IRVINE, Calif. – February 12, 2019 – AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, has previously reported a 72% 2-year survival rate and a 54% 5-year survival rate in patients treated with its cancer stem cell-targeting immunotherapy, ROOT OF CANCER. Today, AIVITA announced new data indicating that non-responders to its immunotherapy had, on average, 150,000 times more pre-existing PD-1 proteins in their bloodstreams than responders. These findings suggest a means to optimize patient inclusion criteria in AIVITA’s trials evaluating ROOT OF CANCER. Further, these findings indicate that the use of anti-PD-1 checkpoint inhibitor drugs in combination with AIVITA’s cancer stem cell-targeting immunotherapy could improve outcomes in previously unresponsive patient populations.

PD-1 is a protein on the surface of cells which regulates the immune response and suppresses T cell inflammatory activity. PD-1 levels were monitored in cancer patient samples obtained in a randomized Phase 2 clinical trial by observing concentrations of a plasma biomarker consisting of soluble fragments of the PD-1 checkpoint protein that are shed by the patient’s T cells. The biomarker can be used to predict immune response to AIVITA’s personalized cancer immunotherapy.

“Exorbitantly high levels of PD-1 appear to be interfering with T cell activation in the non-responsive 28% of our treated patients,” said Dr. Gabriel Nistor, Chief Science Officer at AIVITA. “This suggests anti-PD-1 checkpoint inhibitors could be used to counter this inhibiting effect, and allow our immunotherapy to work in patient populations that would otherwise be unresponsive.”

“These data underscore a natural partnership, in which a combination therapy would be greater than either of its parts,” said Dr. Hans Keirstead, CEO of AIVITA.

AIVITA has recently received IND clearance to begin a Phase 1B clinical trial testing this combination approach. AIVITA’s open-label, single-arm, phase 1B treatment study will establish safety and track efficacy of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma.

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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