KING OF PRUSSIA, PA — SEED Therapeutics, Inc. reported new preclinical data showing anticancer activity of its RBM39 degrader candidate ST-01156 in neuroblastoma and said the drug is being evaluated in an ongoing Phase 1 clinical trial.
The company said ST-01156 achieved complete tumor regression in an in vivo neuroblastoma model using a dosing regimen aligned with its current clinical study.
The Phase 1 dose escalation trial (NCT07197554) is underway at six U.S. oncology centers and is designed to assess safety, pharmacokinetics, and target engagement, with completion projected by the first quarter of 2027.
SEED said the drug demonstrated activity across multiple neuroblastoma models, including established cell lines and patient-derived samples.
The company also identified MYC overexpression as a potential marker of treatment sensitivity and CDKN2A/B deletion as a potential marker of resistance.
These biomarkers may be used to guide patient selection as the trial progresses.
ST-01156 targets RBM39, an RNA-binding protein involved in gene expression processes that support cancer cell growth.
SEED said the drug works by degrading the target protein, affecting multiple cancer-related pathways including cell cycle progression and DNA repair.
Neuroblastoma is a rare pediatric cancer with limited treatment options and may qualify for regulatory programs such as orphan drug designation.
“ST-01156’s advancement into clinical testing in 2026 marks a pivotal milestone for SEED and for patients with RBM39 dependent cancers, including neuroblastoma — a pediatric cancer with very limited effective treatment options,” said James Tonra, president and chief scientific officer of SEED Therapeutics.
“The identification of MYC and CDKN2A/B status as potential biomarkers is the product of SEED’s focus on identifying the patients who will significantly benefit from ST-01156,” Tonra said.
“Seeing ST-01156 achieve complete tumor regression in a neuroblastoma model, at the same dosing schedule now in the clinic, is deeply gratifying and scientifically meaningful,” said Lan Huang, co-founder of SEED Therapeutics.
“Our focus at SEED is on ensuring that the molecular insight behind this program translates into real outcomes for patients with very few options,” Huang said.
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