IRVINE, Calif. – February 4, 2020 – AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, announced today that it has reached its patient enrollment target in the Company’s Phase 2 clinical trial for glioblastoma. The trial has achieved its enrollment target ahead of schedule and under budget, with a notable 94% treatment manufacturing success rate.

AIVITA’s eight-site, single-arm study is investigating AV-GBM-1, a novel immunotherapy targeting autologous tumor-initiating cells that are responsible for the rapid growth and proliferation of the disease.

The highly sophisticated immunotherapy product requires short term cell culture and a successful leukapheresis in order to generate the final treatment product. AIVITA achieved a 97% success rate growing tumor-initiating cells from each patient, and 97% success rate in collecting sufficient monocytes from the peripheral blood from which to derive dendritic cells, resulting in a 94% overall success rate for manufacturing a final product.

“An extremely high manufacturing success rate combined with a very low cost of goods makes this approach highly desirable from both a clinical and commercial viability perspective,” said Bob Dillman, M.D., Chief Medical Officer of AIVITA. “We’re already exploring new ways to further increase efficiency and expand the applicability of this approach.”

AIVITA is investigating the clinical efficacy of its immunotherapy alone and in combination with PD-1 inhibitors, having determined that a significant portion of unresponsive subjects from a previous trial had elevated PD-1 levels. The Company is also exploring ways in which the technology could be deployed as a maintenance treatment, recognizing that cancer recurrence may come from dormant cancer cells that go undetected by conventional treatments.

“I want to thank the investigators and clinical sites who have done such an excellent job of managing patient care for the trial and helped us reach this important milestone,” said Hans S. Keirstead, Ph.D., Chairman and Chief Executive Officer of AIVITA. “These successes are certainly challenging prior expectations of personalized medicine.”

AIVITA is currently conducting three distinct clinical studies in the USA 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 is enrolling approximately 55 patients to receive the tumor-initiating 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 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 women with ovarian cancer.

###