Candel Therapeutics NASDAQ: CADL Chief Executive Officer Dr. Paul Peter Tak said the company remains focused on advancing its viral immunotherapy programs following newly presented prostate cancer data and as it prepares for a planned biologics license application submission by the end of the year.
Speaking during a Stifel-hosted discussion with senior biotech analyst Stephen Willey, Tak said Candel had just presented data at the American Urological Association annual meeting in Washington, D.C., where the company’s presentation was “extremely well-received.” He described Candel as a developer of viral immunotherapies for difficult-to-treat solid tumors, including prostate cancer, pancreatic cancer, non-small cell lung cancer and glioblastoma.
The company has two investigational medicines in the clinic: aglatimagene and linoserpaturev. Tak said Candel has proof of concept for each indication and medicine under development and is in a “very stable financial position,” with a runway that he said could extend into commercialization.
Aglatimagene Data in Localized Prostate Cancer
Much of the discussion centered on aglatimagene, Candel’s lead program in localized prostate cancer. Tak said the therapy is delivered directly into the prostate in an outpatient procedure that typically takes 15 to 20 minutes and is followed by two weeks of treatment with valacyclovir tablets.
Tak described the approach as a form of gene therapy rather than an oncolytic virus. He said the treatment is designed to destroy cancer cells locally and “teach the patient’s own immune system how to recognize and kill the tumor cells.” He also emphasized that aglatimagene is an off-the-shelf product that does not require a complex cold chain.
The company’s phase III trial evaluated aglatimagene in combination with standard-of-care radiotherapy in patients with intermediate- and high-risk localized prostate cancer. Tak said the trial reached its primary endpoint in December 2024 after a long follow-up period, with results supported by secondary endpoints and histologic confirmation.
Tak said the rationale for pursuing localized prostate cancer was based on medical need, noting that the current radical treatment options are prostatectomy and radiotherapy, both of which carry risks of recurrence and long-term complications. He said recurrence occurs in about 30% of patients despite radical treatment.
Disease-Free Survival Endpoint and Follow-Up
The primary endpoint in the trial was disease-free survival, which Tak said was agreed to with the U.S. Food and Drug Administration under a special protocol assessment. He defined an event as the presence of tumor cells in a two-year biopsy, local or regional recurrence confirmed by imaging or biopsy, metastases or death from any cause.
Tak said the inclusion of deaths from non-prostate cancer causes diluted the signal, but the study still showed statistical significance on the primary endpoint. He said the two-year biopsy was used because it is an objective research tool to detect cancer cells, even though it is not routinely performed in standard clinical practice.
At the AUA meeting, Candel presented additional follow-up data with a median follow-up of 58 months. Tak said the company reproduced the prostate cancer-specific disease-free survival finding, excluding deaths unrelated to prostate cancer. He cited a hazard ratio of 0.61 and a P value of 0.0031 for that measure.
Tak also said the updated data showed longer time to salvage anticancer therapy, such as long-term androgen deprivation therapy, as well as a lower incidence of and longer time to metastases in the aglatimagene arm compared with placebo. In intermediate-risk patients, who made up 85% of the trial population, he said Candel observed a hazard ratio of 0.1 for time to metastases.
Willey asked about the smaller high-risk subgroup, where he said the data appeared less favorable. Tak said the high-risk group included about 100 patients and characterized the finding as “statistical noise,” adding that the company does not see a biological rationale for a different effect in that narrowly defined high-risk subset.
BLA Timing and Manufacturing
Tak said Candel continues to guide for a BLA submission before the end of the year. He said the company does not currently plan another data cut before the filing, though it intends to continue following patients for safety and clinically meaningful endpoints.
Tak said the company has not yet shared the newest AUA data with the FDA, but noted that the agency has already granted aglatimagene regenerative medicine advanced therapy, or RMAT, designation based on the data package.
Asked what could limit the timing of the filing, Tak pointed to chemistry, manufacturing and controls work. He said Candel had already partnered with MilliporeSigma, also known as SAFC, in Carlsbad, California, and had completed enabling work before the data readout. Tak said the company chose not to scale up commercial manufacturing before seeing the phase III results, calling that approach the appropriate use of shareholder capital.
“The gating factor is CMC,” Tak said, adding that the company has had “very good meetings” with the FDA and remains on track for a year-end submission.
Commercial Opportunity in Prostate Cancer
Tak said a small majority of patients in the phase III trial were enrolled at community centers, supporting the company’s view that administration can fit into routine practice. He said the injection uses a thin needle and can be performed in standard urology settings.
Tak estimated that in the United States alone, about 65,000 patients per year choose radiotherapy as radical treatment for localized prostate cancer. He said Candel believes that number could increase if aglatimagene is approved, because improved outcomes with radiotherapy could influence shared decision-making between patients and physicians.
Tak said payer research suggests favorable views of the product profile because the treatment is well-tolerated, did not show an increase in serious adverse events and would represent a one-time treatment course consisting of three administrations. He described the potential U.S. opportunity as a $10 billion to $16 billion market.
Lung Cancer Phase III Plans
Willey also asked about Candel’s planned phase III trial in second-line non-small cell lung cancer after PD-1 therapy. Tak said the study will compare patients continuing KEYTRUDA with two administrations of aglatimagene against patients stopping KEYTRUDA and receiving docetaxel, with overall survival as the primary endpoint.
Tak said the trial is expected to enroll about 500 patients globally and is powered at 90%. He said Candel plans to start the study “very shortly.”
Tak said the company’s phase II data showed at least a doubling of expected median overall survival, particularly in non-squamous non-small cell lung cancer, compared with docetaxel’s typical median overall survival of less than one year. He said administration in lung cancer is done by bronchoscopy in an outpatient setting, takes about 45 minutes and is aligned with existing clinical practice.
About Candel Therapeutics NASDAQ: CADL
Candel Therapeutics NASDAQ: CADL is a clinical-stage immuno-oncology company focused on the development of next-generation oncolytic viral therapies designed to treat solid tumors. The company's lead candidate, CAN-2409, is a locally administered, gene-delivered viral therapy engineered to selectively replicate in cancer cells and induce immunogenic cell death. Candel leverages proprietary virus engineering platforms to enhance tumor-specific replication and stimulate anti-tumor immune responses, aiming to improve outcomes for patients with high unmet medical needs.
In addition to its lead program, Candel's pipeline includes CAN-3110, an oncolytic herpes simplex virus targeting recurrent high-grade glioma, and other novel viral constructs being explored for a variety of solid tumor indications.
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