IRVINE, Calif. – Sep 21, 2023 – AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, today announced the publication of a case report and literature review by distribution partners commercially deploying AIVITA’s Vaccine Kit, describing collateral benefits in a patient with systemic lupus erythematosus following vaccination using AIVITA’s anti-SARS-CoV-2 vaccine kit. The paper, titled “Significant improvement of systemic lupus erythematosus manifestation in children after autologous dendritic cell transfer: a case report and review of literature” was published in the journal Therapeutic Advances in Vaccines and Immunotherapy.

In the report, hospital researchers deploying AIVITA’s Vaccine Kit but not associated with AIVITA reference AIVITA’s published studies demonstrating that ex vivo dendritic cell incubation with peptides from the SARS-CoV-2 S-protein can elicit an immunogenic response in the body through the response of T cells and B cells. This case report concerns a 13-year-old female patient with lupus who experienced collateral benefits following administration of the kit-made vaccine, suggesting that the dendritic cell vaccine can also control autoimmunity by inducing a tolerogenic response.

The full open-access text can be viewed here: https://doi.org/10.1177/25151355231186005

About AIVITA’s Vaccine Kit

AIVITA’s Vaccine Kit enables a subject-specific personal vaccine that consists of autologous dendritic cells and lymphocytes incubated with one or multiple target antigens. Creation of the vaccine requires minimally equipped facilities 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, using the Kit. The patient’s dendritic cells and lymphocytes are incubated with antigen 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 great promise including eradicating tumors, without harmful side effects in melanoma, and renal cell cancer, and prolonging progression-free survival in glioblastoma. Our Vaccine Enabling Kit for infectious diseases is targeted to emerging nations enabling point-of-care vaccine production in minimally equipped facilities by minimally trained third-party technicians.

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.

###