Patients
Immunotherapy has the potential to transform how cancer patients are treated. Candel’s research suggests that our viral immunotherapies may support this revolution.
Immunotherapy has the potential to transform how cancer patients are treated. Candel’s research suggests that our viral immunotherapies may support this revolution.
The patient is always our focal point. When we develop our investigational treatments, patients remain the priority 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 cancer immunotherapy candidates to be precisely delivered, with robust systemic effects. Ultimately, we believe this may enable a broad and specific anti-tumor immune response, while limiting systemic toxicity that could impact a patient’s quality of life.
Our off-the-shelf viral immunotherapy candidates are designed to produce a long-lasting, completely individualized response, specific to the patient and their cancer. We invite you to learn more about our active clinical trials and to explore resources for these disease areas.
Diseases that we are currently studying:
Prostate Cancer
Brain Cancer
Pancreatic Cancer
Lung Cancer
In the US alone, every year approximately:
men are are given the news that they have prostate cancer.
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.
Candel Therapeutics’ Clinical Trials in
In the United States alone, every year approximately 200,000 men are given the news that they have prostate cancer. Of the approximately 150,000 men in the United States. 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 investigational 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)
Click the link below to learn more about this study on clinicaltrials.gov.
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: Progression-free survival
Enrollment of the phase 2 study in localized prostate cancer patients choosing active surveillance has been completed with 187 evaluable patients.
Investigator-sponsored open label phase 1 clinical trial of CAN-3110 (rQNestin) for recurrent high-grade glioma
Recently reported data:
Click the link below to learn more about this study on clinicaltrials.gov.
Candel Therapeutics’ Clinical Trial in
High-grade glioma (most of these patients will have 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). Expected median overall survival in patients with recurrent high-grade glioma is only < 6 to 9 months. Investigator-sponsored open label phase 1 clinical trial of CAN-3110 (rQNestin) for recurrent high-grade glioma
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.
Candel Therapeutics’ Clinical Trial in
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 LK et al. Cancer Immunol Immunother, 2015;64:727-36).
Randomized phase 2 clinical trial of CAN-2409 followed by valacyclovir combined with standard of care for borderline resectable pancreatic adenocarcinoma (PaTK02)
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.
Candel Therapeutics’ Clinical Trials in
Lung cancer is the leading cause of cancer death in the United States, with about 150,000 deaths annually and 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. Results showed that intratumoral bronchoscopic delivery of CAN-2409 followed by valacyclovir demonstrated that this regimen is a feasible and well tolerated approach that resulted in potent CD8 positive T-cell activation within the tumor and in the peripheral blood (Predina JD et al. Mol Ther 2021;29:658-670).
Standard of care treatment for stage III/IV NSCLC includes immune checkpoint inhibitors (ICI), yet only ~15-40% of patients respond. CAN-2409 has demonstrated synergy with immune checkpoint inhibitors in preclinical studies (Speranza MC et al. Neuro Onc, 2018;20:225-235). Based on these results and our phase 1 clinical trial data, we designed a phase 2 clinical trial. Read more below.
Open-label phase 2 clinical trial of CAN-2409 followed by valacyclovir in combination with standard of care immune checkpoint inhibitor (ICI) for stage III/IV non-small cell lung cancer patients (LuTK02)
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.
Candel Therapeutics is committed to developing viral immunotherapies that are designed with the goal of significantly improving survival while maintaining quality of life in patients with 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.
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 investigational therapy’s risk/benefit profile for patients. Candel has two investigational therapies in clinical trials: CAN-2409 and CAN-3110, which have unique expanded access policies. In alignment with the 21st Century Cures Act, Candel may adjust these policies at any time as we continue to evaluate our position on expanded access. These policies and any updates shall be posted on the Candel website.
CAN-2409
Candel Therapeutics believes that access to non-approved, investigational drugs is best given through a clinical trial. We understand that there may be circumstances under which a patient does not qualify for participation in a clinical trial. Under such circumstances Candel Therapeutics will carefully consider provision of access to CAN-2409 to individual patients on a case-by-case basis.
Learn more about Candel’s Expanded Access Policy
CAN-3110
Candel Therapeutics believes that access to non-approved, investigational drugs is best given through a clinical trial. At this time, Candel Therapeutics does not currently consider expanded access for CAN-3110. Please click this link for information on our clinical trials of CAN-3110.