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Valo Therapeutics receives regulatory approval to expand Phase I trial

Valo Therapeutics received approval from Germany’s PEI (Paul Ehrlich Institute) to extend the tumor types to be treated in the company’s current Phase I trial into two subtypes of sarcoma.

“This extension of the study into sarcoma is significant as it broadens the range of patients we can recruit into our PeptiCRAd-1 study. These sub-types of sarcoma are particularly interesting as they have very high expression levels of our two target antigens. The recent opening of a third recruitment center in Tübingen is especially relevant here, as that center has a major sarcoma patient population across southwest Germany. 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 regression,” says Paul Higham, CEO of ValoTx.

The subtypes, synovial and myxoid round cell sarcoma, have high levels of expression of the well-known, tumor specific antigen targets MAGE-A3 and NY-ESO-1, and hence are an ideal target for ValoTx’s lead cancer immunotherapy program, PeptiCRAd-1 (Peptide-coated Conditionally Replicating Adenovirus 1). PeptiCRAd-1 is made up of ValoTx’s proprietary oncolytic virus, VALO-D102, coated with MAGE-A3 and NY-ESO-1 peptides. No other oncolytic virus therapy targets tumor antigens in this way.

Read more: Reinventing immunotherapy

ValoTx’s Phase I, first-in-human trial of PeptiCRAd-1 is currently in three tumor types: melanoma, triple negative breast cancer and non-small cell lung cancer. Up to 15 patients will be treated with PeptiCRAd-1 in combination with the checkpoint inhibitor, pembrolizumab. PeptiCRAd-1 combines the immune system activating potency of an oncolytic virus and the power of anti-tumor cytotoxic T-cells.

Photo of Paul Higham: Teresa Walton