Candel Therapeutics Secures FDA Orphan Drug Designation for Glioma Candidate

Candel Therapeutics’ (Nasdaq: CADL) share price rose by nearly 10% in intraday trading on Friday after the company announced it had been granted Orphan Drug Designation by the FDA for CAN-3110, a next generation oncolytic viral immunotherapy for the treatment of recurrent high-grade glioma (rHGG). The company presented Phase 1b data regarding the feasibility and safety of multiple doses of CAN-3110 in a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

CAN-3110 was previously granted Fast Track Designation by the FDA for the treatment of rHGG, and results from Arm A of Candel’s ongoing Phase 1b clinical trial in rHGG were published in Nature, demonstrating a strong anti-tumoral response associated with extended survival.

“Building on the momentum of the FDA’s Fast Track Designation, recently granted to this program, the Orphan Drug Designation for CAN-3110 further reinforces the potential of this therapy and underscores the urgent need for novel and effective treatments for patients with rHGG,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel.

“This designation not only reinforces our commitment to offering new hope and potential patient treatment options, but it also enables us to leverage development incentives and accelerate our efforts to evaluate new indications in the clinic. We are continuing our work in the phase 1b clinical trial of CAN-3110 and look forward to sharing further clinical updates in the second half of 2024.”

In the United States, there are six cases of glioma diagnosed per 100,000 people every year.

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 and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable PDAC (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 phase 1b clinical trial in rHGG. 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:

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Candel Therapeutics Secures FDA Orphan Drug Designation for Glioma Candidate

Catie Corcoran

Biotech Editor