RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Regenerative Medicine Advanced Therapy (United States)

Structure/Sequence

Sequence Code 545601180

Clinical Trials associated with Aglatimagene besadenovec

NCT04495153

/ Active, not recruitingPhase 2

CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC Patients

The purpose of this clinical trial is to evaluate the effects of adding CAN-2409 + prodrug for stage III/IV NSCLC patients who are on standard of care first line immune checkpoint inhibitor (ICI) treatment with evidence that the clinical response is inadequate. CAN-2409 is a viral immunotherapy approach that induces tumor-infiltrating T-cells and a consequent PD-L1 up-regulation. A combination of CAN-2409 added to standard of care (SOC) checkpoint inhibitors may lead to improved long-term outcomes for patients with NSCLC who have suboptimal response to ICI therapy.

Start Date13 Oct 2020

Sponsor / Collaborator

Candel Therapeutics, Inc.

[+1]

NCT03603405

/ RecruitingPhase 1/2IIT

Phase I-II Study Evaluating HSV-tK + VALACYCLOVIR GENE THERAPY Combination with Radiotherapy and Chemotherapy for Newly Diagnosed Anaplastic Astrocytoma and Glioblastoma Multiforme.

Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).

Start Date28 Feb 2018

Sponsor / Collaborator

The Methodist Hospital Research Institute

NCT03576612

/ CompletedPhase 1

Phase I Study of Neoadjuvant GMCI Plus Immune Checkpoint Inhibitor Combined With Standard of Care for Newly Diagnosed High-Grade Gliomas

The purpose of this phase I trial is to test the safety of combining GMCI, an immunostimulator, plus nivolumab, an immune checkpoint inhibitor (ICI), with standard of care radiation therapy, and temozolomide in treating patients with newly diagnosed high-grade gliomas.
Gene Mediated Cytotoxic Immunotherapy (GMCI) involves the use of aglatimagene besadenovec (AdV-tk) injection into the tumor site and oral valacyclovir to kill tumor cells and stimulate the immune system. Nivolumab is an immune checkpoint inhibitor that may also stimulate the immune system by blocking the PD-1 immune suppressive pathway. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors and temozolomide is a chemotherapy drug that kills tumor cells. Giving GMCI, nivolumab, radiation therapy, and temozolomide may work better in treating patients with high-grade gliomas

Start Date27 Feb 2018

Sponsor / Collaborator

Candel Therapeutics, Inc.

[+2]

100 Clinical Results associated with Aglatimagene besadenovec

100 Translational Medicine associated with Aglatimagene besadenovec

100 Patents (Medical) associated with Aglatimagene besadenovec

Literatures (Medical) associated with Aglatimagene besadenovec

01 Feb 2025·Biochemical genetics

The Combinatorial Effect of Ad-IL-24 and Ad-HSV-tk/GCV on Tumor Size, Autophagy, and UPR Mechanisms in Multiple Myeloma Mouse Model

Article

Author: Hosseini, Seyed Younes ; Irani, Shiva ; Abdoli, Asghar ; Poorghobadi, Shima ; Baesi, Kazem ; Sadat, Seyed Mehdi

Multiple myeloma is a type of malignant neoplasia whose treatment has changed over the past decade. This study aimed to investigate the effects of combination of Adenovector-carrying interleukin-24 and herpes simplex virus 1 thymidine kinase/ganciclovir on tumor growth, autophagy, and unfolded protein response mechanisms in mouse model of multiple myeloma. Six groups of mice, including Ad-HSV-tk/GCV, Ad-IL-24, Ad-HSV-tk/IL-24, Ad-GFP, and positive and negative controls, were investigated, and each group was injected every 72 h. The tumor size was measured several times. The expression of LC3B evaluated through western blotting and ASK-1, CHOP, Caspase-3, and ATF-6 genes in the UPR and apoptosis pathways were also analyzed by the quantitative polymerase chain reaction (qPCR) method. The present results showed that the injection of Ad-HSV-tk/GCV, Ad-HSV-tk/IL-24, and metformin reduced the tumor size. The expression of LC3B was significantly higher in the treatment groups and positive control groups compared to the negative control group. The expression of CHOP, caspase-3, and ATF-6 genes was significantly higher in the Ad-IL-24 group compared to the other treatment groups. Besides, the ASK-1 expression was significantly lower in the Ad-IL-24 group as compared to the other groups. Overall, the results indicated that the presence of the HSV-tk gene in the adenovectors reduced the size of tumors and induced autophagy by triggering the expression of LC3B protein. The presence of the IL-24 might affect tumor growth but not as much the therapeutic effect of HSV-tk. Furthermore, the results indicated that co-administration of IL-24 and HSV-tk had no synergistic effect on tumor size control.

