Immunovaccine's Lead Immuno-Oncology Candidate to Enter Investigator-Sponsored Phase 2 Clinical Trial in DLBCL in Combination with Approved Anti-PD-1 Drug
"While immunotherapies, such as checkpoint inhibitors, are rapidly changing the standard of care in many cancers, it has been reported that only about 20 percent of patients are able to respond to these therapies alone, leaving the vast majority of patients with a significant unmet medical need," said Frederic Ors, Chief Executive Officer at
Researchers conducting the investigator-sponsored study will test the novel immunotherapy combination in patients whose DLBCL expresses survivin, a tumor antigen highly expressed in 60 percent of DLBCL patients. DPX-Survivac stimulates the immune system to produce T cell responses targeting survivin. The non-randomized, open-label study is expected to enroll 25 evaluable participants at five centers in
This clinical trial is the third ongoing triple-combination study using DPX-Survivac with low-dose cyclophosphamide and other immuno-modulating agents. The Company announced earlier this year that an investigator-sponsored Phase 2 study will evaluate the anti-tumor activity of Merck's pembrolizumab with DPX-Survivac and cyclophosphamide in patients with recurrent, platinum-resistant ovarian cancer. In addition,
Advanced analysis of one of the patients in
- The patient experienced changes in tumor-infiltrating T cells, which correlated with an immune response produced by DPX-Survivac and detected in the blood.
- Tumor cells showed significant PD-L1 expression, which indicates the likely suppression of the anti-tumor activity of their T cells. This effect may be alleviated with anti PD-1 or anti PD-L1 agents.
Based on these findings, and to bring the clinical program in line with
According to the
DPX-Survivac consists of survivin-based peptide antigens formulated in the Company's proprietary DepoVax™ delivery platform. DPX-Survivac is thought to work by eliciting a cytotoxic T-cell immune response against cells presenting survivin peptides. Survivin, recognized by the
Immunovaccine Forward-Looking Statements
This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals.
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