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Aglatimagene Besadenovec · 4 trials · 3 indications
To evaluate whether treatment with aglatimagene besadenovec (CAN-2409) plus valacyclovir and continued pembrolizumab improves overall survival (OS) compared to standard of care (SoC) docetaxel chemotherapy, in participants with Stage IV non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed following prior pembrolizumab-based platinum chemoimmunotherapy
Tumor response as measured by RECIST criteria including overall response rate (ORR) and/or disease control rate (DCR)
Frequency of adverse events
Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer
| Arm | Type | Description |
|---|---|---|
| Arm 1:Continued pembrolizumab with two courses of Aglatimagene besadenovec plus prodrug | EXPERIMENTAL | Patients continue to receive pembrolizumab with two courses of Aglatimagene besadenovec plus valacyclovir |
| Arm 2: Docetaxel | ACTIVE_COMPARATOR | Patients receive standard of care docetaxel |
| ProstAtak® | EXPERIMENTAL | Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT |
| Control | PLACEBO_COMPARATOR | Placebo + valacyclovir + radiation therapy +/- ADT |
| Cohorts | OTHER | Cohort 1A and 1B - persistent but stable disease at least 18 weeks after starting ICI treatment Cohort 2A and 2B - radiographic progressive disease at least 18 weeks after starting ICI treatment Cohort 3 - refractory disease defined as progressed by imaging at least 9 weeks after starting ICI treatment (CLOSED TO ENROLLMENT) |
| CAN-2409 | ACTIVE_COMPARATOR | Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir |
| Placebo | PLACEBO_COMPARATOR | Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir |
| Name | Type | Description |
|---|---|---|
| Aglatimagene Besadenovec | BIOLOGICAL | via intratumoral injections into lung or lymph nodes at two timepoints |
| Valacyclovir | DRUG | Oral, for14 days following each aglatimagene besadenovec injection |
| Pembrolizumab | BIOLOGICAL | every 3 weeks (Q3W) or every 6 weeks (Q6W) |
| Docetaxel | DRUG | every 21 days with standard premedication |
| Aglatimagene besadenovec + valacyclovir | BIOLOGICAL | Patients will receive three courses of ProstAtak® each consisting of aglatimagene besadenovec injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: 1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. 2. The second injection will be 0-3 days before initiation of radiation therapy. 3. The third injection will be 15-22 days after the 2nd injection. The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each AdV-tk injection. Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification. |
| Placebo + valacyclovir | BIOLOGICAL | Patients will receive three courses each consisting of placebo injection + oral valacyclovir. Placebo injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: 1. The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. 2. The second injection will be 0-3 days before initiation of radiation therapy. 3. The third injection will be 15-22 days after the 2nd injection. The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each placebo injection. Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification. |
| placebo | BIOLOGICAL | Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir. |
Inclusion Criteria: 1. Age ≥ 18 years, at the time of signing the informed consent. 2. Histologically confirmed metastatic Stage IV non-squamous NSCLC. 3. Measurable disease per RECIST v1.1 with at least 1 thoracic lesion amenable to intratumoral injection (e.g., pathological lymph node or lung les...
Aglatimagene Besadenovec is an investigational gene therapy being studied for the treatment of non-squamous non-small cell lung cancer and prostate cancer. In prostate cancer, it is evaluated in patients treated by radiotherapy and in those undergoing active surveillance. It is also being tested in non-small cell lung cancer.
Aglatimagene Besadenovec is a gene therapy that belongs to the -vec/-gene target class. It is designed to deliver a gene to cancer cells, and it is administered together with the prodrug valacyclovir. The therapy is being studied to induce an immune response against tumors.
Aglatimagene Besadenovec is being developed by Candel Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CADL. The company is conducting clinical trials of this investigational gene therapy in oncology indications.
Aglatimagene Besadenovec is currently in Phase 3 clinical development. It has received Fast Track, Regenerative Medicine Advanced Therapy (RMAT), and Orphan Drug designations from the FDA. The drug is investigational and has not been approved by the FDA.
Aglatimagene Besadenovec is being studied in several clinical trials. NCT01436968 is a Phase 3 trial in localized prostate cancer with radiation therapy. NCT02768363 is a Phase 2 trial in prostate cancer during active surveillance. NCT04495153 is a Phase 2 trial in non-small cell lung cancer. NCT07660094 is a Phase 3 trial in non-squamous non-small cell lung cancer.
Aglatimagene Besadenovec is also known as aglatimagene besadenovec plus valacyclovir. In clinical trials, it is referred to as CAN-2409, as seen in the trial titles for prostate cancer and non-small cell lung cancer studies.