This section highlights FDA-related milestones and regulatory updates for drugs developed by Candel Therapeutics (CADL).
Over the past two years, Candel Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CAN-2409 and CAN-3110. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CAN-2409 - FDA Regulatory Timeline and Events
CAN-2409 is a drug developed by Candel Therapeutics for the following indication: Prostate cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CAN-2409
- Announced Date:
- May 27, 2025
- Indication:
- Prostate cancer
Announcement
Candel Therapeutics, Inc. announced that Candel management will host a webcast and conference call on Tuesday, June 3, 2025, at 1:00PM ET.
AI Summary
Candel Therapeutics, Inc. announced that its management will host a webcast and conference call on Tuesday, June 3, 2025, at 1:00 PM ET. During this session, the leadership team will discuss their recent positive phase 3 clinical results for CAN-2409 in patients with localized, intermediate-to-high risk prostate cancer. The clinical trial demonstrated a statistically significant 30% reduction in disease recurrence compared with placebo when combined with standard-of-care radiation therapy. The webcast will also include insights from top prostate cancer specialists who served as principal investigators for the study. Interested parties can register through the Candel website and are encouraged to join early to ensure a smooth connection. This call offers investors and stakeholders a detailed overview of the promising treatment results and future directions for this innovative approach to cancer therapy.
Read Announcement- Drug:
- CAN-2409
- Announced Date:
- May 22, 2025
- Indication:
- Prostate cancer
Announcement
Candel Therapeutics, Inc. announced that results from the Company's positive phase 3 clinical trial of aglatimagene besadenovec (CAN-2409) in patients with intermediate-to-high-risk localized prostate cancer will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, IL, from May 30 to June 3, 2025.
AI Summary
Candel Therapeutics, Inc. announced that it will present positive phase 3 clinical results for its candidate aglatimagene besadenovec (CAN-2409) in patients with intermediate-to-high-risk localized prostate cancer at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The event is scheduled in Chicago, IL, from May 30 to June 3, 2025. The phase 3 study showed that CAN-2409, when combined with standard-of-care radiation therapy, resulted in a statistically significant 30% reduction in disease recurrence compared to placebo. This important finding highlights CAN-2409's potential to improve treatment outcomes for prostate cancer patients. The presentation is expected to offer detailed insights into the study methodology, clinical benefits, and the future development of this innovative, multimodal immunotherapy approach for localized prostate cancer.
Read Announcement- Drug:
- CAN-2409
- Announced Date:
- April 23, 2025
- Indication:
- Prostate cancer
Announcement
Candel Therapeutics, Inc. announced that an abstract was accepted for an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 to June 3, 2025, in Chicago, IL.
AI Summary
Candel Therapeutics, Inc. announced that an abstract from its Phase 3 clinical trial of CAN-2409 has been accepted for an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The event will be held in Chicago, IL, from May 30 to June 3, 2025. The trial data, focused on treating patients with intermediate-to-high risk localized prostate cancer, is a key part of the Company’s clinical stage development strategy for their multimodal immunotherapy, CAN-2409.
The oral presentation will take place during the "Oral Abstract Session – Genitourinary Cancer – Prostate, Testicular, and Penile" on Tuesday, June 3, 2025, from 9:45 AM to 12:45 PM CT in Hall A at the McCormick Place Convention Center. Dr. Theodore DeWeese, serving as the national principal investigator, will lead the session, highlighting important insights from the study.
Read Announcement- Drug:
- CAN-2409
- Announced Date:
- April 1, 2025
- Indication:
- Prostate cancer
Announcement
Candel Therapeutics, Inc. announced the publication of a manuscript reporting the results of a phase 1b clinical trial exploring safety and tolerability of the combination of CAN-2409 plus prodrug (valacyclovir) and nivolumab, in addition to standard of care (neurosurgery, radiotherapy, and temozolomide), in patients with newly diagnosed high-grade glioma.
AI Summary
Candel Therapeutics, Inc. announced the publication of a manuscript detailing the results of a phase 1b clinical trial for patients with newly diagnosed high-grade glioma. The study explored the safety and tolerability of combining CAN-2409 with valacyclovir (a prodrug) and nivolumab, alongside standard treatments such as neurosurgery, radiotherapy, and temozolomide. The manuscript, published in the journal Neuro-Oncology, highlights that the combination treatment was generally well tolerated and produced evidence of both local and systemic immune activation.
The trial involved 41 patients, with 35 completing the full treatment regimen. Researchers observed changes in immune cell profiles and cytokine levels, suggesting enhanced activation of the patient’s immune system. These results support further exploration of immunotherapy combinations and indicate that CAN-2409 may have potential as a versatile treatment option in various solid tumors.
Read Announcement- Drug:
- CAN-2409
- Announced Date:
- March 26, 2025
- Indication:
- Prostate cancer
Announcement
Candel Therapeutics announced final survival data from a phase 2a clinical trial of CAN-2409 in patients with stage III/IV NSCLC, inadequately responding to ICI treatment.