01 Feb 2025·Cancer research communications

Dynamic Tracking of Tumor Microenvironment Modulation Using Kaede Photoconvertible Transgenic Mice Unveils New Biological Properties of Viral Immunotherapy

Article

Author: Richardson, Erin ; Li, Zhi ; Withers, David R. ; Tak, Paul P. ; Willis, Claire ; Idris, Suaad ; Guo, Qiuchen ; Barone, Francesca ; Diers, Anne R.

Abstract:

CAN-2409 is a replication-defective adenovirus that delivers the herpes simplex virus–thymidine kinase gene to infected cells. Intratumoral administration of CAN-2409, followed by prodrug, results in the formation of a toxic metabolite able to induce immunogenic cell death, exposure of tumor-associated antigens, and activation of local and systemic immune responses. We used a dynamic labeling model with MC38 tumor cells implanted in photoconvertible Kaede mice. Violet light was used to label the tumor microenvironment (TME), distinguishing retained versus newly entering cells and allowing real-time monitoring of immune compartment changes within tumors. Administration of CAN-2409 + prodrug led to control of tumor growth and significantly increased effector CD8+ T-cell responses. Photolabeling of the TME revealed that rather than enhancing recruitment of T cells to the tumor, CAN-2409 altered the TME whereby newly entering and retained CD8+ T cells were significantly more proliferative. CAN-2409 supported reinvigoration of tumor-associated antigen–specific CD8+ T cells and expansion of regulatory T cells of an altered phenotype. Moreover, the combination of CAN-2409 + prodrug and anti–CTLA-4 antibody treatment further improved control of tumor growth, in part by the enhanced CD8+ T-cell–mediated effector function and diminished regulatory T cell–mediated immunosuppression. Collectively, these data defined at least two temporally distinct pathways underpinning the mechanism of action of CAN-2409 that overcome cell exhaustion and decrease immune suppression. The results also support the rationale for future clinical trials of CAN-2409 treatment combined with anti–CTLA-4 antibody therapy.

Significance::

This study utilized a novel photoconvertible mouse tumor model to track immune cell trafficking upon treatment with an investigational viral immunotherapy (CAN-2409), revealing enhanced T-cell responses after viral immunotherapy associated with local proliferation of T cells within tumors that could further enhance antitumor efficacy in combination with immune checkpoint inhibitors. These findings define temporally and spatially distinct interactions of immune cells that could be harnessed by novel therapeutics.

03 Oct 2023·Expert opinion on biological therapy

Oncolytic virotherapies for pediatric tumors

Review

Author: Atchley, Travis J ; Johnston, James M ; Laskay, Nicholas Mb ; Gross, Evan G ; Markert, James M ; Estevez-Ordonez, Dagoberto ; Hamo, Mohammad A

INTRODUCTION:

Many pediatric patients with malignant tumors continue to suffer poor outcomes. The current standard of care includes maximum safe surgical resection followed by chemotherapy and radiation which may be associated with considerable long-term morbidity. The emergence of oncolytic virotherapy (OVT) may provide an alternative or adjuvant treatment for pediatric oncology patients.

AREAS COVERED:

We reviewed seven virus types that have been investigated in past or ongoing pediatric tumor clinical trials: adenovirus (AdV-tk, Celyvir, DNX-2401, VCN-01, Ad-TD-nsIL-12), herpes simplex virus (G207, HSV-1716), vaccinia (JX-594), reovirus (pelareorep), poliovirus (PVSRIPO), measles virus (MV-NIS), and Senecavirus A (SVV-001). For each virus, we discuss the mechanism of tumor-specific replication and cytotoxicity as well as key findings of preclinical and clinical studies.

