In this interview, Dr. Mark Garzotto, Chair of Urology at the Portland Clinic Research Institute, urologic oncologist, and principal investigator with extensive experience in prostate cancer clinical research, discusses the evolving data for aglatimagene besadenovec + valacyclovir in combination with EBRT.
Dr. Garzotto recently presented the updated results during his plenary oral presentation at the American Urological Association Annual Meeting 2026, highlighting the accumulating clinical benefit observed across multiple endpoints with extended follow-up.
Worth a listen: the OncLive interview provides an excellent insight into the clinical relevance of the findings and the potential implications for men undergoing treatment for localized prostate cancer with curative intent.
https://t.co/1dh7J9FRak
Exciting weeks ahead for the team at Candel Therapeutics.
Following the presentation of extended phase 3 data for aglatimagene besadenovec in localized prostate cancer at #AUA2026, we look forward to presenting and engaging with investors at upcoming healthcare conferences, including Stifel and Jefferies.
These discussions are important opportunities to share our vision for the future of multimodal immunotherapies, with the goal of helping patients live longer, free from cancer recurrence and progression.
A big thank you to our team, investigators, patients, and partners who continue to make this progress possible.
https://t.co/F9guC29T8E
At #BioEquityEurope, our CEO @paulpetertak presented phase 2 data for aglatimagene in advanced NSCLC.
50% of patients survived beyond 24 months despite prior immune checkpoint inhibitor failure, with a long-term survival tail supporting phase 3 initiation.
@BioCentury#CADL
We will host an investor conference call following the oral plenary presentation of extended phase 3 data for aglatimagene besadenovec in localized prostate cancer by Mark G. Garzatto, M.D., Professor of Urology at Oregon Health & Science University and the Portland VA Medical Center, at the American Urological Association Annual Meeting.
These data continue to build on the potential of a novel immunotherapy approach in a curative-intent setting.
More details here: https://t.co/EEv85IbfcA
Today, we announced an important step toward bringing innovation to patients with localized prostate cancer.
We have entered into a commercialization agreement with EVERSANA to support the potential U.S. launch of aglatimagene besadenovec (CAN-2409).
This collaboration strengthens our ability to prepare for launch in a focused, capital-efficient way, leveraging EVERSANA’s capabilities across data and analytics, medical affairs, market access, and field operations.
Our strategy is deliberate during this stage of the company: build a high-performing commercial model around a network of expert partners, while maintaining flexibility and discipline as we approach our planned BLA submission in Q4 2026.
For patients, this is about readiness.
For physicians, this is about access.
For our team, this is about execution.
Localized prostate cancer has not seen meaningful innovation in decades. We believe aglatimagene has the potential to change that, if approved, by offering a new treatment approach aligned with curative intent.
We are building not just a therapy, but the foundation to deliver it.
More to come as we continue to advance toward registration and potential launch.
https://t.co/J0yWOjZBZ5
@EVERSANAcompany@ideapharma@CandelTx
Our Chief Scientific Officer, Francesca Barone, is presenting at #IOVC2026 in Iceland on April 27th on aglatimagene besadenovec (CAN-2409), our locally delivered viral immunotherapy for solid tumors.
https://t.co/BFaFPDOCH7
@baroneExpMed $CADL
Stories like this remind us why we do what we do: https://t.co/lTnZPGul2L
The journey of Kyle Donahue, featured in Parade, is both deeply personal and scientifically meaningful. Diagnosed with recurrent glioblastoma and initially given only months to live, she is now a five-year survivor after participating in a clinical trial of linoserpaturev (CAN-3110). Clinical trials are where hope meets science. For a disease where median survival is typically measured in months and long-term survival remains rare, such outcomes are extraordinary, and instructive.
What stands out is not only the individual story, but what it represents:
The potential of viral immunotherapy to reshape the tumor microenvironment. The importance of activating the immune system in ways that may lead to durable responses. And critically, the indispensable role of patients who choose to participate in clinical trials.
In glioblastoma, progress has been frustratingly slow for decades. But we are now seeing signals that suggest we may finally be turning a corner.
We should be careful not to overinterpret early data. Yet we should be equally careful not to underestimate what these signals mean for patients and for the field.
The treatment paradigm for newly diagnosed, localized prostate cancer is evolving but important gaps remain.
In an insightful discussion, Dr. Neal Shore highlights a key reality: many patients pursuing curative intent are still faced with trade-offs that meaningfully impact quality of life.
Despite progress, ~30% of patients still experience treatment failure with current radiation or surgical approaches. At the same time, patients are becoming more vocal about avoiding androgen deprivation therapy (ADT), given its well-known effects on fatigue, cognition, sexual function, and cardiovascular health.
This is driving a clear shift, toward:
- Precision, image-guided interventions.
- Local therapies that enhance efficacy without systemic burden.
- New combinations that preserve quality of life.
Aglatimagene besadenovec (CAN-2409) aims to do exactly that: improve outcomes while potentially avoiding testosterone suppression.
The direction is clear: Patients want treatments that are not only effective but also compatible with long-term health and daily life. That is the bar we should all be aiming for.
https://t.co/CZCYEE1WVR
Thrilled to share an important milestone for Candel Therapeutics.
Our abstract with new data has been selected for oral plenary presentation in the session “Practice-changing, Paradigm-shifting Clinical Trials in Urology” at the American Urological Association Annual Meeting 2026 in Washington, D.C. (May 15–18, 2026).
https://t.co/yGaSTccOmJ
@oshea9_harry@paulpetertak We observed in other indications such impressive increase in the activation status of immune cells that we estimate the target number for recruitment of the PRTK05 study will be sufficient to show differences, we will report median, mean and FC from baseline and against controls.
