ovapuldencel-T (AVOVA-1) / Lisata Therap, AiVita Biomedical - LARVOL DELTA

Double-Blind Randomized Phase 2 Trial Testing Personal Cancer Vaccines in Patients with Advanced Ovarian Cancer. (PubMed, Vaccines (Basel)) - "There were no survival differences in this underpowered study. AV-OVA-1 was manufactured reliably and injections were well tolerated."

Journal • P2 data • Infectious Disease • Movement Disorders • Novel Coronavirus Disease • Oncology • Ovarian Cancer • Respiratory Diseases • Solid Tumor

Randomized phase 2 trial of personal dendritic cell (DC)-autologous tumor antigen (ATA) vaccines in newly diagnosed advanced ovary cancer. (ASCO 2023) - P2 | "The addition of DC-ATA AV-OVA-1, a personal vaccine consisting of autologous DC pulsed with ATA, was investigated to pursue improving OS... Manufacturing DC-ATA was feasible and treatment well-tolerated. There were no differences in AE, PFS or OS between study arms, but survival analyses were severely underpowered. An enhanced immune response was detected after DC-ATA."

Clinical • Metastases • P2 data • Ewing Sarcoma • Infectious Disease • Novel Coronavirus Disease • Oncology • Ovarian Cancer • Respiratory Diseases • CSF2 • IFNG • IL4

Tumor collection and establishment of tumor-initiating cell cultures to serve as the antigen source for AV-OVA-1 dendritic cell vaccines for patients with newly diagnosed advanced ovarian cancer (SITC 2022) - P2 | "Trial Registration Clinicaltrials. gov NCT00331526 Ethics Approval This study was approved by the Western IRB, approval number 20171661; all participants gave written informed consent before taking part."

Preclinical • Oncology • Ovarian Cancer • Solid Tumor

Leukapheresis to obtain monocytes to produce dendritic cells for manufacturing AV-OVA-1 personal vaccines in a randomized phase II trial in patients with newly diagnosed advanced ovarian cancer (SITC 2022) - P2 | "Batches of patient-specific AV-GBM-1 were produced by incubating autologous DC with a lysate of irradiated TICs, then aliquoted into individual doses. Trial Registration Clinicaltrials. gov NCT00331526 Ethics Approval This study was approved by the Western IRB, approval number 20171661; all participants gave written informed consent before taking part"

Clinical • P2 data • Oncology • Ovarian Cancer • Solid Tumor • IL4

Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Advanced Epithelial Ovarian Carcinomas (clinicaltrials.gov) - P2 | N=99 | Active, not recruiting | Sponsor: Aivita Biomedical, Inc. | Trial completion date: May 2022 ➔ Mar 2023

Trial completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Advanced Epithelial Ovarian Carcinomas (clinicaltrials.gov) - P2; N=99; Active, not recruiting; Sponsor: Aivita Biomedical, Inc.; Trial primary completion date: May 2022 ➔ Jan 2022

Clinical • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Advanced Epithelial Ovarian Carcinomas (clinicaltrials.gov) - P2; N=99; Active, not recruiting; Sponsor: Aivita Biomedical, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2022 ➔ May 2022; Trial primary completion date: Dec 2022 ➔ May 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

AIVITA Biomedical Closes $25 Million Financing Round (PRNewswire) - "AIVITA Biomedical, Inc...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..."

Financing • Glioblastoma • Gynecologic Cancers • Melanoma • Oncology • Ovarian Cancer

AIVITA Biomedical presents updates from ongoing ovarian cancer and glioblastoma clinical studies at 2020 AACR Virtual Annual Meeting (Businesswire) - P2, N=99; NCT02033616; Sponsor: Aivita Biomedical, Inc; "The presentation from Lisa Abaid, MD, principal investigator of the Phase 2 clinical trial of AVOVA-1 in advanced ovarian cancer, showed the trial is progressing as planned and the treatment has been well-tolerated. Enrollment for the study continues for both tumor collection and randomization."

Enrollment open • P2 data • Trial status • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

AIVITA Biomedical to present at Biotech Showcase 2020 (PRNewswire) - "Dr. Keirstead will be presenting details on AIVITA's platform cancer technology, a next generation immunotherapy targeting the tumor-initiating stem cells, with strong clinical data evidencing 72% survival at 2-years, and 54% survival at 5-years post-treatment. AIVITA is currently conducting three clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma."

Clinical data

Brain cancer patients display appropriate immune responses and decreasing tumor biomarkers in AIVITA biomedical's phase 2 clinical trial (PRNewswire) - P2, N=99; NCT02033616; "AIVITA Biomedical, Inc...announced today updated data from its ongoing glioblastoma Phase 2 clinical trial investigating AIVITA's platform immunotherapy targeting tumor-initiating cells. In approximately 80% of treated patients, sequential blood plasma biomarker analyses have identified the induction of a type II hypersensitivity response, followed by a dendritic cell-mediated antibody response. This immunological response is accompanied by decreased tumor load in approximately 81% of those same patients, equivalent to 65% of the total number of treated patients."

P2 data

Brain cancer patients display decreasing tumor biomarkers after treatment with novel immunotherapy in AIVITA Biomedical's phase 2 clinical trial (PRNewswire) - P2, N=99; NCT02033616; Sponsor: Aivita Biomedical, Inc; "AIVITA Biomedical, Inc....announced today updated clinical data from its ongoing glioblastoma Phase 2 clinical trial, investigating AIVITA's platform immunotherapy targeting tumor-initiating cells. Blood plasma biomarker analyses have identified a robust immune response and a decrease of tumor biomarkers in 65% of treated patients, in a sample that represents 29% of the total Phase 2 clinical trial size."

P2 data

AIVITA completes treatment of first patient in phase 2 ovarian cancer trial (PRNewswire) - "AIVITA Biomedical...announced today that its first patient has completed treatment in its multi-center Phase 2 ROOT OF CANCER ovarian cancer trial. The patient has received the eighth and final dose of the study therapy under the guidance of Principal Investigator Dr. Lisa Abaid of Gynecologic Oncology Associates in Newport Beach, CA."

Trial status