AIVITA Biomedical's Phase 2 Glioblastoma Trial Shows Improved Progression Free Survival

IRVINE, Calif., June 8, 2021 /PRNewswire/ -- AIVITA Biomedical, Inc., a private biotechnology company specializing in innovative stem cell applications, today announced data from its multi-center Phase 2 clinical trial of its personalized cancer vaccine, AV-GBM-1, in patients with newly diagnosed glioblastoma (GBM).

The analysis focused on the 57 Phase 2 patients who received eight doses of AV-GBM-1 over approximately six months. At the time of the analysis, surviving patients had completed therapy and had been followed between 10.1 and 27.6 months from enrollment. The median length of PFS was 10.4 months (95% confidence interval; 8.6 to 11.7 months), an improvement of approximately 50% compared to a median PFS of 6.9 months (95% confidence interval; 5.8 to 8.2 months) in the landmark STUPP study¹ that established the standard of care for patients with newly diagnosed GBM. This represents a 42% reduction in the risk of progression or death at 6.9 months. Median survival has not been reached and will be assessed after the final patient has a minimum follow up of 15 months. Overall, the treatment was well tolerated. There were 54 serious adverse events among 28 of 57 patients but none were attributed to the vaccine.

"The potential for AV-GBM-1 to significantly improve PFS in newly diagnosed GBM patients over and above current standard of care is very encouraging," said Robert O. Dillman, M.D., chief medical officer of AIVITA. "We look forward to confirming this benefit in a randomized Phase 3 multi-center trial."

AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor neoantigens derived from self-renewing tumor-initiating cells isolated from tumors after routine surgical debulking. The treatment is administered to patients via subcutaneous injection. The treatment is uniquely pan-antigenic, targeting multiple antigens, including all neoantigens, from autologous tumor-initiating cells that are responsible for the tumor growth.

"This milestone is an encouraging first step in the fight against GBM, a disease that has a devastating impact on patients and their families," said study principal investigator Daniela Bota, M.D., Ph.D., director, University of California, Irvine (UCI) Alpha Stem Cell Clinical and medical director, UCI Health Comprehensive Brain Tumor Program.

AIVITA is currently conducting two clinical studies in the United States investigating its platform immunotherapy in patients with GBM and melanoma.                           

About AIVITA Biomedical
Founded in 2016 by pioneers in the stem cell 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.

¹ Stupp R et al.  Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 2005;352:987-996.

SOURCE AIVITA Biomedical, Inc.

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