CT-95 / Context Therap - LARVOL DELTA

CT-95 in Advanced Cancers Associated With Mesothelin Expression (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Context Therapeutics Inc. | N=50 ➔ 70

Enrollment change • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Epithelial Ovarian Cancer • Lung Adenocarcinoma • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Peritoneal Mesothelioma • Pleural Mesothelioma • Solid Tumor

Context Therapeutics Reports First Quarter 2025 Operating and Financial Results (GlobeNewswire) - "...'We expect to report initial clinical data for CTIM-76 in the first half of 2026 and for CT-95 by mid-2026....We also plan to file an IND for CT-202, a potential best-in-class Nectin-4 x CD3 bispecific antibody, in mid-2026 as we continue to advance our portfolio of innovative T cell-engaging therapies for solid tumors'."

IND • P1 data • Solid Tumor

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

Preclinical • Oncology

Determination of first in human dose of the T cell-redirecting bispecific antibody CT-95 targeting mesothelin (AACR 2025) - "Relative to doses in the one-month repeat dose GLP-compliant toxicology study, the proposed starting dose for CT-95 (0.1 μg/kg) is 30-fold lower than the NOAEL (3 μg/kg) and 100-fold lower than the HNSTD (10 μg/kg). The weight of evidence of these data supports the safety of the proposed clinical starting dose of 0.1 μg/kg for CT-95."

P1 data • Oncology • IL2RA • MSLN

Context Therapeutics Doses First Patient in Phase 1 Clinical Trial of CT-95 (GlobeNewswire) - "Context Therapeutics...announced that the first patient has been dosed in the Phase 1 clinical trial of CT-95, a mesothelin ('MSLN') x CD3 T cell engaging ('TCE') bispecific antibody designed to target mesothelin-expressing cancers. The Company anticipates sharing initial data for the CT-95 Phase 1 trial in mid-2026....The Phase 1 clinical trial of CT-95 (NCT06756035) is an open-label, dose escalation and expansion study to evaluate the safety and efficacy of CT-95 in subjects with MSLN-expressing advanced solid tumors, including ovarian, pancreatic, lung, and mesothelioma cancers....The dose escalation portion of the study is expected to enroll up to 30 patients."

P1 data • Trial status • Mesothelioma • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer

Context Therapeutics Announces Poster Presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025 (GlobeNewswire) - "Context will present data highlighting the selection of the first-in-human dose of CT-95, using the minimal anticipated biological effect level ('MABEL') approach, as required for immune agonist drugs. This is the dose level expected to lead to a minimal biological effect level in humans."

P1 data • Solid Tumor

Context Therapeutics Reports Full Year 2024 Operating and Financial Results (Businesswire) - "...'Looking ahead, we anticipate dosing the first patient in our Phase 1 clinical trial of CT-95, targeting mesothelin-expressing cancers, in Q2 2025. Additionally, we expect to share initial clinical data from the CTIM-76 Phase 1 trial in the first half of 2026 and from the CT-95 Phase 1 trial in mid-2026'."

P1 data • Trial status • Endometrial Cancer • Ovarian Cancer • Solid Tumor • Testicular Cancer

CT-95 in Advanced Cancers Associated with Mesothelin Expression (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Context Therapeutics Inc.

New P1 trial • Biliary Cancer • Cholangiocarcinoma • Epithelial Ovarian Cancer • Lung Adenocarcinoma • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Peritoneal Mesothelioma • Solid Tumor

Context Therapeutics Reports Third Quarter 2024 Operating and Financial Results (GlobeNewswire) - "Pipeline Updates: (i) In September 2024, announced an exclusive worldwide license agreement with BioAtla, Inc. to develop and commercialize CT-202, a Nectin-4 x CD3 bispecific antibody. Context expects to file an Investigational New Drug ('IND') application for CT-202 in mid-2026; (ii) In July 2024, completed the acquisition of CT-95, a potentially first-in-class Mesothelin x CD3 bispecific antibody that has received IND clearance from the U.S. Food and Drug Administration. The Company believes that CT-95 is on track for dosing the first patient in the Phase 1 trial in the first quarter of 2025."

IND • New P1 trial • Solid Tumor

Context Therapeutics Acquires Phase 1-ready T cell Engager CT-95 (GlobeNewswire) - "Context Therapeutics Inc...announced that it has entered into an asset purchase agreement under which the Company has acquired CT-95, formerly owned by Link Immunotherapeutics, Inc. ('Link'), a mesothelin ('MSLN') x CD3 T cell engaging ('TCE') bispecific antibody with first-in-class potential that has received Investigational New Drug ('IND') clearance from the U.S. Food and Drug Administration. CT-95 is on track for Phase 1 initiation in the first quarter of 2025....'We intend to fund the acquisition of CT-95 and its advancement through the dose escalation portion of a Phase 1 clinical trial with Context’s existing cash'."

IND • M&A • New P1 trial • Oncology • Solid Tumor

LNK101, a highly differentiated T-cell engager (TCE) targeting CD3 and mesothelin (MSLN) in solid tumors (SITC 2023) - "In cynomolgus monkeys, LNK101 is tolerated and shows pharmacologic activity. LNK101 is a promising novel treatment for MSLN-expressing solid tumors."

Oncology • Solid Tumor • IL2RA • MSLN

T Cell Engaging Bispecific Antibodies Produce Durable Response in Mesothelin-Positive Patient-Derived Xenograft Models of Pediatric AML (ASH 2021) - "Antibody single-chain variable region (scFv) sequences derived from amatuximab recognizing MSLN and from either blinatumomab or AMG330 targeting CD3 were used to engineer and express two MSLN/CD3-targeting BsAbs: MSLN AMA -CD3 L2K and MSLN AMA -CD3 AMG respectively...Chemotherapy (DA) consisted of 3 doses of 1.5 mg/kg daunorubicin iv and 5 doses of 50 mg/kg cytarabine ip...Conclusion These data validate the efficacy of MSLN-targeting BsAbs in PDX models with endogenous MSLN expression. Because prior MSLN-directed therapies appeared safe in humans, MSLN-targeting BsAbs could be ideal immunotherapies for MSLN-positive pediatric AML patients."

IO biomarker • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • B2M • MSLN