IRVINE, Calif. – June 3, 2019 – AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, announced today that Chief Medical Officer Dr. Robert O. Dillman presented clinical data on melanoma patients treated with patient-specific vaccines on June 1 at the 55^th Annual Meeting of ASCO in Chicago, Illinois. The data is being published concurrently in the journal Melanoma Management.

The abstract and publication describe survival data for 72 patients pooled from two Phase 2 trials. In the first trial conducted in 54 patients, the projected median overall survival was 54% at a time when median follow up was 4.5 years (Dillman et al.  Cancer Biother Radiopahrm 2009;24:311-319.). Actual 5-year survival was 50% once all patients had been followed a minimum of five years. In the second Phase 2 trial patients were randomized for treatment with either their patient-specific dendritic cell vaccine (DCV) or patient-specific tumor cell vaccine (TCV). In both treatment arms the source of antigen was autologous tumor cells that were self-renewing in cell culture. Median overall survival was better in the DCV-treated patients: median survival 40.3 vs 20.5 months, 3-year actual survival of 61% vs 25% (p=0.018), and a 70% reduction in the risk of death (p=0.0053) [Dillman et al. J Immunother Cancer 2018;6:19.] The data for DCV-treated patients was pooled in order to address questions related to survival of specific subsets of patients [Dillman et al. Melanoma Manag 2019]. All patients had been followed for five years. The data showed that for melanoma patients who had recurrent Stage III disease that was not measurable at the time DCV-treatment was initiated, the 5-year survival rate was 72%.  In melanoma patients who had previous Stage IV melanoma but did not have measurable disease at the time of treatment, the 5-year survival rate was 53%. Patients with measurable Stage IV melanoma had a median survival of 18.5 months with a two-year survival rate of 46%, which compares favorably to results achieved with anti-PD-1 checkpoint inhibitors in similar patients.

AIVITA is currently conducting three clinical studies investigating its platform ROOT OF CANCER therapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN™ skincare line to support the treatment of women with ovarian cancer.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from purified autologous self-renewing tumor-initiating cells.

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 the 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.

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.

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