Enrollment into Celldex Therapeutics, Inc’s (NASDAQ:CLDX) Phase 1/2 study of CDX-014 in progressed renal cell carcinoma (RCC) has opened. The study which is open to all patients with both clear cell and papillary RCC is being conducted in the United States before it can be spread out in another ten sites. Celldex Therapeutics’s Chief Medical Officer, Thomas Davis says that the study will enhance the company’s mission of being able to meet the needs of those patients who have severe cancer situations.
A Phase 2 study which will enroll approximately 25 patients will also take place. Its primary agenda will be to assess the anti-tumor activity of CDX-014 at the recommended dose while a secondary agenda will be all about safety and tolerability. The patients will be inappropriate candidates if at all they have not had an advanced/metastatic clear cell or papillary renal cell carcinoma. It is also desired that they must have experienced progressive disease after at least two therapies.
What does CDX-014 have to offer?
There is a lot. First, it is a well-known novel antibody-drug that gets into the transmembrane protein T-cell immunoglobulin mucin-1 (TIM-1). TIM-1, on the other hand, has everything to do with various cancers with a notable mention of renal cell and ovarian carcinomas in which it is majorly expressed. CDX-014 can kill tumor cells without necessarily having to hit back negatively at the immune response. This makes it possible to use it in the future in a combination therapy.
However, the design of CDX-014 should give it stability in the bloodstream which should not hinder the release of MMAE upon internalization into TIM-1.
What anyone should know about Celldex Therapeutics, Inc
The company is out to build on a novel, disease-specific therapies that will help in either suppressing or be enhancing the body’s immune response depending on the purpose of the opted therapy. It primary goal is to put to rest the devastating diseases for which available treatments are not enough hence the need for therapeutics.