Context Therapeutics (CNTX) investor relations material

Pipeline overview and development strategy

• Three T-cell engager (TCE) programs are in development for solid tumors: Claudin 6 (CTIM-76), mesothelin (CT-95), and Nectin-4 (CT-202).

• CTIM-76 targets Claudin 6 and CD3, aiming to force immune-cancer cell interaction and is primarily focused on ovarian cancer.

• CT-95 is being explored for pancreatic and other cancers, with preliminary data expected in September.

• CT-202 targets Nectin-4, with plans to address urothelial, colorectal, breast, and lung cancers; first clinical data anticipated in 2027.

• All programs were acquired and use different protein engineering formats tailored to each target.

Clinical progress and trial design

• CTIM-76 entered the clinic in early 2023, with a phase I-A data update expected soon, covering efficacy, safety, pharmacokinetics, and biomarkers.

• The trial design evolved to focus on ovarian cancer due to high target prevalence and easier enrollment.

• Dose escalation started with subtherapeutic levels, moving to active doses, and added cohorts to increase ovarian patient numbers.

• About 15 patients have been treated at target doses, mostly platinum-resistant and ADC-experienced ovarian cancer cases.

• Q3W (every three weeks) dosing is being explored for patient convenience and strategic alignment with other therapies.

Preclinical and early clinical data

• Preclinical assays show a 500-fold therapeutic window and strong in vivo efficacy.

• Early clinical data revealed a deep and durable response in a heavily pretreated ovarian cancer patient at the 140 mcg dose.

• Safety profile is favorable, with only one Grade 1 cytokine release syndrome (CRS) event and no dose-limiting toxicities.

• Pharmacokinetics are linear and dose-proportional, with good T-cell extravasation and cytokine response.

• Low CRS rates are attributed to Claudin 6 tumor restriction and steroid prophylaxis.