AIVITA Biomedical Closes $25 Million Financing Round

AIVITA Biomedical, Inc., a private biotechnology company developing personalized vaccines for the treatment of cancer and prevention of COVID-19, has closed its Series B-2 financing round for up to $25 million. Financing was provided by several life sciences investment firms.

Proceeds will support clinical development of AIVITA's personalized immunotherapy programs, including Phase 2 studies in glioblastoma and ovarian cancer, as well as AIVITA's application for commercial approval of its melanoma immunotherapy via Japan's expedited regenerative medicine regulatory pathway. Proceeds will also support AIVITA's ongoing development of a personalized vaccine for COVID-19 prevention, which is currently in a Phase 2/3 study.

"The completion of this financing round reflects strong asset development, an outstanding team and a focused strategy," said Hans S. Keirstead, Ph.D., chairman and chief executive officer of AIVITA. "AIVITA has clearly proven that personalized pan-antigenic vaccines are highly efficacious, safe and inexpensive to produce."

AIVITA's cancer immunotherapy programs are designed to target the seed of all cancers – tumor initiating cells – with a pan-antigenic approach that targets all neoantigens on those cells. Previous studies of these cancer immunotherapies have demonstrated promising safety and efficacy in multiple cancer types. AIVITA's COVID-19 vaccine program uses the same autologous cell therapy platform, with patients' own dendritic cells loaded with SARS-CoV-2 spike proteins and re-administered to potentially provide enhanced protection against viral mutations. The company has also leveraged its core technologies to create a skincare line launching in the US market in January 2021, known as Root of Skin™ MD, which dedicates net proceeds toward the treatment of cancer.

CLINICAL TRIAL DETAIL

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.