Company Served as Sponsor and Provided Operational Leadership
for Study Conducted in Partnership with TGen and Virta Health
SCOTTSDALE, Ariz. – March 19, 2026 – TD2 Oncology, a leading oncology-focused contract research organization (CRO), today announced that it served as the clinical trial sponsor and had full operational responsibility for a randomized Phase II trial evaluating the addition of a medically supervised ketogenic diet (MSKD) to standard triplet chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Results from the trial demonstrated a statistically significant improvement in median progression-free survival, and median overall survival in patients receiving a medically supervised ketogenic diet alongside chemotherapy. The trial, conducted in partnership with TGen (Translational Genomics Research Institute) and Virta Health (which provided the remote ketogenic diet platform, daily monitoring, and nutritional coaching), has been published in the journal Cancer (Jameson GS, Roe DJ, Borazanci E, et al. A randomized phase II trial of gemcitabine, nab-paclitaxel, cisplatin with or without a medically supervised ketogenic diet for patients with metastatic pancreatic cancer. Cancer. 2026;e70343. doi:10.1002/cncr.70343).
The trial (NCT04631445) randomized patients 1:1 to receive gemcitabine, nab-paclitaxel, and cisplatin (on days 1 and 8 of a 21-day cycle) with either a medically supervised ketogenic diet or a usual diet. The MSKD was delivered remotely with daily ketone monitoring (goal beta-hydroxybutyrate 0.5–3.0 mM) and achieved nutritional ketosis in 15 of 16 patients (median 39.4% of days in ketosis). Key results showed promising trends favoring the MSKD arm:
The MSKD combined with triplet chemotherapy was feasible and safe, with only grade 1–2 diet-related adverse events, no increase in chemotherapy toxicity, no treatment-related deaths, and no detriment to quality of life. Exploratory analyses also revealed beneficial microbiome changes in the MSKD arm.
“Pancreatic cancer remains one of the most challenging malignancies, and we are thrilled to have supported this innovative study that investigates metabolic approaches alongside standard-of-care chemotherapy,” said Stephen Gately, PhD, President and CEO of TD2 Oncology. “Our successful partnership with TGen and Virta Health enabled efficient execution of this multi-center trial, seamless delivery of the medically supervised ketogenic diet, and rapid translation of results into publication. The encouraging signals of improved survival and response rates — achieved without added toxicity — highlight the potential of integrating a medically supervised ketogenic diet to enhance patient outcomes. We also want to express our deepest gratitude to the clinical investigators, research teams, and especially the patients and their families who participated in this trial. Their courage and dedication made this important study possible. We look forward to larger confirmatory studies and continued collaboration with these outstanding partners to bring new hope to patients and their families.”
TD2 Oncology provided end-to-end operational leadership — including trial design support, project administration, regulatory coordination, data management, and oversight — in close partnership with TGen and Virta Health, contributing to the study’s successful completion and publication.