Candel Therapeutics, Inc.

Candel Therapeutics Announces Publication of Phase 2a Trial Data that Demonstrated Prolonged Survival after Systemic Immune Reactivation by Aglatimagene Besadenovec plus Valacyclovir in Patients with Unresectable Stage III/IV NSCLC with an Inadequate Response to ICI

Candel Therapeutics published final Phase 2a data in the Journal for ImmunoTherapy of Cancer showing median overall survival of 24.5 months with aglatimagene besadenovec plus valacyclovir in stage III/IV NSCLC patients with inadequate response to immune checkpoint inhibitors. That compares with a docetaxel standard-of-care benchmark of only 9.8-11.8 months, with non-squamous patients doing best (25.4 months mOS in the evaluable cohort) and 69% of multi-lesion patients showing abscopal responses; grade 3 treatment-related adverse events occurred in 13.7% of patients. The data provide independent validation supporting the ongoing global Phase 3 AURORA trial of aglatimagene plus pembrolizumab versus docetaxel, enrolling at approximately 150 sites in metastatic non-squamous NSCLC.

•1mo ago

Candel Therapeutics Announces Integrated Clinical and Biomarker Data That Showed Durable Local and Systemic Immune Activation after Aglatimagene Besadenovec in Intermediate-Risk Localized Prostate Cancer

Candel Therapeutics announced integrated immunological biomarker data from the phase 2 PrTK05 trial showing durable local and systemic T-cell activation after aglatimagene in intermediate-risk localized prostate cancer. The phase 3 PrTK03 subgroup (635 patients) showed a 41% reduction in recurrence or prostate-cancer-death risk (HR 0.59; p=0.0034) and 76.6% negative biopsy rates versus 60.7% in controls. Biodistribution and shedding data remain on track for the planned Q4 2026 BLA submission to the FDA, keeping the regulatory timeline intact ahead of the approval decision.

•1mo ago

Candel Therapeutics Announces New Data Showing Sustained Immune Remodeling More Than Two Years After Aglatimagene Besadenovec Treatment in Localized Prostate Cancer at ASTRO 2026

Candel Therapeutics presented new AI-enabled digital pathology biomarker data at ASTRO 2026 from its completed phase 3 trial of aglatimagene besadenovec in localized intermediate- to high-risk prostate cancer. The data show aglatimagene plus radiation significantly increased intratumoral lymphocyte infiltration and lymphocyte-tumor engagement versus placebo plus radiation, sustained more than two years after treatment. Previously reported biopsy data showed 80% of aglatimagene patients with negative biopsies versus 63% of controls (p=0.0018). Management says the findings support durable immune remodeling and a planned Biologics License Application submission; aglatimagene holds FDA Fast Track and RMAT designations but is not yet approved.

•1mo ago

Candel Therapeutics Appoints Martine Zimmermann, PharmD, to its Board of Directors

Candel Therapeutics appointed Martine Zimmermann, PharmD, to its Board of Directors effective September 8, 2026, adding more than 30 years of global regulatory affairs and quality expertise across all phases of drug development. The timing matters: the company is preparing a planned Biologics License Application submission for its lead candidate aglatimagene besadenovec in the fourth quarter of 2026, with the appointment framed as strengthening the board for potential commercial readiness. Zimmermann currently serves as EVP, Head of Regulatory Affairs, Quality and Alliance Management at Inventiva S.A., and previously held senior regulatory leadership roles at Ipsen Biopharmaceuticals and spent more than 13 years at Alexion Pharma International.

•1mo ago

Candel Therapeutics Reports Second Quarter 2026 Financial Results and Recent Corporate Highlights

Candel reported a Q2 net loss of $38.9 million, reflecting increased R&D and manufacturing spend, but ended the quarter with $201.6 million in cash to fund operations into Q1 2028. The company is on track to submit a BLA for aglatimagene in Q4 2026 for localized prostate cancer, following the publication of pivotal Phase 3 data in The Lancet Oncology that showed a 39% improvement in disease-free survival. To prepare for a potential 2027 launch, Candel appointed a new Chief Commercial Officer and signed a commercialization agreement with EVERSANA, while also initiating a global Phase 3 trial for aglatimagene in NSCLC.

