AIVITA Biomedical Announces New Clinical Data in Ongoing Phase 2 Brain Cancer Trial

Date: Jul 08, 2019

IRVINE, Calif. – July 8, 2019 – AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, announced today new clinical data from its ongoing glioblastoma Phase 2 clinical trial investigating AIVITA’s platform immunotherapy targeting cancer stem cells. Blood plasma biomarker analyses have identified predictive markers of efficacy in seven of eight treated subjects, a sample that represents 15% of the total clinical trial size.

The findings were made by analyzing data collected from AIVITA’s ongoing Phase 2 clinical study in glioblastoma and data collected from completed Phase 2 clinical trials in melanoma which had demonstrated 72% 2-year survival, and 54% 5-year survival. In both the current and past trials, blood was collected from subjects at one week after dose administration. Principal component analysis, an advanced statistical tool used in making predictive models, was performed to analyze the immune responses in all patients from both trials. The majority of glioblastoma patients had the same cytotoxic and immunoglobulin responses that were associated with survival in the previous melanoma trials.

“The data indicate that all mechanistic pathways with anti-tumoral effects are being activated in the surviving melanoma patients and seven out of eight of the treated glioblastoma patients, in particular the cytotoxic Th1-Th17 response and an immunoglobulin Th2 response,” said Dr. Gabriel Nistor, AIVITA’s Chief Science Officer. “It just makes sense; this is how the immune system fights cancer.”

The findings add to AIVITA’s understanding of the mechanism of action behind its next-generation cancer stem cell targeting immunotherapy and could offer physicians an early indication of how patients will respond to treatment.

“Predictive markers of efficacy, an outstanding patient recruitment rate and a manufacturing success rate of over 95%; this is shaping up to be a highly successful clinical trial in a field that desperately needs a win,” said Dr. Hans S. Keirstead, AIVITA’s Chief Executive Officer.

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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