DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/8j8c8p/celldexs_cdx011) has announced the addition of the "Celldex's CDX-011 for GPNMB-positive breast cancer" report to their offering.
Celldex's CDX-011 is in phase III for metastatic breast cancer that expresses GPNMB. CDX-011 is an antibody-drug conjugate, meaning that a cytotoxic drug is linked to a monoclonal antibody. The antibody binds to cancer cells (as well as normal cells) that express the target antigen, and then releases the cytotoxic drug right into the target cell, causing its death.
The antibody component of CDX-011 targets the protein GPNMB, which is overexpressed in a number of tumor types including breast, melanoma and glioma. Phase II data in breast cancer established that CDX-011 is an active drug in those tumors that sufficiently express GPNMB, although the exact tipping point of GPNMB expression needed for CDX-011 to be effective is only partially defined.
Celldex is currently conducting a phase III trial of CDX-011 in metastatic breast cancer patients defined by 25% GPNMB expressing epithelial tumor cells with triple-negativity. This report reviews the rationale for targeting GPNMB, the strength of the phase II data, the likelihood of success in phase III and regulatory approval, the market opportunity and revenue projects as defined by GPNMB expression levels, and the competitive landscape for CDX-011.
Key Topics Covered:
1. Potential Indications for CDX-011
3. Efficacy Profile
4. Safety Profile
5. Clinical and regulatory opinion
- Convincing evidence of activity driven by GPNMB expression
- Responses, survival, and PFS benefit
- Pivotal phase III trial designed to support Accelerated Approval
- Could patients with a lower GPNMB expression also benefit from CDX-011?
- Is capecitabine an adequate control group for the pivotal study?
- Pivotal trial's primary endpoint is a composite of tumor responses and PFS
- In what other treatment settings could CDX-011 be used?
- Will Celldex or a partner need to develop a companion diagnostic in parallel with CDX-011's clinical development?
- CDX-011 is currently on clinical hold by the FDA
6. Competitive Landscape
7. The Market and Revenue Projections
- Aeterna Zentaris
- Bukwang Pharm.Co
- Clovis Oncology
- Cyclacel Pharm.
- Daiichi Sankyo
- Merrimack Phrm
- Nippon Kayaku
- Piramal Enterpr
- Puma Biotech
- Syndax Pharm.
For more information visit http://www.researchandmarkets.com/research/8j8c8p/celldexs_cdx011