CT-95 / Context Therap - LARVOL DELTA

Ongoing Phase 1 trial of CT-95 (MSLN x CD3) is approaching target dose levels (The Manila Times) - "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 CRS greater than Grade 2 has been observed in any cohort. No DLT has been observed and an MTD has not been reached."

P1 data • Trial status • Colorectal Cancer • Epithelial Ovarian Cancer • Malignant Pleural Mesothelioma • Non Small Cell Lung Cancer • Pancreatic Cancer

Trial in Progress: A Phase 1, First-in-Human Study of CT-95, a mesothelin (MSLN)-Directed Bispecific Cell engager (TCE) in Subjects with Advanced Solid Tumors (SITC 2025) - P1 | "Part 1a dose optimization will evaluate two doses in approximately 40 patients, with efficacy and further safety as primary objectives. The first patient was dosed1 in April 2025.Conclusions Approved by Salus IRB on Dec 12, 2024 (NEXT Oncology)Ethics Approval This study has been approved by the following Institutional Review Boards (earliest date cited): Salus on 12 December 2024 WCG on 14 March 2025 All participants were informed about the study, had the opportunity to ask questions, and voluntarily agreed to participate."

Clinical • First-in-human • Metastases • P1 data • Colorectal Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • MSLN

Context Therapeutics Announces Poster Presentations at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting (GlobeNewswire) - "Context’s poster presentations will include a Trial in Progress poster for the Phase 1 clinical trial evaluating CT-95, a Mesothelin x CD3 TCE, as well as a poster for preclinical efficacy, safety and pharmacokinetic data regarding Context’s asset, CT-202, a Nectin-4 x CD3 TCE."

Preclinical • Trial status • Solid Tumor

18F-FDG and 68Ga-FAPI PET/CT in evaluation of esophageal cancer (EANM 2025) - "Se, Sp and Ac for 68Ga-FAPI-46 PET/CT were 100%, 81,25% and 91,67% respectively vs. 95,00%, 43,75% and 72,22% for 18F-FDG PET/CT respectively (Table 2). Table 2: Diagnostic accuracy of 68Ga-FAPI and 18F-FDG PET/CT on a per-region basis in patents with esophageal cancer Value Se,% Sp,% PPV, % NPV, % Ac,% 68Ga-FAPI-46 PET/CT 100 81,25 86,96 100 91,67 18F-FDG PET/CT 95 43,75 67,86 87,50% 72,22 Conclusion 68Ga-FAPI-46 PET/CT shows better diagnostic performance in the assessment of the metastatic lymph node lesions than 18F-FDG PET/CT in patients with esophageal cancer."

Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

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