Abstract 5534: Evaluation of clinical safety and immunogenicity of DPX-0907, a multi-epitope vaccine for the treatment of breast, ovarian and prostate cancers
Bibliographic record
Abstract
Abstract A successful cancer vaccine needs to overcome tumor-induced immune suppression while enhancing protective Type1-biased tumor-specific immune responses. To achieve this, enhanced vaccine delivery technologies are needed. We have developed a novel liposome-in-oil depot vaccine platform called DepoVaxTM (DPX) which increases the potency of peptide-based cancer vaccines and elicits a strong cytotoxic T cell response. DPX-0907 is a human DPX-based vaccine containing 7 HLA-A2 restricted peptides and is indicated for breast, ovarian and prostate cancer. The antigens were carefully selected with a multi-targeted approach that focuses on proteins involved in pathways that are critical for the survival of a cancer cell. This reduces the likelihood of immune escape through loss of antigen expression/presentation as a tumor responds to vaccine-induced immune pressure. We recently showed that DPX-0907 produces stronger and better sustained immune responses in HLA-A2 transgenic mice than a GM-CSF/ emulsion vaccine. A multicenter phase I clinical trial was initiated in five US clinical sites in March 2010 to evaluate the safety and immunogenicity of DPX-0907 in patients with advanced breast, ovarian or prostate cancer. The open label, dose escalation study recruited patients into one of 2 dose levels (0.25 mL and 1 mL). The vaccine was administered subcutaneously every three weeks for a total of three vaccinations. PBMC's were collected prior to each vaccination and at three time points following the last vaccination. These samples were also used to monitor the immunosuppressive MDSC population in patients receiving the vaccine treatment. In addition, immune monitoring of vaccine-induced responses is based on multi-parametric intracellular cytokine staining of multiple immune cell types and the functional analysis of peptide-MHC-multimer positive CD8 T cells. This first- in-man trial has generated important safety information that support the use of DepoVax for delivering multi-peptide based vaccines. The extensive immune monitoring will aid in the rational design of future DPX-0907 and other DepoVax-based vaccine trials. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 102nd Annual Meeting of the American Association for Cancer Research; 2011 Apr 2-6; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2011;71(8 Suppl):Abstract nr 5534. doi:10.1158/1538-7445.AM2011-5534
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".