Kanvas Biosciences, a spatial biology company based in Princeton, New Jersey, has unveiled promising results from a clinical trial focused on fecal microbiota transplantation (FMT) and anti-
PD-1 re-induction in treating
microsatellite instability-high (MSI-H) refractory cancers. The findings were presented at the Society for Immunotherapy of Cancer (SITC) meeting, revealing that FMT facilitated a response to reintroduced anti-PD-1 in patients whose MSI-H cancers were refractory to the immune checkpoint inhibitor.
Dr. Kyle Jacoby, Vice President of Clinical Research at Kanvas Bio, highlighted the significance of their lead drug candidate, KAN-001. The strains in KAN-001 were derived from the same donor who provided the FMT material for the clinical trial. These strains successfully engrafted in the participants, de-risking the clinical development of
KAN-001. This drug aims to enhance outcomes for
cancer patients resistant to immune checkpoint inhibitors like anti-PD-1.
The trial involved 15 participants: 10 with
colorectal cancer, two with
small bowel adenocarcinomas, one with pancreatic adenocarcinoma, one with endometrial adenocarcinoma, and one with a pineal brain tumor. Each underwent FMT via colonoscopy, receiving a transplant from a metastatic MSI-H colorectal cancer patient who had a complete response to anti-PD-1 therapy. Key findings included:
- A 20% response rate among participants, including one colorectal cancer patient with an ongoing complete response lasting over two years.
- High engraftment levels, with significant donor strain presence in most participants.
- No occurrences of immune checkpoint inhibitor-induced colitis.
Dr. Erez Baruch of The University of Texas MD Anderson Cancer Center, the presenting author, emphasized the importance of the gut microbiome in responding to anti-PD-1 therapy, although the exact mechanisms were previously unclear. The trial results indicate that FMT can enable a response to reintroduced anti-PD-1 in patients with MSI-H cancers that were refractory to the treatment.
Kanvas Bio is planning to engage with the FDA in January 2025 to request a pre-Investigational New Drug meeting for KAN-001, aiming to initiate a clinical trial for the drug swiftly. The company, which specializes in spatial mapping of the microbiome and profiling host gene expression, is advancing its capabilities to develop live biotherapeutics that can restore microbiome health and improve outcomes for patients with microbiome-associated diseases.
Kanvas Biosciences leverages technology initially developed at Cornell University and holds an exclusive license. The company's investors include DCVC, Lions Capital LLC, FemHealth Ventures, Germin8, Ki Tua Fund, Pangaea Ventures, Triple Impact Capital, and Uncommon Denominator. The company is dedicated to pioneering microbiome drug discovery and has built a platform to accelerate the development of next-generation therapeutics.
For more details about Kanvas Biosciences and its therapeutic pipeline, interested parties can visit their website or meet the team at SITC's annual meeting in Houston.
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