AIVITA Biomedical Announces Publication of Phase 1 and Phase 2 Trial Results of its COVID-19 Vaccine Candidate

• Personal vaccine made at point-of-care generated enhanced T-cell responses in 96.8% of evaluable subjects within 28 days
• Immediate and short-term toxicity is less than any other currently available COVID-19 vaccine
• Ships and stores at +4^oC, enabling inexpensive and widespread distribution

IRVINE, Calif., Aug. 29, 2022 /PRNewswire/ -- AIVITA Biomedical, Inc., a biotech company specializing in innovative cell applications, today announced the publication of safety and efficacy results from Phase 1 and Phase 2 clinical trials investigating its anti-SARS-CoV-2 vaccine candidate AV-COVID-19 that is made at point-of-care by third-party personnel. The results were published in the article "A Personal COVID-19 Dendritic Cell Vaccine Made at Point-of-Care: Feasibility, Safety, and Antigen-Specific Cellular Immune Responses" in the journal Human Vaccines & Immunotherapeutics. Across both studies, AV-COVID-19 was well-tolerated with very few and low-grade adverse events. Single injections induced desirable antigen-specific T-cell responses in 94% of participants at 14 days and 97% of participants at 28 days.

"Our vaccine uniquely induces direct cell-mediated immune memory," explained Gabriel Nistor, M.D., chief science officer at AIVITA. "This is an important distinction from currently available COVID-19 vaccines which all induce a transitory antibody-mediated immune response."

"The superior safety profile is likely due to our vaccine containing only the subject's primed immune cells and none of the viral antigen, virus, mRNA, DNA, animal components or immune adjuvants found in other vaccines," said Robert O. Dillman, M.D., chief medical officer at AIVITA. "This may alleviate vaccine hesitancy, providing an option for those who are dubious of current vaccine modalities or have strict prohibitions regarding the use of animal components."

The objectives of these studies were to provide safety and immune response data for single injections of different formulations of the AV-COVID-19 SARS-CoV-2 vaccine and to also establish the feasibility of preparing personal dendritic cell vaccines at point-of-care.

In the double-blind, randomized Phase 1 trial, 31 subjects ages 20-62 years received one of nine formulations of autologous dendritic cells and lymphocytes (DCL) incubated with 0.10, 0.33, or 1.0 μg of recombinant SARS-CoV-2 spike protein, and then admixed with saline or 250 or 500 μg of granulocyte-macrophage colony-stimulating factor (GM-CSF). Subjects were assessed for safety and humoral response. All formulations were well-tolerated with no acute allergic events, serious adverse events (SAE), or grade 3 or 4 adverse events (AE). Immune response was determined by an enzyme-linked immunosorbent assay (ELISA) used to measure antigen-specific immunoglobulin levels specific for the S-protein recombinant binding domain (RBD). Comparisons were made between results at day-0 and day-28. Investigators found that 21/30 (70%) subjects had an increase in anti-RBD antibody levels on day-28.

In the double-blind, randomized Phase 2 trial, 145 subjects ages 19.5-82.5 years received one of three formulations of the personalized dendritic cell-lymphocyte product, then were assessed for safety and cellular response. All three formulations of the vaccine were well-tolerated with no high-grade or serious adverse events reported. The percentage of patients reporting any adverse events was 52.9%. The percentage of patients with grade 1 adverse events was 47.1% and the percentage of patients with grade 2 adverse events was 5.8%. Immune response was determined using an enzyme-linked assay (ELISPOT) which assessed T-lymphocyte responses against the spike protein. Subjects who had a SARS-CoV-2 response prior to vaccination were omitted from efficacy calculations, as this would infer prior infection or vaccination. Of the 126 evaluable subjects, 119 (94.4%) had increased ELISPOTS by day 14 and 122 (96.8%) by day 28.

The successful manufacturing of vaccines for 176/176 subjects across two study sites supports the feasibility of point-of-care vaccine production in minimally equipped facilities by minimally trained third-party technicians using AIVITA's Vaccine-Enabling Kit.

"As COVID-19 rates continue to spike globally with new variants, many regions are still without access to COVID-19 vaccines due to their lack of ultra-cold chain distribution required by mRNA vaccines, the lack of supply, or the high cost," said Hans S. Keirstead, Ph.D., chief executive officer at AIVITA. "Our Vaccine-Enabling Kit can be shipped anywhere in the world, enabling distributed scaled manufacturing, and can be modified within days to accommodate new variants or entirely new pathogens."

About AIVITA's Vaccine-Enabling Kit

AIVITA's Vaccine-Enabling Kit enables a subject-specific personal vaccine that consists of autologous dendritic cells and lymphocytes incubated with a quantity of SARS-CoV-2 spike protein. Creation of the vaccine requires basic laboratory techniques and AIVITA's ready-made kit of materials. Treatment starts with a blood draw from which the subject's own immune cells are isolated and monocytes matured into antigen-presenting dendritic cells. The patient's dendritic cells and lymphocytes are incubated with spike protein and delivered as a single dose of preventative vaccine via a single subcutaneous injection.

About AIVITA Biomedical

Founded in 2016 by pioneers in the cell therapy industry, AIVITA Biomedical, Inc. utilizes its expertise in cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its therapeutic pipeline. Our cancer immunotherapy targets the seed of all cancers, tumor-initiating cells, with a unique pan-antigenic approach that targets all neoantigens specific to the patient's cancer. Our patient-specific cancer treatments have shown tremendous promise in eradicating tumors, without harmful side effects, in melanoma and glioblastoma clinical studies. Our COVID-19 Vaccine Enabling Kit is targeted to emerging nations enabling point-of-care vaccine production in minimally equipped facilities by minimally trained third-party technicians.

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SOURCE AIVITA Biomedical, Inc.