Patients
Immunotherapy has the potential to transform how cancer patients are treated. Candel’s research suggests that our viral immunotherapies may support this revolution.
Our Message to Patients
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
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 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)
- 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 U.S. Food and Drug Administration (FDA) and completed enrollment of 711 patients.
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
- 62 patients with presumed radiologic evidence of recurrent high-grade glioma are planned to undergo stereotactic biopsy under monitored general or local anesthesia and, upon disease confirmation, will be treated per the trial protocol.
- Primary outcome measure: Maximum tolerated dose of first-in-class herpes simplex virus-1 oncolytic viral immunotherapy CAN-3110 injected into recurrent high-grade gliomas, with or without previous immunomodulation with cyclophosphamide.
- Arm C is studying the effects of multiple CAN-3110 injections in patients with recurrent high-grade glioma, supported by the Break Through Cancer foundation.
Recently reported data:
- CAN-3110 was well tolerated without dose-limiting toxicities.
- Median overall survival (mOS) in arm A remains ongoing at 11.8 months and remains supported by arm B, which observed mOS at 12.0 months.
- Responses were observed in both injected and uninjected lesions in patients with multifocal disease.
- Transformative patient case studies observed in arm A and arm B.
- Positive HSV-1 serology, before or after CAN-3110 injection, was a predictor of response and was associated with improved survival in 66% of patients who had 14.2 mOS , which is twice the expected median overall survival in this therapy-resistant population.
- Approximately 30% of seronegative patients at baseline seroconverted after CAN-3110 treatment. Those patients also exhibited increased survival, suggesting the possibility of leveraging this mechanism and further improving survival upon multiple injections.
- The activation of both local and systemic immune response, including the expansion of the T-cell repertoire diversity, as well as HSV-1 immune status correlate with survival, suggesting that CAN-3110 can enhance anti-cancer immune responses even in immunosuppressive tumor microenvironments.
- Additional extensive biomarker studies including histology, transcriptomics, and single cell sequencing are ongoing.
Click the link below to learn more about this study on clinicaltrials.gov.
Candel Therapeutics’ Clinical Trial in
Brain Cancer
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
- 62 patients with presumed radiologic evidence of recurrent high-grade glioma are planned to undergo stereotactic biopsy under monitored general or local anesthesia and upon disease confirmation will be treated per the trial protocol.
- Primary outcome measure: Maximum tolerated dose of investigational immunotherapy CAN-3110 injected into recurrent high-grade 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.
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 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)
- The purpose of this clinical trial is to evaluate the effects of viral immunotherapy using CAN-2409 and valacyclovir added to chemoradiation and surgery in non-metastatic borderline resectable disease.
- Primary outcome measures:
- Safety
- Overall survival through 24 months
- March 2023 Update: In connection with its cost management and dynamic portfolio management initiatives, Candel elected to pause new enrollment in this randomized phase 2 clinical trial evaluating CAN-2409 in borderline resectable pancreatic adenocarcinoma subject to additional funding. All patients enrolled to date will continue to be followed for overall survival.
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
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)
- The aim of this clinical trial is to test the effects of viral immunotherapy using CAN-2409 and oral valacyclovir for stage III/IV NSCLC who are on standard of care first line ICI but with evidence of suboptimal response (either disease progression or stable disease at time of study enrollment).
- Primary outcome measures:
- Safety
- Tumor response as measured by RECIST criteria including overall response rate and/or disease control rate
- Recently reported data:
- Robust evidence of local and systemic anti-tumor activity in patients with inadequate response to immune checkpoint inhibitors.
- Disease control rate of 77 percent (20/26) in patients entering trial with disease progression (cohort 2).
- Sustained and ongoing clinical responses greater than 1 year.
- CAN-2409 favorably changed the trajectory of tumor progression.
- Decreased tumor size of RECIST target lesions in most patients.
- Reduced uninjected tumor size in 14/21 patients (67 percent).
- Overall response rate of 13 percent (4/30) across cohorts 1 and 2.
- Durable disease stabilization.
- Consistent induction of local and systemic cytotoxic T cell response.
- Increased infiltration of CD8+ T cells in the tumor microenvironment.
- Systemic expansion of effector T cells and increase in soluble granzyme B levels in peripheral blood.
- Favorable safety/tolerability profile.
- Only two administrations with relatively simple procedure.
- Most treatment-related adverse events were grade 1 or 2.
- Robust evidence of local and systemic anti-tumor activity in patients with inadequate response to immune checkpoint inhibitors.
- The study has been expanded to evaluate a three course regimen of CAN-2409 followed by oral valacyclovir.
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.
Expanded Access Policy
Candel 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. 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 investigational 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.