AIVITA Biomedical's Phase 2 Glioblastoma Trial Shows Improved Progression Free Survival

IRVINE, Calif., Nov. 17, 2020 /PRNewswire/ -- AIVITA Biomedical, Inc., a private biotechnology company specializing in innovative stem cell applications, today announced data from its multi-center Phase 2 clinical trial of its personalized cancer vaccine, AV-GBM-1, in patients with newly diagnosed glioblastoma (GBM).

The analysis focused on 57 patients who were scheduled to receive up to eight doses of AV-GBM-1 over approximately six months. At the time of the analysis, surviving patients had completed therapy and had been followed between 7.2 and 24.2 months. The median length of progression free survival was 10.0 months (95% CI 8.5 to 11.5 months), an improvement of approximately 45% compared to a median of 6.9 months (95% CI 5.8 to 8.2 months) progression free survival in the landmark study that established the standard of care for patients with newly diagnosed GBM. This represented a 38% reduction in risk of progression or death at 6.9 months of treatment. The latest data from the trial was presented at the 35^th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC).

"The improvement in glioblastoma patients who were treated with AV-GBM-1, compared to studies with the standard of care, is a very promising indication that our therapy confers benefit to patients in need," said Robert O. Dillman, M.D., chief medical officer of AIVITA.

AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor antigens derived from self-renewing tumor-initiating cells. The treatment is administered in a series of subcutaneous injections. The treatment is uniquely pan-antigenic, targeting multiple antigens from autologous tumor-initiating cells that are responsible for the rapid growth of the disease.

"This is a major victory against glioblastoma, a devastating disease that has evaded treatment for far too long," said Hans S. Keirstead, Ph.D., chairman and chief executive officer of AIVITA. "We now have excellent results from Phase 2 clinical studies in both melanoma and glioblastoma, underscoring the tremendous potential of this personalized cancer immunotherapy."

AIVITA is currently conducting three clinical studies in the United States investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma 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 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) from enrollment date, and secondary endpoints include progression-free survival (PFS) from enrollment date and OS measured from date of surgery during which tumor was collected to grow the tumor initiating cells. Additional analyses will include OS/PFS 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.

For additional information about AIVITA's AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298

About AIVITA Biomedical
AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITA's skin care products support the treatment of people with cancer.

SOURCE AIVITA Biomedical, Inc.