AIVITA Biomedical Announces Publication Concerning a Predictive Biomarker for Melanoma Patients Treated with the Company’s Platform Immunotherapy

Data Suggests sPD-1 Served as a Predictive Biomarker in Phase 2 Melanoma Trials

Date: Oct 02, 2019

IRVINE, Calif. – October 2, 2019 – AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, today announced the publication of an article titled Preliminary observations on soluble programmed death-1 protein as a prognostic and predictive biomarker in patients with metastatic melanoma treated with patient-specific autologous vaccines in the oncology journal Oncotarget. Robert O. Dillman, M.D., Chief Medical Officer at AIVITA, and other key members of the AIVITA team authored the article.

The publication suggests that because of its role as an immune checkpoint, levels of soluble programmed cell death protein-1 (sPD-1) could be useful as a prognostic biomarker or predictive biomarker in cancer patients treated with vaccines. The authors theorized that very low blood levels of sPD-1 may indicate lack of an existing anti-cancer immune response, while very high levels may indicate an active immune response that is suppressed. In between these extremes, a decrease in PD-1 following cancer vaccine injections may indicate an enhanced immune response that has not been suppressed.

Blood samples were obtained at baseline and four weeks later during a randomized trial in which patients with metastatic melanoma were treated with either AIVITA’s immunotherapy, or an active control article. Median survival was more than twice as long in patients treated with AIVITA’s immunotherapy. The combination of a very low baseline sPD-1, or absence of a very high PD-1, at baseline followed by a decline in sPD-1 at week-4 of the study was predictive of surviving 3 or more years in patients treated with AIVITA’s immunotherapy, but not with the control article.  Among patients treated with AIVITA’s immunotherapy, these sPD-1 criteria appropriately classified 80% of 3-year survivors, and 86% of patients who did not survive three years.

“These observations suggest that sPD-1 may be a useful biomarker for melanoma patients being treated with our platform immunotherapy, and/or to predict efficacy after only three injections,” said Dr. Robert O. Dillman, Chief Medical Officer at AIVITA. “We look forward to confirming these results in larger studies and investigating whether it can predict response in other cancers.”

AIVITA is currently conducting three clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN™ skincare line to support the treatment of women with ovarian cancer.

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 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. 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 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). 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 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.  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.

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