On November 2, 2020 AIVITA Biomedical, Inc., a private biotechnology company specializing in innovative stem cell applications, reported that treatment has been completed for all 57 patients in the Phase 2 clinical trial of AV-GBM-1 in patients with glioblastoma (Press release, AIVITA Biomedical, NOV 2, 2020, View Source [SID1234569640]). The company was able to manufacture final product at a notable 94% success rate, showing strong commercial and clinical viability.

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The eight-site, single-arm study investigates AV-GBM-1, AIVITA’s novel immunotherapy for the treatment of glioblastoma that targets the autologous tumor-initiating cells responsible for the rapid growth and proliferation of the disease. AIVITA achieved a 97% success rate in both growing tumor-initiating cells from each patient and in collecting sufficient monocytes from the peripheral blood from which to derive dendritic cells, resulting in a 94% overall success rate for manufacturing a final treatment given to patients. AV-GBM-1 was well-tolerated, and no patients experienced severe adverse events attributed to the treatment, and no patients discontinued treatment because of side-effects.

"This milestone brings us closer to having a better understanding of the potential for AV-GBM-1 to effectively treat patients with glioblastoma," said Bob Dillman, M.D., chief medical officer of AIVITA. "With such a high manufacturing success rate and no significant side effects, we are hoping this technology will chart a new path forward in immunotherapy."

Out of the 57 patients who participated in the study, the average number of doses injected was 6.9 out of a possible 8. The study’s primary endpoint is overall survival (OS) from enrollment date of patients treated with AV-GBM-1, with secondary endpoints including progression free survival from enrollment date and OS and PFS from date of surgical resection. AIVITA expects new interim findings to be presented at future medical meetings in November.

AIVITA is currently conducting three independent clinical studies investigating its platform immunotherapy in patients with glioblastoma, ovarian cancer and melanoma. AIVITA is also seeking conditional commercial approval of its melanoma treatment in Japan.

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 tumor-initiating cell-targeting immunotherapy, AV-OVA-1, 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 completed treating 57 with the tumor-initiating cell-targeting immunotherapy, AV-GBM-1.

The primary endpoint of the trial is overall survival (OS) and secondary endpoints include progression-free survival (PFS) and OS measured from date of enrollment, OS/PFS measured from date of diagnosis and OS/PFS from date of enrollment based on Karnofsky Performance Status, age, and extent of surgical resection. Tertiary endpoints will include OS/PFS from date of first injection and OS/PFS from date of first injection in patients who completed concurrent CT/RT and had not progressed.

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 tumor-initiating 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.