Business
ImmunityBio Announces Study of ANKTIVA® in Combination with the AdHER2DC Cancer Vaccine as a Potential Therapy to Control Endometrial Cancer
The QUILT 502 trial is testing ImmunityBio’s N-803 (ANKTIVA®) in combination with the AdHER2DC investigational vaccine for endometrial cancer, a
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nThe QUILT 502 trial is testing ImmunityBio’s N-803 (ANKTIVA®) in combination with the AdHER2DC investigational vaccine for endometrial cancer, a gynecological cancer with lower survival rates and limited effective post-second-line treatment.\n\n\n\nThe AdHER2DC vaccine targets the HER2 protein, which is elevated in 30% of endometrial cancer.\n\n\n\nANKTIVA, recently approved for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, is designed to activate the immune cells that kill tumor cells to provide long-term immune response.\n\n\n\nThe Phase1/2 interventional study will enroll 60 participants with HER2-positive endometrial cancer (EC), who will also receive pembrolizumab and lenvatinib, two FDA approved drugs for endometrial cancer.\n\n\n\nThe study is expected to be completed in 2026.\n\n\n\n \n\n\n CULVER CITY, Calif.--(BUSINESS WIRE)--\nImmunotherapy company ImmunityBio, Inc. (NASDAQ: IBRX), today announced the opening of a clinical trial to study ANKTIVA® (nogapendekin alfa inbakicept-pmln) together with the investigational AdHER2DC vaccine (autologous dendritic cells transduced with HER2 expressing adenovirus), in individuals with HER2-expressing endometrial cancer. It marks the latest trial involving ANKTIVA, the company’s IL-15 superagonist immune enhancer, to evaluate ANKTIVA as an agent to replace the short-term activity of checkpoint inhibitor immunotherapies with long-term effectiveness. ANKTIVA was recently approved by the FDA for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors.\n\n\nThis Phase 1/2 QUILT 502 trial (NCT06253494) sponsored by the National Cancer Institute, part of the National Institutes of Health, will study whether the AdHER2DC vaccine in combination with ANKTIVA, pembrolizumab (checkpoint inhibitor), and lenvatinib (kinase inhibitor) can be safely administered in combination and provide preliminary clinical efficacy before a larger, more definitive study.\n\n\nEndometrial cancer is the most common gynecological cancer in the U.S., and affects more than 65,000 women each year with incidence peaking around 50-60 years of age. The 5-year overall survival rate in patients with metastasis is around 20 percent; treatment options after the second-line treatment are limited.\n\n\nThe AdHER2DC vaccine targets the HER2 protein, which is eleva...