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First patient dosed in Valo’s Phase I trial

Valo Therapeutics has announced that the first patient has been treated in its trial of PeptiCRAd-1 (Peptide-coated Conditionally Replicating Adenovirus) in three tumor types.

PeptiCRAd-1 combines two clinically proven cancer immunotherapy approaches: oncolytic adenoviruses and tumor-specific peptides for the generation of strong systemic cytotoxic T-cell responses against multiple tumor antigens. This is achieved by coating the company’s oncolytic adenovirus with immunogenic tumor-specific peptides thereby directing the immune system to specifically target and kill cancer cells.

“Based on strong in vivo data generated by our research team, we expect to see both a potent tumor-directed immune response and changes in the tumor microenvironment that will facilitate tumor control. This first PeptiCRAd program uses well-known, tumor-specific targets (NY-ESO-1 and MAGE-A3) that are highly prevalent on the three tumor types to be included. In the future, the inherent adaptability and flexibility of our platform will allow us to deliver advanced individualized or ‘patient-specific’ cancer treatments,” says Paul Higham, CEO of ValoTx.


The trial

Following this green light, further patients are now being recruited at the Krankenhaus Nordwest in Frankfurt, and at the National Center for Tumor diseases (NCT) in Heidelberg.

PeptiCRAd-1 combines the power of a tumor-specific adenovirus (expressing immune-stimulatory molecules CD40L and OX40L) with immunogenic tumor peptides derived from NY-ESO-1 and MAGE-A3 proteins thereby generating tumor-specific, cytotoxic T-cells that will attack and kill cancer cells.

The trial is designed to evaluate the safety, immune activity, and tumor response of PeptiCRAd-1 alone and then in combination with the immune checkpoint inhibitor (CPI), pembrolizumab in 15 patients with either melanoma, triple-negative breast cancer or non-small cell lung cancer. The trial will explore local and systemic immune activation, and immune responses against the tumor-specific  NY-ESO-1 and MAGE-A3 peptides, as well as clinical responses. It includes intensive immuno-monitoring of tumor and blood samples from patients to confirm the mechanism of action of PeptiCRAd-1 and to identify biomarker-related outcomes, among other signals of clinical benefit.

Photo of Paul Higham: Teresa Walton/Valo Therapeutics