AV-MEL-1 / AiVita Biomedical - LARVOL DELTA

Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma (clinicaltrials.gov) - P1b | N=20 | Recruiting | Sponsor: Aivita Biomedical, Inc. | Trial completion date: May 2024 ➔ May 2026 | Trial primary completion date: May 2022 ➔ May 2024

Checkpoint inhibition • Metastases • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma (clinicaltrials.gov) - P1b; N=20; Recruiting; Sponsor: Aivita Biomedical, Inc.; Trial completion date: May 2023 ➔ May 2024; Trial primary completion date: May 2021 ➔ May 2022

Checkpoint inhibition • Clinical • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma (clinicaltrials.gov) - P1b; N=20; Recruiting; Sponsor: Aivita Biomedical, Inc.; Trial completion date: Dec 2023 ➔ May 2023; Trial primary completion date: Dec 2021 ➔ May 2021

Checkpoint inhibition • Clinical • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

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

Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma (clinicaltrials.gov) - P1b; N=20; Recruiting; Sponsor: Aivita Biomedical, Inc.; Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Clinical • Enrollment open • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma (clinicaltrials.gov) - P1b; N=20; Not yet recruiting; Sponsor: Aivita Biomedical, Inc.; Trial completion date: Jan 2023 ➔ Oct 2023; Trial primary completion date: Jun 2020 ➔ Oct 2021

Checkpoint inhibition • Clinical • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

AIVITA Biomedical Publishes Review of GM-CSF History and Rationale as Vaccine Adjuvant in Melanoma Management (PRNewswire) - "AIVITA Biomedical, Inc...announced...the publication of the paper, 'An update on GM-CSF and its potential role in melanoma management,' in the journal Melanoma Management...Specifically, it appears of benefit for strategies that directly involve dendritic cells, such as with vaccines in which dendritic cells are loaded with antigen ex vivo and injected admixed with GM-CSF. AIVITA currently utilizes GM-CSF as a vaccine adjuvant in clinical studies of its personalized vaccines...AIVITA's melanoma Phase 1B open-label, single-arm study...is not yet open for enrollment."

Clinical • Enrollment status • Melanoma • Oncology

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

AIVITA Biomedical announces publication concerning a predictive biomarker for melanoma patients treated with the company's platform immunotherapy (PRNewswire) - "AIVITA Biomedical...announced the publication of an article titled "Preliminary observations on soluble programmed death-1 protein as a prognostic and predictive biomarker in patients with metastatic melanoma treated with patient-specific autologous vaccines" in the oncology journal Oncotarget...The publication suggests that because of its role as an immune checkpoint, levels of soluble programmed cell death protein-1 (sPD-1) could be useful as a prognostic biomarker or predictive biomarker in cancer patients treated with vaccines."

Biomarker

Newly added product (PRNewswire) - P1, Melanoma

Pipeline update

AIVITA Biomedical receives IND clearance for phase 1b melanoma trial (PRNewswire) - “AIVITA Biomedical, Inc…announced…the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1B clinical trial investigating the Company's ROOT OF CANCER technology in patients with metastatic melanoma. The trial marks the first time AIVITA's cancer immunotherapy technology will be tested in combination with checkpoint inhibitors....AIVITA's open-label, single-arm, phase 1B treatment study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AV-MEL-1 in patients with measurable metastatic melanoma.”

IND • New P1 trial