Cel Sci Corporation (CVM)

[Biobonic]

Northwest Bio is conducting a significantly more complex clinical trial.

The 331 trial participants are enrolled in the Company’s Phase 3 trial of DCVax®-L for Glioblastoma brain cancer.

As previously reported, the Company is working with the contract research organization (CRO) who has managed the trial and a number of independent service firms to complete the data collection and confirmation, and reach data lock for the Phase III trial. All of the data collection and confirmation is done by the independent firms, with the Company in an oversight role.



As also previously reported, coronavirus-related difficulties have impacted most aspects of the process. Trial site personnel have been unavailable due to being reassigned to COVID-19 patient treatments or otherwise, and the limited site personnel have had to work under restrictions. Committee processes such as Institutional Review Boards and Ethics Committees have been, and continue to be, focused mainly on COVID-19 matters, with other matters significantly delayed. Regulatory processes have been similarly focused on COVID-19 matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples needed for certain final data, and the firms conducting the analytics for that final data (such as IDH mutation status), continue to have only limited operations. Even logistical matters such as the shipping of tissue slides have been, and continue to be, subjected to substantial restrictions and delays.



Despite these difficulties, the CRO has completed the final monitoring visits to the trial sites (including a number of them virtually), and has completed the collection of Case Report Form (CRF) data for all patients in the trial. The CRFs contain most, though not all, of the data required for analyzing the trial.



Since the Company’s prior updates, the CRO has also completed the Source Data Verification (SDV) for all of the data contained in the CRFs. Further, the CRO has completed the resolution of the many queries.



The independent service firms have also collected most of the additional data that is not contained in the CRFs, such as additional MRI scans and certain genetic information. The Company is consulting with its advisers to obtain their support for proceeding with initial data lock without waiting for these additional data, and then to include these additional data in the database when they are available.



The primary focus for reaching data lock now is obtaining the trial sites’ data locks. In order to reach overall data lock for the trial, each site’s data must be locked. Preparatory steps must be completed at each site so that the site is ready for sign-off, and then the lead investigator at the site must personally sign off on the data from that site. To that end, the lead investigator must undergo a brief training on the system, review the site data/CRFs and personally complete the confirmation and submit it.

The data collection process is including certain epigenetic and genetic information that is recognized as important in Glioblastoma, such as MGMT methylation status. As part of this process, the Company has also identified a method that can potentially enable an additional important genetic factor — IDH mutation status — to be analyzed using bio samples collected years ago during the trial, and to be analyzed in the same timeframe as the data lock. This IDH mutation factor was unknown when the Company’s trial began and through much of the trial period, but has become recognized as very important in recent years.

The data is not just an OS determination.

Tons of data included in the NWBO clinical trial.