AIVITA Biomedical Completes Phase 1 Study of Personalized COVID-19 Vaccine Candidate, AV-COVID-19

IRVINE, Calif., Feb. 25, 2021 /PRNewswire/ -- AIVITA Biomedical, Inc., a private biotechnology company developing personalized vaccines for the treatment of cancer and prevention of COVID-19, today announced the completion of a Phase 1 clinical study in Indonesia of its personalized vaccine candidate, AV-COVID-19, for the novel coronavirus (SARS-CoV-2).

The 27-participant Phase 1 study showed the treatment was well-tolerated, with no serious adverse events, and that treated individuals produced antibodies. The clinical program is being conducted by PT AIVITA Biomedika Indonesia, a joint venture established between AIVITA and local partners with support from the government of Indonesia. AV-COVID-19 is being manufactured locally by AIVITA. AIVITA is in discussions with regulatory authorities for a Phase 2 study in Indonesia, as well as clinical investigation of AV-COVID-19 in the United States in early 2021.

"We continue to see unprecedented global need for preventative vaccines that can be rapidly scaled and adapted to provide protection against all COVID-19 viral variants," said Hans Keirstead, Ph.D., chief executive officer of AIVITA. "Our personalized vaccine can be created locally to support regional economic stimulation, using a kit that can be produced rapidly at scale. In addition, our materials can be adapted to quickly create new vaccines against mutations of the virus. With this de-centralized model, we can conduct studies in Indonesia while moving toward a clinical trial in the United States early this year, and prepare for worldwide distribution."

AV-COVID-19 was created using AIVITA's autologous cell therapy platform, which has generated multiple therapeutic vaccine programs shown to be safe and effective in early clinical trials for difficult to treat cancers. Vaccine production begins with a basic blood draw from an individual, from which autologous immune cells are extracted using AIVITA's validated methodologies. These cells are loaded with multiple recombinant SARS-CoV-2 spike antigens to create a vaccine that is specific to each individual. The resulting cells are re-administered to the individual, with the purpose of creating fast immune protection against the coronavirus. A kit containing all materials is provided to local sites, which can carry out steps with minimal equipment, to de-centralize manufacturing.

In preclinical studies, AIVITA has shown that multiple SARS-CoV-2 antigens reacted with natural immunoglobulin antibodies from COVID-19 convalescent patient serum, showing that these antigens are suitable immune targets for SARS-CoV-2 vaccine production. The multiple antigens were loaded onto the dendritic cells and the resulting vaccine mounted an appropriate immune response in lymphocytes from the same recipient. Vaccinated mice were also shown to produce antibodies and a strong cellular immune response very quickly, in a third party GLP setting.

If successful in clinical studies, AV-COVID-19 may offer unique benefits compared to traditional vaccine technologies. Using a provided kit, technicians in thousands of laboratories around the world can create the vaccine quickly for individuals in their area. Many of the kit materials can be sourced from local suppliers, and have multiple alternate suppliers. The distributed kit and vaccine manufacturing model also creates a regional economic stimulus. In addition, new vaccines can be created quickly by altering the antigens provided in the kit, to address mutations of the virus.

Previous studies of AIVITA's cancer immunotherapies using the same approach of loading multiple antigens, in this case from self-renewing tumor-initiating cells, into autologous dendritic cells have demonstrated promising safety and efficacy in multiple cancer types. These cancer immunotherapies are developed with a pan-antigenic approach that targets multiple neoantigens on those cells. AIVITA is advancing clinical vaccine programs in glioblastoma, ovarian cancer, and melanoma.

About AIVITA'S Clinical Programs

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 tumor-initiating, 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: https://www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA's glioblastoma Phase 2 single-arm study is active and completed treating 57 patients with the tumor-initiating cell-targeting immunotherapy, AV-GBM-1.

In a final analysis of progression-free survival, patients treated with AV-GBM-1 had a 38% increase in progression-free survival as compared to Stupp's standard of care.

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 tumor-initiating, 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, Inc. is a personalized vaccine company evaluating vaccines for prevention of COVID-19 infection and treatment of cancer. Our immuno-oncology vaccine therapies address the seed of all cancers, tumor-initiating cells, with a unique pan-antigenic approach that targets all neoantigens to overcome a cancer's tendency to mutate over time. Our patient-specific treatments have shown tremendous promise in eradicating tumors without harmful side effects in our melanoma and glioblastoma clinical studies. We have also leveraged our approach to create a proprietary skincare line, which dedicates 100 percent of net proceeds towards advancing revolutionary treatments for patients with cancer, and continue to explore additional applications in human health.

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.

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