Date: 2012-09-17
Type of
information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the International Liver Cancer Association (ILCA1) Annual Meeting
Company: Jennerex (USA) Transgene (France)
Product: JX594/TG6006 (Pexa-Vec)
Action
mechanism:
- 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, i.e., active immunotherapy.
Disease: hepatocellular carcinoma
Therapeutic
area: Cancer - Oncology
Country: South Korea
Trial
details:
- 25 Asian patients with advanced HCC, 20 of whom were refractory to sorafenib and 5 of whom were treatment-naive, were treated with an initial intravenous dose of JX594/TG6006. The 23 patients then received sequential intratumoral doses of JX594/TG6006 at weeks one and three, by sorafenib.
Following treatment with JX594/TG6006 alone at four weeks, 62 percent of patients had disease control as measured by modified RECIST (tumor burden measurement). Tumor biopsies of four patients following intravenous infusion showed four of four patients had local infection of JX594/TG6006 in tumor tissue while normal liver tissue was not affected, providing further evidence of JX-594/TG6006’s tumor selectivity and the ability to administer JX594/TG6006 intravenously. Furthermore, after 6 or 12 weeks, 59 percent of patients had disease control as measured by modified RECIST and 75 percent of patients had objective responses by Choi criteria. 85 percent of patients had disease control by mRECIST and /or Choi response.
Latest
news:
- Jennerex, a private, clinical-stage biotherapeutics company focused on the development and commercialization of targeted oncolytic immunotherapies and Transgene have presented interim Phase 2 clinical data of JX594/TG6006 delivered first intravenously and subsequently through intra-tumoral route demonstrating safety as well as disease control and tumor responses in patients with hepatocellular carcinoma (liver cancer, HCC).
The primary objective of this study was to determine the safety of JX594/TG6006 followed by sorafenib in patients with advanced HCC. The sequential treatment regimen was well tolerated with transient flu-like symptoms and transient leukopenia being the most common side effects related to JX594/TG6006.
The sorafenib side effects observed were consistent with the expected toxicity profile of this product.
Secondary endpoints included the effect of the sequential treatment of JX594/TG6006 followed by sorafenib on disease control and tumor response. Evidence of antitumor activity was observed in both sorafenib-naive and sorafenib-refractory patients. Importantly, this trial also demonstrated the feasibility of the systemic administration of the product (through intravenous injection).
More than 160 patients have been treated with JX594/TG6006 to date. Two Phase 2 studies are currently ongoing with JX594/TG6006. The first one is a multinational Phase 2b study in second line treatment of liver cancer patients. The second one is a Phase 2 study in colorectal cancer.
Is
general: Yes