AI Summary
Candel Therapeutics recently announced the final survival data from its phase 2a trial for CAN-2409, an experimental treatment for patients with stage III/IV non-small cell lung cancer (NSCLC) who did not respond well to immune checkpoint inhibitors (ICIs). In the trial, patients receiving two courses of CAN-2409 achieved a median overall survival (mOS) of 24.5 months. Notably, patients with progressive disease despite ICI therapy reached an mOS of 21.5 months, which is a remarkable improvement when compared to the 9.8-11.8 month mOS typically seen with standard docetaxel chemotherapy.
The data also revealed a “long tail” of survival, with 37% of patients still alive more than two years after treatment. The treatment showed evidence of stimulating a systemic immune response, indicating benefits beyond the injected tumor, while maintaining a favorable safety profile. These results suggest that CAN-2409 could offer a new treatment option for advanced NSCLC patients with limited therapies.
Read Announcement- Drug:
- CAN-2409
- Announced Date:
- February 25, 2025
- Indication:
- Prostate cancer
Announcement
Candel Therapeutics, Inc. announced final overall survival data from the completed randomized controlled phase 2 clinical trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection, in patients with borderline resectable PDAC.
AI Summary
Candel Therapeutics, Inc. announced final overall survival data from its completed phase 2 randomized controlled trial evaluating CAN-2409 plus valacyclovir with standard chemoradiation, followed by surgery, in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC). After an additional nine months of follow‐up, the experimental group achieved an estimated median overall survival of 31.4 months compared to only 12.5 months in the control group. Notably, three of seven patients in the treatment arm remain alive at the data cutoff, with survival times of 66.0, 63.6, and 35.8 months post-enrollment.
The results show that even when disease recurrence occurred, patients treated with CAN-2409 benefitted from salvage chemotherapy, leading to extended post-progression survival. Overall, the therapy was well tolerated, with no dose-limiting toxicities observed, reinforcing its potential as a promising immunotherapy option for this aggressive cancer. These findings suggest a long-term survival benefit for patients with this challenging diagnosis.
Read Announcement- Drug:
- CAN-2409
- Announced Date:
- December 11, 2024
- Indication:
- Prostate cancer
Announcement
Candel Therapeutics, Inc. announced results from a multicenter phase 3 clinical trial evaluating CAN-2409 viral immunotherapy in localized prostate cancer patients.
AI Summary
Candel Therapeutics, Inc. announced positive topline results from a multicenter phase 3 clinical trial evaluating CAN-2409 viral immunotherapy for intermediate-to-high risk localized prostate cancer. The trial was a randomized, double-blind, placebo-controlled study that combined CAN-2409 and its prodrug, valacyclovir, with standard external beam radiation therapy. Results showed a statistically significant and clinically meaningful improvement in disease-free survival compared to radiation therapy alone, including a 14.5% relative improvement at 54 months. The study also demonstrated benefits in patients both with and without short-term androgen deprivation therapy, while maintaining a safety profile consistent with previous research and no new safety signals.
The promising results highlight the potential of using viral immunotherapy to transform treatment for localized prostate cancer. Candel plans to engage in discussions with the FDA regarding the regulatory pathway for this innovative approach, which could offer a new, effective option for patients facing this common cancer diagnosis.
Read Announcement- Drug:
- CAN-2409
- Announced Date:
- May 23, 2024
- Indication:
- Prostate cancer
Announcement
Candel Therapeutics, Inc announced topline overall survival data from its phase 2 clinical trial of CAN-2409, a multimodal biological immunotherapy candidate, plus valacyclovir (prodrug), together with standard of care (SoC) immune checkpoint inhibitor (ICI) therapy in patients with Stage III/IV non-small cell lung cancer (NSCLC) inadequately responding to ICI (anti-PD-(L)1) therapy.
AI Summary
Candel Therapeutics, Inc. announced promising topline overall survival data from its phase 2 trial for CAN-2409, a multimodal biological immunotherapy candidate, plus valacyclovir, when combined with standard immune checkpoint inhibitor therapy. In patients with Stage III/IV non-small cell lung cancer who had an inadequate response to immune checkpoint inhibitors, those receiving two administrations of CAN-2409 achieved a median overall survival of 20.6 months compared to 11.6 months for patients treated with standard docetaxel-based chemotherapy.
The treatment also activated the systemic immune response, with increased levels of circulating cytotoxic and memory T cells, which were associated with prolonged survival. Additionally, the therapy showed a beneficial effect on both injected and uninjected tumors, highlighting an abscopal response. Notably, CAN-2409 continued to show a favorable safety and tolerability profile, reinforcing its potential as a promising option for this difficult-to-treat patient group.
Read Announcement- Drug:
- CAN-2409
- Announced Date:
- May 20, 2024
- Indication:
- Prostate cancer
Announcement
Candel Therapeutics, Inc announced it will be hosting a webcasted R&D breakfast panel featuring prominent scientific and medical thought leaders to discuss topline overall survival data from its phase 2 clinical trial of CAN-2409, its multimodal biological immunotherapy candidate, in Non-Small Cell Lung Cancer (NSCLC).
