On December 29, 2020 AIVITA Biomedical, Inc., a private biotechnology company developing personalized vaccines for the treatment of cancer and prevention of COVID-19, reported that it has closed its Series B-2 financing round for up to $25 million (Press release, AIVITA Biomedical, DEC 29, 2020, View Source [SID1234573307]). Financing was provided by several life sciences investment firms.
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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.
For additional information about AIVITA’s AVOVA-1 trial patients can visit: View Source
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.