Genoa, Italy – March 12, 2026 – Valo Therapeutics, a clinical-stage biotechnology company developing next-generation cancer immunotherapies, convened investigators and study teams in Genoa for a meeting supporting the ongoing Phase I START clinical trial (NCT05492682) evaluating PeptiCRAd-1, its proprietary immunotherapeutic platform.

The meeting brought together investigators, clinical operations teams, and sponsor representatives from leading oncology centers across Italy to discuss the progress and next steps of the trial, which is evaluating PeptiCRAd-1 in combination with the immune checkpoint inhibitor pembrolizumab in patients with injectable solid tumors.

The study follows authorization from the Italian Medicines Agency (AIFA), granted in October 2025, allowing the initiation of the Phase I clinical trial in Italy. The approval enables the evaluation of Cohort 2, in which patients receive PeptiCRAd-1 administered via both subcutaneous (SC) and intratumoral (IT) routes in combination with pembrolizumab as part of the START study.

During the meeting, participants reviewed the scientific rationale and clinical development strategy for the PeptiCRAd platform. The agenda included presentations on the PeptiCRAd technology, the study design, and interim clinical findings from the trial, as well as operational discussions regarding site activation, patient recruitment strategies, and clinical trial management. The meeting also provided a forum for investigators to exchange insights and coordinate the implementation of the trial across participating sites.

Investigators from several major oncology centers attended the meeting, including representatives from Federico II University, IRCCS San Raffaele, IRCCS Candiolo, and Humanitas Research Hospital, alongside clinical operations partners and Valo Therapeutics leadership.

Marcella Origgi, CEO of Valo Therapeutics, commented:

"Bringing together our investigators and clinical partners is an essential step in progressing the development of PeptiCRAd-1. Direct relationship‑building increases mutual trust ensuring the efficient execution of the trial.

The authorization of the trial in Italy and the strong collaboration between clinical sites represent important milestones in our mission to develop innovative immunotherapies for patients with cancer."

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

"The investigator meeting provided an important opportunity to align all participating sites on the study protocol and operational aspects of the trial aimed at evaluating the therapeutic potential of PeptiCRAd-1 in combination with pembrolizumab. When the collaboration between investigators and the sponsor is close, the benefits for the patients could be maximized and high-quality clinical data could be generated."

Scientific founder and advisor Vincenzo Cerullo also highlighted the scientific rationale of the approach:

"The PeptiCRAd platform is designed to harness the immune system by combining the tumor-killing potential of oncolytic viruses with the precision of peptide-based immune targeting resulting in a affordable in vivo T cell therapy for precision cancer treatment."

The investigator meeting concluded with a Q&A session and networking discussion aimed at strengthening collaboration across participating sites as the trial continues to enroll patients.

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.