Candel Therapeutics’s stock has soared by 172% after its Phase III trial evaluating CAN-2409, a viral immunotherapy in localised prostate cancer patients, met its primary endpoint.
Researchers from the Massachusetts-based clinical-stage biopharma have announced that CAN-2409, designed as a multimodal biological immunotherapy candidate aimed at prompting an immune response from a patient’s prostate in tackling prostate tumours, demonstrated a statistically significant and clinically meaningful benefit when combined with radiation therapy alongside the antiviral drug valacyclovir.
Patients saw an average 14.5% relative improvement in disease-free survival when compared with the placebo arm of the study after 54 months. At the same time, the study saw an increase in the proportion of patients achieving a prostate-specific antigen typically associated with prostate cancer.
The company's stock jumped 172% at market opening today (11 December) from a close of $4.61 to an open of $12.65, with the stock price continuing to grow.
The Phase III trial (NCT01436968), conducted under a Special Protocol Assessment (SPA) with the US Food and Drug Administration (FDA), saw a generally consistent safety profile with no new safety signals being flagged during the randomised, double-blind, placebo-controlled, multicenter clinical trial.
Dr. Glen Gejerman, principal investigator, said: “The improvement observed in disease-free survival in this Phase III clinical trial is clinically meaningful. We have not seen significant advances in this indication in decades. CAN-2409 has demonstrated the potential to significantly improve long-term outcomes without adding substantial toxicity to standard-of-care radiation.
“If approved, this approach has the potential to transform the treatment paradigm in prostate cancer, offering patients with localized disease an effective treatment option that may reduce the risk of disease recurrence.”
Now, the company has announced it plans to use results from this Phase III trial to advance its marketing application to US authorities.
Paul Peter Tak, president and CEO of Candel, said: “This study validates previous observations of CAN-2409 activity seen in difficult-to-treat solid tumours, often resistant to immunotherapy, and confirms our previous observation of synergies with radiation therapy in models of prostate cancer.
“Importantly, this study was conducted under a Special Protocol Assessment agreed with the FDA, on key aspects of study design, meaning that safety and efficacy data generated from the study could be sufficient for the Company to seek regulatory approval for CAN-2409 in this indication.”
Elsewhere in the field of prostate cancer treatment, Arvinas and Pfizer have shared preliminary outcomes from the Phase Ib segment of the TACTIVE-U sub-trial of vepdegestrant. Meanwhile, the UK-based pharmaceutical company AstraZeneca has reported positive results from its Phase III CAPItello-281 trial.
