Date: 2018-10-12
Type of
information: Halting of the trial
phase: 3
Announcement: discontinuation of the trial
Company: Immune Design (USA - MA)
Product: CMB305 (LV305 and G305) - dendritic-cell targeting, lentiviral vector encoding the NY-ESO-1 gene05
Action
mechanism:
- immunotherapy product/TLR4 agonist. CMB305 is a cancer immunotherapy product candidate that involves the sequential dosing of LV305 and G305. LV305 is a hybrid vector from the ZVex™ discovery platform that specifically targets dendritic cells in vivo and delivers the RNA for NY-ESO-1, enabling the dendritic cells to express the entire tumor antigen and potentially induce a diverse set of CTLs targeting NY-ESO-1 in tumors. G305, in contrast, is designed to boost the CTL response via the induction of antigen-specific CD4 "helper" T cells. G305 consists of recombinant NY-ESO-1 protein formulated with a proprietary synthetic small molecule called glucopyranosyl lipid A (GLA), the novel TLR4 agonist at the core of the GLAAS™ platform. CMB305 is intended to be an "off-the shelf" therapy that does not require patient-specific manufacturing or ex vivo manipulation of patient samples.
Disease: synovial sarcoma
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On October 11, 2018, Immune Design announced program updates CMB305 cancer vaccine program in development for the treatment of cancer. Based on a recent review of the CMB305 program, including an early analysis of the ongoing Phase 2 study that showed the combination of CMB305 and Tecentriq® (atezolizumab) is not likely to show a survival benefit in relapsed synovial sarcoma patients, the company has decided to discontinue the SYNOVATE trial . Immune Design will seek external collaborations to explore the continued development of CMB305 in sarcoma.
- • On October 16, 2017, Immune Design announced that based on productive discussions with the FDA, it plans to initiate a pivotal Phase 3 trial to support a Biologics License Application (BLA) for CMB305, a novel cancer vaccine, in patients with synovial sarcoma.
- The randomized Phase 3 trial will evaluate CMB305 monotherapy vs. placebo in patients with NY-ESO-1+locally advanced unresectable or metastatic synovial sarcoma, a sub type of soft tissue sarcoma, who have no evidence of progression after first-line chemotherapy. Immune Design intends to start the study in mid-2018 and enroll 248 patients aged twelve and older. Patients will be randomized 1:1 to receive either CMB305 monotherapy or placebo. The trial will have progression free survival (PFS) followed by overall survival (OS) as co-primary endpoints. If the PFS endpoint is successful, the FDA offered that it may support full approval of CMB305. Depending on the rate of events, final PFS analysis may occur as early as 24 months from the first patient dosed.
Is
general: Yes
