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By Jeremy Golden, Benzinga
A clinical-stage biopharmaceutical company has been granted Fast Track Designation by the FDA for a first-in-class drug candidate.
Focused on developing multimodal biological immunotherapies to help patients fight cancer, Candel Therapeutics, Inc. (NASDAQ: CADL) was granted the designation for CAN-3110, a replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate for patients with recurrent high-grade glioma (HGG). The Needham, Mass.-based company hopes CAN-3110 will improve overall survival in this patient population.
A phase 1b clinical trial of CAN-3110 in recurrent HGG, led by E. Antonio Chiocca, MD, PhD, Head of the Department of Neurosurgery at Brigham & Women’s Hospital and Professor at Harvard Medical School, is ongoing. Candel Therapeutics plans to report additional data, including the potential benefits from multiple injections of CAN-3110, from the clinical trial in the second half of 2024.
Designed to facilitate the development and expedite the review of medicines that can treat serious conditions, Fast Track Designation offers an investigational medicine eligibility for more frequent interactions with the FDA to discuss the candidate’s development plan. The medicine may be eligible for priority review if relevant criteria are met.
“Receiving FDA Fast Track Designation for CAN-3110 reinforces the critical need to find effective treatment options for patients with recurrent HGG and further supports the potential of CAN-3110 to address the challenges that the standard of care and conventional therapies have failed to meet,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “A strong local and systemic anti-tumoral response and improved survival in patients with recurrent HGG was observed following a single injection of CAN-3110 in the Phase 1b trial.”
Additionally, Candel and academic collaborators at the Brigham and Women’s Hospital published results from the ongoing phase 1b clinical trial in the high-impact journal Nature, demonstrating that CAN-3110 was well tolerated with no dose-limiting toxicity reported. The investigators observed a near-doubling of the expected median overall survival (mOS) after a single CAN-3110 injection, achieving a mOS of about 12 months, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition.
Positive HSV-1 serology was a predictor of response and was associated with improved survival; the mOS in this population reached 14 months. 50 to 80% of American adults have oral herpes (HSV-1), which causes cold sores or fever blisters near or in the mouth. Caused by HSV-1 or HSV-2, genital herpes affects one out of every six people in the U.S. aged 14 to 49.
Furthermore, increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after administration were also associated with improved survival, suggesting that CAN-3110 can elicit both a local and systemic antitumoral response.
“Recurrent HGG is one of the most aggressive malignancies for which there is no cure, representing a significant and urgent unmet need,” Chiocca, the study director, said. “With Fast Track Designation, I look forward to the potential of accelerating the development of CAN-3110 and the possibility of bringing this differentiated therapy to patients with recurrent high-grade glioma as we strive to improve outcomes and provide hope for patients and their families.”
In December 2023, Candel Therapeutics also received Fast Track Designation for both non-small cell lung cancer (NSCLC) and pancreatic cancer, a validation from the FDA on the potential of CAN-2409, its most advanced product candidate. An investigational viral immunotherapy, CAN-2409 is designed to stimulate an individualized, systemic immune response to the patient’s specific tumor. CAN-2409 plus valacyclovir in combination with continued PD-1/PD-L1 agents is being evaluated in an ongoing, open-label phase 2 clinical trial in patients with late-stage NSCLC.
Featured photo by Hush Naidoo Jade Photography on Unsplash.
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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