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CAN-2409+ valacyclovir · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Study Arm | EXPERIMENTAL | CAN-2409 + valacyclovir |
| Name | Type | Description |
|---|---|---|
| CAN-2409 + valacyclovir | BIOLOGICAL | CAN-2409 will be administered intratumorally followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each injection. |
Inclusion Criteria: * Pathologically documented non-small cell carcinoma (cytology or histology) that is accessible via standard-of-care staging procedures: (1) EBUS or (2) surgical approaches (eg mediastinoscopy, mediastinotomy or VATS). * Resectable with negative lymph nodes based on imaging with...
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CAN-2409 is an investigational oncology therapy being studied for malignant glioma and lung cancer. In malignant glioma, it has been evaluated in a Phase 2a study combined with standard radiation therapy for conditions including glioblastoma multiforme, anaplastic astrocytoma, and high grade glioma. It has also been studied in patients with resectable non-small cell lung cancer.
CAN-2409 is being developed by Candel Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CADL. The company is conducting clinical research on this investigational therapy for oncology indications.
CAN-2409 is in Phase 2 clinical development. A Phase 2a study of CAN-2409 with standard radiation therapy for malignant glioma has been completed. An additional Phase 1 study in resectable non-small cell lung cancer has also been completed. The drug is investigational and not yet approved.
CAN-2409 has been studied in two completed clinical trials. NCT00589875 was a Phase 2a study of CAN-2409 with standard radiation therapy for malignant glioma, enrolling 52 participants in the United States. NCT03131037 was a Phase 1 study of intratumoral gene mediated cytotoxic immunotherapy in patients with resectable non-small cell lung cancer, enrolling 12 participants.
CAN-2409 has received Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy (RMAT) designations from the U.S. Food and Drug Administration. These designations are intended to facilitate development and review of therapies for serious conditions.
CAN-2409 is not being studied with a biomarker-selected patient population in its clinical trials. The completed trials enrolled patients based on their cancer diagnosis rather than on specific molecular biomarkers.