ImMucin Designated Orphan Drug for Multiple Myeloma

Vaxil Bio announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to ImMucin for the treatment of multiple myeloma (MM).

ImMucin is an immunotherapeutic agent that trains the patient’s immune system to identify and destroy cells, which display a short specific 21-mer portion of the cancer-associated (marker) expression of MUC1 in patients with multiple myeloma. This marker appears on 90% of all cancer cells but not in patient’s blood, a factor that can enhance its potency.

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Vaxil completed a Phase 1/2 clinical study with ImMucin in MM patients, which showed a high safety profile, strong diversified T/B-cell immunity in all 15 patients across MHC repertoires and initial indications of clinical efficacy; 11 out of the 15 treated patients demonstrated stable disease or clinical improvement, which did not require any further treatment. An ongoing follow-up study in patients who responded clinically to ImMucin has shown that some patients have not required any further treatment for their disease in the four years since ImMucin treatment. ImMucin is also being evaluated in a Phase 1/2 study for the treatment of patients with metastatic breast cancer who are also receiving 1st first-line hormone therapy.

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