• Multiple Myeloma News
    • May 10, 2018

    FDA Orphan Status for Myeloma T Cell Therapy

The U.S. Food & Drug Adminstration (FDA) granted orphan status to a targeted immunotherapy drug for myeloma called galinpepimut (GPS) on May 9, 2018. 

GPS is a vaccine that targets the WT1 antigen which, according to manufacturer SELLAS Life Sciences Group, “is one of the widely expressed cancer antigens” found a variety of cancer types, including myeloma.  According to dictionary.com, antigens “stimulate the production of antibodies and combine specifically with them.”

The vaccine manipulates a person’s own immune system and other drugs to produce more CD4 and CD8, molecules on cells that identify and stimulate activity on T cells which then attack and kill myeloma cells.

SELLAS, a spinoff business from Memorial Sloan Kettering Cancer Center, has “reported median progression-fee survival (PFS) of 23.6 months in the high-risk MM setting” as compared 12 months with other treatments.

SELLAS is developing GPS vaccines for other cancers including solid and liquid tumors.

About Author

Greg Brozeit

Greg Brozeit is an independent consultant who specializes in strategic outreach, community building, and public policy advocacy. He has broad experience working with myeloma patients, physicians, and researchers. Most recently he advised Dr. Bart Barlogie at the Myeloma Institute for Research and Therapy. He worked for more than 14 years with the International Myeloma Foundation. Greg founded its advocacy program and later serving as the inaugural director of IMF Europe.Greg has also worked for a national civic education organization, in aging research advocacy, as a U.S. Senate legislative staff member, and as a secondary school teacher. He is married with two sons and lives in Northeast Ohio.

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