Transgene and Bispebjerg and Frederiksberg Hospital, University of Copenhagen, have announced that the first patient has been dosed in a phase 1 clinical trial evaluating BT-001 in patients with proficient mismatch repair (pMMR) rectal cancer.
The investigator-sponsored OV-PRIME-R trial is assessing BT-001, an armed oncolytic virus administered through intratumoral injection, followed by intravenous pembrolizumab treatment. The study is focused on patients with localised pMMR rectal cancer, a population representing around 95% of rectal cancer cases and one that has historically shown limited response to immunotherapy alone.
The trial is designed to investigate the safety, tolerability and efficacy of neoadjuvant treatment with BT-001 combined with an anti-PD1 antibody before standard surgery.
Researchers hope that the approach could help address limitations associated with current treatment options. While neoadjuvant chemo-radiotherapy can reduce recurrence and preserve organs in some patients, fewer than 30% of patients achieve a complete response and some still experience distant recurrence.
BT-001 is being co-developed by Transgene and BioInvent. The therapy was created using Transgene’s Invir.IO platform and is engineered to express GM-CSF and BioInvent’s full-length anti-CTLA-4 monoclonal antibody.
Henry G. Smith, Associate Professor and consultant surgeon at Abdominal Center K, Bispebjerg and Frederiksberg Hospital University of Copenhagen and Principal Investigator, said: “We are excited to launch this investigator-sponsored trial, which explores an innovative approach to treating rectal cancer in patients with proficient mismatch repair status.”
He added: “By combining BT-001, an armed oncolytic virus, with anti-PD-1 therapy, in patients with localized disease, we aim to enhance the immune response and potentially improve outcomes for patients by reducing the risks of relapse or even reducing the number who need surgery at all.”
Smith continued: “This study represents an important step toward more effective and less toxic treatment strategies for this underserved population.”
Emmanuelle Dochy, Chief Medical Officer of Transgene, explained: “We are proud to support this investigator-sponsored trial in collaboration with the University of Copenhagen, evaluating BT-001 in patients with rectal cancer at high risk of relapse and severe toxicities from standard of care.”
She added: “BT-001 has already demonstrated excellent tolerability and the ability to transform ‘cold’ tumors into biologically active ones. This study aims to further validate its potential to improve outcomes and quality of life for cancer patients.”
