Sensei Biotherapeutics Provides Corporate Update and Highlights Key Upcoming Milestones
Sensei Biotherapeutics (NASDAQ: SNSE) provided updates on its lead program, solnerstotug (SNS-101), a conditionally active antibody targeting VISTA in cancer treatment. The company has enrolled 45 patients in the dose expansion portion of its Phase 1/2 clinical trial, with full enrollment of approximately 60 patients expected by Q1 2025.
The trial evaluates solnerstotug both as monotherapy and in combination with Libtayo® in patients with advanced solid tumors. Most enrolled 'hot' tumor patients have either progressed on prior anti-PD-1 therapy or are PD-L1 negative. The drug continues to show good tolerability with a best-in-class pharmacokinetic profile, with dose optimization focusing on 3 and 15 mg/kg Q3W levels.
Clinical data update is expected in Q2 2025, including patient follow-up data from dose escalation cohorts. The company maintains cash runway into Q2 2026.
Sensei Biotherapeutics (NASDAQ: SNSE) ha fornito aggiornamenti sul suo programma principale, solnerstotug (SNS-101), un anticorpo attivato condizionatamente che mira al VISTA nel trattamento del cancro. L'azienda ha arruolato 45 pazienti nella fase di espansione del dosaggio del suo studio clinico di Fase 1/2, con un arruolamento completo di circa 60 pazienti previsto entro il primo trimestre del 2025.
Lo studio valuta solnerstotug sia come monoterapia sia in combinazione con Libtayo® in pazienti con tumori solidi avanzati. La maggior parte dei pazienti con tumori 'caldi' arruolati ha mostrato progressione dopo una precedente terapia anti-PD-1 o è negativa per PD-L1. Il farmaco continua a mostrare una buona tollerabilità con un profilo farmacocinetico migliore della sua categoria, con l'ottimizzazione della dose che si concentra sui livelli di 3 e 15 mg/kg ogni 3 settimane.
Un aggiornamento sui dati clinici è previsto per il secondo trimestre del 2025, inclusi i dati di follow-up dei pazienti dai gruppi di aumento della dose. L'azienda mantiene un margine di cassa fino al secondo trimestre del 2026.
Sensei Biotherapeutics (NASDAQ: SNSE) proporcionó actualizaciones sobre su programa principal, solnerstotug (SNS-101), un anticuerpo activado condicionalmente que se dirige a VISTA en el tratamiento del cáncer. La compañía ha inscrito a 45 pacientes en la fase de expansión de dosis de su ensayo clínico de Fase 1/2, con una inscripción completa de aproximadamente 60 pacientes esperada para el primer trimestre de 2025.
El ensayo evalúa solnerstotug tanto como monoterapia como en combinación con Libtayo® en pacientes con tumores sólidos avanzados. La mayoría de los pacientes con tumores 'calientes' inscritos han progresado en terapia anti-PD-1 previa o son negativos para PD-L1. El fármaco sigue mostrando una buena tolerabilidad con un perfil farmacocinético líder en su clase, con la optimización de la dosis centrada en niveles de 3 y 15 mg/kg cada 3 semanas.
Se espera una actualización de datos clínicos en el segundo trimestre de 2025, incluidos los datos de seguimiento de pacientes de los grupos de escalado de dosis. La compañía mantiene un capital suficiente hasta el segundo trimestre de 2026.
Sensei Biotherapeutics (NASDAQ: SNSE)는 암 치료에서 VISTA를 표적으로 하는 조건부 활성 항체인 solnerstotug (SNS-101)에 대한 주요 프로그램 업데이트를 제공했습니다. 회사는 1상/2상 임상시험의 용량 확장 단계에 45명의 환자를 등록했으며, 2025년 1분기까지ประมาณ 60명의 환자가 모두 등록될 것으로 예상하고 있습니다.
이 연구는 advanced solid tumors가 있는 환자에게 solnerstotug를 단독 요법으로 및 Libtayo®와의 병용 요법으로 평가합니다. 등록된 '핫' 종양 환자의 대다수는 기존의 anti-PD-1 치료에서 진행되었거나 PD-L1 음성입니다. 이 약물은 최적화된 용량이 3 및 15 mg/kg Q3W 수준에 집중됨에 따라 최고의 약리학적 프로필과 좋은 내약성을 계속 보여주고 있습니다.
