Context Therapeutics Presents Preclinical and Translational Data for CT-95, a Mesothelin Targeting T Cell Engager, at 2025 AACR Annual Meeting
Context Therapeutics presented preclinical and translational data for their cancer treatment candidate CT-95 at the 2025 AACR Annual Meeting in Chicago. CT-95 is a mesothelin x CD3 T cell engaging bispecific antibody designed to treat solid tumors.
Key findings from the preclinical studies show that CT-95:
- Selectively binds to mesothelin-expressing cells
- Targets a unique membrane-proximal region of mesothelin
- Avoids impact of shed mesothelin sink
- Demonstrates high activity and good tolerance in various models
- Activates T cells without broad cytokine release
The company has already begun Phase 1 clinical trials and expects to share initial clinical data by mid-2026. The treatment targets mesothelin expressing cancers, including pancreatic, ovarian, and mesothelioma, addressing a significant unmet medical need.
Context Therapeutics ha presentato dati preclinici e traslazionali sul loro candidato terapeutico contro il cancro CT-95 durante l'AACR Annual Meeting 2025 a Chicago. CT-95 è un anticorpo bispecifico che lega mesotelina e CD3, progettato per trattare tumori solidi.
I principali risultati degli studi preclinici indicano che CT-95:
- Si lega selettivamente alle cellule che esprimono mesotelina
- Riconosce una regione unica prossimale alla membrana della mesotelina
- Evita l'effetto di assorbimento dovuto alla mesotelina liberata
- Mostra elevata attività e buona tollerabilità in diversi modelli
- Attiva le cellule T senza causare un rilascio ampio di citochine
L'azienda ha già avviato studi clinici di Fase 1 e prevede di condividere i primi dati clinici entro la metà del 2026. Il trattamento è rivolto a tumori che esprimono mesotelina, come quelli pancreatici, ovarici e il mesotelioma, rispondendo a un importante bisogno medico non soddisfatto.
Context Therapeutics presentó datos preclínicos y traslacionales de su candidato para el tratamiento del cáncer CT-95 en la Reunión Anual AACR 2025 en Chicago. CT-95 es un anticuerpo bispecífico que une mesotelina y CD3, diseñado para tratar tumores sólidos.
Los hallazgos clave de los estudios preclínicos muestran que CT-95:
- Se une selectivamente a células que expresan mesotelina
- Apunta a una región única cercana a la membrana de la mesotelina
- Evita el efecto de absorción por mesotelina liberada
- Demuestra alta actividad y buena tolerancia en varios modelos
- Activa células T sin provocar una liberación generalizada de citoquinas
La compañía ya ha iniciado ensayos clínicos de Fase 1 y espera compartir los primeros datos clínicos a mediados de 2026. El tratamiento está dirigido a cánceres que expresan mesotelina, incluyendo páncreas, ovario y mesotelioma, abordando una necesidad médica significativa no cubierta.
Context Therapeutics는 2025년 시카고에서 열린 AACR 연례회의에서 암 치료 후보물질 CT-95의 전임상 및 중개 연구 데이터를 발표했습니다. CT-95는 고형암 치료를 위해 설계된 메소텔린과 CD3를 표적으로 하는 이중특이성 T세포 결합 항체입니다.
전임상 연구의 주요 결과는 CT-95가 다음과 같음을 보여줍니다:
- 메소텔린을 발현하는 세포에 선택적으로 결합
- 메소텔린의 독특한 막 근접 부위를 표적
- 분비된 메소텔린에 의한 흡수 효과를 회피
- 여러 모델에서 높은 활성과 우수한 내약성 입증
- 광범위한 사이토카인 방출 없이 T 세포 활성화
회사는 이미 1상 임상시험을 시작했으며 2026년 중반까지 초기 임상 데이터를 발표할 예정입니다. 이 치료법은 췌장암, 난소암, 중피종 등 메소텔린 발현 암을 대상으로 하며, 중요한 미충족 의료 수요를 해결합니다.
Context Therapeutics a présenté des données précliniques et translationnelles sur leur candidat traitement contre le cancer CT-95 lors de la réunion annuelle AACR 2025 à Chicago. CT-95 est un anticorps bispécifique engageant les cellules T via la mésothéline et CD3, conçu pour traiter les tumeurs solides.
Les résultats clés des études précliniques montrent que CT-95 :
- Se lie sélectivement aux cellules exprimant la mésothéline
- Cible une région unique proche de la membrane de la mésothéline
- Évite l'impact du réservoir de mésothéline libérée
- Démontre une forte activité et une bonne tolérance dans divers modèles
- Active les cellules T sans provoquer une libération massive de cytokines
L'entreprise a déjà lancé des essais cliniques de phase 1 et prévoit de partager les premières données cliniques d'ici mi-2026. Le traitement cible les cancers exprimant la mésothéline, notamment le pancréas, les ovaires et le mésothéliome, répondant à un besoin médical important non satisfait.
Context Therapeutics stellte präklinische und translationale Daten zu ihrem Krebsmedikamentenkandidaten CT-95 auf dem AACR Jahreskongress 2025 in Chicago vor. CT-95 ist ein bispezifischer Antikörper, der Mesothelin und CD3 auf T-Zellen bindet und zur Behandlung solider Tumoren entwickelt wurde.
