IRVINE, Calif. – March 1, 2019 – AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, announced today that the Company will be presenting mechanism of action findings and study design details at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium taking place February 28 to March 2 in San Francisco, CA. Chief Science Officer Dr. Gabriel Nistor will present a poster concerning Th17 responses to an autologous immunotherapy targeting cancer stem cells. Chief Medical Officer Dr. Robert O. Dillman will present a poster concerning AIVITA’s randomized Phase 2 trial of patient-specific immunotherapy targeting cancer stem cells.

The ASCO-SITC Clinical Immuno-Oncology Symposium is a three-day meeting focused on clinical and translational research in immune-oncology. Dr. Nistor’s poster presentation will take place March 1 in Poster Session B of the Melanoma/Skin Cancers track. It will highlight how an autologous cancer immunotherapy can induce a Th17 phenotype preceding a Th1 type response. The findings are important for applications in settings in which tumor infiltration with Th17+ cells correlate with survival, such as in advanced ovarian cancer.

Dr. Dillman’s poster presentation will take place March 1 in Poster Session B of the Breast and Gynecologic Cancers track. It will inform attendees of the design and methodologies of AIVITA’s active Phase 2 clinical trial for ovarian cancer. The trial was initiated in November 2017 at a single site and has thus far received 11 appropriate patient tumor samples, with all 11 having successfully been expanded into viable cell lines for use in the creation of the Company’s autologous vaccine. Additional clinical sites are being initiated.

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.

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.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

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).

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

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.

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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