AIVITA Biomedical to Exhibit ROOT OF CANCER Immunotherapy at 33rd SITC Annual Meeting

IRVINE, Calif., Nov. 7, 2018 /PRNewswire/ -- AIVITA Biomedical, Inc. today announced that the Company will present a next generation immunotherapy at The Society for Immunotherapy of Cancer's (SITC) 33rd Annual Meeting, taking place November 9-11 at the Walter E. Washington Convention Center in Washington, DC. Attendees will have the opportunity to meet and speak with AIVITA senior leadership, including researchers and clinical staff developing AIVITA's patient-specific cancer immunotherapy.

The SITC Annual Meeting is one of the preeminent cancer meetings of the year and will provide an audience of international cancer researchers, regulators and healthcare professionals with cutting-edge research presentations and interactive educational opportunities relating to cancer research and clinical care. The meeting is aimed at improving outcomes for current and future patients with cancer.

Visitors to AIVITA's exhibit booth 117 will have the opportunity to meet with Chief Medical Officer Dr. Robert O. Dillman, MD, as well as key members of Dr. Dillman's clinical team. AIVITA's Chief Executive Officer Dr. Hans S. Keirstead and Vice President of Business Development Kevin Green will also be attendance.

AIVITA's treatment consists of autologous dendritic cells loaded with patient-specific antigens from the patient's tumor-initiating cells. Previously, this treatment was tested in two Phase 2 trials in patients with advanced melanoma and approved for Phase 3 testing. The first Phase 2 trial demonstrated a 72% 2-year survival rate and a 54% 5-year survival rate. The second randomized Phase 2 trial demonstrated similar results, with a significantly longer median survival compared to the control arm.

AIVITA's ROOT OF CANCER technology is the subject of two ongoing Phase 2 trials in the USA, one in patients with advanced ovarian cancer and another in patients with newly diagnosed glioblastoma. The Company is also pursuing commercialization of the treatment for melanoma patients in Japan and pursuing a strategic partnership to complete development and commercialize in Japan.

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 patient-specific tumor antigens from autologous self-renewing tumor-initiating cells.

AIVITA's ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who will be randomized in a 2:1 ratio to receive either the autologous dendritic cell vaccine 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 double-blind study is active and will enroll approximately 55 patients to receive the treatment candidate.

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: https://clinicaltrials.gov/ct2/show/NCT03400917

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 women with ovarian cancer.

SOURCE AIVITA Biomedical

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