•2mo ago

Candel Therapeutics to Present Extended Data from Phase 3 Results of Aglatimagene Besadenovec at ASTRO 2026

Candel Therapeutics announced that an abstract featuring extended data from the Phase 3 trial of aglatimagene besadenovec was accepted for presentation at the ASTRO 2026 Annual Meeting. The poster presentation will focus on quantitative digital pathology defining immune activation in localized prostate cancer. Chief Scientific Officer Francesca Barone is scheduled to present the data on September 29, 2026, in Boston.

•2mo ago

Candel Therapeutics Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Candel Therapeutics granted 285,000 stock options to newly appointed Chief Commercial Officer Mark Sims as an employment inducement under Nasdaq Rule 5635(c)(4). The options have an exercise price of $10.03 per share, equal to the closing price on the grant date, and vest over four years contingent on continued service. The company remains a clinical-stage biopharmaceutical entity focused on multimodal immunotherapies, with lead candidates including CAN-2409 and CAN-3110.

•3mo ago

Candel Therapeutics Announces Initiation of Global Pivotal Phase 3 AURORA Trial Evaluating Aglatimagene Besadenovec (CAN-2409) in Advanced Non-Small Cell Lung Cancer Patients with Inadequate Response to Immune Checkpoint Inhibitors

Candel Therapeutics has initiated the global pivotal Phase 3 AURORA trial evaluating aglatimagene besadenovec plus valacyclovir in combination with pembrolizumab for advanced non-small cell lung cancer. The randomized open-label trial plans to enroll patients across more than 150 sites with a primary endpoint of overall survival, comparing the regimen against standard-of-care docetaxel. This advancement builds on Phase 2 data showing a median overall survival of 25.4 months in the intended patient population, compared to approximately 11 months for current standard care.

•4mo ago

Candel Therapeutics Appoints Mark Sims as Chief Commercial Officer

Candel Therapeutics appointed Mark Sims as Chief Commercial Officer, effective July 6, 2026, to lead the commercial strategy and launch readiness for aglatimagene besadenovec. The appointment supports the planned Biologics License Application submission in the fourth quarter of 2026 and a potential commercial launch in 2027 for intermediate- to high-risk localized prostate cancer. Mr. Sims joins from AstraZeneca, where he most recently served as Vice President and Global Franchise Head for EGFRm Lung Cancer.

•4mo ago

Candel Therapeutics Announces Publication in The Lancet Oncology of Pivotal Phase 3 Data Demonstrating Significant Improvement in Disease-Free Survival with Aglatimagene Besadenovec (CAN-2409) in Localized Prostate Cancer

Candel Therapeutics announced the publication of its pivotal Phase 3 trial data for aglatimagene besadenovec in The Lancet Oncology, demonstrating a 30% improvement in disease-free survival for patients with localized prostate cancer. The peer-reviewed data confirms a statistically significant hazard ratio of 0.70 (p=0.016) and a 38% improvement in prostate cancer-specific DFS, supporting the company's plan to submit a Biologics License Application in the fourth quarter of 2026. Extended follow-up data presented recently showed a 39% improvement in prostate cancer-specific DFS after 58 months of median follow-up, with a favorable safety profile and high pathological complete response rates (80% vs 63% for placebo).

•4mo ago

Candel Therapeutics Reports Extended Clinical Benefit Over Multiple Clinical Endpoints in Patients from Phase 3 Trial of Aglatimagene Besadenovec (CAN-2409) in Localized Prostate Cancer Under Prolonged Follow-up at AUA 2026 Annual Meeting

Candel Therapeutics presented extended follow-up data from its pivotal Phase 3 trial of aglatimagene in localized prostate cancer at the AUA 2026 Annual Meeting. The data confirmed a statistically significant 39% improvement in disease-free survival (HR 0.61, p=0.0031) in the intention-to-treat population after a median follow-up of 58 months. In the intermediate-risk subgroup, which comprised 85% of patients, the treatment showed a 90% reduction in time to metastasis and a 41% improvement in disease-free survival, reinforcing the asset's potential to reduce recurrence and metastatic risk. Candel plans to submit a Biologics License Application (BLA) to the FDA in the fourth quarter of 2026, citing these durable clinical benefits as support for approval.

•5mo ago