Overview
Northwest Biotherapeutics (OTCQB:NWBO) told investors that it would discuss initial results of the phase 1/2 trial of DCVax-Direct in inoperable solid tumors including metastatic colon, pancreatic, sarcoma, melanoma and others prior to ASCO. This morning they issued a press release summarizing early results and I understand that management will host a conference call this afternoon, Tuesday, May 27 at 4:15 PM, to discuss the results in more detail. There are a number of questions that will doubtlessly be addressed on the call this afternoon. This note gives my initial reaction to the press release.
Characteristics of Patients Enrolled in the Trial
In the treatment of most solid tumors, the first treatment is surgical resection of the tumor to remove as much of the primary tumor mass as possible. This is then followed by chemotherapy and radiation to further reduce the size of the tumor and its metastases. This trial is being conducted in patients with inoperable tumors due either to the location of the tumor or because the tumor has metastasized to the extent that surgery would not be of benefit.
The patient group in which DCVax Direct is being tested has very advanced disease. There is no therapy approved in this setting although patients may still be given chemotherapy and radiation in an effort to do something. There is obviously an urgent and unmet medical need for therapy for these patients. Again, the key point to consider is that because their tumors cannot be resected, the tumor is usually large and growing at time of treatment. These are very difficult to treat patients. If DCVax Direct is ultimately approved, its primary use will be in less severely ill, surgically resected patients who would be expected to respond better.
Description of Trial
DCVax Direct is injected into one tumor site which does not necessarily have to be on the exterior of the body. Imaging technology can allow the injection to be delivered to interior tumor masses. The initial phase 1 portion of the trial involves 36 patients. The treatment regimen includes a total of six treatments given at day 0, day 7, day 14 and week 8, week 16 and week 32. The repeated vaccinations are intended to create and build over time an immune response against the tumor.
The Company indicated that in the early stages of the trial that the protocol required that each patient treated would receive two injections. Then the investigators would have to wait 2 to 3 weeks before enrolling the next patient. This is a typical safety precaution in a first in human trial. This initially slowed enrollment but in March those restrictions were lifted and the remainder of the 36 patients have either been enrolled or have completed screening. Enrollment occurs after screening and manufacturing have been completed.
I discuss and give my initial interpretation of results on a blog on my website. It is available to investors who do not yet subscribe to my website.
Disclosure: I am long NWBO.