Patients

Immunotherapy has the potential to revolutionize how cancer patients are treated. Candel’s research suggests that our oncolytic viral immunotherapies may support this revolution.

Our Message to Patients

The patient is always our focal point. When we develop our treatments, patients remain top of mind throughout the entire process, from the earliest preclinical studies through later-stage clinical development.

At Candel, we aspire to significantly improve a patient’s survival while maintaining their quality of life. We are developing our oncolytic virus-based cancer immunotherapies to be precisely delivered, with robust systemic effects. Ultimately, we believe this may enable a broad and multifactorial immune response, while limiting toxicity and other factors that could potentially impact a patient’s quality of life.

Our viral-based platforms allow us to calibrate our treatments based on each cancer that we target. We invite you to learn more about our active clinical trials and to explore resources for these disease areas.

Diseases that we currently target:
Prostate Cancer
Brain Cancer
Pancreatic Cancer
Lung Cancer

Prostate Cancer

In the US alone, every year approximately:

200000

men are are given the news that they have prostate cancer.

59000

develop prostate cancer recurrence and all options after recurrence are non-curative.

Standard treatments include surgery, radiation and hormone-therapy, all with significant and, in many cases, risk of life changing side effects.These include life-long medical castration and a series of other toxic therapies that may include chemotherapy, additional androgen suppression and other investigational agents. Improving first-line treatment, where there are currently no approved pharmaceutical therapies available, would address this very-significant unmet medical need.

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

Active Clinical Trials

Patients are our focus, and clinical trials are a crucial element in developing new medicines.

If you are interested in participating in a clinical research study for prostate, brain, pancreatic or non-small cell lung cancer, please visit clinicaltrials.gov.

Candel Therapeutics’ Clinical Trials in

Prostate Cancer

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 oncolytic 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 anticipates enrolling 711 patients.

For additional information, please visit:

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. Oncolytic 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 – we call this course of action “Proactive Surveillance.”

Candel Therapeutics’ Clinical Trials in

Brain Cancer

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.

We have completed a phase 2 clinical trial of CAN-2409 followed by valacyclovir as adjuvant oncolytic viral immunotherapy to surgical resection for patients with newly diagnosed malignant glioma (Wheeler LA et al. Neuro Oncol 2016;18:1137-45). Survival outcomes were most notably improved in patients with minimal residual disease after gross total resection.

Candel is leveraging both our virus-based platforms in combination with standard of care to provide potential therapeutic options to this patient population.

Open label phase 1 clinical trial of the combination of CAN-2409 given intra-cranially at the time of initial tumor resection followed by valacyclovir and nivolumab together with standard of care (radiation therapy, and temozolomide) in patients with high-grade gliomas (BrTk04)

  • Based on preclinical studies and our clinical data demonstrating synergy with anti-PD-1 therapy (Speranza et al 2018), and in conjunction with our collaborators at Bristol-Myers Squibb Co. (BMS) and the Adult Brain Tumor Consortium (ABTC), we launched this phase 1 clinical trial to study the effects of CAN-2409 in first-line patients in combination with nivolumab, an immune checkpoint inhibitor, marketed by BMS as Opdivo®.
  • The purpose of this study Is to evaluate safety and effectiveness of oncolytic viral immunotherapy using intra-tumoral administration of CAN-2409 in first-line patients in combination with nivolumab.
  • Primary outcome measure: Incidence of adverse events
  • For additional information, please visit:

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

  • 108 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 oncolytic viral immunotherapy CAN-3110 injected into recurrent malignant gliomas, with or without previous immunomodulation with cyclophosphamide.
  • For additional information, please visit:

Candel Therapeutics’ Clinical Trial in

Pancreatic Cancer

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 oncolytic 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 oncolytic 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.
  • For additional information, please visit:

Candel Therapeutics’ Clinical Trials in

Lung Cancer

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 oncolytic 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 oncolytic viral immunotherapy using CAN-2409 and valacyclovir with immune checkpoint inhibitors in stage III/IV NSCLC.

Randomized 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 oncolytic 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.
  • For additional information, please visit:

Expanded Access Policy

Candel is committed to developing immunotherapies that are designed with the goal to significantly improve survival while maintaining quality of life – from early- to late-stage cancer. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients. Candel encourages patient participation in our clinical trials to access our investigational therapies.

Expanded access is defined as use of an investigational therapy outside of clinical trial when the primary purpose is to diagnose, prevent, or treat a serious or life-threatening condition in a patient. This is different from a clinical trial, where comprehensive safety and efficacy data are collected on an investigational therapy to determine the therapy’s risk/benefit profile for patients.

Candel believes participation in our clinical trials is the most appropriate way to access our investigational therapies, and we do not offer any expanded access programs at this time.

In alignment with the 21st Century Cures Act, Candel may adjust this policy at any time as we continue to evaluate our position on expanded access. This policy and any updates shall be posted on the Candel website.

© 2021 by Candel Therapeutics