NC318 / NextCure - LARVOL DELTA

The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=159 | Active, not recruiting | Sponsor: Yale University | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • EGFR • ROS1

NC318, an Anti-Siglec-15 Humanized mAb, Alone and in Combination with Pembrolizumab in Immunotherapy Pretreated NSCLC (IASLC-WCLC 2023) - P2 | "NC318 alone (800 mg IV weekly) and in combination (NC318 400 mg IV every 2 weeks) with standard dosing of pembrolizumab is well tolerated and has activity in pts previously treated with PD1 axis inhibitor therapy. Pts continue to accrue to NC318 800 mg IV weekly, with an additional arm evaluating combination therapy with NC318 800 mg IV weekly and pembrolizumab 200 mg IV every 3 weeks planned."

Combination therapy • Cardiovascular • CNS Disorders • Dermatology • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Psoriasis • Solid Tumor • SIGLEC15

A Phase 2 Study of Anti-Siglec-15 Antibody, NC318, in Combination with Pembrolizumab (NCT04699123) Demonstrates Clinical Activity in Patients with Advanced PD-1 Axis Inhibitor Refractory NSCLC (GlobeNewswire) - P2 | N=141 | NCT04699123 | "Key findings from the trial include: Efficacy data demonstrate that the combination of NC318 and pembrolizumab is active in advanced PD-1 axis inhibitor refractory NSCLC: 28% of patients (5/18) had durable clinical benefit (partial response or stable disease lasting greater than 6 months by RECIST and/or irRC) with three of these being confirmed responses. To date, both monotherapy and combination arms have been well tolerated, with six Grade 3 treatment-related adverse events (TRAEs) [transverse myelitis (1), infusion reactions (3), rash (1) and pneumonitis (1)] and four Grade 2 TRAEs [infusion reactions (2), pericarditis (1) and psoriasis (1)] between both arms.....Based on these early encouraging results, Yale is continuing to enroll patients to gain further evidence of clinical activity of NC318,'..."

P2 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

NextCure Provides Business Update and Reports Second Quarter 2023 Financial Results (GlobeNewswire) - "Yale Cancer Center to present in September, 'NC318, an Anti-Siglec-15 Humanized mAb, Alone and in Combination with Pembrolizumab in Immunotherapy Pretreated NSCLC', at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=109 | Completed | Sponsor: NextCure, Inc. | Active, not recruiting ➔ Completed

Metastases • Trial completion • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

NC318, an Anti-Siglec-15 Humanized Monoclonal Antibody, Alone and in Combination with Pembrolizumab in Immunotherapy Pretreated Non Small Cell Lung Cancer (LUNG-SPORE 2023) - P2 | N=25 | NCT04699123 | "NC318 alone and in combination with pembrolizumab is well tolerated and has activity in pts previously treated with PD1 axis inhibitor therapy."

P2 data

Clinical benefit through Siglec-15 targeting with NC318 antibody in subjects with Siglec-15 positive advanced solid tumors (SITC 2021) - P1/2 | "Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

Clinical • IO biomarker • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=109 | Active, not recruiting | Sponsor: NextCure, Inc. | Recruiting ➔ Active, not recruiting | N=187 ➔ 109 | Trial completion date: Dec 2023 ➔ Jan 2023 | Trial primary completion date: Dec 2023 ➔ Jan 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

NextCure Provides Update and Reports Third Quarter 2022 Financial Results (GlobeNewswire) - "Business Highlights: NC318 (S15 mAb) - Based on the totality of the NC318 monotherapy data, including no responses in the amended Phase 2 portion of the trial, we have decided to discontinue development of our NC318 program. We will support Yale University’s ongoing NC318 investigator initiated combination trial."

Discontinued • Oncology

Clinical benefit through Siglec-15 targeting with NC318 antibody in subjects with Siglec-15 positive advanced solid tumors (SITC 2021) - P1/2 | "Conclusions NC318 shows promising early evidence of disease control in subjects with Siglec-15 positive advanced or metastatic solid tumors in phase 1 & 2 studies, prompting evaluation of S15 expression as a predictive biomarker in the prospective study at 800mg q1w dosing. Trial Registration NCT03665285"

Clinical • IO biomarker • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • SIGLEC15

A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2; N=173; Recruiting; Sponsor: NextCure, Inc.; Trial completion date: May 2021 ➔ Dec 2023; Trial primary completion date: May 2021 ➔ Dec 2023

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

NextCure Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results (GlobeNewswire) - "Expected Upcoming Milestones: (i) NC318 Phase 2 update: fourth quarter of 2022 (Amended Phase 2: S15+ selection with CLIA assay, 800 mg dosed Q1W); (ii) NC318 anti-PD-1 Combo (Yale University Investigator-Initiated trial): second half of 2022; (iii) NC410 Phase 1 update: second half of 2022; (iv) NC762 initial Phase 1 data: second half of 2022; (v) NC525 Investigational New Drug Application (IND) filing: fourth quarter of 2022."

IND • P1 data • P2 data • Acute Myelogenous Leukemia • Breast Cancer • Head and Neck Cancer • Hematological Malignancies • Leukemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SITC 2021 | Targeting Siglec-15 with NC318 in Siglec-15-positive advanced solid tumors (VJOncology) - "Omid Hamid, MD...outlines the clinical benefit of targeting Siglec-15 with the monoclonal antibody NC318 in patients with Siglec-15-positive advanced solid tumors...This interview took place during the 36th Society for Immunotherapy of Cancer (SITC) Annual Meeting in Washington, D.C."

