Candel Therapeutics and IDEA Pharma Announce Strategic Partnership to Advance Path-to-Market Commercialization Efforts for CAN-2409
Candel Therapeutics (Nasdaq: CADL) has formed a strategic commercial partnership with IDEA Pharma to advance commercialization efforts for CAN-2409. The partnership follows positive phase 3 data for CAN-2409 in intermediate-to-high risk, localized prostate cancer, which demonstrated:
- 30% decrease in disease recurrence
- Statistically significant improvement in disease-free survival
- Higher pathological complete response rate (80.4% vs 63.6% in placebo)
IDEA Pharma will provide strategic commercial input through 2026, supporting Candel's BLA submission for CAN-2409 in prostate cancer. The partnership grants Candel access to IDEA's dedicated team of oncology commercialization experts to optimize go-to-market strategy.
Candel Therapeutics (Nasdaq: CADL) ha stretto una partnership commerciale strategica con IDEA Pharma per avanzare gli sforzi di commercializzazione di CAN-2409. La partnership segue i dati positivi della fase 3 per CAN-2409 nel carcinoma prostatico localizzato a rischio intermedio-alto, che hanno dimostrato:
- Una diminuzione del 30% nella recidiva della malattia
- Un miglioramento statisticamente significativo nella sopravvivenza libera da malattia
- Un tasso di risposta completa patologica più elevato (80,4% rispetto al 63,6% nel gruppo placebo)
IDEA Pharma fornirà un input commerciale strategico fino al 2026, supportando la presentazione della BLA di Candel per CAN-2409 nel carcinoma prostatico. La partnership consente a Candel di accedere al team dedicato di esperti in commercializzazione oncologica di IDEA per ottimizzare la strategia di ingresso nel mercato.
Candel Therapeutics (Nasdaq: CADL) ha formado una asociación comercial estratégica con IDEA Pharma para avanzar en los esfuerzos de comercialización de CAN-2409. La asociación sigue a los datos positivos de la fase 3 para CAN-2409 en cáncer de próstata localizado de riesgo intermedio-alto, que demostraron:
- Una disminución del 30% en la recurrencia de la enfermedad
- Una mejora estadísticamente significativa en la supervivencia libre de enfermedad
- Una tasa de respuesta completa patológica más alta (80.4% frente al 63.6% en placebo)
IDEA Pharma proporcionará aportes comerciales estratégicos hasta 2026, apoyando la presentación de la BLA de Candel para CAN-2409 en cáncer de próstata. La asociación otorga a Candel acceso al equipo dedicado de expertos en comercialización oncológica de IDEA para optimizar la estrategia de lanzamiento al mercado.
Candel Therapeutics (Nasdaq: CADL)는 IDEA Pharma와 전략적 상업 파트너십을 체결하여 CAN-2409의 상업화 노력을 추진하고 있습니다. 이 파트너십은 중간에서 고위험의 국소 전립선암에 대한 CAN-2409의 3상 데이터가 긍정적이라는 결과를 바탕으로 하며, 다음과 같은 결과를 보여주었습니다:
- 질병 재발률 30% 감소
- 질병 없는 생존율에서 통계적으로 유의미한 개선
- 병리학적 완전 반응율 증가 (80.4% 대 63.6% 위약)
IDEA Pharma는 2026년까지 전략적 상업적 조언을 제공하여 Candel의 전립선암에 대한 CAN-2409의 BLA 제출을 지원합니다. 이 파트너십을 통해 Candel은 IDEA의 전담 종양학 상업화 전문가 팀에 접근하여 시장 진출 전략을 최적화할 수 있습니다.
Candel Therapeutics (Nasdaq: CADL) a formé un partenariat commercial stratégique avec IDEA Pharma pour faire avancer les efforts de commercialisation de CAN-2409. Ce partenariat fait suite à des données positives de phase 3 pour CAN-2409 dans le cancer de la prostate localisé à risque intermédiaire à élevé, qui ont démontré :
- Une diminution de 30 % des récidives de la maladie
- Une amélioration statistiquement significative de la survie sans maladie
- Taux de réponse complète pathologique plus élevé (80,4 % contre 63,6 % dans le groupe placebo)
IDEA Pharma fournira des contributions commerciales stratégiques jusqu'en 2026, soutenant la soumission de la BLA de Candel pour CAN-2409 dans le cancer de la prostate. Ce partenariat donne à Candel accès à l'équipe dédiée d'experts en commercialisation oncologique d'IDEA pour optimiser la stratégie de mise sur le marché.
