IRVINE, Calif. – September 20, 2018 – AIVITA Biomedical announced today that it has dosed its first of 10 patients currently enrolled as part of its Phase 2 trial in patients with advanced ovarian cancer. The trial is designed to investigate AIVITA Biomedical’s patient-specific cancer treatment consisting of autologous dendritic cells loaded with autologous antigens from the patient’s tumor-initiating cells.

AIVITA is enrolling approximately 99 patients in the Company’s ROOT OF CANCER ovarian cancer trial to be randomized in a 2:1 ratio to receive either the Company’s patient-specific cancer treatment or a control agent consisting of autologous monocytes. The treatment will be administered in a series of injections along with standard care.

“We’re proud of the manufacturing team here at AIVITA who have made this important moment possible,” said Dr. Bob Dillman, Chief Medical Officer at AIVITA. “The team has contributed manufacturing efficiencies which have greatly improved the success rate and speed of creating this treatment, allowing us to treat more patients more reliably. We’ve since randomized several additional patients in this trial and activity is accelerating as we sign on more hospitals and receive additional tumors.”

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 54% 5-year survival rate compared to a 29% 5-year survival rate for an active control arm. 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 also the subject of an ongoing Phase 2 clinical trial treating glioblastoma in the USA. The Company is also currently applying for conditional approval to commercialize the treatment for melanoma in Japan and is considering Japanese strategic partners for this program.

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of female cancer deaths, with an estimated 22,240 new diagnoses in 2018 and 14,070 deaths. The median age at diagnosis is 63, with a 5-year survival rate of less than 50% for all, and about 35% for the two thirds who have advanced disease (stage III or IV) at the time of initial diagnosis. Current standard of care includes surgical debulking and several courses of chemotherapy.

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 autologous self-renewing tumor-initiating cells.

The ovarian Phase 2 double-blind study will enroll 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

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.

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