Patients

In the US alone, every year approximately 200,000 men are given the news that they have prostate cancer. Of the approximately 150,000 men in the U.S. who were diagnosed in 2020 before their prostate cancer had metastasized, roughly 105,000 are considered intermediate- or high-risk of progression and  approximately 45,000 are considered to be low-risk. For the intermediate- and high-risk patients, the standard of care is radical prostatectomy and radiotherapy often in conjunction with androgen deprivation therapy or chemical castration. Weighing the balance between therapeutic efficacy and side effects linked to therapy, about 10% of the intermediate-risk patients, and approximately 40% of the low-risk patients decide, in consultation with their physicians, to adopt a close monitoring approach known as active surveillance that involves periodic imaging, biomarker evaluation and biopsies.

We are evaluating treatments for patients with newly diagnosed prostate cancer from low to intermediate-high-risk disease.

Randomized controlled phase 3  clinical trial of CAN-2409 followed by valacyclovir with standard radiation therapy for localized intermediate or high-risk prostate cancer (PrTK03)

• The purpose of this study is to evaluate the effectiveness of viral immunotherapy using intra-tumoral administration of CAN-2409 followed by valacyclovir.
• Patients are randomized to active treatment versus control at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.
• Primary outcome measure: disease-free survival.
• This study is being conducted under a Special Protocol Assessment (SPA) agreement with The Food and Drug Administration (FDA) and completed enrollment of over 700 patients.

Click the link below to learn more about this study and review eligibility on clinicaltrials.gov.  Please scroll down toward the bottom (“Contacts and Locations”) to identify clinical sites near you.

Randomized controlled phase 2 clinical trial of CAN-2409 followed by valacyclovir for patients undergoing active surveillance for localized prostate cancer: the ULYSSES trial (PrTK04)

More than 50% of patients with prostate cancer are diagnosed at early stages of disease with low grade, low volume, asymptomatic disease. Active Surveillance (AS) is an approach to manage patients with regular Prostate-Specific Antigen (PSA) and biopsy-based monitoring of disease status. This approach is aimed at deferring radical treatment, however, within 10 years of diagnosis, between 21 and 38% of men will have developed progressive cancer and require invasive treatments. Viral immunotherapy using CAN-2409 may provide these patients with a low-risk local intervention and the opportunity to delay or prevent disease progression without the need for surgery or radiation.

Primary outcome measure: Disease-free survival

We have completed enrolling a 187-patient phase 2 study in localized prostate cancer patients choosing active surveillance.

Glioblastoma is associated with very poor prognosis, with five-year survival rates of less than 10%, and median survival of less than 15 months (Tran, Journal of Clinical Neurology, 2010). The standard of care pharmacologic agent, temozolomide, was approved over 20 years ago, in 1999, with no new agent significantly supplanting its use since then, further underscoring the profound unmet medical need in this condition. There remains a significant need for effective therapies to treat this disease.

Open label phase 1 clinical trial of CAN-3110 (rQNestin) for recurrent malignant glioblastoma

• 51 subjects with presumed radiologic evidence of recurrent malignant glioma are planned to undergo stereotactic biopsy under monitored general or local anesthesia and upon disease confirmation will be treated in the protocol.
• Primary outcome measure: maximum tolerated dose of viral immunotherapy CAN-3110 injected into recurrent malignant gliomas, with or without previous immunomodulation with cyclophosphamide.

Click the link below to learn more about this study and review eligibility on clinicaltrials.gov.  Please scroll down toward the bottom (“Contacts and Locations”) to identify clinical sites near you.

Pancreatic cancer has a poor prognosis and limited therapeutic alternatives. Few drugs have been approved for pancreatic cancer in the last two decades, yielding extremely modest improvements in patient outcomes. Pancreatic cancer represents a dire, unmet medical need.

We have completed a phase 1 clinical trial, showing that viral immunotherapy using CAN-2409 followed by valacyclovir can be safely combined with pancreatic cancer standard of care without added toxicity. Clinical response and survival appeared to compare favorably to expected outcomes and demonstrated increased infiltration by CD8 positive T cells (Aguilar et al, Cancer Immunol Immunother, 2015).

Randomized phase 2 clinical trial of CAN-2409 followed by valacyclovir combined with standard of care for advanced non-metastatic pancreatic adenocarcinoma (PaTK02)

• The purpose of this study is to evaluate the effects of viral immunotherapy using CAN-2409 and valacyclovir added to chemoradiation and surgery in non-metastatic locally advanced disease.
• Primary outcome measures: 1) Percentage of patients with a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. 2) Safety.

Click the link below to learn more about this study and review eligibility on clinicaltrials.gov.  Please scroll down toward the bottom (“Contacts and Locations”) to identify clinical sites near you.

Lung cancer is the leading cause of cancer death in the United States, with about 150,000 deaths annually. Until recently the five-year survival rate of lung cancer patients was less than 5%. The introduction of checkpoint inhibitor treatments, such as the anti-PD1 therapies nivolumab and pembrolizumab, has improved this significantly. Still, the majority of patients are non-responsive to immune checkpoint inhibition therapy; thus, there remains a major unmet medical need for more effective treatments.

We completed a phase 1 clinical trial in patients with non-small cell lung cancer (NSCLC) who were candidates for surgery. This trial demonstrated that viral immunotherapy by bronchoscopic intratumoral delivery of CAN-2409 in lung tumors followed by valacyclovir treatment is a feasible and well tolerated approach that resulted in potent CD8 positive T-cell activation in the tumor and in the peripheral blood (Predina JD et al. Mol Ther [2021]).

Standard of care treatment for stage III/IV NSCLC includes immune checkpoint inhibitors, yet only ~15-40% of patients respond. CAN-2409 has demonstrated synergy with immune checkpoint inhibitors in preclinical studies (Speranza, Neuro Onc, 2017). Based on these results and our phase 1 clinical trial data, we designed a phase 2 clinical trial to evaluate safety and efficacy of combining viral immunotherapy using CAN-2409 and valacyclovir with immune checkpoint inhibitors in stage III/IV NSCLC.

A phase 2 clinical trial of CAN-2409 followed by valacyclovir in combination with standard of care immune checkpoint inhibitor for stage III/IV non-small cell lung cancer patients (LuTK02) 

• The aim of this study is to test the effects of viral immunotherapy using CAN-2409 and valacyclovir in combination with standard of care checkpoint inhibitor treatment in patients with stage III/IV NSCLC
• Primary outcome measures: 1) Tumor response as measured by response evaluation criteria in solid tumors (RECIST) 2) Safety.

Click the link below to learn more about this study and review eligibility on clinicaltrials.gov.  Please scroll down toward the bottom (“Contacts and Locations”) to identify clinical sites near you.