EXPERT OPINION:

Substantial progress has been made in the past 10 years regarding the clinical use of OVT. From our review, OVT has favorable safety profiles compared to chemotherapy and radiation treatment. However, the antitumor effects of OVT remain variable depending on tumor type and viral agent used. Although the widespread adoption of OVT faces many challenges, we are optimistic that OVT will play an important role alongside standard chemotherapy and radiotherapy for the treatment of malignant pediatric solid tumors in the future.

103

News (Medical) associated with Aglatimagene besadenovec

28 May 2025

·ir.candeltx.com

Candel Therapeutics Receives FDA Regenerative Medicine Advanced Therapy Designation for CAN-2409 for the Treatment of Prostate Cancer

NEEDHAM, Mass., May 28, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAN-2409 (aglatimagene besadenovec), the Company’s biological immunotherapy lead candidate, for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. CAN-2409 was also previously granted FDA Fast Track designation for the same indication. The FDA’s RMAT designation is intended to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse, or cure serious or life-threatening diseases where preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition. The designation provides opportunities for intensive FDA guidance and organizational commitment to potentially support and expedite drug development. The designation also offers eligibility for mechanisms designed to speed Biologics License Application (BLA) review and approval, with potential opportunities for rolling review and priority review. The RMAT designation was granted on the basis of the positive data from Candel’s phase 3 randomized, placebo-controlled clinical trial evaluating the efficacy and safety of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) external beam radiation therapy, in newly diagnosed, localized, intermediate-to-high-risk prostate cancer. Data announced by Candel in December 2024 showed that the phase 3 trial met its primary endpoint and demonstrated statistically significant improvement in disease-free survival (DFS) (p=0.0155) with a 30% reduction (HR 0.70) in the risk for prostate cancer recurrence or death due to any cause in patients who received CAN-2409 plus prodrug, combined with SoC radiotherapy (n=496), compared with patients who received placebo combined with SoC radiotherapy (n=249). CAN-2409 improved prostate-specific DFS with a 38% risk reduction compared with placebo (HR 0.62; p=0.0046). There was also a significant increase in the proportion of patients achieving a prostate-specific antigen (PSA) nadir of <0.2 ng/ml in the CAN-2409 treatment arm compared to the placebo arm (67.1% vs. 58.6%, respectively; p=0.0164). Furthermore, the data showed an 80.4% pathological complete response in the 2-year post-treatment biopsies after CAN-2409 administration compared to 63.6% in the control arm (p=0.0015). The safety profile of CAN-2409 was generally consistent with previous studies, with no new safety signals identified. Key aspects of the study design, including the primary endpoint, were agreed with the FDA under a Special Protocol Assessment (SPA). “Receiving the FDA’s RMAT designation underscores the critical unmet need in patients with early, localized prostate cancer and validates the promising clinical activity observed with CAN-2409. This designation further supports the design of our phase 3 study, including the DFS primary endpoint agreed upon with the FDA during the SPA negotiation,” stated Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. Dr. Tak continued, “We look forward to collaborating with the FDA to pursue an expeditious approval of CAN-2409 once we submit our BLA—currently anticipated at the end of 2026. Our aim is to introduce a new treatment option for patients at the early stages of prostate cancer, a disease that has seen minimal innovation over the past two decades. We expect the RMAT designation to facilitate the BLA filing process and bring us closer to achieve this objective.” About CAN-2409 CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a nucleotide analog that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Because of its mechanism of action, CAN-2409 has pan solid tumor treatment potential. Encouraging monotherapy activity as well as combination therapy activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitor (ICI) treatment, have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated. Candel has recently completed a successful phase 3 clinical trial of CAN-2409 in localized prostate cancer and positive phase 2a clinical trials of CAN-2409 in non-small cell lung cancer (NSCLC) and borderline resectable pancreatic ductal adenocarcinoma (PDAC). CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the FDA for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy, and localized primary prostate cancer. CAN-2409, plus prodrug, has also been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. Candel’s pivotal phase 3 clinical trial in prostate cancer was conducted under a SPA agreed with the FDA. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC. About Candel Therapeutics Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and HSV gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform; CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including the timing and availability of additional data and key data readout milestones and presentations; expectations regarding the submission of the BLA for CAN-2409 in intermediate-to-high-risk localized prostate cancer; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult to treat, solid tumors; and expectations regarding the potential benefits conferred by RMAT designation. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor Contact: Theodore Jenkins VP, Investor Relations and Business Development Candel Therapeutics, Inc. tjenkins@candeltx.com Media Contact: Ben Shannon ICR Healthcare CandelPR@westwicke.com

