Candel Therapeutics Reports Progress in Clinical Programs and Q1 2024 Financial Results

Candel Therapeutics, a clinical-stage biopharmaceutical company, announces significant progress in its clinical and preclinical programs, including promising overall survival data from its phase 2 trial of CAN-2409, a multimodal biological therapy for pancreatic cancer treatment, which has received FDA Fast Track and Orphan Drug Designations. The company's advancements have significant implications for improving patient outcomes and reshaping the treatment paradigm for this devastating disease." This description focuses on the primary topic (Candel Therapeutics' progress in its clinical programs), the main entity (Candel Therapeutics), the context (pancreatic cancer treatment), and the significant actions and implications (promising overall survival data and FDA designations). The description also provides objective and relevant details that will help an AI generate an accurate visual representation of the article's content, such as the company's logo, medical imagery related to pancreatic cancer, and graphics illustrating the trial's results.

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Bijay Laxmi
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Candel Therapeutics Reports Progress in Clinical Programs and Q1 2024 Financial Results

Candel Therapeutics Reports Progress in Clinical Programs and Q1 2024 Financial Results

Candel Therapeutics Inc. (NASDAQ: CADL), a clinical-stage biopharmaceutical company, has announced significant progress in its clinical and preclinical programs, as well as its Financial Results for the first quarter ended March 31, 2024. The company provided updates on the phase 2 trial of its lead candidate CAN-2409, a multimodal biological therapy being evaluated for the treatment of pancreatic cancer.

The FDA has granted Candel Therapeutics both Fast Track Designation and Orphan Drug Designation for CAN-2409 for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC). The phase 2 randomized clinical trial is evaluating CAN-2409 in combination with valacyclovir prodrug and standard of care chemoradiation followed by resection for borderline resectable PDAC. Updated overall survival data from the trial showed that CAN-2409 more than doubled the survival rates compared to standard of care alone.

Why this matters: The progress of Candel Therapeutics' clinical programs, particularly the promising overall survival data from the CAN-2409 phase 2 trial, has significant implications for the treatment of pancreatic cancer, a disease with a high mortality rate. This breakthrough could lead to improved patient outcomes and increased hope for those diagnosed with this devastating disease.

"We recently reported data from the phase 2 randomized clinical trial of CAN-2409 in borderline resectable pancreatic cancer, showing that CAN-2409, when added to standard of care, more than doubled the median overall survival obtained with standard of care alone," said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel Therapeutics. "We are pleased that the FDA has now granted Candel with both Orphan Drug and Fast Track Designation to this program as we seek to reshape the treatment paradigm in pancreatic cancer."

Candel Therapeutics also reported its financial results for the first quarter of 2024. Research and development expenses were $4.1 million, compared to $5.5 million for the same period in 2023. General and administrative expenses were $3.8 million, compared to $4.2 million in the first quarter of 2023. The company reported a net loss of $8.2 million for the quarter, compared to a net loss of $8.8 million in the first quarter of 2023. As of March 31, 2024, Candel Therapeutics had cash and cash equivalents of $25.7 million.

In addition to the progress with CAN-2409, Candel Therapeutics presented its second drug candidate from the enLIGHTEN Discovery Platform, a first-in-class multimodal immunotherapy candidate, at the recent American Association for Cancer Research (AACR) Annual Meeting. The company also expects to present topline overall survival data from the phase 2 clinical trial of CAN-2409 in patients with stage III/IV non-small cell lung cancer at the upcoming American Society of Clinical Oncology (ASCO) meeting in Chicago on June 3, 2024.

"It was a catalyst-rich first quarter for Candel, marked by significant advances across both our clinical and preclinical programs," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "Notably, as our clinical data mature with long-term follow-up, we are beginning to observe highly differentiated results in long-term survival of patients treated with our viral immunotherapies."

Candel Therapeutics' progress in its clinical programs, particularly the promising overall survival data from the CAN-2409 phase 2 trial in pancreatic cancer, highlights the potential of its viral immunotherapy approach. The company's strong financial position and upcoming data presentations at major medical conferences underscore its commitment to advancing its pipeline and bringing novel cancer innovations to patients in need.

Key Takeaways

  • Candel Therapeutics' CAN-2409 doubles survival rates in pancreatic cancer patients.
  • FDA grants Fast Track and Orphan Drug Designations for CAN-2409.
  • Candel reports $25.7M in cash and equivalents as of March 31, 2024.
  • Company presents new immunotherapy candidate at AACR Annual Meeting.
  • Candel to present topline survival data at ASCO meeting on June 3, 2024.