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CDX-1307: a novel vaccine under study as treatment for muscle-invasive bladder cancer
Michael A Morse1, Deborah A Bradley, Tibor Keler
1Duke University Medical Center, 10 Bryan Searle Drive, 477 Seeley G. Mudd Building, Durham, NC 27710, USA. morse004@mc.duke.edu
Abstract:
Cancer vaccines have demonstrated clinical benefit, however greater efficacy could be achieved by enhancing their immunogenicity. Owing to cancer vaccines depending on uptake and cross-presentation of tumor antigens by antigen-presenting cells (APCs), we hypothesized that greater immunogenicity would accompany strategies that direct antigen to APC-expressed mannose receptors, initiating a pathway increasing class I and II presentation to T cells. CDX-1307 consists of a human monoclonal antibody targeting the mannose receptor, fused to the human chorionic gonadotropin-β chain (hCG-β), a tumor antigen frequently expressed by epithelial cancers including bladder cancer. In Phase I studies of cancer patients, CDX-1307 was well tolerated and induced significant hCG-β-specific cellular and humoral immune responses when co-administered with GM-CSF and the Toll-like receptor agonists resiquimod and poly-ICLC. An ongoing Phase II trial evaluates CDX-1307 in patients with newly diagnosed, resectable, hCG-β-expressing bladder cancer, where low tumor burden and early intervention may provide greater potential for benefit.
Insights
This study introduces CDX-1307, a novel cancer vaccine targeting mannose receptors on antigen-presenting cells (APCs). Early trials show it effectively boosts anti-tumor immune responses, particularly for bladder cancer.
Area of Science:
- Immunology
- Oncology
- Vaccine Development
Background:
- Cancer vaccines show promise but require enhanced immunogenicity for greater efficacy.
- Current vaccines rely on antigen-presenting cell (APC) uptake and cross-presentation of tumor antigens.
- Targeting mannose receptors on APCs may improve antigen presentation and T-cell responses.
Purpose of the Study:
- To evaluate the immunogenicity and safety of CDX-1307, a novel cancer vaccine.
- To investigate the potential of CDX-1307 in patients with human chorionic gonadotropin-β (hCG-β)-expressing epithelial cancers, including bladder cancer.
Main Methods:
- CDX-1307 comprises a mannose receptor-targeting antibody fused to the hCG-β tumor antigen.
- Phase I studies involved cancer patients co-administered CDX-1307 with GM-CSF and Toll-like receptor agonists (resiquimod and poly-ICLC).
- An ongoing Phase II trial assesses CDX-1307 in patients with newly diagnosed, resectable, hCG-β-expressing bladder cancer.
Main Results:
- CDX-1307 was well-tolerated in Phase I studies.
- Significant hCG-β-specific cellular and humoral immune responses were induced.
- The vaccine demonstrated potential for enhancing anti-tumor immunity.
Conclusions:
- CDX-1307 is a promising immunotherapeutic agent for cancer treatment.
- Targeting mannose receptors offers a viable strategy to enhance vaccine immunogenicity.
- Further evaluation in Phase II trials for bladder cancer is warranted.
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