Candel Therapeutics (Nasdaq: CADL) hat eine strategische Partnerschaft mit IDEA Pharma gebildet, um die Kommerzialisierungsbemühungen für CAN-2409 voranzutreiben. Diese Partnerschaft folgt auf positive Phase-3-Daten für CAN-2409 bei lokalisiertem, intermediärem bis hohem Risiko von Prostatakrebs, die folgendes zeigten:
- 30%ige Verringerung der Krankheitsrezidive
- Statistisch signifikante Verbesserung des krankheitsfreien Überlebens
- Höhere Rate an pathologischen Komplettansprachen (80,4% gegenüber 63,6% in der Placebo-Gruppe)
IDEA Pharma wird bis 2026 strategische kommerzielle Inputs bereitstellen und Candel bei der Einreichung der BLA für CAN-2409 bei Prostatakrebs unterstützen. Die Partnerschaft gewährt Candel Zugang zu IDEAs engagiertem Team von Onkologie-Commercialization-Experten, um die Markteinführungsstrategie zu optimieren.
- Phase 3 trial showed 30% decrease in disease recurrence
- Significantly higher complete response rate (80.4% vs 63.6% placebo)
- Strategic partnership secured for commercialization through 2026
- Advancing towards BLA submission for prostate cancer indication
- None.
Insights
Candel Therapeutics' partnership with IDEA Pharma represents a significant strategic advancement in their commercialization pathway for CAN-2409. The timing is particularly notable following the impressive Phase 3 data in localized prostate cancer, which demonstrated a
This data package strongly positions CAN-2409 for the upcoming BLA submission. The robustness of these clinical endpoints – both disease-free survival and pathological complete response – provides compelling evidence of efficacy that should strengthen the regulatory submission. For an oncology product, particularly in prostate cancer where treatment options for localized disease remain , these results represent potential practice-changing outcomes.
IDEA's commercial expertise will prove valuable as Candel navigates the complex oncology marketplace. Rather than building an extensive commercial infrastructure internally, this partnership allows Candel to access specialized commercialization knowledge while maintaining focus on their broader pipeline development. The arrangement through 2026 indicates a substantial commitment spanning from pre-approval planning through potential market entry and early commercial phases.
The partnership structure – with Candel retaining leadership of the overall commercial strategy while leveraging IDEA's expertise – suggests a thoughtful approach to resource allocation that preserves strategic control while addressing capability gaps for this critical stage of development.
This strategic partnership arrives at a pivotal inflection point for Candel Therapeutics. With positive Phase 3 data in hand and BLA submission preparations underway, the company is transitioning from purely clinical development to pre-commercial activities – a critical evolution requiring specialized expertise.
IDEA Pharma brings significant value through their focus on pharmaceutical product positioning and commercialization strategy. For Candel, this represents an efficient approach to accessing commercial capabilities without the immediate overhead of building a full internal commercial organization. This capital-efficient model is particularly valuable for clinical-stage biotechs managing cash resources while advancing toward potential approval.
The partnership's timing signals confidence in CAN-2409's regulatory pathway following the strong Phase 3 results. While prostate cancer represents the initial focus, the mention of "advancing broader pipeline across multiple indications" suggests a strategic commercialization framework that could extend beyond this first indication.
For investors, this partnership demonstrates management's focus on execution toward market entry. It addresses a critical question for clinical-stage companies approaching potential approval: how will they effectively commercialize their asset? By securing specialized expertise through 2026, Candel has established a clearer path to potential revenue generation while maintaining strategic flexibility. The absence of financial terms in the announcement prevents assessment of specific economic impacts, but the partnership structure appears designed to maximize CAN-2409's commercial potential as it approaches potential market entry.
NEEDHAM, Mass., March 20, 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, together with IDEA Pharma, a Division of SAI MedPartners (IDEA), a pioneering biopharmaceutical strategy consultancy, today 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
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.
About the IDEA Pharma Solution
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
About IDEA Pharma
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
About CAN-2409
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.
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 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
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, advancement and commercialization of current and future development programs; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s programs, including the ability of its programs to treat a broad range of solid tumors and improve patient survival; and expectations regarding the potential benefits and duration of the Company’s strategic commercial partnership with IDEA. 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 pre-clinical 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 filed with the SEC and 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@icrhealthcare.com
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1 Ling AL, et al. Nature. 2023;623(7985):157-166.
FAQ
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