Context Therapeutics Presents Preclinical and Translational Data for CT-95, a Mesothelin Targeting T Cell Engager, at 2025 AACR Annual Meeting

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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

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 30% of cancers. One challenge in developing MSLN-targeted therapies has been the presence of MSLN fragments, also referred to as shed MSLN, found in both blood and the tumor microenvironment that can serve as a decoy or sink for MSLN-targeting antibodies. CT-95 is a fully humanized bispecific T cell engager that has a moderate affinity but high avidity for membrane-bound MSLN, that is intended to minimize the impact of the shed MSLN. The clinical trial is being conducted at clinical sites in the US. More information about the CT-95 clinical trial (NCT06756035) can be found on https://clinicaltrials.gov/.

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

FAQ

What is Context Therapeutics (CNTX) CT-95 cancer treatment targeting?

CT-95 targets mesothelin-expressing cancers, specifically pancreatic, ovarian, and mesothelioma cancers. It's a T cell engaging bispecific antibody designed to concentrate drug activity within the tumor microenvironment.

When will Context Therapeutics (CNTX) release initial clinical data for CT-95?

Context Therapeutics expects to share initial clinical data for CT-95 in mid-2026, following the recent dosing of their first patient in the Phase 1 clinical trial.

What are the key preclinical results for Context Therapeutics (CNTX) CT-95?

CT-95's preclinical results show selective binding to mesothelin-expressing cells, avoidance of shed mesothelin sink, high activity and good tolerance in test models, and T cell activation without broad cytokine release.

Where did Context Therapeutics (CNTX) present their CT-95 cancer treatment data?

Context Therapeutics presented their CT-95 preclinical and translational data at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago, IL, from April 25-30, 2025.

What stage of development is Context Therapeutics (CNTX) CT-95 currently in?

CT-95 is currently in Phase 1 clinical trials, with the first patient recently dosed, marking its transition from preclinical to clinical-stage development.