임상 데이터 업데이트는 2025년 2분기에 공개될 예정이며, 용량 상승 집단의 환자 추적 데이터가 포함됩니다. 회사는 2026년 2분기까지의 현금 유동성을 유지하고 있습니다.
Sensei Biotherapeutics (NASDAQ: SNSE) a fourni des mises à jour sur son programme phare, solnerstotug (SNS-101), un anticorps activé de manière conditionnelle ciblant VISTA dans le traitement du cancer. L'entreprise a inscrit 45 patients dans la phase d'expansion de dose de son essai clinique de Phase 1/2, avec une inscription complète d'environ 60 patients attendue d'ici le premier trimestre 2025.
L'essai évalue solnerstotug à la fois en tant que monothérapie et en combinaison avec Libtayo® chez des patients présentant des tumeurs solides avancées. La plupart des patients atteints de tumeurs 'chaudes' inscrits ont soit progressé après une thérapie anti-PD-1 antérieure, soit sont négatifs pour PD-L1. Le médicament continue de montrer une bonne tolérance avec un profil pharmacocinétique de premier ordre, l'optimisation de la dose se concentrant sur les niveaux de 3 et 15 mg/kg toutes les 3 semaines.
Une mise à jour des données cliniques est attendue au deuxième trimestre 2025, y compris des données de suivi des patients des cohortes d'escalade de dose. L'entreprise maintient un fonds de roulement jusqu'au deuxième trimestre 2026.
Sensei Biotherapeutics (NASDAQ: SNSE) hat Updates zu seinem Hauptprogramm, solnerstotug (SNS-101), einem bedingt aktiven Antikörper, der VISTA im Rahmen der Krebsbehandlung zielt, bereitgestellt. Das Unternehmen hat 45 Patienten in der Dosisexpansionsphase seiner klinischen Phase 1/2-Studie eingeschrieben und erwartet eine vollständige Einschreibung von etwa 60 Patienten bis zum ersten Quartal 2025.
Die Studie bewertet solnerstotug sowohl als Monotherapie als auch in Kombination mit Libtayo® bei Patienten mit fortgeschrittenen soliden Tumoren. Die meisten eingeschriebenen 'heißen' Tumorpatienten haben entweder auf frühere Anti-PD-1-Therapien nicht angesprochen oder sind PD-L1-negativ. Das Medikament zeigt weiterhin eine gute Verträglichkeit mit einem besten seiner Klasse Pharmakokinetik-Profil, wobei die Dosisoptimierung auf 3 und 15 mg/kg alle 3 Wochen fokussiert.
Ein Update zu den klinischen Daten wird im zweiten Quartal 2025 erwartet, einschließlich Nachverfolgungsdaten von Patienten aus den Dosissteigungskohorten. Das Unternehmen sorgt für finanzielle Mittel bis zum zweiten Quartal 2026.
- Drug shows good tolerability and best-in-class pharmacokinetic profile
- Cash runway extends into Q2 2026
- Trial enrollment progressing well with 45 out of 60 patients enrolled
- Most enrolled patients have previously failed anti-PD-1 therapy or are PD-L1 negative, indicating challenging patient population
- Final efficacy data not available until Q2 2025
Insights
The Phase 1/2 clinical trial update for solnerstotug (SNS-101) reveals critical progress in VISTA-targeted immunotherapy. With 45 patients enrolled and targeting 60 patients by Q1 2025, the trial's scope is substantial for an early-phase study. The focus on "hot" tumor patients with prior PD-1 therapy resistance is strategically significant, as it addresses a important market gap in immunotherapy-resistant cancers.
The well-tolerated safety profile and optimal pharmacokinetics at 3 and 15 mg/kg Q3W doses are particularly noteworthy. The biomarker analysis strategy, combining peripheral immunophenotyping with genomic and transcriptomic analyses, demonstrates a sophisticated approach to patient stratification and response prediction.
In simpler terms: This drug is showing promise in treating cancers that have stopped responding to existing immunotherapies, with minimal side effects. The company is carefully selecting the right dose and identifying which patients are most likely to benefit from the treatment.
This update carries significant weight for Sensei's valuation prospects. The company's cash runway extending into Q2 2026 provides adequate financial cushion through critical clinical milestones. The upcoming Q2 2025 data readout represents a major catalyst that could drive stock movement, particularly given the
The strategic positioning of solnerstotug in the immunotherapy resistance space addresses a substantial unmet need and market opportunity. The focus on VISTA, a target correlated with poor survival rates, could command premium pricing if approved. The partnership with Regeneron for the Libtayo combination study adds credibility and potential partnership opportunities.
