CT-202 / BioAtla, Context Therapeutics - LARVOL DELTA

Context Therapeutics…announced that the first patient has been dosed in the Phase 1 clinical trial of CT-202, a Nectin-4 x CD3 TCE bispecific antibody (GlobeNewswire) - "The Phase 1 study (NCT07545122) is an open-label, dose escalation trial designed to evaluate safety, tolerability, and preliminary efficacy in patients with Nectin-4 expressing recurrent, unresectable or metastatic refractory/resistant urothelial, colorectal and triple-negative breast cancers."

First-in-human • Trial status • Colorectal Cancer • Triple Negative Breast Cancer • Urothelial Cancer

A Phase 1a/1b, First-Time-in-Human Study of CT-202, a Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, Urothelial Cancers (clinicaltrials.gov) - P1 | N=162 | Recruiting | Sponsor: Context Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Colorectal Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • NECTIN4

Recent and Upcoming Business Highlights (GlobeNewswire) - "Phase 1a interim data for ongoing CTIM-76 (CLDN6 x CD3) trial expected in June 2026; Phase 1a interim data for ongoing CT-95 (MSLN x CD3) trial expected in September 2026; Phase 1 initiation for CT-202 (Nectin-4 x CD3) trial expected in third quarter of 2026."

New P1 trial • P1 data • Platinum resistant • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Lung Adenocarcinoma • Malignant Pleural Mesothelioma • Ovarian Cancer • Pancreatic Adenocarcinoma • Testicular Cancer

A Phase 1a/1b, First-Time-in-Human Study of CT-202, a Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, Urothelial Cancers (clinicaltrials.gov) - P1 | N=162 | Not yet recruiting | Sponsor: Context Therapeutics Inc.

New P1 trial • Breast Cancer • Colorectal Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • NECTIN4

Targeting solid tumors with pH-dependent dual-specific TCEs: First-in-human development of CT-202 (AACR 2026) - "CT-202 represents a novel dual pH-selective bispecific TCE targeting Nectin-4 x CD3, designed to optimize tumor selectivity and minimize off-tumor toxicity. Preclinical data validate the differentiated pharmacological and safety attributes of this modality, justifying its advancement to first-in-human Phase 1 trials. This approach highlights the potential of dual pH-dependent bispecific antibodies as a next-generation platform for the selective immunotherapy of Nectin-4-expressing solid tumors."

First-in-human • IO biomarker • P1 data • Oncology • Solid Tumor

CT-202: Nectin-4 x CD3 bispecific TCE in preclinical development for patients with bladder, non-small cell lung, colorectal, breast, and head and neck cancer. (The Manila Times) - "CT-202 has shown in preclinical studies to exhibit little to no binding to CD3 or the target antigen in healthy tissue (normal alkaline microenvironment). However, in acid conditions that mirror the tumor microenvironment (high glycolysis), the binding of the antibodies to their target molecules is strong."

Preclinical • Bladder Cancer • Breast Cancer • Colorectal Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer

CT-202: a dual pH-dependent Nectin-4 x CD3 bispecific T cell engager (SITC 2025) - "In vivo studies with CT-202 indicate that the therapeutic index was improved more than 30-fold relative to non-pH dependent variants, supporting the potential differentiation of pH-dependent bispecific antibodies versus more traditional bispecific antibodies.Results Our results suggest CT-202 is a promising new immune-activating therapeutic modality for the treatment of Nectin-4-positive cancers that reduces the risk of on-target, off-tumor T cell activation through pH-dependent binding to both the Nectin-4 and CD3 arms.Conclusions The safety and tolerability features highlight the developability of CT-202 in solid tumors that express Nectin-4. An IND application is expected in the middle of 2026.Ethics Approval All animal studies will be conducted in facilities that comply with all appropriate GLP, OECD, USDA, AALAC and fully approved by the institution's IACUC committees."

Breast Cancer • Oncology • Solid Tumor • NECTIN4

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

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 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

BioAtla and Context Therapeutics Announce Exclusive Worldwide License Agreement to Develop and Commercialize BA3362, a Nectin-4 x CD3 T Cell Engaging Antibody (GlobeNewswire) - "Context to obtain exclusive development and commercialization rights to BA3362; ioAtla to receive $15.0 million in upfront and near-term milestones, and further potential clinical, regulatory and commercial milestones of up to $118.5 million, plus royalties on net sales; Context anticipated IND filing for BA3362 in mid-2026."

IND • Licensing / partnership

A novel dual CAB Nectin-4 x CD3 bispecific antibody targeting solid tumors (SITC 2023) - "Non-CAB Nectin4 x CD3 bispecific antibody was also well tolerated at a dose of 5mg/kg but induced high levels of IL-6, while the CAB Nectin-4 x CAB CD3 bispecific antibody induced minimal IL-6 cytokine response. Conclusions The generation of CAB T-cell engagers (TCEs) with activity in the disease microenvironment minimizes on-target, off-tumor toxicities, thereby enabling TCEs with strong anti-tumor activity and increased tolerability for potentially enhanced therapeutic index in the clinic."

Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • IL6 • NECTIN4