NC762 / NextCure - LARVOL DELTA

A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=40 | Terminated | Sponsor: NextCure, Inc. | Trial completion date: Oct 2024 ➔ Jan 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Oct 2024 ➔ Jan 2024; Due to the limited activity in Phase 1, NextCure decided to discontinue development of the anti-B7-H4 antibody monotherapy trial (NC762-01) to move forward with a prioritized B7-H4 ADC program.

Metastases • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=40 | Active, not recruiting | Sponsor: NextCure, Inc. | Recruiting ➔ Active, not recruiting | N=170 ➔ 40

Enrollment change • Enrollment closed • Metastases • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

NextCure Provides Business Update and Reports Third Quarter 2023 Financial Results (GlobeNewswire) - "Q3 2023 Business Highlights and Updates: (i) Phase 1b updates for NC410 (LAIR-2 Fusion) and NC762 (B7-H4 mAb) by year end; (ii) Operational update for NC525 (LAIR-1 mAb) Phase 1a by year end."

P1 data • Trial status • Hematological Malignancies • Solid Tumor

NextCure Provides Business Update and Reports Second Quarter 2023 Financial Results (GlobeNewswire) - "NC762 (B7-H4 mAb): Continued enrollment in the Phase 1b dose expansion study in patients with solid tumors and high expression of B7-H4; Phase 1b update is expected in the fourth quarter of 2023."

Enrollment status • P1 data • Oncology • Solid Tumor

NextCure Provides Business Update and Reports First Quarter 2023 Financial Results (GlobeNewswire) - "NextCure, Inc...today provided a business update and reported first quarter 2023 financial results. NC410 (LAIR-2 fusion): Continued enrollment in the Phase 1b/2 clinical trial evaluating NC410 in combination with pembrolizumab in patients with immune checkpoint refractory or naïve solid tumors. Phase 1b update is expected in the fourth quarter of 2023. NC762 (B7-H4 mAb): Continued enrollment in the Phase 1b dose expansion study in patients with solid tumors and high expression of B7-H4. Phase 1b update is expected in the fourth quarter of 2023. NC525 (LAIR-1 mAb)...Initial Phase 1a data are expected in the fourth quarter of 2023."

Enrollment status • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

NextCure Provides Business Update and Reports Full Year 2022 Financial Results (GlobeNewswire) - "Business Highlights and Near-Term Milestones - NC762 (B7-H4 mAb): (i) Continued enrollment in the Phase 1b dose expansion study in patients with solid tumors and high expression of B7-H4; (ii) Phase 1b update is expected in the fourth quarter of 2023."

Enrollment status • P1 data • Breast Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Thoracic Cancer

A phase 1/2, open-label, dose-escalation, safety and tolerability study of NC762 in subjects with advanced or metastatic solid tumors (SITC 2022) - 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 • P1/2 data • Breast Cancer • Melanoma • Oncology • Pancreatic Cancer • Solid Tumor • FCGR3A • VTCN1

NextCure Presents Initial Data from Clinical Trial of NC762 and a Trial in Progress Poster for NC410 Combo at the 2022 Society for Immunotherapy of Cancer Annual Meeting (GlobeNewswire) - P1/2 | N=170 | NCT04875806 | Sponsor: NextCure, Inc. | "NextCure...will present initial clinical data from a Phase 1 clinical trial of NC762...at the Society for Immunotherapy of Cancer (SITC) annual meeting in Boston....Initial data from the Phase 1 dose-escalation trial show that NC762 appears to be safe and well-tolerated with early signs of disease control in patients with advanced tumors. Highlights include: Data come from five patient cohorts (n=18), who received NC762 up to 20 mg/kg once every two weeks. There were no dose-limiting toxicities....Safety expansion studies are ongoing, prospectively enrolling subjects with biopsy confirmed B7-H4 positive tumors (ovarian, endometrial, breast, and non-small cell lung) to finalize the selection of a recommended Phase 2 dose."

P1 data • Breast Cancer • Endocrine Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Thoracic Cancer

NextCure Provides Update and Reports Third Quarter 2022 Financial Results (GlobeNewswire) - "Business Highlights: NC762 (B7-H4 mAb) - Completed the Phase 1a dose escalation portion of the trial and demonstrated that NC762 was safe and well tolerated. Initiated the Phase 1b expansion trial."

Trial status • Oncology • Solid Tumor

NextCure to Give Two Presentations at Society for Immunotherapy of Cancer Annual Meeting (GlobeNewswire) - "NextCure, Inc...announced two presentations at the Society for Immunotherapy of Cancer (SITC) annual meeting, to be held in Boston in November 8-12, 2022. NextCure will share new data from its Phase 1 clinical study of NC762 and a high level overview of its ongoing NC410 combination study during poster sessions."

P1 data • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

"Note: NC762 from Nextcure targets B7-H4 (not B7-H6)" (@jbdotdotdot)

NCR3LG1 • VTCN1

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

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

A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2; N=170; Recruiting; Sponsor: NextCure, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

NextCure Initiates Phase 1/2 Clinical Trial of NC762 for Solid Tumors (GlobeNewswire) - "NextCure....announced the initiation of a Phase 1/2 clinical trial for NC762, a humanized B7-H4 monoclonal antibody....'We look forward to reporting initial data from this trial in mid-2022.'"

P1/2 data • Trial status • Oncology • Solid Tumor

[VIRTUAL] Development and functional characterization of NC762, a novel therapeutic antibody targeting B7-H4, for the treatment of malignancies (AACR 2021) - "Furthermore, a mutant of NC762 with a low FcγR binding IgG1 domain showed similar activity as the DLE IgG1, demonstrating an ADCC-independent mechanism of tumor growth restriction mediated by B7-H4 mAb treatment. Together, these results indicate that even with the ADCC-enhanced IgG1κ region, NC762 is able to mediate ADCC-independent anti-tumor activity for the eradication of B7-H4 expressing tumors; and is expected to provide benefit in multiple oncology indications."

Breast Cancer • Oncology • Solid Tumor • FCGR3A

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

A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2; N=176; Not yet recruiting; Sponsor: NextCure, Inc.

Clinical • New P1/2 trial • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

NextCure Presents Preclinical Data for NC762 at American Association for Cancer Research (AACR) Annual Meeting 2021 (GlobeNewswire) - “NextCure, Inc…presented preclinical and investigational new drug (IND)-enabling data for NC762 at the American Association for Cancer Research (AACR) Annual Meeting 2021…Key highlights from the presentation include: NC762 demonstrated specificity for human B7-H4, which is widely expressed in multiple cancers. In a dose-dependent manner, NC762 inhibited tumor growth in a xenograft murine tumor model in the absence of peripheral blood mononuclear cells (PBMCs)…IND-enabling studies in non-human primates demonstrated a half-life of approximately 8-10 days and no safety concerns in toxicology studies or cytokine release assays were observed.”

Preclinical • Oncology

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