Hygrovest Ltd (ASX:HGV, OTC:MMJJF) welcomes the dosing by its Finland-based investment Valo Therapeutics Oy (ValoTx) of the first patient in a Phase I trial of PeptiCRAd-1 (Peptide-coated Conditionally Replicating Adenovirus) in three tumour types.
The German-based trial will involve 15 patients with melanoma, triple-negative breast cancer or non-small cell lung cancer.
Innovative approach
PeptiCRAd-1 is an innovative approach never before used combining two clinically proven cancer immunotherapy approaches - oncolytic adenoviruses and tumour-specific peptides for the generation of strong systemic cytotoxic T-cell responses against multiple tumour antigens.
This is achieved by coating ValoTx’s proprietary oncolytic adenovirus with immunogenic tumour-specific peptides thereby directing the immune system to specifically target and kill cancer cells.
No other oncolytic virus therapy delivers tumour targets in this simple but effective and adaptable way.
Investment in ValoTx
Hygrovest made its initial investment in ValoTx, an immunotherapy company developing antigen-coated oncolytic viruses as therapeutic vaccines against cancer in November 2021.
ValoTx’s lead platform, PeptiCRAd, was developed out of the laboratory of Professor Vincenzo Cerullo at the University of Helsinki. It turns oncolytic adenoviruses into powerful activators of systemic anti-tumour cytotoxic T-cell immunity without the need to generate and manufacture multiple genetically modified viruses.
Patient recruitment
The first patient has been administered with PeptiCRAd-1 successfully, without any initial safety concerns and the Safety Data Committee has concluded that the study can continue enrolment.
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.
About PeptiCRAd-1
PeptiCRAd-1 combines the power of a tumour-specific adenovirus (expressing immune-stimulatory molecules CD40L and OX40L) with immunogenic tumour peptides derived from NY-ESO-1 and MAGEA3 proteins thereby generating tumour-specific, cytotoxic T-cells that will attack and kill cancer cells.
The trial is designed to evaluate the safety, immune activity, and tumour 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.
This trial will explore local and systemic immune activation and immune responses against the tumour-specific NY-ESO-1 and MAGE-A3 peptides, as well as clinical responses.
It includes intensive immuno-monitoring of tumour 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.
“Major milestone”
ValoTx CEO Paul Higham said, “I’m delighted we have commenced clinical development with the first patient treated in our Phase I trial of PeptiCRAd-1.
"Our thanks go to Prof Dr med. Elke Jäger and her team at the hospital Krankenhaus Nordwest in Frankfurt and Prof Guy Ungerechts and his team at the National Center for Tumor Diseases (NCT) in Heidelberg, for all their excellent preparatory work to reach this major milestone.
"Based on strong in vivo data generated by our research team, we expect to see both a potent tumour-directed immune response and changes in the tumour microenvironment that will facilitate tumour control.
"This first PeptiCRAd program uses well-known, tumour-specific targets (NY-ESO-1 and MAGE-A3) that are highly prevalent on the three tumour types to be included.
"In the future, the inherent adaptability and flexibility of our platform will allow us to deliver advanced individualised or ‘patient-specific’ cancer treatments.”