Turin, Italy; Helsinki, Finland – June 8th 2026 – Valo Therapeutics Oy, a clinical-stage biotechnology company developing next-generation cancer immunotherapies, announced that the first patient has been dosed with PeptiCRAd-1 in the ongoing Phase I START clinical trial at Candiolo Cancer Institute, FPO-IRCCS, Italy.

The START study is evaluating the safety, tolerability, and preliminary anti-tumor activity of PeptiCRAd-1 in patients with advanced solid tumors, including in combination with pembrolizumab. The trial explores innovative administration strategies, including intratumoral and subcutaneous delivery, aimed at enhancing systemic anti-tumor immune responses.

The dosing of the first patient follows regulatory and ethics approval supporting the continued clinical development of the PeptiCRAd platform.

Valo Therapeutics Oy previously completed the first stage of the Phase I START study in Germany and reported encouraging interim clinical results, including favorable tolerability, immune activation, and early signs of anti-tumor activity. The study is now continuing in Italy with Cohort 2, evaluating additional treatment strategies designed to further enhance systemic immune responses

PeptiCRAd is Valo Therapeutics  proprietary peptide-coated oncolytic adenovirus platform designed to combine the tumor-selective activity of oncolytic immunotherapy with targeted activation of anti-cancer T-cell responses. The platform is intended to enhance immune recognition of tumors and improve responses to immune checkpoint inhibition.

Dr. Vanesa Gregorc, Principal Investigator at Candiolo Cancer Institute, FPO-IRCCS, Deputy Scientific Director, Director of Clinical Research and Innovation, and Director of the Phase I Unit and Clinical Research Unit, stated:

“The initiation of patient dosing in the START trial represents an important milestone in the clinical translation of next-generation oncolytic immunotherapies. PeptiCRAd combines tumor-selective viral therapy with targeted immune activation, offering a highly innovative strategy for patients with advanced solid tumors who currently have limited therapeutic options. We are encouraged by the scientific rationale supporting this approach and look forward to evaluating the clinical and immunological outcomes of the study.”

Lukasz Kuryk, Chief Development Officer at Valo Therapeutics, added:

“This milestone reflects years of translational and clinical development focused on advancing next-generation oncolytic immunotherapies for patients with difficult-to-treat cancers. The START trial is designed not only to evaluate safety, but also to better understand how PeptiCRAd can shape anti-tumor immune responses in combination with checkpoint inhibition. We are encouraged to see the study actively progressing and to bring this innovative therapeutic strategy into clinical evaluation.”

Marcella Origgi, Chief Executive Officer of Valo Therapeutics, commented:

“The dosing of the first patient in the START trial represents an important milestone for Valo Therapeutics and for the broader field of cancer immunotherapy. We believe the PeptiCRAd platform has the potential to address important limitations associated with current immunotherapy approaches by combining potent immune activation with tumor selectivity. Advancing this program together with leading clinical investigators is a major achievement for the company and and it constitutes an important starting point to expand treatment options for patients.”

Valo Therapeutics expects patient recruitment activities to continue throughout 2026.

About PeptiCRAd

PeptiCRAd-1 is a first-in-class immunotherapy that leverages a peptide-coated, conditionally replicating adenovirus to stimulate tumor-specific immune responses. By combining oncolytic virotherapy with tumor-targeting peptides, this approach is designed to induce robust cytotoxic T-cell responses and enhance the efficacy of immune checkpoint inhibitors such as pembrolizumab enabling a novel therapeutic paradigm—effectively delivering “in vivo T-cell therapy” directly within the patient.

About Valo Therapeutics

Valo Therapeutics is a biotechnology company focused on the development of innovative immunotherapies based on its PeptiCRAd platform technology. The company aims to harness the power of oncolytic viruses and tumor antigen targeting to improve outcomes for patients with aggressive and treatment-resistant cancers.