Clinical ResultFast TrackImmunotherapyPhase 2Phase 3

22 May 2025

·www.fiercebiotech.com

Candel sheds more light on successful late-stage trial of prostate cancer immunotherapy

Candel Therapeutics is taking incremental steps on its way to submitting an application for approval in the fourth quarter of next year for its prostate cancer candidate CAN-2409. The company will discuss results of a phase 3 trial of the immunotherapy next weekend at the American Society of Clinical Oncology conference in Chicago.\n In December, the share price of Candel Therapeutics surged by more than 200% when the company revealed the success of a phase 3 trial of its multimodal biological immunotherapy CAN-2409 (aglatimagene besadenovec) in localized prostate cancer.Five months later, Candel has unveiled more information from the study, bolstering the value of the first-in-class treatment. The company will discus the results next weekend at the American Society of Clinical Oncology (ASCO) conference in Chicago.In the study of patients with immediate- to high-risk, newly diagnosed localized prostate cancer, those in the treatment arm were given an injection of CAN-2409 into the prostate, plus oral prodrug valacyclovir, in addition to standard-of-care external beam radiation treatment. Meanwhile, participants in the control arm received placebo and radiation.In showing a 30% reduction versus placebo in the risk of prostate cancer recurrence or death, the study accomplished its primary endpoint of disease-free survival (DFS).As an example of the new data Candel is presenting, analysis of patient biopsy samples two years after treatment show that CAN-2409 induced pathological complete responses in 80% of the 496 patients in the treatment arm versus a 64% rate for the 249 participants in the control arm.To one of the principal investigators in the study, Glen Gejerman, M.D., of Hackensack Meridian Health, this tissue analysis indicates that the “cancer may have been eliminated at the microscopic level,” he said in a release.“Effective local control of prostate cancer is essential in patients who seek treatment with curative intent, as patients with positive prostate biopsies, two or more years after radical treatment, face a well-established higher risk of disease spreading within the pelvic region, developing distant metastases, and ultimately dying from prostate cancer during long-term follow-up,” he added.Candel CEO Paul Peter Tak, M.D., Ph.D., added that the company is “advancing its preparations” on its way to applying for approval of CAN-2409 by the end of 2026. At the ASCO conference, which starts next week, Candel also will discuss that DFS improvement was evident in patients who received androgen deprivation therapy and those who did not. There also was a higher level of patients reaching a prostate-specific antigen nadir in the treatment arm at 67% versus 59% in the placebo group.Another topic will be the low incidence of serious adverse events—1.7% in the CAN-2409 arm versus 2.2% in the control arm. The most prevalent side effects were flu, fever and chills.According to Candel, the study is the first multicenter, randomized phase 3 trial in localized prostate cancer in more than two decades to achieve each of its primary and secondary endpoints. When Candel revealed the success of the trial in December, it also said that CAN-2409 came up short in a phase 2b study of 190 patients with low- to intermediate-risk localized prostate cancer as the treatment had no statistically significant effect on the time to radical treatment and the percentage of patients with prostate cancer-free biopsies after one year.The 26-year-old Massachusetts-based company also is investigating CAN-2409 in non-small cell lung cancer and borderline resectable pancreatic adenocarcinoma.In November 2023, the cash-strapped company announced that it would lay off 50% of its staff in a restructuring move to stay afloat. Along with the cash savings, the company said it was looking for a partner to buy into CAN-2409.

