Valo Therapeutics Announces Regulatory Approval to Expand Phase I Immuno-oncology Trial into Sarcoma

Valo Therapeutics Announces Regulatory Approval to Expand Phase I Immuno-oncology Trial into Sarcoma

Four cancer types now included in PeptiCRAd-1 with Pembrolizumab trial: sarcoma, melanoma, triple negative breast cancer and non-small cell lung cancer

Helsinki, Finland, 29 Nov 2023 – Valo Therapeutics Oy (ValoTx), the developer of novel, adaptable immunotherapies for cancer, announces it has 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. 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.

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. (1). 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.

Paul Higham, CEO of ValoTx, commented, “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.”

Sarcomas develop in the bones and soft tissues, such as arms, legs, chest, or abdomen, and usually manifest as a painless lump or swelling. There are around 12,000 cases of soft tissue cancers, which are more common in adults, in the US each year. The American Cancer Society provides information on 5-year relative survival rates for soft tissue cancer, based on people diagnosed between 2010 and 2016. This ranges from 81% for localized cancer, to just 15% if the cancer has spread to distant parts of the body such as the lungs. Overall survival across all stages is 65%. (2), (3).