On October 30, 2019 AIVITA Biomedical, Inc., a biotechnology company specializing in innovative stem cell applications, reported the publication of an article titled "Genomic, Proteomic, and Immunologic Associations with a Durable Complete Remission of Measurable Metastatic Melanoma Induced by a Patient-Specific Dendritic Cell Vaccine" in the journal Human Vaccines and Immunotherapeutics (Press release, AIVITA Biomedical, OCT 30, 2019, View Source [SID1234550028]). Robert O. Dillman, M.D., Chief Medical Officer at AIVITA, Gabriel Nistor, M.D., Chief Science Officer, and Aleksandra J. Poole, Ph.D., Vice President, Research & Development, authored the article.
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The article focuses on a melanoma patient treated in a prior Phase 2 study with AIVITA’s immunotherapy, autologous dendritic cells loaded with autologous tumor antigens derived from tumor-initiating cells. The analyses concern the immune mechanism of action that led to a complete response in the patient with progressive, refractory, metastatic melanoma. The analyses included elucidation of the genes in the patient’s tumor cells and normal cells, more than 100 blood markers before and after vaccination, and the patient’s immune cells.
The article is available at Taylor & Francis Online here: View Source
CLINICAL TRIAL DETAIL
OVARIAN CANCER
AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous cancer stem cell-targeting immunotherapy or autologous monocytes as a comparator.
Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.
For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616
GLIOBLASTOMA
AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the cancer stem cell-targeting immunotherapy.
Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.
For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917
MELANOMA
AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.
Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.