Context Therapeutics Highlights CT-95 and CT-202 Programs at 2025 SITC Annual Meeting

Rhea-AI Summary

Context Therapeutics (Nasdaq: CNTX) presented posters on its CT-95 and CT-202 bispecific T cell engager programs at the SITC 40th Annual Meeting (Nov 7–9, 2025).

CT-95 (mesothelin x CD3) is avidity enhanced and affinity tuned; as of the Oct 30, 2025 cutoff the Phase 1 trial has enrolled 6 patients and is dosing Cohort 3 (priming 0.18 µg/kg, full dose 0.6 µg/kg). No cytokine release syndrome > Grade 2, no dose limiting toxicities, and no MTD reached; initial Phase 1a data is anticipated in mid-2026.

CT-202 (nectin-4 x CD3) shows potent preclinical activity with favorable PK/safety and the company expects to complete regulatory filings to support a first-in-human trial in Q2 2026. Presentation materials will be posted in the company’s Publications and Posters section.

Positive

• Phase 1 CT-95 enrolled 6 patients as of Oct 30, 2025
• CT-95: No CRS > Grade 2 observed across cohorts
• CT-95: No DLTs observed and MTD not reached
• CT-202: regulatory filings targeted for Q2 2026 to enable first-in-human trial

Negative

• CT-95 target dose exposure projected to start at Cohort 4 and has not yet been reached
• Clinical dataset is early with only 6 patients enrolled, limiting conclusions
• No clinical efficacy or objective response data reported in the update

PHILADELPHIA, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors, today shared two posters discussing the Company’s CT-95 and CT-202 programs at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting, being held November 7–9, 2025 in National Harbor, MD.

CT-95 and CT-202 Highlights and Near-Term Milestones

CT-95: Mesothelin x CD3 bispecific TCE

• CT-95 is avidity enhanced and affinity tuned to localize therapeutic activity to the tumor microenvironment.
• In an ongoing Phase 1 trial, Context has enrolled 6 patients as of the October 30, 2025 cutoff, and is currently enrolling Cohort 3 with a priming dose of 0.18 µg/kg and a full dose of 0.6 µg/kg.
• Based on preclinical data, CT-95 is projected to achieve target dose exposure starting at Cohort 4.
• No cytokine release syndrome (CRS) greater than Grade 2 has been observed in any cohort. No dose limiting toxicity (DLT) has been observed and a maximum tolerated dose (MTD) has not been reached.
• Based on this safety profile, we are continuing dose escalation for CT-95 toward target dose levels. Context anticipates providing initial Phase 1a data in the middle of 2026.
  

CT-202: Nectin-4 x CD3 bispecific TCE

• Preclinical data supports best-in-class potential of CT-202.
• Demonstrates potent preclinical activity with a favorable pharmacokinetic and safety profile, supporting its expected transition into clinical studies.
• Expect to complete necessary regulatory filings to support the initiation of a first-in-human trial in the second quarter of 2026.
  

A copy of the presentation materials will be made available on the “Publications and Posters” section of the Company’s website at https://www.contexttherapeutics.com/publications.

About CT-95
CT-95 is a mesothelin (“MSLN”) x CD3 TCE 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 CT-202
CT-202 is a Nectin-4 x CD3 TCE bispecific antibody that targets Nectin-4, a cell surface protein that is highly and frequently overexpressed in a variety of solid tumors, including bladder, colorectal, lung and breast. Nectin-4 is a clinically validated target for cancer therapy using a traditional antibody-drug conjugate (“ADC”), but it is also associated with certain adverse events, including neuropathy and rash. CT-202 is a pH-dependent TCE that is designed to be preferentially active within the tumor microenvironment.

About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context’s goal is to build 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) the ability of the Company, its employees and certain SITC presenters to participate in and present at conferences, (ii) our expectation to provide initial Phase 1a data for CT-95 in the middle of 2026, (iii) our expectations regarding the target dose levels and target dose exposure of CT-95, (iv) our projections that CT-95 will achieve target dose exposure starting at Cohort 4, (v) our expectation to complete necessary regulatory filings to support the initiation of a first-in-human trial for CT-202 in the second quarter of 2026, (vi) our expectations to transition CT-202 into clinical trials, (vii) the potential benefits, characteristics, safety and side effect profile of our product candidates, and (viii) the likelihood data will support future development. 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

How many patients has Context Therapeutics (CNTX) enrolled in the CT-95 Phase 1 trial as of Oct 30, 2025?

The company reported 6 patients enrolled in the CT-95 Phase 1 trial as of Oct 30, 2025.

What safety events has CNTX reported for CT-95 through the Oct 30, 2025 cutoff?

CNTX reported No cytokine release syndrome above Grade 2, No dose limiting toxicities, and a maximum tolerated dose not reached.

When does Context expect initial Phase 1a data for CT-95 (CNTX)?

The company anticipates providing initial Phase 1a data in mid-2026.

What is the planned timeline for CT-202 (CNTX) to enter human trials?

CT-202 is expected to complete regulatory filings to support a first-in-human trial in Q2 2026.

Where can investors find the CT-95 and CT-202 presentation materials from SITC 2025?

Presentation materials will be posted on Context Therapeutics’ Publications and Posters webpage.

What dose is being used in CT-95 Cohort 3 in the CNTX Phase 1 trial?

Cohort 3 is using a priming dose of 0.18 µg/kg and a full dose of 0.6 µg/kg.