AIFA Authorizes Clinical Trial of PeptiCRAd-1 in Combination with Pembrolizumab in Italy
Helsinki, Finland / Naples, Italy, 26th January, 2026
Valo Therapeutics Oy (ValoTx), a clinical-stage biotechnology company developing next-generation oncolytic virus–based cancer immunotherapies, announced that the Italian Medicines Agency (AIFA) has authorized the initiation of a Phase I clinical trial evaluating PeptiCRAd-1 in combination with the immune checkpoint inhibitor pembrolizumab in patients with injectable solid tumors in Italy.
The authorization follows a positive scientific and ethical assessment conducted through the European clinical trial authorization process and allows Italy to participate as an additional Member State in the ongoing European study.
The study was initiated in Germany, where seven patients have already been treated. Following positive and encouraging interim clinical data, Valo Therapeutics is expanding the trial into Cohort 2, which will evaluate additional subcutaneous administration of PeptiCRAd-1 to further enhance immune activation. Up to eight patients will be treated in Italy as part of this cohort. The trial will continue with comprehensive immunomonitoring to support biomarker discovery and patient stratification.
The approved trial is a Phase I, open-label, non-randomized study designed to evaluate the safety and immune activity of PeptiCRAd-1, a tumor-specific peptide-coated, conditionally replicating adenovirus, in patients with solid tumors known to express the cancer antigens NY-ESO-1 and MAGE-A3 (ClinicalTrials.gov ID: NCT05492682).
“This authorization from AIFA enables us to expand the clinical development of PeptiCRAd-1 into Italy,” said Marcella Origgi, CEO of Valo Therapeutics. “Valo has achieved this significant milestone by having submitted the CTIS on August 9th. I am confident that many biotech and pharma companies would be delighted to achieve this challenging objective within our timeline. My message to them is: Italy is a favourable environment for conducting phase 1 clinical trials with its strong clinical oncology network. This approval supports our strategy to advance innovative, immunotherapies across Europe.”
Professor Vincenzo Cerullo, Scientific Founder of Valo Therapeutics, commented: “I am extremely pleased to see the PeptiCRAd technology that originated from our academic research continue to progress into clinical development. Initiating this study in Italy marks a key step in translating academic innovation into clinically actionable immunotherapy, reinforcing the potential of the PeptiCRAd platform to shape next-generation cancer treatment. We look forward to seeing how PeptiCRAd-1 can further advance cancer immunotherapy for patients.”
Lukasz Kuryk, PhD, VP Translational and Clinical Science of Valo Therapeutics, added: “The expansion into Cohort 2 with subcutaneous administration is supported by the encouraging immune signals observed to date. This next phase will allow us to further explore immune activation, optimize treatment delivery, and deepen our understanding of biomarkers that may guide future patient selection.”
The trial will be conducted at qualified Italian clinical sites that are internationally recognized for excellence in oncology research.
Further updates will be provided as the study progresses—stay tuned for more news.
About PeptiCRAd-1
PeptiCRAd-1 is a novel cancer immunotherapy platform that combines an oncolytic adenovirus with tumor-specific peptides, transforming the patient’s tumor into an in situ vaccine. The approach is designed to stimulate both innate and adaptive immune responses and to enhance the efficacy of immune checkpoint inhibition across multiple solid tumor indications.
About Valo Therapeutics
Valo Therapeutics is a clinical-stage biotechnology company developing personalized and precision cancer immunotherapies based on its proprietary PeptiCRAd platform. By combining viral vectors with peptide-based targeting strategies, ValoTx aims to unlock durable anti-tumor immune responses tailored to individual patients.
Contact:
Dr Marcella Origgi, CEO
+39 3409196605
www.valotx.com