Bicycle Therapeutics plc (BCYC), a clinical-stage pharmaceutical company, announced updates from its EphA2 pipeline at the American Association for Cancer Research (AACR) Annual Meeting 2026.
The details presented include Phase 1/2 data from its lead investigational drug, Nuzefatide Pevedotin in previously treated metastatic urothelial cancer, and preclinical data across a broad range of pancreatic ductal adenocarcinoma (PDAC) and head and neck squamous cell carcinoma xenograft models.
Company Profile
Bicycle Therapeutics develops medicines named Bicycle molecules, and the company is evaluating
- Nuzefatide pevedotin, formerly BT5528, - Bicycle Drug Conjugate (BDC) targeting EphA2, - Bicycle Radioconjugates for radiopharmaceutical use,- Zelenectide pevedotin (formerly BT8009),- BT7480, a Bicycle Tumour-Targeted Immune Cell Agonist (Bicycle TICA) targeting Nectin-4 and agonising CD137.
AACR 2026 Data Updates
The presentations and updated data at the AACR include the following,
Phase 1/2 data Nuzefatide pevedotin (nuzefatide), formerly BT5528, in combination with nivolumab in metastatic urothelial cancer (mUC) patients
Results from the Phase 1/2 trial evaluating Nuzefatide 6.5mg/m2 once every two weeks plus Nivolumab 480mg once every four weeks in 14 patients with mUC who had previously progressed on a checkpoint inhibitor (10 while on enfortumab vedotin) include,
-40% confirmed overall response rate (ORR) (4/10) among patients with EphA2+ tumours and 100% confirmed ORR (3/3) among patients with EphA2+ tumours that were monomethyl auristatin E (MMAE)-naïve.
Nuzefatide in combination with Nivolumab was generally well tolerated.
Further, dose-ranging studies identified 8mg/m2 once every 4 weeks as the preferred dose for monotherapy, and the first patient was dosed in a 2L+ Pancreatic ductal adenocarcinoma Phase 2 trial.
Additional human imaging data of Bicycle Imaging Agent (BIA) targeting EphA2 in patients with PDAC
Seven patients with histologically confirmed PDAC underwent PET/CT imaging up to three hours post-injection of the EphA2 BIA. Data demonstrated rapid tumour uptake and excretion, primarily via the kidneys, in six of seven patients.
Also, EphA2 BIA PET imaging successfully detected multiple liver, bone, lymph node, and peritoneal metastases.
Preclinical assessment of Nuzefatide anti-tumour activity in patient-derived xenograft (PDX) models of PDAC.
EphA2 expression was found in all 16 PDAC PDX models, and out of the 14 PDAC PDX models assessed for anti-tumour activity, 10 models were sensitive to Nuzefatide, and six showed high sensitivity.
Preclinical assessment of Nuzefatide anti-tumour activity in cell-line-derived xenograft (CDX) models of head and neck squamous cell carcinoma or HNSCC Nuzefatide demonstrated potent preclinical anti-tumour activity in EphA2-expressing CDX models of HNSCC.
"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," said Bicycle Therapeutics CEO Kevin Lee, PhD.
BCYC has traded between $4.24 and $9.55 over the last year. The stock closed Monday's trade at $5.29, down 0.75%.
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