Candel Therapeutics, Inc. Common Stock Canaccord Genuity's 46th Annual Growth Conference
Review the key takeaways and the transcript of this earnings call.
- Candel Therapeutics Inc is developing off-the-shelf viral immunotherapies with two clinical assets: Aglatimagene (also called 2409) and CAN-3110 (Linx-12).
- Aglatimagene is a replication-defective adenovirus delivering a thymidine kinase gene, primarily targeting localized prostate cancer and non-small cell lung cancer (NSCLC).
- In 2024, Aglatimagene showed positive Phase 3 results in localized prostate cancer with a 30% reduction in disease-free survival risk compared to standard radiation therapy.
- Aglatimagene is also in development for NSCLC, with a Phase 3 registrational study recently initiated for non-squamous patients non-responsive to first-line checkpoint inhibitors.
- CAN-3110 is a classical oncolytic virus modified to selectively replicate in tumor cells expressing the Nestin promoter, being developed for brain cancer, specifically recurrent glioblastoma.
- Aglatimagene has received fast track and orphan drug designations and an ARMOR designation from the FDA, facilitating close communication and regulatory alignment.
- The company plans to submit a Biologics License Application (BLA) for Aglatimagene in prostate cancer by the end of 2026, with manufacturing scale-up and comparability studies progressing well.
- Physician feedback on Aglatimagene's 30% disease recurrence reduction in prostate cancer has been very encouraging, noting it as a meaningful clinical improvement and a potential alternative to androgen deprivation therapy (ADT).
- The company estimates the commercial opportunity for Aglatimagene in localized prostate cancer at $10 to $16 billion, targeting the 65,000 patients annually treated with radiotherapy in the intermediate to high-risk population.
- The NSCLC Phase 3 study will enroll 500 patients randomized 1:1 to Aglatimagene versus docetaxel, with median overall survival as the primary endpoint; prior Phase 2 data showed median overall survival up to 24.5 months in non-squamous patients.
- Aglatimagene is administered via two injections into accessible lung lesions, inducing both local and systemic immune responses, including abscopal effects on non-injected tumors.
- CAN-3110 is injected directly into recurrent glioblastoma tumors and has shown median overall survival of 12 months after a single injection, with some patients surviving over 49 months in Phase 1 trials.
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Transcript
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All right. Good afternoon, everyone, and thank you for joining us at the 46th Annual Canaccord Genuity Growth Conference here in sunny Boston today. I'm John Newman. I'm one of the biotech analysts here at the firm. Very excited to have Candel with us today. We're joined by Dr. Francesca Barone, the Chief Scientific Officer. Welcome. First question, for anyone that's not familiar with Candel, and everyone should be, could you give us an overview of the company and specifically your lead asset, aglatimagene?
Thank you, John, and for having us here today. Candel Therapeutics is a biopharmaceutical company, developing off-the-shelf viral immunotherapies. These drugs are aimed at local delivery to achieve systemic immunization.
We have two clinical assets. One is aglatimagene besadenovec, or aglatimagene I would refer to that, and it was also called CAN-2409, so some- of the literature still refer it as that.
That is an off-the-shelf replication-defective adenovirus. It delivers a gene, thymidine kinase. It's given together with a prodrug, and the aim is basically to induce immunization, in situ immunization of the patients against the tumor or antigens. The main indication is localized prostate cancer. We had unveiled in 2024 a positive phase III randomized trial results, where aglatimagene demonstrated superiority around 30% to reduce disease-free survival risk for patients treated with aglatimagene as compared to patient treated with standard of care radiation. This asset is also in development for non-small cell lung cancer. We've completed a phase II study in this indication. We just very recently started recruitment for a new registrational, a potentially registrational phase III study called AURORA in non-small cell lung cancer patients with non-squamous disease that are non-responsive to first-line checkpoint inhibitors.
This is stage 4 disease.
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