Bicycle Therapeutics plc presented data at the American Association for Cancer Research (AACR) Annual Meeting 2026 that its EphA2‑targeted drug conjugate, nuzefatide pevedotin, has shown encouraging early clinical activity. In a Phase 1 combination study, 6.5 mg/m² Q2W nuzefatide plus nivolumab produced a 40 % confirmed overall response rate in 10 patients with metastatic urothelial cancer who had progressed on prior checkpoint therapy, and the safety profile was notable for the absence of grade 3 treatment‑related adverse events of clinical interest, with only a single grade 3 fatigue case that resolved without dose reduction.
The company also disclosed that the first patient in its Phase 2 study of nuzefatide in second‑line pancreatic ductal adenocarcinoma (PDAC) was dosed in April 2026. The study will evaluate an 8 mg/m² Q2W dose, which was identified as the preferred monotherapy dose during dose‑range‑finding studies.
Human imaging data presented at the meeting further support EphA2 as a viable target and highlight the potential of Bicycle’s radioligand platform to accelerate future development of targeted radiopharmaceuticals.
These findings represent the first evidence of clinical activity for nuzefatide pevedotin in two distinct tumor types and set the stage for the upcoming Phase 3 urothelial cancer trial. The data reinforce Bicycle’s strategy to focus on its most advanced assets and are likely to influence investor perception of the company’s near‑term clinical trajectory.
CEO Kevin Lee emphasized the significance of the results, stating, "EphA2 is a potentially high value target that is widely expressed in cancer and has been considered undruggable following the failure of multiple antibody‑based approaches due to toxicity or insufficient efficacy. Encouraging results presented at AACR demonstrate the potential of our Bicycle platform to drug this target with a generally well‑tolerated and differentiated safety profile and enhances our understanding of how best to deploy EphA2‑targeted therapeutics."
Bicycle’s Q4 2025 earnings, released on March 17 2026, beat analyst expectations with an EPS of –$0.29 versus a consensus estimate of –$1.00, and revenue of $48.0 million far exceeding the $7.08 million estimate. The company reported cash reserves of $628.1 million as of December 31 2025, providing a strong runway for continued clinical development. Q1 2026 earnings are expected on April 30 2026.
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