Northwest Biotherapeutics, a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, announced that, in the ongoing Phase 1/2 clinical trial of DCVax-Direct for all types of inoperable solid tumors, all nine out of nine patients who have received four of the six planned injections are showing tumor cell death, tumor shrinkage, substantial immune cell accumulation in their tumors and/or stabilization (i.e., stopping the progression) of their advanced cancer. In addition, in three of these nine patients, biopsies now show no live tumor cells in the injected tumor. 

 

To date, 20 patients (including the nine referenced above) have received at least three of the six total injections, and 13 of these 20 patients are showing tumor cell death, tumor shrinkage, substantial accumulation of immune cells in the tumors, and/or stabilization of their disease. The company plans to report more details when the patients are further along in the treatment regimen. The first three injections are given in the first 2 weeks of the 32-week treatment regimen (at Day 0, Day 7 and Day 14). 

 

So far, nine of the patients have received four of the six planned injections, and all nine of these nine patients are showing tumor cell death, tumor shrinkage, substantial accumulation of immune cells in the tumors, and/or stabilization of the patients’ disease. The 4th injection is administered in week eight of the 32-week treatment regimen. (The overall treatment regimen includes six injections at Days 0, 7 and 14, and Weeks 8, 16 and 32.)

 

Also, in a new finding, biopsies taken in three of these nine patients now show no live tumor cells in the tumor that was injected. These three cases include diverse, advanced and particularly aggressive cancers: one metastatic pancreatic cancer case, one metastatic colon cancer case and one metastatic sarcoma case. These patients’ tumors show some enlargement on imaging scans, but the biopsies show that live tumor cells are no longer detectable and immune cells are now found there. Each of these three patients was treated with the lowest dose level (2 million cells per treatment).

 

In these three patients, as well as the other patients in the trial, only one of their tumors has been injected with DCVax-Direct. The company plans to inject multiple tumors in its further studies of DCVax-Direct. 

 

“These early glimpses are indicating an increasingly encouraging picture – especially the absence of any live tumor cells in three of the patients who have received four of the six planned injections of DCVax-Direct,” commented Linda Powers, CEO of NW Bio. “The 4th injection is still quite early, as it is just eight weeks into the 32-week treatment regimen. For patients with such advanced, metastatic, inoperable cancers, who have failed other existing treatments, these are exciting findings.”

 

“We are also quite encouraged to see the patients’ reactions growing as the treatments progress,” noted Powers. “As of the 3rd injection in week 2 of the treatments, we now have 65% of the patients (13 of 20) showing some positive effects, and as of the 4th injection in week eight of the treatments, we now have 100% of the patients (nine of nine) 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 1 portion of the trial, and proceed with the Phase 2 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 nine patients who have received four 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 is a personalized immune therapy for all types of inoperable solid tumor cancers, using dendritic cells (the master cells of the immune system) to mobilize the full immune system to attack the patient’s cancer. DCVax-Direct is administered by direct injection into the patient’s tumors, and can reach tumors in virtually any location in the body (with image guidance for interior locations).

 

Date: June 11, 2014

Source: Northwest Biotherapeutics