Phase 3ASCOClinical ResultImmunotherapyPhase 2

22 May 2025

·firstwordpharma.com

ASCO25 abstract drop: Roche's Itovebi cuts risk of death; detailed PhIII data from Jazz+PharmaMar, Candel

Analysts got their first taste of data to be presented at this year's American Society of Clinical Oncology (ASCO) meeting in a wave of abstracts released Thursday evening. FirstWord has sorted through the data drop to find the most meaningful results and potential advances in cancer care. Some initial standouts include updated data for Roche's PI3K inhibitor Itovebi, Jazz Pharmaceuticals and PharmaMar's alkylating agent Zepzelca, as well as Candel Therapeutic's viral-based immunotherapy CAN-2409.Check back regularly as FirstWord continues its coverage of ASCO abstracts and presentations. We'll also be on the ground in Chicago starting May 30, so be sure to follow along as FirstWord makes sense of what results could be practice-changing — and which candidates fell flat. Itovebi reduces risk of deathRoche shared updated overall survival (OS) data for Itovebi (inavolisib) in patients with PIK3CA-mutated, HR-positive/HER2-negative, advanced breast cancer. In the Phase III INAVO120 study, participants who received Itovebi in combination with Pfizer's CDK 4/6 inhibitor Ibrance (palbociclib) and fulvestrant experienced a media OS of 34 months compared to 27 months for controls, representing a 33% reduction in the risk of death."This is the first time that overall survival has been improved by a PI3 kinase pathway targeted drug," lead study author Nicholas Turner commented during a pre-ASCO press briefing. The Itovebi triplet was approved by the FDA last October after demonstrating a 57% benefit on the primary endpoint of progression-free survival (PFS) in INAVO120. 'Clinically meaningful' survival for ZepzelcaJazz and PharmaMar reported detailed findings from the Phase III IMforte study, which is evaluating Zepzelca (lurbinectedin) with Roche's PD-L1 inhibitor Tecentriq (atezolizumab) as a first-line maintenance treatment for extensive-stage small-cell lung cancer (SCLC). Patients who received the experimental duo achieved a median PFS of 5.4 months, more than double the 2.1 months seen with Tecentriq alone, representing a significant 46% reduction in disease progression. The OS results were described as "clinically meaningful," reaching 13.2 months in the combination arm versus 10.6 months for Tecentriq alone, with a hazard ratio of 0.73.Zepzelca has been approved in the US since 2020 for metastatic SCLC patients whose disease progressed on or after platinum-based chemotherapy.CAN-2409 continues cutting riskCandel provided an update on a Phase III study evaluating CAN-2409 to treat intermediate-to-high risk, localised prostate cancer. The biotech had revealed in December that CAN-2409 achieved the study's primary endpoint of disease-free survival (DFS), demonstrating a 30% reduction in the risk of recurrence or death when combined with standard radiation therapy. The latest dataset shows that when non-prostate cancer-related deaths are excluded from the analysis, the risk reduction jumps to 38%. Additionally, per the updated readout — which features a median of four-year follow-up data — CAN-2409 still has not yet reached median DFS, compared to 86.1 months for the placebo arm.Editors Anna Bratulic, Matthew Dennis, and Elizabeth Eaton contributed to this report