Interview • Video

NextCure and Collaborators Provide Clinical and Research Updates on NC318 and NC410 Candidates at Society for Immunotherapy of Cancer Annual Meeting (GlobeNewswire) - P1/2, N=173; NCT03665285; Sponsor: NextCure, Inc.; "Data are derived from patient cohorts in both Phase 1 (n=49) and Phase 2 (n=47) of these studies. One NSCLC CR and one NSCLC PR patient from the Phase 1 study remain on therapy for 2.8 and 2.2 years, respectively. NC318 appears to show evidence of disease control with better outcomes in S15+ patients compared to S15- patients. The disease control rate across all tumors in both studies was 37% with a median progression-free survival (PFS) of 5.0 months."

P1/2 data • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

NextCure Reports Third Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "Clinical and biomarker data for NC318 and NC410 programs to be presented at the upcoming Society for Immunotherapy of Cancer (SITC) annual meeting on November 10-14, 2021.."

Biomarker • Clinical data • Oncology

The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2; N=141; Recruiting; Sponsor: Yale University; N=97 ➔ 141

Clinical • Combination therapy • Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • EGFR • ROS1

NextCure to Give Three Presentations at Society for Immunotherapy of Cancer Annual Meeting (GlobeNewswire) - "NextCure, Inc...announced that new data from two clinical studies and one research study will be presented during oral and poster sessions at the Society for Immunotherapy of Cancer (SITC) annual meeting....The data come from clinical studies evaluating NC318, a Siglec-15 antibody, and NC410, a LAIR-2 fusion protein, in patients with advanced/metastatic solid tumors. In addition, in collaboration with the National Cancer Institute at the National Institutes of Health, non-clinical data will be presented from a research study evaluating NC410’s impact on T cell activation, myeloid cell polarization and anti-tumor activity."

Clinical data • Oncology • Solid Tumor

Single agent anti-tumor activity in PD-1 refractory NSCLC: phase 1 data from the first-in-human trial of NC318, a Siglec-15-targeted antibody (SITC 2019) - "NC318 has been well tolerated across multiple dose levels and has shown encouraging anti-tumor activity when administered as monotherapy. Single agent anti-tumor activity was observed in 5 of 7 NSCLC subjects refractory to PD-1 therapies."

IO Biomarker • P1 data • PD(L)-1 Biomarker • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

[VIRTUAL] Trial in progress: A phase I/II, open-label, dose-escalation, safety and tolerability study of NC318 in subjects with advanced or metastatic solid tumors. (ASCO 2020) - P1/2 | "The RP2D was defined and the phase 2 opened to enrollment October 2019. Research Funding: NextCure, Inc."

Clinical • IO Biomarker • P1/2 data • Breast Cancer • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer

The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2; N=97; Recruiting; Sponsor: Yale University; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • EGFR • ROS1

A Safety and Tolerability Study of NC318 in Combination With Chemotherapy for Subjects With Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1/2; N=0; Withdrawn; Sponsor: NextCure, Inc.; N=165 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Combination therapy • Enrollment change • Trial withdrawal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

NextCure Reports Second Quarter 2021 Financial Results (GlobeNewswire) - "NC318: Clinical Laboratory Improvement Amendments (CLIA) validated assay available for S15+ patient selection to effectively evaluate NC318 activity in patients with S15+ tumors. Resumed enrollment of a non-small cell lung cancer (NSCLC) adenocarcinoma cohort in the ongoing Phase 2 monotherapy trial....NC410: On track to report initial clinical data in the fourth quarter of 2021. NC762: Started the Phase 1 portion of a Phase 1/2 clinical trial in patients with advanced or metastatic solid tumors."

Clinical • Clinical data • Enrollment status • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

NextCure Reports First Quarter 2021 Financial Results (GlobeNewswire) - "Upcoming Milestones: (i) Commenced the Yale University Phase 2 investigator-initiated clinical trial of NC318 in combination with pembrolizumab in patients with advanced non-small cell lung cancer with anticipated initial data in the first half of 2022; (ii) On track to initiate the NC762 Phase 1 clinical trial in the second quarter of 2021 and report initial data in mid-2022; (iii) On track to report NC318 Phase 2 monotherapy update in the fourth quarter of 2021; (iii) Continue enrolling patients in the Phase 1 portion of a Phase 1/2 clinical trial for NC410 and on track to report initial clinical data in the second half of 2021; (iv) Present trial in progress poster for NC410 at the upcoming 2021 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting."

Clinical protocol • P1 data • P2 data • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

NextCure Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results (GlobeNewswire) - "Yale University plans to initiate in the second quarter of 2021, an investigator-initiated Phase 2 trial of NC318 as a monotherapy and in combination with pembrolizumab in patients with advanced non-small cell lung cancer...with anticipated initial data first half of 2022. Report NC318 Phase 2 monotherapy data in the fourth quarter of 2021. NC410: Enrollment is on track and the company expects to announce initial clinical data from the Phase 1 portion of the trial in the second half of 2021. NC762: An investigational new drug (IND) application has been filed with the U.S. Food and Drug Administration (FDA) for NC762...which is upregulated in multiple solid tumor types...Research and development expenses were $46.6 million and $12.1 million for the year and quarter ended December 31, 2020, respectively..."

Commercial • IND • P1 data • P2 data • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology

The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2; N=97; Not yet recruiting; Sponsor: Yale University

Clinical • Combination therapy • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor