Kanvas Biosciences, a spatial biology company, has unveiled clinical trial results at the 2024 Society for Immunotherapy of Cancer (SITC) meeting, showing the potential of fecal microbiota transplantation (FMT) in combination with anti-PD-1 re-induction to treat patients with microsatellite instability-high (MSI-H) refractory cancers. The trial demonstrated that FMT enabled a positive response to reintroduced anti-PD-1 therapy in patients whose cancers had been resistant to immune checkpoint inhibitors (ICIs), suggesting the gut microbiome’s impact on anti-tumoral immunity across various cancers.
Dr. Kyle Jacoby, Vice President of Clinical Research at Kanvas Bio, explained, “The strains in our lead drug candidate, KAN-001, were isolated from the same donor whose FMT material was used in this trial. All strains present in KAN-001 were successfully engrafted in the patients, significantly de-risking the clinical development of our drug.” KAN-001 is designed to improve outcomes for cancer patients who are resistant to ICIs like anti-PD-1.
The trial included 15 participants with various cancer types, including colorectal, small bowel, pancreatic, endometrial, and pineal brain tumors. All patients received FMT from a metastatic MSI-H colorectal cancer patient who had a complete response to anti-PD-1 therapy. Key findings included:
- 20% of participants (3 out of 15) responded to treatment, with one patient achieving an ongoing complete response for over two years.
- High engraftment rates of donor strains were observed in most participants.
- No incidents of ICI-induced colitis were reported.
Dr. Erez Baruch, presenting author and Medical Oncology Fellow at The University of Texas MD Anderson Cancer Center, noted, “Our results confirm that FMT enables a response to anti-PD-1 in patients with MSI-H cancers previously resistant to the therapy.”
Kanvas Bio plans to meet with the FDA in January 2025 for a pre-Investigational New Drug (IND) discussion and aims to initiate clinical trials for KAN-001 soon after.
