we now have 100% of the patients (9 of 9) showing some positive effects. The patients also report feeling significantly better."
"Patience will be important as we move through the rest of the treatment regimen for all 36 patients in the Phase I portion of the trial, and proceed with the Phase II portion of the trial. The data may get either better or worse as more data is collected. However, something interesting and encouraging seems to be unfolding so far."
This growing body of initial early data is a result of both imaging scans and biopsies. The 9 patients who have received 4 injections show a range of tumor reactions, from shrinkage to no growth to some enlargement. However, in all of these patients, the biopsies show substantial tumor cell death, and in the cases of enlargement, the biopsies show major infiltration and accumulation of immune cells in and around the tumors – potential indications of an immune response to the cancer.
DCVAX-DIRECT TRIAL UPDATE INDICATES FURTHER POSITIVE RESPONSES; 3 CASE STUDIES SHOW NO LIVE TUMOR CELLS IN INJECTED TUMORS
The Street reports themselves -
06/11/14 - 08:15 AM EDT
Celldex noted that data from solid tumor expansion cohorts in ... and preparing to submit our initial New Drug Application (NDA).
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While CDX-1135 remains in the early stages of development, we believe positive pilot results may lead some investors to compare CDX-1135 to other complement modulating drugs like Soliris from Alexion Pharmaceuticals (ALXN). However, we think that these comparisons are premature given the lack of clinical data. For reference, Soliris is approved in the US for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), and is being evaluated for a number of additional indications. Sales of the drug in 2012 topped $1.1B, and we note that Soliris is not currently being studied in DDD despite completion of Phase I testing that showed improvement in symptoms.
Preclinical data support the broad study of varlilumab in combination with a number of other anti-cancer agents including but not limited to checkpoint inhibitors, chemotherapies, targeted therapies and vaccines. Varlilumab will enter at least four combination studies in the second half of 2014.