Cancer treatment has long been dominated by traditional approaches such as surgery, radiation, and chemotherapy. But in recent years, a wave of innovation has emerged, driven by the promise of immunotherapies that harness the body's own immune system to fight cancer. Among the companies at the forefront is Candel Therapeutics Inc (NASDAQ:CADL), a biotech company dedicated to creating transformative cancer therapies. With its lead candidate, CAN-2409, and a promising pipeline, Candel aims to bring new hope to patients battling some of the most challenging cancers.
In a recent interview with Proactive, Candel’s CEO, Paul Peter Tak, shared his vision for the company’s impact on cancer treatment. "We aim to create a paradigm shift in treating non-metastatic, localized prostate cancer," he explained.
Tak’s ambition comes at a time when the medical field has seen little progress in treating early-stage prostate cancer, with no new drug approvals in over 20 years. Candel's approach focuses on the unmet need of patients with low- to intermediate-risk prostate cancer, many of whom currently face active surveillance with little to no treatment options as well as on that of patients with intermediate-to-high risk prostate cancer with a curative intent.
Addressing unmet needs in prostate cancer
Prostate cancer remains one of the most common cancers in men, and while survival rates are high for those diagnosed with early-stage disease, the treatment landscape has remained stagnant. Current options for patients with localized, non-metastatic prostate cancer are limited to radical prostatectomy or radiotherapy, both of which come with significant side effects. These treatments can lead to a range of complications, including urinary incontinence, erectile dysfunction, and a loss of quality of life.
"For many patients in the active surveillance population, these treatments feel more burdensome than beneficial," said Tak. "They face difficult decisions about whether to undergo radical treatment for a tumor that is often slow-growing and asymptomatic."
Approximately 40% of low-risk prostate cancer patients and 10% of intermediate-risk patients opt for active surveillance rather than immediate treatment, as the risks of radical therapies may outweigh the potential benefits. Yet, even under active surveillance, many of these patients face constant anxiety and the inevitable progression of the disease.
This is where Candel’s lead viral immunotherapy candidate, CAN-2409, comes into play. CAN-2409 is designed to address this gap by offering a treatment option that is both well-tolerated and easy to administer. “Our goal in this population is to extend progression-free survival, delaying or even avoiding the need for radical treatments," Tak emphasized.
In a phase 2b clinical trial, which is set to read out in December, 187 patients are being evaluated to determine if CAN-2409 can shift the current treatment paradigm. If successful, this could lead to a revolutionary new option for patients who currently receive no treatment at this stage.
CAN-2409 is also being evaluated in a phase 3 clinical trial in intermediate-to-high risk prostate cancer patients who receive standard of care radiotherapy. The goal in this population is to increase the percentage of patients that will achieve disease-free survival. This phase 3 clinical trial is also expected to read out in December.
A unique approach to immunotherapy
CAN-2409 is not your typical immunotherapy. Unlike immune checkpoint inhibitors, which have proven effective in treating other cancers but often produce a non-specific immune response, CAN-2409 works by specifically targeting the patient's tumor. "We’re not just trying to stimulate the immune system broadly," Tak explained. "We’re educating the immune system to recognize and attack the cancer cells in these patients." The treatment generates a vaccination-like effect, creating a targeted immune response against tumor-specific molecules.
Importantly, CAN-2409 is an off-the-shelf product that can be stored at 4°C and remains stable for months. This stands in contrast to therapies like CAR T-cell or other gene therapies, which often require customization for each individual patient.
The promising potential of CAN-2409 has already been demonstrated in clinical trials for other cancers. Earlier this year, Candel conducted a randomized trial in pancreatic cancer, a disease notorious for its poor prognosis. Patients receiving CAN-2409 showed dramatically improved overall survival compared to those receiving only standard of care. Based on this data, Candel was granted Fast Track and Orphan Drug Designation for CAN-2409 in pancreatic cancer. These encouraging results were followed by a successful trial in non-small cell lung cancer, where CAN-2409 was shown to double the expected median survival for patients with metastatic disease compared to historical controls.
Expanding the possibilities with CAN-3110
While CAN-2409 is the star of Candel's pipeline, the company is also developing CAN-3110, a promising therapy for glioblastoma and other solid tumors. Glioblastoma, one of the deadliest forms of brain cancer, has proven to be an especially tough target for cancer treatments. "The industry has seen numerous failures in glioblastoma research, but we believe that overcoming failure is key to progress," Tak said.
Candel’s approach with CAN-3110 involves injecting a modified herpes simplex virus directly into the tumor, which activates the immune system to target and destroy cancer cells. In a clinical trial, patients with recurrent high-grade glioma (including glioblastoma) who received a single injection of CAN-3110 showed a doubling of expected survival. "This is a remarkable result compared to historical controls with a median survival of less than 6-9 months," said Tak. The treatment is well-tolerated, with minimal side effects, and the company has already initiated further studies to explore the potential of multiple injections.
Beyond glioblastoma, CAN-3110 could be developed in other cancers, including melanoma, triple-negative breast cancer, and sarcoma. Preclinical studies have demonstrated anti-tumor efficacy and robust immune activation in models of melanoma, laying the groundwork for expanding the treatment’s application.
The road ahead: funding and strategic partnerships
As with any biotech company, funding remains a critical consideration. Candel is currently funded through the first quarter of next year, with a strong focus on delivering key clinical data to support future financing efforts. "Our runway is extending through March, and we have four major data readouts within that period," Tak explained. "If the prostate cancer data are positive, we anticipate strong interest from pharmaceutical companies for strategic partnerships."
Tak emphasized that any potential deal must be aligned with the company’s long-term vision. "We are not interested in short-term gains at the expense of long-term value. We want to ensure that Candel's innovations are positioned to make the greatest impact on patients' lives."
Whether it's providing a new option for prostate cancer patients or tackling some of the deadliest cancers with CAN-2409 and CAN-3110, Candel's mission is clear: to transform cancer treatment and improve the quality of life for patients facing the toughest battles.