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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 non-small cell lung cancer, including non-squamous non-small cell lung cancer, and prostate cancer, including prostate cancer patients treated by radiotherapy. It is in Phase 2 clinical development for these oncology indications.
Aglatimagene besadenovec targets HSV-tk, a herpes simplex virus thymidine kinase. It is a gene therapy modality that is being evaluated in combination with a prodrug, such as valacyclovir, for the treatment of certain cancers.
Aglatimagene besadenovec is being developed by Candel Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol CADL on a public stock exchange.
Aglatimagene besadenovec is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. It has received Fast Track, Regenerative Medicine Advanced Therapy (RMAT), and Orphan Drug designations from the FDA.
Aglatimagene besadenovec is being studied in several clinical trials. NCT07660094 is a Phase 3 trial in non-squamous non-small cell lung cancer, NCT07332000 is a Phase 2 biomarker study in prostate cancer, NCT04495153 is a Phase 2 trial in non-small cell lung cancer, and NCT02768363 is a Phase 2 trial in prostate cancer.
Aglatimagene besadenovec is also known as aglatimagene besadenovec plus valacyclovir. The clinical trials NCT04495153 and NCT02768363 refer to the drug as CAN-2409, indicating that Aglatimagene besadenovec is the same as CAN-2409.