Date: 2014-02-25
Type of
information: Initiation of development program
phase: 1-2
Announcement:
Company: Transgene (France)
Product: 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 (active immunotherapy).
Disease: advanced solid tumors
Therapeutic
area: Cancer - Oncology
Country: France
Trial
details: The Phase 1b/2 trial will evaluate Pexa-Vec in combination with metronomic cyclophosphamide, a drug used in combination with other therapies to treat a wide variety of cancers. The trial, expected to be initiated later in 2014, is sponsored by Bergonié Institute (Bordeaux, France).
Latest
news:
- • On February 25, 2014, Transgene has announced plans for a Phase 1b/2 trial with Pexa-Vec that is to be funded by the Institut National du Cancer (INCa). This trial will be part of an INCa-funded program called CLIP², that is facilitating patient access to innovative treatments and promoting global exchanges in cutting edge research that involve academic-initiated research and novel therapies being developed by biotechnology and pharmaceutical companies. “It is noteworthy that Transgene will be one of the first biotechnology companies to have a trial funded by INCa” said Philippe Archinard, Chairman and Chief Executive Officer of Transgene. “This trial complements the development plan we are finalizing with our partners, which is expected to include a global Phase 3 trial in advanced liver cancer, as well as exploratory and supportive Phase 2 studies in a variety of cancer types and with various other therapies. We look forward to providing soon a more comprehensive update on our plans for Pexa-Vec once our partner SillaJen’s acquisition of Jennerex has closed.”
Is
general: Yes