AI Summary
Candel Therapeutics, Inc. announced an upcoming webcasted R&D breakfast panel during the 2024 American Society of Clinical Oncology Annual Meeting. The event, scheduled for Monday, June 3, 2024 at 7:00 AM Central Time in Chicago, will focus on discussing topline overall survival data from the phase 2 clinical trial of its immunotherapy candidate CAN-2409 in patients with Non-Small Cell Lung Cancer (NSCLC).
Paul Peter Tak, MD, PhD, President and CEO of Candel, will host and moderate the discussion alongside a panel of respected scientific and medical experts, including Dr. Charu Aggarwal, Dr. Roy S. Herbst, and Dr. Daniel H. Sterman. The session will explore the potential of CAN-2409 as a multimodal biological therapy designed to trigger a targeted immune response against tumors. A live webcast will be available on Candeltx.com under the Investors section.
Read Announcement- Drug:
- CAN-2409
- Announced Date:
- April 11, 2024
- Indication:
- Prostate cancer
Announcement
Candel Therapeutics, Inc.announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAN-2409, Candel's most advanced multimodal biological immunotherapy candidate, for the treatment of pancreatic cancer.
AI Summary
Candel Therapeutics, Inc. announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to CAN-2409, its leading biological immunotherapy candidate for treating pancreatic cancer. This key designation highlights the promise of CAN-2409 in addressing one of the most challenging and deadly forms of cancer. CAN-2409 is a multimodal therapy that works by delivering a gene directly to a tumor, where it converts an oral drug into a toxic metabolite that helps destroy cancer cells while stimulating the body’s immune response.
The Orphan Drug Designation provides incentives such as financial support for further research and the possibility of extended market protection if the therapy is approved. This milestone underlines Candel’s commitment to developing innovative treatments that aim to improve survival rates and offer a new option for patients battling pancreatic cancer.
Read Announcement- Drug:
- CAN-2409
- Announced Date:
- April 4, 2024
- Indication:
- Prostate cancer
Announcement
Candel Therapeutics, Inc. announced updated interim survival data from the ongoing randomized phase 2 clinical trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection for borderline resectable pancreatic ductal adenocarcinoma (PDAC). Survival data were updated with eight months of further follow-up since the first analysis presented at the 2023 Society for Immunotherapy (SITC) Annual Meeting.
AI Summary
Candel Therapeutics, Inc. announced updated interim survival results from its ongoing randomized phase 2 clinical trial. The study is evaluating CAN-2409 plus the prodrug valacyclovir, in combination with standard chemoradiation, followed by surgery for patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC). With an additional eight months of follow-up since the initial analysis at the 2023 SITC Annual Meeting, the data showed a notable improvement in survival outcomes. Patients receiving CAN-2409 had an estimated median overall survival of 28.8 months, while those on the standard treatment control group had a median survival of only 12.5 months. Additionally, the 24-month survival rate was 71.4% for the CAN-2409 group compared to 16.7% for the control group, and at 36 months the rates were 47.6% versus 16.7%. The treatment was generally well tolerated with no new safety concerns observed.
Read Announcement
CAN-3110 - FDA Regulatory Timeline and Events
CAN-3110 is a drug developed by Candel Therapeutics for the following indication: Recurrent high-grade Glioma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CAN-3110
- Announced Date:
- October 4, 2024
- Indication:
- Recurrent high-grade Glioma
Announcement
Candel Therapeutics, Inc. announced the Company will present a poster at the Society for Immunotherapy of Cancer's (SITC) 39th Annual Meeting taking place November 6-10, 2024 in Houston, Texas and virtually.
AI Summary
Candel Therapeutics, Inc. announced it will present a poster at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting. The event will take place from November 6-10, 2024, in Houston, Texas, and online. The poster, titled "Therapeutic potential of CAN-3110 in Ras-Raf pathway altered melanoma," will be presented by Dr. Anne Diers, Senior Director of Research at the company.
The presentation is scheduled for November 8, 2024, at Exhibit Halls A and B in the George R. Brown Convention Center. This poster session highlights Candel’s ongoing research on CAN-3110, a promising HSV-1 oncolytic immunotherapy candidate designed to target melanoma with altered Ras-Raf pathways. More details about the presentation will be available on the company’s website after the event.
Read Announcement- Drug:
- CAN-3110
- Announced Date:
- May 30, 2024
- Indication:
- Recurrent high-grade Glioma
Announcement
Candel Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAN-3110, a next generation oncolytic viral immunotherapy, for the treatment of recurrent high-grade glioma (rHGG). Glioblastoma (GBM) is the most common and aggressive form of high-grade glioma.
AI Summary
Candel Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its next-generation oncolytic viral immunotherapy, CAN-3110, for treating recurrent high-grade glioma (rHGG). This serious brain cancer, which includes glioblastoma as its most common and aggressive form, has few effective treatment options. The designation provides development incentives and the potential for up to seven years of marketing exclusivity if the therapy is approved, highlighting the urgent need for innovative treatments. CAN-3110 is currently under evaluation in a multi-institutional phase 1b clinical trial, which has already shown promising signs of safety and anti-tumor activity. Candel Therapeutics plans to present additional clinical data, focusing on the feasibility and safety of multiple dosing, at the upcoming 2024 ASCO Annual Meeting.
Read Announcement
