Type of information: Production agreement
Compound: Pexa-Vec (formerly JX-594), JX-970
Company: Sillajen (Republic of Korea) ABL Europe (France)
Therapeutic area: Technology - Services - Cancer - Oncology
Type agreement: production - manufacturing
- oncolytic virus/gene therapy/oncolytic immunotherapy.
- Pexa-Vec (pexastimogene devacirepvec) is an oncolytic immunotherapy that utilizes the vaccinia poxvirus strain as its backbone. This strain has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells; Pexa-Vec was engineered to enhance this by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express the immunogenic GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack.
- Pexa-Vec is designed to attack cancer through three diverse mechanisms of action:
- 1) the lysis of cancer cells through viral replication,
- 2) the shutdown of the blood supply to tumors through vascular targeting and destruction, and
- 3) the stimulation of the body's immune response against cancer cells,(active immunotherapy).
- JX-970 is an oncolytic virus that is derived from a Western Reserve strain vaccinia virus, and its tumor selectivity has been optimized through deletion of thymidine kinase (TK) and vaccinia growth factor (VGF). In addition, it expresses GM-CSF to stimulate immune responses. In nonclinical studies, the JX-970 backbone exerted a tumor debulking effect and at the same time demonstrated a selective preference for tumor tissues.
- • On May 16, 2016, SillaJen and ABL Europe, an ABL company providing GMP production services for virus vaccine, gene therapy and oncolytic products, have entered into a commercial manufacturing agreement for SillaJen's lead product candidate, Pexa-Vec (formerly JX-594). SillaJen is currently conducting a multinational, randomized, Phase 3, open-label study of Pexa-Vec in patients with advanced liver cancer. This study , named the PHOCUS trial, is designed to enroll 600 patients who have not received prior systemic treatment for their cancer.
- • On January 22, 2018, SillaJen and ABL Europe have expanded their strategic manufacturing collaboration. Under the current agreement, ABL is currently manufacturing Pexa-Vec (formerly JX-594) for SillaJen's multinational, randomized Phase 3, open-label study of Pexa-Vec in patients with advanced liver cancer. Under the expanded agreement, ABL will also provide development, manufacturing & QC release testing services for SillaJen's pipeline product, JX-970.