For the average investor: The company has enough money to complete its current studies and the upcoming results in Q2 2025 could significantly impact the stock price. The relatively small market cap suggests room for growth if the treatment proves effective.
- Solnerstotug (SNS-101) dose expansion arm anticipated to be fully enrolled by end of Q1 2025 -
- Clinical data update expected in Q2 2025 -
BOSTON, Jan. 08, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today provided corporate updates on its lead program, solnerstotug (SNS-101) and upcoming milestones.
“2024 was a noteworthy year for Sensei and our pioneering lead program, solnerstotug. We demonstrated that solnerstotug can overcome the safety and pharmacological hurdles associated with first-generation antibodies targeting the immune checkpoint VISTA, positioning it as the first program in its class with potential to demonstrate clinically meaningful antitumor responses. Moreover, despite enrolling a predominantly ‘cold’ tumor patient population that was unlikely to respond to immunotherapy, solnerstotug demonstrated promising early signs of activity,” said John Celebi, President and Chief Executive Officer. “Looking ahead, 2025 is set to be a pivotal year as we seek to share our first significant efficacy data at optimal doses that include a ‘hot’ tumor patient population more likely to respond to immunotherapy that nonetheless has primary or acquired resistance to PD-1 inhibitors. With cash runway into the second quarter of 2026, we are positioned to advance solnerstotug through the completion of the Phase 1 portion of this study.”
Highlights and Milestones
Solnerstotug (SNS-101)
Solnerstotug is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates.
Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of solnerstotug (SNS-101) as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) in patients with advanced solid tumors. Key findings and updates as of January 1, 2025 include:
- A total of 45 patients have been enrolled in the dose expansion portion of the Phase 1/2 clinical trial.
- The majority of the “hot” tumor patients enrolled in the combination dose expansion to date have progressed on a prior anti-PD-1 therapy or are PD-L1 negative, making it highly unlikely that these patients would respond upon re-challenge with anti-PD-1 alone.
- Sensei expects to complete enrollment of the dose expansion with approximately 60 patients by the end of Q1 2025.
- The Company expects to report data from evaluable patients in Q2 2025. Patient follow-up data from the dose escalation cohorts will also be presented.
- Solnerstotug continues to be well tolerated with a best-in-class pharmacokinetic profile.
- Dose optimization is now focused on dose levels of 3 and 15 mg/kg Q3W to support the Phase 2 doses in several patient populations under consideration.
- Efforts are ongoing to explore biomarker correlates of clinical benefit using peripheral immunophenotyping and tumor genomic and transcriptomic analyses.
About Sensei Biotherapeutics
Sensei Biotherapeutics (Nasdaq: SNSE) is a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients. Through its TMAb™ (Tumor Microenvironment Activated biologics) platform, Sensei develops conditionally active therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment to unleash T cells against tumors. Sensei’s lead product candidate is solnerstotug, a conditionally active antibody designed to block the V-domain Ig suppressor of T cell activation (VISTA) checkpoint selectively within the low pH tumor microenvironment, where VISTA acts as a suppressor of T cells by binding the receptor PSGL-1. For more information, please visit www.senseibio.com, and follow the company on X @SenseiBio and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe”, “designed to,” “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Sensei’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of Sensei’s product candidates, the timing of Sensei’s Phase 1/2 clinical trial of solnerstotug (SNS-101), including reporting of data therefrom, and its belief that its existing cash and cash equivalents will be sufficient to fund its operations into the second quarter of 2026. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Sensei’s product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Sensei’s product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Sensei’s product candidates; the risk that Sensei’s product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Sensei anticipates; risks associated with Sensei’s dependence on third-party suppliers and manufacturers, including sole source suppliers, over which Sensei may not always have full control; risks regarding the accuracy of Sensei’s estimates of expenses, capital requirements and needs for additional financing; and other risks and uncertainties that are described in Sensei’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on November 14, 2024 and Sensei’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
Michael Biega
Senior Director, Investor Relations
Sensei Biotherapeutics
mbiega@senseibio.com
Media Contact:
Joyce Allaire
LifeSci Advisors
Jallaire@lifesciadvisors.com
FAQ
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