IRVINE, Calif. – February 5, 2019 – AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, announced today important findings which indicate a mechanism of action for its ROOT OF CANCER technology. Serum biomarker analyses and in vitro cellular modeling performed with cancer patient samples collected in a randomized Phase 2 clinical trial demonstrated a statistically significant association between long-term survival and activation of a specific subset of lymphocytes.

AIVITA’s findings point to a category of T lymphocytes called Th17 cells common in tissue surrounding tumors, which can transform from passive tolerating T cells into cytotoxic, tumor-fighting cells. Linear regression analyses were performed on serum samples collected after 3 weekly subcutaneous injections of a vaccine specifically targeting tumor-initiating cells, otherwise known as cancer stem cells. The findings indicate that the patient’s endogenous Th17 cells undergo a cytotoxic transformation in response to AIVITA’s ROOT of CANCER treatment.

“Our data suggest that Th17 cells in untreated cancer patients have an antigen repertoire that is incomplete or below a sufficient signal-strength threshold to be effective,” said Dr. Gabriel Nistor, AIVITA’s Chief Science Officer. “It is clear that AIVITA’s cancer stem cell vaccine elevates an appropriate antigenic signal in all immune responding cells, and particularly induces a cytotoxic transformation of the Th17 subpopulation.”

“Previous immunotherapy approaches have proven that dendritic cells can deliver a payload, but they chose the wrong payload,” said Dr. Hans S. Keirstead, AIVITA’s Chief Executive Officer. “These mechanistic data confirm that our treatment causes the patient to mount a vigorous immune attack against the very seed of cancer, the cancer stem cell. And now, within a few weeks, we can predict survival of those 72% of treated patients that survive.”

AIVITA is extending and confirming its mechanism of action data in three active clinical studies of its platform ROOT of CANCER therapy, in patients with ovarian cancer, glioblastoma or 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 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 single-arm 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: 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 autologous dendritic cell vaccine 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.

###