The current
COVID-19
pandemic has presented a significant health and economic challenge around the world and is affecting our employees, partners and business operations. The full extent to which the
COVID-19
pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted.
In response to the global spread of the COVID-19 pandemic, we implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on our employees, our business, including our clinical trials, and our partners. We have implemented work-from-home policies for most of our employees in response to the
COVID-19
pandemic. The effects of our work-from-home policies may negatively impact productivity, disrupt our business and delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition. We continue to work with our partners, including the NCI and MD Anderson, to mitigate the impact the
COVID-19
pandemic is having on our business.
Clinical and Regulatory Developments
Under our Cooperative Research and Development Agreement, or CRADA, the NCI is undertaking a phase 2 clinical trial testing autologous peripheral blood lymphocytes genetically modified with the
system to express TCRs that recognize neoantigens expressed by patients with a broad range of solid tumors. In response to the
COVID-19
pandemic, the NCI has implemented work restrictions that have delayed its activities for this clinical trial. As a result, we have assumed the final product-engineering runs that we expect will enable the NCI to begin enrolling patients more quickly after it has lifted these restrictions.
We recently received feedback from the FDA to our
pre-IND
meeting request for the TCR clinical trial we are planning with MD Anderson. We expect this trial will evaluate treatments using (i) TCR
+
T cells expressing recipient-derived (autologous) TCRs, which we refer to as our Personalized TCR Approach, and (ii) TCR
+
T cells expressing third party (allogeneic) TCRs from a library, which we refer to as our Library TCR Approach. The feedback from the FDA will inform the clinical trial design and IND submission for this clinical trial. We are closely monitoring the impact that
COVID-19
may have on both our and our partners’ ability to prepare for this clinical trial.
Each of the clinical trials of our Controlled
IL-12
program continues to progress. As previously announced, patient enrollment is now complete in our phase 1 clinical trial of adult patients with rGBM evaluating
Ad-RTS-hIL-12
plus daily veledimex in combination with OPDIVO, as well as our Phase 1 clinical trial of patients with rGBM evaluating
Ad-RTS-hIL-12
as a monotherapy. We expect to provide an update for each of these clinical trials at the American Society of Clinical Oncology (ASCO) 2020 Annual Meeting, including a subset of patients with unifocal disease who received a single administration of
Ad-RTS-hIL-12
with 20 mg daily dosing of veledimex along with low-dose steroids.
We also continue to enroll patients in our phase 2 clinical trial evaluating Controlled
IL-12
in combination with
PD-1
antibody Libtayo
®
(cemiplimab-rwlc) for the treatment of rGBM in adults. Despite patient enrollment slowing in some centers since the
COVID-19
pandemic outbreak, we continue to expect to complete our projected enrollment during the first half of 2020. We have also begun evaluating
Ad-RTS-hIL-12
plus veledimex in a clinical trial of
Ad-RTS-hIL-12
plus veledimex for the treatment of glioma in the pontine region of the brain, known as diffuse intrinsic pontine glioma, or DIPG.
Eden BioCell has continued to make significant progress preparing for a clinical trial of
-generated CD19-specific RPM CAR
+
T therapies using patient-derived (autologous) T cells to treat patients with relapsed or refractory CD19
+
leukemias and lymphomas. We expect Eden BioCell to submit an IND in Taiwan for this clinical trial in 2020 and we have elected to prioritize our resources on this clinical trial to support our autologous program while retaining the ability to pursue an autologous clinical trial in the United States in the future.
All our preparations have been made for our U.S. Phase 1 trial clinical trial infusing donor-derived T cells after allogeneic BMT for recipients who have relapsed with CD19
+
leukemias and lymphomas with our CD19-specific CAR
+
T therapies manufactured using our RPM technology. This clinical trial is being performed in collaboration with MD Anderson, which has informed us that, in response to the
COVID-19
pandemic, it has limited operations and is delaying the site initiation required to begin enrolling patients in this clinical trial.