Clinical ResultPhase 3Drug ApprovalASCORadiation Therapy

100 Deals associated with Aglatimagene besadenovec

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15074

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Localized Prostate Carcinoma	Phase 3	United States	Candel Therapeutics, Inc.	01 Sep 2011
Localized Prostate Carcinoma	Phase 3	Puerto Rico	Candel Therapeutics, Inc.	01 Sep 2011
metastatic non-small cell lung cancer	Phase 2	United States	NYU Langone Health	13 Oct 2020
metastatic non-small cell lung cancer	Phase 2	United States	Candel Therapeutics, Inc.	13 Oct 2020
Recurrent Prostate Carcinoma	Phase 2	United States	Candel Therapeutics, Inc.	01 May 2016
Recurrent Prostate Carcinoma	Phase 2	Mexico	Candel Therapeutics, Inc.	01 May 2016
Pancreatic adenocarcinoma	Phase 2	United States	Candel Therapeutics, Inc.	01 Oct 2015
Pancreatic adenocarcinoma	Phase 2	Mexico	Candel Therapeutics, Inc.	01 Oct 2015
Glioblastoma Multiforme	Phase 2	United States	Candel Therapeutics, Inc.	01 Mar 2007
High grade glioma	Phase 2	United States	Candel Therapeutics, Inc.	01 Mar 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01436968 (Phase 3, ASCO2025)	Phase 3	Localized Prostate Carcinoma	745	CAN-2409+prodrug	ttoyjbwvsl(wosmdwzbxr) = pupqajtpku axtqhvjfcj (wdgyjwnakw )	Positive	30 May 2025
				Placebo+prodrug	ttoyjbwvsl(wosmdwzbxr) = hdwweirkec axtqhvjfcj (wdgyjwnakw )
NCT04495153 (GlobeNewswire) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma	46	CAN-2409 (cohort 1 and 2)	nsuehdzwow(didmnvmjti) = vtwfkcozsi pxlbtvfyja (tymswwwslz )	Positive	26 Mar 2025
				CAN-2409 (cohort 2)	nsuehdzwow(didmnvmjti) = ibrxmhaeig pxlbtvfyja (tymswwwslz )
NCT02446093 (PaTK02, Company_Website) Manual	Phase 2	Pancreatic Cancer Neoadjuvant	13	CAN-2409 + valacyclovir + SoC	ifroocazha(rulzrpvdqs) = njghckiqus dspilgqzso (fpyucrooey ) View more	Positive	25 Feb 2025
				SoC	ifroocazha(rulzrpvdqs) = btpeyzzbkd dspilgqzso (fpyucrooey ) View more
NCT01436968 (PipelineReview) Manual	Phase 3	Prostatic Cancer	745	CAN-2409 plus Standard of care external beam radiation therapy	wftcpfibbv(kakoqyoion): HR = 0.7, P-Value = 0.0155 Met View more	Positive	11 Dec 2024
				Standard of care external beam radiation therapy
NCT04495153 (ASCO2024) Manual	Phase 2	Non-Small Cell Lung Cancer	73	CAN-2409 + valacyclovir	ritdwfekti(zuclujighy) = tzfqomjlhd gcysredezw (jnegsikjnt, 14.3 - NA) View more	Positive	24 May 2024
				CAN-2409 + valacyclovir (C1, stable disease)	ritdwfekti(zuclujighy) = atgdanunkh gcysredezw (jnegsikjnt )
NCT02446093 (PaTK02, Biospace) Manual	Phase 2	Pancreatic Cancer	13	CAN-2409+valacylovir or acyclovir+chemoradiation or SBRT	atfihchtrr(tvydxrwnzm) = none memckxpdcm (vqxgldhooe )	Positive	04 Apr 2024
				chemoradiation or SBRT
NCT00589875 (BrTK02, CTgov)	Phase 2	Glioblastoma Multiforme \| High grade glioma	52	Radiation therapy+Temozolomide+Valacyclovir+CAN-2409	loqaajbbtf = pluzwqmwfu nbawkgujlc (qjozzfadqr, yanvzyrdku - gydlmdwppg) View more	-	03 Apr 2024
NCT02446093 (PaTK02, SITC2023)	Phase 2	Locally Advanced Pancreatic Adenocarcinoma Neoadjuvant soluble granzymes B \| IL-10 \| IFNÎ³	19	CAN-2409+prodrug	zbogjbbcje(oeqsxxjzcc) = hstkhlerqk eolwmzzxbo (xphyawdpcc ) View more	Positive	02 Nov 2023
				CAN-2409+Prodrug (Standard of care (SOC) chemoradiation (CR) and surgery)	zbogjbbcje(oeqsxxjzcc) = dmplbwubet eolwmzzxbo (xphyawdpcc ) View more
NCT04495153 (Corporate Publications) Manual	Phase 2	Non-Small Cell Lung Cancer Second line	40	CAN-2409+valacyclovir+immune checkpoint inhibitor	xjqljhnqnq(qkhzhmsjpo) = zsrzilzpnb fedlblirao (tpjemaasgy ) View more	Positive	26 Sep 2023
NCT03576612 (SITC 12022 \| SITC 22022) Manual	Phase 1	High grade glioma First line	41	valacyclovir+CAN-2409+nivolumab (patients with methylated MGMT promoter undergoing gross total resection (GTR))	plduojbkkh(xuhbqxyoio) = ckkowmwkqb nulvkxegcy (pwlqkvyuwq )	Positive	01 Nov 2022
				valacyclovir+CAN-2409+nivolumab (patients with methylated MGMT promoter undergoing sub-total resection (STR))	plduojbkkh(xuhbqxyoio) = gxyuugnkyh nulvkxegcy (pwlqkvyuwq )

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