Viagenpumatucel-L (HS 110) is a cancer vaccine that Heat Biologics is developing to treat advanced non-small cell lung cancer (NSCLC). It stimulates a patient’s own immune system to target lung cancer cells.
How viagenpumatucel-L works
Viagenpumatucel-L is an allogeneic tumor vaccine, or one composed of tumor cells that have been treated and processed. It contains lung cancer cells that have been modified to stimulate an immune response against many NSCLC tumor-associated antigens, or proteins overproduced by NSCLC cells. It is designed to trigger an immune response that targets many different antigens. This gives it an advantage over cancer treatments that stimulate a response against a single antigen.
Viagenpumatucel-L in clinical trials
A multicenter randomized Phase 2 trial (NCT02117024) is comparing the safety and effectiveness of a combination of viagenpumatucel-L and cyclophosphamide with traditional, single-agent chemotherapy in patients with advanced NSCLC who have received at least two unsuccessful cancer treatments. The primary goal of the study is to see whether the combination therapy prolongs survival, compared with standard treatment.
Researchers are no longer recruiting participants for the study, which began in July 2014 and aimed to enroll 123 patients. Its estimated completion date is September 2018, with final data on the trial’s primary outcome expected in late 2017.
A Phase 1b/2 trial called DURGA (NCT02439450) is testing the safety and effectiveness of a combination of viagenpumatucel-L and Opdivo (nivolumab), an immune checkpoint inhibitor, in patients with NSCLC. Immune checkpoint inhibitors target proteins that put brakes on an immune response. Inhibiting the proteins releases the brakes, allowing for a more robust immune response.
Patients included in this study must have received at least one previous unsuccessful treatment for incurable or metastatic NSCLC. The trial is assessing the combo’s safety, patients’ ability to tolerate it, and patients’ objective response rate to it — a measure of a cancer drug’s ability to reduce the size of a tumor. It is also evaluating patients’ overall survival and the time it takes for their disease to progress, for up to three years.
The study began in April 2015 and has an estimated completion date of March 2019, with the collection of final data on its primary outcome expected in March 2018. Researchers expect to enroll 100 patients and are still recruiting at sites in Alabama, Indiana, Kentucky, Missouri, Ohio, Oregon, and Pennsylvania.
Preliminary data from the DURGA trial reported in June 2016 suggested that adding viagentpumatucel-L to Opdivo did not significantly change the safety of the treatment. In case studies of three trial patients, two who responded to the vaccine showed increases in activated T-cells and immune cells directed against tumor-associated antigens.
In data that BioHeat reported in December 2016 and presented in March 2017, the combination treatment continued to show a favorable safety profile. In addition, the immune response was associated with tumor reduction. Five patients with an immune response had the reduction, while there was no tumor reduction in patients who did not show an immune response.
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