Collaborations & Partnerships
Why does the world need UbiVac’s vaccine?
While checkpoint blockade has radically improved outcomes for patients with cancer, the majority of patients still do not benefit from treatment with checkpoint blockers alone. It has been documented that patients who do not experience benefit from checkpoint blockade lack activated immune cells invading their cancer (PMID:31318407). Thus, administering a checkpoint blocker to take the brakes off the activated cancer killer cells, doesn’t eliminate the cancer if the patient’s tumor is lacking these cancer killer cells. UbiVac believes they have the answer to this problem. UbiVac reported at AACR 2023, that every patient that received DPV-001 had an increase in activated T cells invading their cancer. UbiVac sees this as critical information and a step forward in developing effective treatments for patients with advanced cancer. Additional data, presented at the Society for Immunotherapy of Cancer meeting in November 2023, identified significant unregulation of the LAG-3 checkpoint molecule on the tumor-reactive T cells invading the patients tumor by week 2 of treatment. This was before the addition of anti-PD-1 and documents that DPV-001 can activate tumor-reactive cancer killer cells in as little as 2 weeks.
UbiVac has first-in-human combination immunotherapy in the clinic
UbiVac has a clinical trial collaboration with Providence Cancer Institute and Incyte to evaluate the safety, tolerability, and preliminary efficacy of UbiVac’s investigational product, DPV-001™, a first-in-class immune activator and cancer vaccine, combined with sequenced administration of the programmed death-1 (PD-1, retifanlimab, INCMGA00012). Some patients also receive Incyte’s anti-GITR (INCAGN01876). UbiVac is excited to be collaborating with Providence and Incyte, a leader in immuno-oncology, to investigate whether this combination immunotherapy strategy, that is so effective in preclinical models, can augment tumor destructive immune responses in patients. Updated immunological findings were presented at the 2023 AACR meeting (Poster available at Newsroom tab – scientific publications). Additional data is scheduled to be presented at the Society for Immunotherapy of Cancer meeting in November 2023.
What UbiVac has discovered from this first-in-human trial
The studies presented at AACR 2023 documented vaccine alone could activate T cells in the peripheral blood by week 2 and that every patient had an increase in T cells invading the tumor by week 8. These T cells were turned on (expressed activation markers CD39 and CD103) and expressed molecules that can kill cancer cells (Interferon-g and granzyme B). Additional analyses identified that while these cancer killer cells were turned on and prepared to kill cancer cells, they also had upregulated LAG-3, a molecule that can turn off the T cells cancer killing function. This has led to plans to initiate a third arm to the trial that will administer UbiVac’s vaccine, plus anti-LAG-3 and anti-PD-1. UbiVac sees this as evidence-based tailoring of immunotherapy that has promise of increasing response rates and possibly cures of patients with cancer.
Cancer vaccines to play a critical role in treating advanced cancer
UbiVac believes that cancer vaccines will be a critical part of therapies for patients with advanced cancer that fail checkpoint blockade therapies. While adding vaccine to anti-PD-1 alone may improve outcomes for some patients, based on animal studies, difficult to treat cancers will likely require combinations of immunotherapies. That is where UbiVac has focused its attention and has trials planned to move forward.
Cancer vaccines to play a role in treating newly discovered cancers
UbiVac has FDA approval to initiate a trial that combines UbiVac’s DPV-001 with standard of care chemotherapy for patients with locally advanced breast cancer. In these patient’s chemotherapy is typically given for 7-to-8 months to shrink the cancer so that the tumor will be smaller after chemotherapy and more easily removed surgically. Animal studies and some human studies have shown that treatments that activate the immune system can further shrink these early-stage cancers. When treatment is administered before surgery it is termed “neoadjuvant” treatment. In some patients that received neoadjuvant immunotherapy, there was no tumor remaining when the surgeon went to operate. UbiVac believes that including DPV-001 as neoadjuvant treatment for breast cancer can improve tumor shrinkage and maybe eliminate the patient’s cancer.
UbiVac’s partner agrees neoadjuvant cancer vaccines hold promise
CanWell pharma in collaboration with UbiVac plans to launch, in China, the same neoadjuvant trial described above for patients with locally advanced breast cancer. UbiVac has entered a drug supply and licensing arrangement with CanWell Pharma. Under the agreement, CanWell is responsible for development and commercialization of DPV-001 in Head and Neck cancer (HNSCC), Breast cancer, and Non-Small Cell Lung Cancer (NSCLC) in Greater China. UbiVac is responsible for manufacturing and product supply. UbiVac received upfront and some of the scheduled milestone payments and royalties. UbiVac sees this strategic partnership with CanWell Pharma as an exciting opportunity to build on the domestic clinical studies and accelerate the development of our immunotherapeutic product, DPV-001.
Cancer’s dark matter are antigens contained in UbiVac’s vaccine
UbiVac is collaborating with scientists at the Earle A. Chiles Research Institute and Shimadzu Scientific Instruments on a project to characterize the surfaceome of head and neck cancers (HNSCC). This represents an important area of investigation as recent reports document that a major component of the antigens the immune system can recognize were previously undescribed. This led to their description as “Dark Matter” and a commentary on their importance to developing innovative cancer immunotherapies was recently published in a high impact cancer journal (PMID: 37040070). Discovery of these antigens requires coordinated RNAseq and mass spectroscopy (LC/MS-MS), thus our collaboration with Shimadzu, makers of highly sensitive mass spectroscopy devices and their experienced scientists, has been a great advantage. An update on these studies will be presented at the Society for Immunotherapy of Cancer meeting in November 2023.
UbiVac advances its portfolio of platform therapies through collaborations, licensing, and research efforts. The company continues to work with leading universities and hospitals, including Providence Health System (Portland, Oregon), Oregon Health and Science University, and the Free University of Amsterdam in the Netherlands.