Sensei Biotherapeutics is set to abandon its sole clinical-stage asset solnerstotug as it prepares to cut its workforce and consider next steps.
This news comes just weeks after the immuno-oncology biotech released positive Phase I dose expansion data for solid-tumour candidate and announced plans to proceed to Phase II testing.
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In a Phase I/II study (NCT05864144) with the drug, the six-month progression-free survival (PFS) reached 50% in anti-PD-L1 resistant patients treated with 15mg/kg solnerstotug. Solnerstotug is a monoclonal antibody targeting V-domain Ig suppressor of T-cell activation (VISTA), designed to be conditionally active in a low-pH tumour microenvironment. This data was presented at the European Society for Medical Oncology (ESMO) Congress 2025, held October 17–21 in Berlin, Germany.
Sensei had planned to initiate two Phase II studies in 2026 in patients with anti-PD-L1-resistant non-small cell lung cancer (NSCLC) and merkel cell carcinoma (MCC) subject to FDA feedback and capital fundraising, as per its announcement following the ESMO presentations.
It now emerges that the biotech has withdrawn plans for further clinical testing and is exploring options for the future, including a sale of its assets, a merger, a sale of the company, or a wind-down of operations. The decision comes from the Board of Directors after extensive discussions around the company’s pipeline and market conditions, according to Sensei. The biotech also said it plans to initiate job losses in effort to preserve cash.
“Our role now is to steward the company and its assets with care, including an orderly wind-down of the ongoing Phase I/II clinical trial and preservation of shareholder value,” said John Celebi, president and CEO of Sensei.
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By GlobalDataSensei’s turbulent history
Last year, Sensei had announced it would be slashing 46% percent of its workforce and closing its research site in Rockville, Maryland, US. The move was described as an organisation-wide restructure to focus its resources on advancing solnerstotug, then called SNS-101, in the company’s Q3 earnings press release in November 2024.
Sensei has suffered multiple setbacks in recent years, including a series of abandoned clinical and preclinical programmes. Back in 2021, the biotech discontinued development of SNS-301, its only other asset to reach clinical-stage investigation. SNS-301 was a first-in-class nanoparticle vaccine targeting human aspartate β-hydroxylase (ASPH) and was being investigated in various cancer types including chronic myelomonocytic leukemia (CMML) and head and neck squamous cell carcinoma (HNSCC). In the last few years, at least four Phase I or II-stage trials investigating SNS-301 were withdrawn or terminated after being announced, as per GlobalData, the parent company of Pharmaceutical Technology.
