AIVITA Biomedical Announces 96% Immune Response Against SARS-CoV-2 in Phase 2 Clinical Trial of a Personalized Vaccine

IRVINE, Calif., Sept. 13, 2021 /PRNewswire/ -- AIVITA Biomedical, Inc., a private biotechnology company specializing in innovative cell therapies, today announced results from its Phase 2 clinical study testing AIVITA's anti-SARS-CoV-2 Vaccine Enabling Kit, which allows any minimally-equipped facility to make personalized COVID-19 vaccines during the course of 2 patient visits one week apart. The Phase 2 study showed that the personalized vaccine generates an enhanced immune memory response to SARS-CoV-2 in 96% of vaccinated subjects, in an environment dominated by the delta variant. The study also demonstrated that the personalized vaccine generates very few and low grade adverse events, with no serious adverse events.

The randomized and double-blinded study enrolled 145 subjects ages 19.5-82.8 years, to investigate three different quantities of S-protein incubated with each subject's own dendritic cell-lymphocyte product to produce the vaccine. Blood samples were collected to assess immune memory response at the time of vaccination, and 2 and 4 weeks later. Immune response was determined using enzyme-linked immune spots (ELISpot) assays to directly detect enhanced SARS-CoV-2-responsive immune memory cells. Indeed, the cellular nature of this vaccine renders it unique in it's ability to provide a direct cell-mediated immune memory following vaccination. An immune memory response against SARS-CoV-2 was enhanced in 96% of vaccinated subjects; subjects that had an ongoing SARS-CoV-2 response prior to vaccination were omitted from efficacy calculations, as this would infer a prior SARS-CoV-2 natural infection or a prior SARS-CoV-2 vaccine. There was no difference among the three formulations. All 3 formulations of the vaccine were well-tolerated with no high-grade or serious adverse events reported. The percentage of patients showing any toxicity was 52.9%, with the percentage of patients showing grade 1 adverse events being 47.1% and the percentage of patients showing grade 2 adverse events being 5.8%. Three days after vaccination, there were no new types of adverse events nor worsening of pre-existing laboratory abnormalities. None of the laboratory abnormalities were felt to be clinically significant by the local investigators and none were attributed to the vaccine.

"Our product is unique amongst COVID-19 vaccines in that it is a medical device, not a drug," said Hans S. Keirstead, Ph.D., chief executive officer at AIVITA. "Our Vaccine-Enabling Kit allows any country to generate personalized vaccines in their own hospitals or minimally-equipped healthcare facilities."

"Having only 53% of subjects experience adverse events is much lower than that reported for other COVID-19 vaccines that are currently available, for which 90-100% of subjects reported adverse events," said Robert Dillman, M.D., chief medical officer of AIVITA. "The vast majority of adverse events reported by subjects were characterized as mild, that is, grade 1 in severity, befitting a personalized vaccine."

AIVITA's Vaccine Enabling Kit is designed for emerging nations, and individuals who desire a personalized vaccine. Thus, the randomized double-blind Phase 2 clinical trial was run in Indonesia, where high SARS-CoV-2 infection rates have facilitated several COVID-19 vaccine clinical studies. AIVITA's study was led by RSPAD Gatot Soebroto Army (President's) Hospital in Jakarta, in collaboration with PT Rama Emerald Multi Sukses and AIVITA Biomedical subsidiary PT AIVITA Biomedika Indonesia.

AIVITA Biomedical is pre-releasing its findings due to the urgent need for solutions to the global pandemic. A manuscript further detailing the results from this Phase 2 and AIVITA's prior Phase 1B clinical study for COVID-19 is being prepared for publication.

Phase 1B study of AV-COVID-19 in Indonesia

A previous Phase 1B study was completed in Indonesia of 31 healthy Indonesia subjects including 28 randomized in a 3x3 design. In that study, all 9 formulations were well-tolerated with no acute allergic reactions. 33 adverse events were reported by 20 subjects (65%). 85% were mild (grade 1) and 15% moderate (grade 2) in severity with most adverse events characterized as local injection site reactions or systemic flu-like symptoms such as headache, arthralgias or myalgias. There were no grade 3 or 4 adverse events and there were no serious adverse events.  Laboratory tests were unremarkable. This data was reviewed by a US data safety monitoring board (DSMB).

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 stem 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.

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as applicable. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations and assumptions, as well as other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date as of which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on a number of assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions. This communication is neither an offer to sell nor a solicitation of an offer to buy any of the securities described herein.

SOURCE AIVITA Biomedical, Inc.