Candel Therapeutics & IDEA Pharma Announce Strategic Partnership to Advance Path-to-Market Commercialization Efforts for CAN-2409

Candel Therapeutics, Inc. together with IDEA Pharma, a Division of SAI MedPartners (IDEA) recently announced a strategic commercial partnership. Under this agreement, IDEA will provide strategic commercial input throughout the development and commercialization process for Candel’s lead asset, CAN-2409.

This partnership comes at a pivotal time for Candel following positive phase 3 data for CAN-2409 in intermediate-to-high risk, localized prostate cancer, which showed a statistically significant improvement in disease-free survival with 30% decrease in disease recurrence and a statistically significant increase in pathological complete response rate in the 2-year post-treatment biopsies (80.4% in the CAN-2409 arm versus 63.6% observed in the placebo arm).

The IDEA team will help guide Candel’s commercial strategy development and support the Company’s commercial projects related to CAN-2409. Through this partnership, Candel will gain access to a dedicated team of experts with extensive experience in oncology commercialization and go-to-market strategy optimization.

“This strategic partnership with IDEA comes at a critical time as we prepare for our BLA submission for CAN-2409 in prostate cancer and advance our broader pipeline across multiple indications,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. “By leveraging IDEA’s commercial expertise, we can combine our expertise focused on building a robust commercialization strategy to help bring our potentially transformative treatments, once approved, to patients who need them.”

Mike Rea, CEO of IDEA, said: “We are delighted to partner with Candel, whose CAN-2409 product candidate has demonstrated compelling clinical results across multiple solid tumors. Our approach provides Candel with the commercial expertise needed to maximize the value of its assets, while Candel continues to lead the overall commercial strategy.”

This partnership is expected to run through 2026.

The bespoke IDEA Pharma solution provides biotech companies with the services traditionally provided by a chief commercial officer, combined with consultancy support from a cross-functional team (clinical, regulatory, analytics, medical, and commercial) to create a seamless transition and execution between commercially desirable strategies and clinical feasibility.  Furthermore, the IDEA Pharma solution is designed to strengthen biotech leadership team decision-making at critical junctures and help to identify both known and unknown uncertainties to navigate and drive value creation.  For more information, please visit: https://mailchi.mp/ideapharma.com/rc8u93athq

IDEA Pharma, a division of SAI MedPartners, is a global practice, recognized as the leading experts in pharmaceutical innovation, path-to-market strategy, and applied innovation. IDEA Pharma was acquired by SAI MedPartners in November 2024, and as part of the wider portfolio of companies, is able to offer additional capabilities including Market Research, Market Access and Pricing and Competitor Intelligence.  IDEA Pharma is based in both the UK and US, with offices in London and New York.  To learn more about IDEA Pharma, visit https://www.ideapharma.com or follow on LinkedIn, Twitter, Instagram

CAN-2409, 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 and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite 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 un-injected distant metastases for broad anti-tumor activity, based on in situ vaccination against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors 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 other therapeutic strategies.

Currently, Candel is evaluating CAN-2409 in non-small cell lung cancer (NSCLC), in an ongoing phase 2a clinical trial. The Company recently announced positive, statistically significant topline data for CAN-2409 based on a large, randomized, placebo-controlled phase 3 clinical trial of CAN-2409 in localized prostate cancer. In the Company’s randomized phase 2a clinical trial of CAN-2409 in borderline resectable pancreatic ductal adenocarcinoma (PDAC), positive survival data showed notable improvement in estimated median overall survival of 31.4 months after experimental treatment with CAN-2409 plus standard of care versus only 12.5 months in the control group in patients with PDAC, who received only standard of care. Median survival post-progression was 21.2 months in patients who received CAN-2409 compared to 7.2 months in the control arm. CAN-2409 plus prodrug (valacyclovir) has been granted fast track designation by the U.S. Food and Drug Administration (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. Candel’s pivotal phase 3 clinical trial in prostate cancer was conducted under a special protocol assessment agreed with the FDA. The FDA has also granted orphan drug designation to CAN-2409 for the treatment of PDAC.

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 Herpes simplex virus (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. In October 2023, the Company announced that Nature published results from this ongoing clinical trial: CAN-3110 was well tolerated and the investigators observed nearly two-fold increase in median overall survival compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.¹ 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