AIVITA Biomedical Announces Publication of Phase 1 and Phase 2 Trial Results for its COVID-19 Vaccine Candidate
- Personal, point-of-care vaccine generated enhanced T-cell responses in 96.8% of evaluable subjects within 28 days
- Immediate and short-term toxicity is lower than any other currently available COVID-19 vaccine
- Shipped and stored at +4ohC, allowing inexpensive and widespread distribution
IRVINE, Calif., August 29, 2022 /PRNewswire/ — AIVITA Biomedical, Inc., a biotechnology company specializing in innovative cellular applications, today announced the publication of safety and efficacy results from Phase 1 and Phase 2 clinical trials of its SARS-CoV-2 AV-COVID-19 vaccine candidate which is manufactured at the point of care by third-party personnel. The results were published in the article “A Personal Dendritic Cell COVID-19 Vaccine Made at the Point of Care: Feasibility, Safety, and Antigen-Specific Cellular Immune Responsesin the journal Human Vaccines & Immunotherapeutics. In both studies, AV-COVID-19 was well tolerated with very few adverse effects and low intensity. Single injections induced desirable T cell responses specific to the antigen in 94% of participants at 14 days and 97% of participants at 28 days.
“Our vaccine uniquely induces cell-mediated direct immune memory,” explained Gabriel Nistor, MD, Scientific Director at AIVITA. “This is an important distinction from currently available COVID-19 vaccines which all induce a transient antibody-mediated immune response.”
“The superior safety profile is likely due to the fact that our vaccine contains only the primed immune cells of the subject and none of the viral antigens, viruses, mRNA, DNA, animal components or immune adjuvants found in other vaccines,” said declared Robert O. Dillman, MD, Chief Medical Officer at AIVITA. “It may alleviate vaccine hesitancy, providing an option for those who doubt current vaccine modalities or who have strict prohibitions on the use of animal components.”
The objectives of these studies were to provide data on the safety and immune response for single injections of different formulations of the AV-COVID-19 SARS-CoV-2 vaccine and also to establish the feasibility of preparing personal vaccines. based on dendritic cells at the point of care. .
In the phase 1 randomized, double-blind trial, 31 subjects between the ages of 20 and 62 received one of nine formulations of dendritic cells and autologous lymphocytes (DCL) incubated with 0.10, 0.33 or 1, 0 μg of recombinant SARS-CoV-2 spike protein, then mixed with saline or 250 or 500 μg of granulocyte-macrophage colony-stimulating factor (GM-CSF). Subjects were evaluated for safety and humoral response. All formulations were well tolerated with no acute allergic events, serious adverse events (SAEs) or grade 3 or 4 adverse events (AEs). Immune response was determined by an enzyme immunoassay (ELISA) used to measure levels of recombinant protein S-binding domain (RBD)-specific antigen-specific immunoglobulins. Comparisons were made between day 0 and day 28 results. Investigators found that 21/30 (70%) subjects had increased anti-RBD antibody levels by day 28.
In the phase 2 randomized double-blind trial, 145 subjects aged 19.5 to 82.5 years received one of three formulations of the personalized dendritic cells-lymphocytes product, then were evaluated for safety and response cellular. All three vaccine formulations were well tolerated and no high-grade or serious adverse events were reported. The percentage of patients reporting 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 cell responses against the spike protein. Subjects who had a SARS-CoV-2 response prior to vaccination were omitted from efficacy calculations, as this would imply 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.
Successful manufacturing of vaccines for 176/176 subjects at two study sites supports the feasibility of point-of-care vaccine production in sparsely-equipped facilities by minimally trained third-party technicians using AIVITA’s Vaccine Activation Kit .
“As COVID-19 rates continue to rise globally with new variants, many regions still lack access to COVID-19 vaccines due to their lack of ultra-cold chain distribution. required by mRNA vaccines, lack of supply or high cost,” said Hans S. Keirstead, Ph.D., CEO of AIVITA. “Our vaccine activation kit can be shipped anywhere in the world, enabling large-scale distributed manufacturing, and can be modified in days to accommodate new variants or entirely new pathogens.”
About AIVITA’s Vaccine Activation Kit
AIVITA’s Vaccine Activation Kit enables a subject-specific personal vaccine that consists of autologous dendritic cells and lymphocytes incubated with an amount of SARS-CoV-2 spike protein. Creating the vaccine requires basic laboratory techniques and AIVITA’s ready-to-use kit of materials. Treatment begins with a blood draw from which the subject’s own immune cells are isolated and the monocytes matured into antigen-presenting dendritic cells. The patient’s dendritic cells and lymphocytes are incubated with the spike protein and administered as a single dose of preventive vaccine via a single subcutaneous injection.
About AIVITA Biomedical
Founded in 2016 by pioneers in the cell therapy industry, AIVITA Biomedical, Inc. uses its expertise in high-purity cell growth and directed differentiation to enable safe, efficient, and cost-effective manufacturing systems that support its therapeutic pipeline . Our cancer immunotherapy targets the germ of all cancers, the tumor-initiating cells, with a unique pan-antigenic approach that targets all of the patient’s cancer-specific neoantigens. Our patient-specific cancer treatments have shown tremendous promise in eradicating tumors, without harmful side effects, in clinical studies for melanoma and glioblastoma. Our COVID-19 Vaccine Activation Kit is intended for emerging countries enabling point-of-care vaccine production in poorly equipped facilities by poorly trained third-party technicians.
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SOURCEAIVITA Biomedical, Inc.
