However, scientists have discovered that many myeloma cells are partially or fully missing part of chromosome 13. In multiple myeloma, abnormal cells crowd healthy blood cells out of the bone marrow. These abnormal cells then make abnormal proteins which cause health issues. Multiple myeloma most commonly affects older individuals. Symptoms may include: 

• Appetite loss
• Unintentional weight loss
• Bone pain, often in the spine or chest
• Nausea
• Blood clots
• Thrombocytopenia (low platelet counts)
• Anemia (low red blood cell counts) 
• Hypercalcemia (excess calcium in the blood) 
• Constipation 
• Fatigue
• Frequent or recurrent infections
• Mental fogginess or confusion
• Excessive thirst
• Weakness or numbness in the legs

Treatment options for multiple myeloma include chemotherapy, steroids, proteasome inhibitors, immunomodulators, and histone deacetylase inhibitors.