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US-based Celldex Therapeutics has begun the Phase I/II study of CDX-014, a new antibody-drug conjugate (ADC) to treat renal cell carcinoma (RCC).

CDX-014 is a fully human monoclonal ADC that targets the transmembrane protein T-cell immunoglobulin mucin-1 (TIM-1).

While TIM-1 has a very limited expression in healthy tissue, it is pronounced in several cancers, mostly renal cell and ovarian carcinomas, and is associated with a more malignant phenotype of RCC and tumour progression.

Celldex Therapeutics executive vice president and chief medical officer Thomas Davis said: "Selectively targeting TIM-1, which is expressed in the majority of metastatic renal cell carcinomas, presents a novel approach that could provide new options for patients.

“CDX-014 has also demonstrated an ability to effectively kill tumour cells without negatively impacting immune response in preclinical studies, which may make it an ideal candidate for future combination therapy.”

The Phase I dose-escalation portion of the trial will be focused on evaluating the maximum tolerability of CDX-014 as it is administered in increased doses, as well as a recommended dose for Phase II study to patients with both clear cell and papillary RCC.

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The Phase II trial enrolling approximately 25 patients is designed to evaluate the anti-tumour activity of CDX-014 at the recommended dose in advanced renal cell carcinoma.

"Selectively targeting TIM-1 … presents a novel approach that could provide new options for patients."

The trial's secondary objectives are to determine the safety, tolerability, pharmacokinetics, immunogenicity and additional measures of anti-tumour activity including clinical benefit rate.

CR014 is based on Seattle Genetics' patented technology and is related to a potent cytotoxic, monomethyl auristatin E (MMAE).

The antibody stabilises the bloodstream while releasing MMAE upon internalisation into TIM-1-expressing tumour cells, which kills the tumour cell.

CDX-014 is being developed to address advanced or metastatic clear cell or papillary renal cell carcinoma.

Image: Micrograph displaying RCC. Photo: courtesy of Nephron via Wikipedia.