Wesentliche Ergebnisse der präklinischen Studien zeigen, dass CT-95:
- Selektiv an mesothelin-exprimierende Zellen bindet
- Eine einzigartige membrannahen Region von Mesothelin anvisiert
- Den Einfluss von freigesetztem Mesothelin als „Sink“ vermeidet
- Hohe Aktivität und gute Verträglichkeit in verschiedenen Modellen zeigt
- T-Zellen aktiviert, ohne eine breite Zytokinfreisetzung auszulösen
Das Unternehmen hat bereits Phase-1-Studien gestartet und plant, erste klinische Daten bis Mitte 2026 zu veröffentlichen. Die Behandlung richtet sich gegen mesothelin-exprimierende Krebsarten, darunter Bauchspeicheldrüsen-, Eierstockkrebs und Mesotheliom, und deckt einen erheblichen ungedeckten medizinischen Bedarf ab.
- First patient dosed in Phase 1 clinical trial of CT-95, showing trial execution progress
- CT-95 demonstrates selective binding and high activity in preclinical studies
- Drug shows good tolerability across in vivo models
- Technology avoids shed mesothelin sink issue, a common problem in this type of treatment
- Targeting multiple cancer types (pancreatic, ovarian, mesothelioma) expands market potential
- Initial clinical data won't be available until mid-2026, indicating a long wait for efficacy confirmation
- Currently only preclinical data available, no human efficacy data yet
- Early-stage nature of the program (Phase 1) indicates significant time and capital needed before potential commercialization
Insights
Context Therapeutics' CT-95 enters clinical testing with promising preclinical profile, but investors face long wait until mid-2026 for data.
Context Therapeutics has achieved an important milestone with CT-95, their mesothelin-targeting T cell engager (TCE), by dosing the first patient in their Phase 1 clinical trial. The preclinical data presented at AACR demonstrates several differentiated properties that could translate to clinical advantages. Specifically, CT-95 targets a unique membrane-proximal region of mesothelin and avoids binding to shed mesothelin - a critical feature as shed target proteins often act as decoys that diminish therapeutic efficacy.
The drug candidate's ability to activate T cells without inducing broad cytokine release suggests potential for a more controlled safety profile, which is particularly relevant for TCEs where cytokine release syndrome remains a concern. The company is targeting mesothelin-expressing cancers including pancreatic, ovarian, and mesothelioma - all areas with significant unmet medical needs and limited treatment options.
However, investors should recognize that clinical validation remains distant, with initial data expected in mid-2026. This represents a substantial waiting period before understanding whether the promising preclinical characteristics will translate to human efficacy. While the transition to clinical-stage development represents standard pipeline progress, the extended timeline to meaningful clinical readouts tempers the immediate impact of this news.
Preclinical data demonstrates unique binding location of CT-95 on mesothelin and avoidance of binding to shed mesothelin
Data supports ongoing Phase 1 clinical trial for CT-95
PHILADELPHIA, April 30, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or “Company”) (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors, today announced preclinical and translational data regarding the Company’s clinical asset, CT-95, a mesothelin x CD3 TCE was presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30, 2025 in Chicago, IL.
“There is a high unmet need for effective treatments in mesothelin expressing cancers. CT-95 is affinity tuned and avidity enhanced to concentrate drug activity within the tumor microenvironment,” said Martin Lehr, Chief Executive Officer of Context. “We believe these preclinical and translational data support the clinical strategy to target mesothelin expressing cancers, including pancreatic, ovarian, and mesothelioma. We recently dosed the first patient in our Phase 1 clinical trial of CT-95 and expect to share initial clinical data in mid-2026.”
Findings from preclinical studies evaluating CT-95 in cancer cell lines and tumor models illustrate the potential of CT-95 to treat mesothelin-positive tumors. Notably, CT-95 has shown to:
- Selectively bind to mesothelin-expressing cells and targets a unique, membrane-proximal region of mesothelin
- Avoid impact of shed mesothelin sink
- Be highly active and well tolerated across in vivo models
- Activate T cells without inducing broad cytokine release
A copy of the presentation materials can be accessed on the “Publications and Posters” section of the Company’s website at https://www.contexttherapeutics.com.
About CT-95
CT-95 is a mesothelin (“MSLN”) x CD3 bispecific antibody that is intended to redirect T-cell-mediated lysis toward malignant cells expressing MSLN. MSLN is a membrane protein overexpressed in approximately
About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 TCE, CT-95, a Mesothelin x CD3 TCE, and CT-202, a Nectin-4 x CD3 TCE. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn.
Forward-looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) our expectation to share initial clinical data in mid-2026 for CT-95, (ii) preclinical and translational data supporting our clinical strategy or the potential of CT-95, (iii) the potential benefits, characteristics, safety and side effect profile of our product candidates, (iv) the likelihood data will support future development, and (v) the likelihood of obtaining regulatory approval for our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we therefore cannot assure you that our plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.
Investor Relations Contact:
Jennifer Minai-Azary
Chief Financial Officer
Context Therapeutics Inc.
IR@contexttherapeutics.com
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