Rznomics has signed a clinical trial collaboration and supply agreement with F. Hoffmann-La Roche to assess the former’s RZ-001 in combination with Roche’s atezolizumab, in patients with hepatocellular carcinoma (HCC).
RZ-001 is the first Group I intron based trans-splicing ribozyme-based RNA reprogramming approach.
It was developed using the South Korea-based biopharmaceutical company’s proprietary trans-splicing ribozyme-based RNA reprogramming and editing technology.
Under the partnership, Roche will provide atezolizumab to Rznomics for use in combination with RZ-001 for the planned Phase 1b/2a trial.
Rznomics CEO Seong-Wook Lee said: “We are excited to initiate collaboration with longstanding oncology leader, Roche, to further explore the potential benefits of combining checkpoint blockade with RZ-001.
“We look forward to having this collaboration, evaluating combination therapy and continuing our mission to offer innovative therapies for patients in need.”
The enzyme-based cancer gene therapy targets and cleaves hTERT mRNA and substitutes the mRNA with the therapeutic gene RNA.
RZ-001 specifically causes a cytotoxic impact by trans-ligating an HSVtk-encoding region into the reprogrammed hTERT mRNA, which concurrently suppresses hTERT expression in cancer cells that express hTERT and causes anti-HCC activity.
Additionally, it lowers VEGF expression in the tumours and effectively infiltrates immune cells into the treated tumours.
This results in anti-cancer efficacy and a change in the tumour microenvironment that makes the tumour more immunotherapy responsive, Rznomics said.
According to the biopharmaceutical firm, RZ-001 has shown considerable improvement in anti-cancer efficacy in a dose-dependent manner and therapeutic activity in preclinical tests when combined with atezolizumab.
The company expects that the combination of RZ-001 with atezolizumab may boost response rate and anti-cancer efficacy that could benefit patients with HCC. The clinical trial will assess the safety and efficacy in liver cancer patients.
The US Food and Drug Administration (FDA) and the Ministry of Food and Drug Safety (MFDS) of South Korea have approved Rznomics’ Phase 1/ 2a IND for Glioblastoma and HCC, respectively.
