IRVINE, Calif. –  August 3, 2020 – AIVITA Biomedical, Inc., a private biotechnology company developing personalized vaccines for the treatment of cancer and prevention of COVID-19, announced today the publication of the paper, “An update on GM-CSF and its potential role in melanoma management,” in the journal Melanoma Management. Robert O. Dillman, M.D., chief medical officer at AIVITA, authored the article.

GM-CSF (granulocyte-macrophage colony-stimulating factor) is a white blood cell growth factor used in cancer care to stimulate the recovery of immune cells in patients who have received chemotherapy. It is also required for differentiating monocytes into dendritic cells and has been used as monotherapy in treatment of cancer, though the efficacy of this practice has not been clinically validated.

In the review. Dr. Dillman discusses the GM-CSF’s investigational uses as an anti-melanoma monotherapy and as an adjuvant for anti-melanoma vaccines, finding a strong rationale for GM-CSF as a vaccine adjuvant. Specifically, it appears of benefit for strategies that directly involve dendritic cells, such as with vaccines in which dendritic cells are loaded with antigen ex vivo and injected admixed with GM-CSF. AIVITA currently utilizes GM-CSF as a vaccine adjuvant in clinical studies of its personalized vaccines.

“Randomized trials have failed to confirm significant anticancer activity for monotherapy GM-CSF, but it appears to provide immune enhancing effects and survival benefit when it is admixed with dendritic cells loaded ex-vivo with autologous tumor antigens,” said Dr. Dillman. “Effects were also observed when cytolytic virus that secretes GM-CSF was injected locally into tumors.”

AIVITA is currently conducting three independent 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 development of its cancer therapeutic pipeline.

About AIVITA’S Clinical Trials

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 people with cancer.

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