--News Direct--
By Jeremy Golden, Benzinga
A clinical-stage biopharmaceutical company looks forward to the year ahead with several promising developments in motion.
Focused on the development of multimodal biological immunotherapies to help patients fight cancer, Candel Therapeutics, Inc. (NASDAQ: CADL) is innovating a new frontier in the field of immunotherapy. By leveraging a data-driven approach, the company seems poised to advance next-generation immunotherapies in its pipeline as well as create new product candidates.
Following up on promising initial clinical and biomarker data in hard-to-treat cancers, Candel is moving forward with a focus on strategic key value drivers and catalysts.
Lead Candidates
Based in Needham, Massachusetts, Candel is developing two off-the-shelf clinical-stage investigational viral immunotherapies. Designed to elicit an individualized anti-cancer response, they are 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. It’s in the midst of ongoing late-stage clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2) and localized, non-metastatic prostate cancer (phase 2 and 3).
CAN-3110 is the lead product candidate from the HSV platform. A phase 1 clinical trial in recurrent high-grade glioma (HGG) is currently ongoing.
Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform that leverages human biology and advanced analytics to create new viral immunotherapies for solid tumors.
The year 2023 was a productive one for Candel. The company received Fast Track Designation from the FDA based on encouraging clinical activity and biomarker data from the phase 2 clinical trial of CAN-2409 in NSCLC, was also granted Fast Track Designation based on the positive interim data from the ongoing randomized phase 2 clinical trial in borderline resectable pancreatic cancer, published the activity of CAN-3110 in recurrent high-grade glioma in Nature and presented data on the first molecule that was discovered based on the enLIGHTENTM Discovery Platform at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC).
In NSCLC, the phase 2 clinical trial showed that experimental therapy with CAN-2409 achieved disease control in most of the patients who had an inadequate response to immune checkpoint inhibitor treatment. Importantly, there was an abscopal effect (improvement of uninjected lesions) in most patients with metastatic disease. There was an increase in effector/cytotoxic T cells and natural killer cells in peripheral blood after the second CAN-2409 administration (the booster), which was linked with subsequent improved survival. Candel reports that it has observed an encouraging number of long survivors, which the company believes demonstrates that CAN-2409 may induce a new state of functional immunosurveillance and durable disease control. The gold standard endpoint in this population is overall survival. Based on the currently available treatments, median overall survival ≥ 14 months will be considered a significant improvement compared to standard of care.
Candel also reported positive interim data from a randomized, controlled clinical trial that revealed a notable increase in survival in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) after experimental treatment with CAN-2409 plus standard-of-care treatment compared to standard-of-care control treatment alone. The estimated overall survival rate was 71.4% at 24 months in CAN-2409 treated patients versus 16.7% in the control arm after chemoradiation. In patients with progressive disease, there was both a CA19-9 (tumor biomarker) and a survival response to salvage chemotherapy in the CAN-2409 arm but not in the control arm. Dense aggregates of immune cells were observed in PDAC tissue after CAN-2409 treatment, confirming the activation of a robust antitumoral immune response in this immunosuppressive form of cancer.
“In 2023, we received Fast Track Designation for both NSCLC and pancreatic cancer, a validation from the FDA on the potential of CAN-2409, our most advanced product candidate,to address these unmet medical need cancers,” said Paul Peter Tak, MD PhD FMedSci, President and CEO of Candel. “Clinical data from the ongoing phase 1 clinical trial of CAN-3110 in patients with recurrent high-grade glioma have recently been published in Nature, serving as further recognition of the scientific and clinical excellence of Candel’s programs.”
Candel and collaborators at the Brigham and Women’s Hospital published in the high-impact journal Nature that CAN-3110 was well tolerated with no dose-limiting toxicity reported. The investigators observed a nearly doubling of the expected median overall survival after just a single injection of CAN-3110 when compared to expected survival in patients treated with current chemotherapeutic standards of care. Positive HSV-1 serology was a predictor of response and was associated with improved survival.
Furthermore, increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after treatment were associated with improved survival. Importantly, these results were seen after a single injection of CAN-3110; Candel and its collaborators are currently evaluating a multiple-injection regimen, supported by the Break Through Cancer foundation.
“The data generated with CAN-3110 in recurrent high-grade glioma represents a significant step forward in the development of groundbreaking therapeutic candidates for this difficult-to-treat disease,” said Francesca Barone, M.D. PhD, CSO, at Candel Therapeutics. “At the same time, they provide proof of concept for the expansion of CAN-3110 in other Nestin positive tumors, which include a diverse spectrum from triple negative breast cancer to melanoma to soft tissue sarcoma.”
What’s To Come
Backed by promising clinical and biomarker data in hard-to-treat indications, the company expects six data readouts across three platforms this year, including overall survival data in NSCLC and topline data of the potentially registrational phase 3 clinical trial in prostate cancer.
Those data readouts include:
Topline overall survival (OS) data for CAN-2409 in a phase 2 topline trial for NSCLC in Q2 2024
Updated overall survival data for CAN-2409 in a phase 2 trial for borderline resectable pancreatic cancer in Q2 2024
New data on the second drug candidate from the enLIGHTEN Discovery Platform by Q3 2024
Phase 1 data for CAN-3110 in recurrent high-grade glioma in 2H 2024 for the multiple injection cohort
Phase 2 topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer in Q4 2024
Phase 3 topline data for CAN-2409 in localized intermediate/high-risk prostate cancer in Q4 2024
During the SITC Annual Meeting and the International Oncolytic Virus Conference (both in 2023), Candel presented the first experimental candidate from enLIGHTEN Discovery Platform Alpha 201-macro-1, an investigational, locally-delivered biological oncolytic therapeutic designed to interfere with the CD47/SIRP1a pathway which demonstrated better inhibition of tumor growth when compared to systemic anti-CD47 antibody therapy in a mouse model of breast cancer.
Francesca Barone, M.D. PhD, said “With the enLIGHTEN Discovery Platform, we are leveraging our internal capabilities in advanced analytics, cancer biology and vectorology to design a new class of multimodal therapeutics that can overcome mechanisms of resistance present in the tumor microenvironment.s “This platform is open for collaborations with external partners as illustrated by our collaboration with U Penn aimed at designing a viral gene construct able to support the therapeutic efficacy of CAR-T therapy in pancreatic cancer.”
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 and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). 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.
This article 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 and advancement of development programs, including the timing and availability of additional data, key data readout milestones, including CAN-3110 in HGG; expectations regarding the potential benefits conferred by Fast Track Designation; expectations regarding the therapeutic benefit of its programs, including the potential for its programs to extend patient survival; and expectations regarding cash runway and expenditures. 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 our 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, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s most recent Quarterly Report on Form 10-Q 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.
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