Kanvas Bio Unveils Clinical Data on the Gut Microbiome’s Impact on Anti-Tumoral Immunity at SITC

The clinical trial produced results that de-risk the development of Kanvas Bio’s lead immuno-oncology drug.

Kanvas Biosciences, a full-stack spatial biology company, today announced results from a clinical trial of fecal microbiota transplantation (FMT) and anti-PD-1 re-induction in microsatellite instability-high (MSI-H) refractory cancers. Presented at the third annual Society for Immunotherapy of Cancer (SITC) meeting, the trial data show that FMT enabled a response to reintroduced anti-PD-1 in patients with anti-PD-1 refractory, MSI-H cancers, and suggest that the gut microbiome affects anti-tumoral immunity in a tumor-agnostic manner.

“The strains in our lead drug candidate, KAN-001, were isolated from the same donor who provided FMT material for this clinical trial. All strains present in KAN-001 were delivered to trial participants via FMT, where most if not all successfully engrafted,” said Dr. Kyle Jacoby, Vice President of Clinical Research at Kanvas Bio. “This significantly de-risks the clinical development of KAN-001, which seeks to improve outcomes for cancer patients who have been resistant to immune checkpoint inhibitors (ICIs) like anti-PD-1. With this trial data, Kanvas Bio is in the unique position of having positive human immuno-oncology data on the safety, efficacy and engraftment of the strains that comprise our drug candidate before initiating our own clinical trial for KAN-001.”

Participants in the trial included 10 patients with colorectal cancer, two with small bowel adenocarcinomas, one with pancreatic adenocarcinoma, one with endometrial adenocarcinoma and one with a pineal brain tumor. Each participant underwent FMT via colonoscopy, receiving an FMT from a metastatic MSI-H colorectal cancer patient who achieved a complete response (CR) on anti-PD-1 therapy. Result highlights include:

• Three out of 15 (20%) participants responded to treatment, including one colorectal cancer patient who achieved an ongoing CR >2 years.
• Engraftment was remarkably high, with significant levels of donor strains in the majority of participants.
• No incidents of ICI-induced colitis occurred.

“The gut microbiome has previously been associated with response to anti-PD-1 therapy, but the mechanisms that impact its effect on anti-tumoral immunity have been unclear,” said Dr. Erez Baruch, presenting author and Medical Oncology Fellow at The University of Texas MD Anderson Cancer Center. “Our trial results demonstrate that FMT enables a response to reintroduced anti-PD-1 in patients with anti-PD-1 refractory, MSI-H cancers.” Baruch is presenting these data as abstract #1266 at SITC on November 9 at the George R. Brown Convention Center in Houston, TX.

Kanvas Bio plans to request a pre-Investigational New Drug meeting with the FDA for KAN-001 in January 2025, with the goal of beginning a clinical trial for the drug as soon as possible. For more information on the company’s therapeutic pipeline, or to inquire about partnership opportunities, visit www.kanvasbio.com or speak with the team in-person at SITC’s annual meeting in Houston November 6 - 10. To access the full clinical trial results, see the poster here.

About Kanvas Biosciences

Kanvas Biosciences is a spatial biology company building the world’s first microbiome drug screening, discovery and manufacturing platform to accelerate the development of next generation live biotherapeutics. With an unparalleled ability to spatially map the microbiome and profile host gene expression, and manufacture complex consortia containing hundreds of members that can restore microbiome health, the company is uniquely positioned to develop novel therapeutics that can significantly improve the lives of all patients living with microbiome-associated diseases. Kanvas Biosciences' technology was initially developed at Cornell University and exclusively licensed. The company's notable investors include DCVC, Lions Capital LLC, FemHealth Ventures, Germin8, Ki Tua Fund, Pangaea Ventures, Triple Impact Capital and Uncommon Denominator. Kanvas Biosciences is headquartered in Princeton, NJ. For more information, visit www.kanvasbio.com or follow the company on LinkedIn.

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