April 20, 2026 – Valo Therapeutics, a clinical-stage biotechnology company focused on next-generation cancer immunotherapies, today announced that the Paul-Ehrlich-Institut (PEI) has granted approval for a substantial modification to its ongoing Phase I START clinical trial (NCT05492682). The study is investigating the company’s lead immunotherapy candidate, PeptiCRAd-1, in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab.

The approved amendment introduces refinements to the clinical protocol, supporting the continued evaluation of PeptiCRAd-1 in patients with injectable solid tumors. In particular, the modification enables further development of treatment strategies explored in Cohort 2, where PeptiCRAd-1 is administered via both subcutaneous and intratumoral routes alongside pembrolizumab.

This regulatory decision marks a key step in the clinical progression of the PeptiCRAd platform and reflects ongoing alignment between Valo Therapeutics and European regulatory authorities as the study evolves based on emerging data.

Marcella Origgi, Chief Executive Officer of Valo Therapeutics, stated:
“The approval of this substantial modification underscores the strength of our clinical strategy and the adaptability of our development program. It allows us to build on the insights gained to date and further refine how PeptiCRAd-1 is delivered in combination with checkpoint inhibition. Our goal remains to accelerate the development of innovative immunotherapies that can address unmet needs in oncology.”

Lukasz Kuryk, Chief Development Officer, added:
“This milestone enables us to continue the study with an optimized protocol that reflects both scientific rationale and early clinical experience. Maintaining close interaction with regulatory bodies such as the Paul-Ehrlich-Institut is critical to ensuring that our clinical program advances efficiently while upholding the highest standards of patient safety and data quality.”

About PeptiCRAd-1

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.