UbiVac Announces Positive Results of Phase II Adjuvant Clinical Trial

Contact: info@ubivac.com

June 2, 2017

Chicago, Il. — UbiVac, www.ubivac.com, announced the results of their randomized phase II adjuvant clinical trial in patients with definitively-treated Stage III non-small cell lung cancer (NSCLC). Their data document the ability of UbiVac’s DRibble® cancer vaccine, DPV-001, to expand T cell clones and correlates with induction of immunity against a spectrum of non-small cell lung cancer antigens. While controversial, many experts agree that the absence of anti-cancer immunity is the major roadblock to increasing the proportion of patients who respond to immunotherapy. This study, in patients at high risk of disease recurrence, provides compelling evidence that the DRibble® cancer vaccine, DPV-001, induces and/or augments anti-cancer immunity and provides a strategy to increase objective response rates by combining UbiVac’s patented DRibble® vaccine technology with checkpoint blockade and/or T cell agonist antibody-based therapies.

Rachel Sanborn, M.D., the Principal investigator for the US National Cancer Institute (NCI)-supported study, was senior author for the study that was published in the American Society for Clinical Oncology (ASCO) 2017 meeting abstracts. The results show that patients receiving DPV-001 had a significant (p<0.04) increase in total (CD4 + CD8) TCRs that increased 10-fold over baseline compared to normal controls and the increase in CD4 clones was similar to that seen following Ipilimumab.

“Based on these data, and building on preclinical data published last November in Scientific Reports – Nature, showing significant improvements in response and survival in animals receiving the combination of a DRibble® cancer vaccine plus anti-OX40, UbiVac is moving forward with a combination clinical trial of their DRibble® cancer vaccine in women with triple negative breast cancer (TNBC) and men with advanced prostate cancer” said Dr. Bernard Fox, UbiVac co-founder and CEO. He added, “After more than a decade of developing this disruptive vaccine technology, UbiVac is excited to be able to initiate clinical trials that combine some of the most promising science in the hope of improving outcomes of patients with these devastating diseases.” This bench-to-bedside research characterizing the immune response induced by the cancer vaccine was the result of a long-term collaboration between UbiVac and the Robert W. Franz Cancer Research Center at the Earle A. Chiles Research Institute, a component of Providence Health & Services.

About non-small cell lung cancer (NSCLC)

According to the World Health Organization, 1.59 million people died of lung cancer in 2016. In the US more men and women will die of lung cancer than any other cancer.

Checkpoint blockade and why the majority of patients with lung cancer are not cured

Anti-PD-1 agents (Nivolumab and Pembrolizumab) can provide substantial anti-cancer effects in patients with NSCLC. Unfortunately, the majority of patients fail to respond and many who experience regression ultimately progress and die of their disease. Since anti-PD-1 works by taking the brakes off the immune system, patients lacking an immune response against their cancer fail to respond. Further, it is hypothesized that patients who have an immune response against only a limited number of cancer “targets” may experience an initial tumor regression, but ultimately the tumor will continue to grow as it evades the limited immune response. UbiVac believes that inducing immunity against a large number of cancer targets (antigens) found in lung cancer is required in order to improve response rates to anti-PD-1 therapy and potentially cure patients of their lung cancer. These data, presented in the ASCO abstract, further support that UbiVac’s patented DRibble® vaccine technology can accomplish this task.

UbiVac’s strategy to induce broad anti-cancer immunity and improve patient outcomes

UbiVac's patented platform technology is based on autophagy, the discovery of which was recognized with the 2016 Nobel Prize in Physiology or Medicine, and provided paradigm changing results in animal models which led to a series of clinical trials. Results of these clinical studies, document that UbiVac's lead DRibble® cancer vaccine, DPV-001, is inducing and/or boosting the immune system of patients to recognize and potentially destroy their cancer. This ability to turn on the immune system to recognize cancer is a disruptive first step for the immuno-oncology sector, as only patients with pre-existing immunity are expected to respond to checkpoint blockade (anti-PD-1). Several leaders in the field have suggested that many or most patients with cancer lack anti-cancer immunity, limiting the effectiveness of anti-PD-1. Since UbiVac's lead agent, DPV-001, a novel, 100+ antigen vaccine-based immunotherapy has induced or boosted broad anti-cancer in all patients studied to date, UbiVac's next step is to combine this vaccine with anti-PD-1 antibodies that can overcome cancers ability to block cancer killer cells from destroying cancer.

UbiVac’s DPV-001 DRibble vaccine: Ideal for combination immunotherapy

UbiVac’s DRibble technology has been formulated as the ideal companion for combination immunotherapy, and is complimentary to the pipelines of major pharmaceutical companies currently developing immuno-oncology therapies. In addition to the phase II trial in NSCLC, UbiVac’s technology already is in a clinical trial for men with prostate cancer and will soon open a combination immunotherapy trial with for patients with advanced triple negative breast cancer.

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Contact: info@ubivac.com

Award Number R44CA121612 from the National Cancer Institute supported the research and clinical trial of DPV-001 in patients with NSCLC. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

UbiVac is a clinical stage Immuno-Oncology company engaged in development of immunotherapies to combat cancer. UbiVac’s DPV-001 recently completed a Phase II randomized multi-center adjuvant study for non-small cell lung cancer. UbiVac has ongoing preclinical and discovery programs using DRibble, nanoparticles and spread-defective Cytomegalovirus (sdCMV). Founded in Portland, Ore. in 2005 by Drs. Bernard A. Fox and Hong Ming Hu, UbiVac is a spinout of the Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute at Providence Portland Medical Center. In 2011 UbiVac, in cooperation with Oregon Health & Science University (OHSU), created UbiVac CMV to license sdCMV.