@oshea9_harry@paulpetertak We don’t need to prove our MOA as this has been demonstrated through several experiments in preclinical models and clinical trials in other indications.
@oshea9_harry@paulpetertak We added 15 controls and extend the timeline to accommodate for it. This is an experimental medicine biomarker study and we will use descriptive statistics.
I’m proud to share a significant step forward for Candel Therapeutics:
Positive Interim Data for CAN-3110 in Recurrent Glioblastoma & New Publication in Science Translational Medicine.
Today, we announced positive interim survival results from our phase 1b study of CAN-3110 (linoserpaturev) in recurrent glioblastoma, alongside a landmark publication titled “Serial Multiomics Uncovers Anti-Glioblastoma Responses Not Evident by Routine Clinical Analyses” in Science Translational Medicine.
I want to thank our extraordinary team at Candel, our clinical collaborators (especially @EAChiocca and the Break Through Cancer TeamLab partners), and the courageous patients participating in this study. This is another step in our mission to bring meaningful therapies to patients facing the toughest cancers.
https://t.co/a9u0tbMq4k
Impressive to get so many things wrong in one report by Jacob Plieth from @ApexOnco .
1. The name of CAN-2409 is aglatimagene besadenovec, not agla-vec.
2. The data of the phase 2a clinical trial of CAN-240 in NSCLC has never disappointed. They are in fact very encouraging, reason why the presentation by Professor Charu Aggarwal was selected for oral presentation at World Lung 2025 and why Candel recently had a very constructive end of phase 2 meeting with the FDA. This data also resulted in Fast Track Designation from the FDA; the promising overall survival data got even stronger after prolonged follow up: mOS of 24.5 months after CAN-2409 treatment in NSCLC patients with an inadequate response to immune checkpoint inhibitors in the per protocol population, mOS of 21.5 months after CAN-2409 treatment in NSCLC patients with progressive disease despite immune checkpoint inhibitor in the per protocol population, regression of uninjected lesions in ~two-thirds of patients presenting with multiple lesions, a long tail of survival:37% of patients alive > 2 years after CAN-2409 administration in patients with progressive NSCLC at time of enrollment, mOS of 25.4 months after CAN-2409 treatment in non-squamous NSCLC patients (target population) with progressive disease despite ICI in the per protocol population. To the best of our knowledge, we are not aware of more encouraging data in a comparable population with similar unfavorable baseline prognostic factors (see Candel's corporate slide deck).
3. In this open label phase 2 clinical trial in therapy-resistant cancer, we selected a patient population with known unfavorable prognostic factors: most patients had tumors exhibiting undetectable or low PD-L1 expression; 11% of the patients were current smokers, and > 80% had failed to demonstrate response to both platinum-based chemotherapy and ICI therapy. In standard clinical practice, patients in this population typically discontinue ICI therapy upon disease progression and transition to second-line docetaxel chemotherapy, which is consistently associated with a mOS of less than 12 months. In this population of patients with largely metastatic, progressive cancer despite optimal standard of care, there are unfortunately no placebo effects, there is no regression to the mean or impact of expectation bias. It appears unlikely that the striking OS results reported can be explained by a disproportionately favorable prognostic profile in the evaluable population compared to the enrolled population: comparison of the baseline demographics and characteristics suggests that the evaluable population was representative of the overall study population. These results provide the rationale for a randomized phase 3 clinical trial, which we are preparing for.
4. It's clear that Jacob Plieth did not listen to the presentation at World Lung, as he consistently refers to Professor Aggarwal as 'he' rather than 'she'.
5. It is also incorrect that only data on patients have been presented who received the per protocol regimen of 2 administrations of CAN-2409 plus valacyclovir (the second administration is the booster). Although this early-phase trial for internal decision making was not formally designed for an intention-to-treat (ITT) analysis, an exploratory analysis in the non-squamous population (the target population for this program) showed a mOS of 16.9 months in the ITT — markedly longer than the 12.3-month benchmark reported with docetaxel in this setting. This is all in the corporate slide deck and therefore already in the public domain.
6. ORR data has been presented before. Given the observed pseudo-progression in our trial due to immune cell infiltration (a positive effect!), shown in serial biopsy samples (the gold standard), OS remains the most reliable clinical endpoint, as surrogate markers like ORR may be confounded. This is consistent with the recommendations by SITC and the 'new FDA'.
7. It's not a 'puzzling fact' that Candel doesn't expect to file in the US until Q4 2026, as we have been absolutely clear that we will use this time to scale up commercial manufacturing and put the product on stability, while getting ready for launch excellence. We are on track. See recent Fireside Chats where this is discussed in more detail.
8. The comments about the SPA are also completely wrong and misleading, as Candel has strictly adhered to the agreement with the FDA and the SPA is intact.
Being a journalist comes with a responsibility. Happy to discuss and debate data any time in the context of seeking the truth - nothing about that is personal.
World Lung 2025 – Candel looks to a new agla-vec use https://t.co/oIxk2xjFik
Dr. Charu Aggarwal from @PennMedicine is presenting CAN-2409 NSCLC data at @IASLC 2025.
Candel’s phase 2a trial in ICI-resistant patients showed 21.5 months median OS vs 9.8-11.8 months with standard chemotherapy.
https://t.co/JmzEs6R8va
#WCLC25#LungCancer#ClinicalData
Our CEO @paulpetertak will present at the 44th Annual Canaccord Genuity Growth Conference.
Be sure to connect with us if you're attending the conference.
https://t.co/eZkgnLI0jl
$CADL