In a news release from late January 2022, biopharmaceutical company CASI Pharmaceuticals, Inc. (“CASI”) shared that the Company’s partner, BioInvent International AB (“BioInvent”) recently earned an Orphan Drug designation from the FDA. The Designation was granted to BI-1206, an investigational therapy designed to treat patients with follicular lymphoma.
About Follicular Lymphoma
Follicular lymphoma, a cancer of the lymphatic system, exists under the larger umbrella of non-Hodgkin’s lymphoma (NHL). This slow-growing cancer develops from B-lymphocytes, a type of white blood cell that normally plays a role in immune response and fighting infections. An estimated 1 in every 5 lymphoma diagnoses in America is follicular lymphoma. Overall, this cancer tends to affect older individuals significantly more than any other groups. In particular, this cancer often appears in those aged 60+. Symptoms include:
- Shortness of breath
- Unintended weight loss
- Swollen lymph nodes in the abdomen, neck, groin, and/or underarms
- Drenching night sweats
- Fever
- Fatigue
- Appetite loss
Learn more about follicular lymphoma.
What is BI-1206?
On the Company’s website, CASI describes BI-1206 as:
a high-affinity monoclonal antibody that selectivity bind to FcγRIIB (CD32B), the only inhibitory member of the FcγR family. FcγRIIB is over-expressed in several forms of [non-Hodgkin’s lymphoma] and over-expression has been associated with poor prognosis in difficult-to-treat forms of NHL.
Researchers and scientists believe that blocking FcγRIIB could help make other therapies, such as rituximab, more effective in treating these cancers. Currently, BioInvent is working to evaluate BI-1206 in a series of Phase 1/2 clinical trials. In the first study, researchers are exploring rituximab and BI-1206 as a potential therapy for follicular lymphoma, mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL). Next, the second trial is evaluating BI-1206 in conjunction with Keytruda for patients with solid tumors.
BI-1206 earned Orphan Drug designation from the FDA. This designation is granted to drugs or biologics intended to treat, diagnose, or prevent rare diseases or conditions. Within the United States, a rare condition is one affecting under 200,000 people. Alongside this status, the drug developer also receives benefits including tax credits, fee waivers, increased regulatory assistance, and 7 years market exclusivity upon approval.
