NPX267 / NextPoint - LARVOL DELTA

Targeting HHLA2-mediated immunosuppression with NPX267 and NPX887, two fully human monoclonal antibodies that target KIR3DL3 and HHLA2 respectively (CIMT 2024) - P1 | "Additionally, HHLA2 represents a novel tumor target with limited normal tissue expression. NPX267 and NPX887 are currently being evaluated in Phase I clinical trials for patients with solid tumors known to express HHLA2 / B7-H7 [NCT05958199] and [NCT06240728] respectively."

Oncology • Solid Tumor • HHLA2 • KIR2DS2

A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA-2 (clinicaltrials.gov) - P1 | N=131 | Recruiting | Sponsor: NextPoint Therapeutics, Inc.

Trial completion date • Trial primary completion date • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • HHLA2

A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA-2 (clinicaltrials.gov) - P1 | N=131 | Recruiting | Sponsor: NextPoint Therapeutics, Inc. | Phase classification: P1a/1b ➔ P1

Phase classification • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • HHLA2

A Phase 1a/1b, dose-escalation/dose-expansion study of NPX267 in subjects with solid tumors known to express HHLA2 (SITC 2023) - "4 Key eligibility criteria include histologic diagnosis of tumor types known to express HHLA2, refractory metastatic or locally advanced disease and the absence of autoimmune disease or history of colitis or pneumonitis. HHLA-2 expression will be assessed by immunohistochemistry from archival tissue and fresh biopsies to assess correlation with pharmacodynamic and clinical activity to determine the potential use of HHLA2 expression as a prospective selection marker."

Clinical • IO biomarker • P1 data • Biliary Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Osteosarcoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • EGFR • HHLA2 • PD-L1

A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA-2 (clinicaltrials.gov) - P1a/1b | N=131 | Recruiting | Sponsor: NextPoint Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • HHLA2

NextPoint Therapeutics Announces First Patient Dosed in Phase 1a/b Clinical Trial of NPX267, a Novel Therapeutic Targeting KIR3DL3 to Reactivate Exhausted T and NK Cells in HHLA2+ Solid Tumors (Businesswire) - "NextPoint Therapeutics...announced today that the first patient has been dosed with NPX267 in a Phase 1 first-in-human clinical trial for the treatment of patients with solid tumors known to express HHLA2, a tumor antigen strongly upregulated in many human tumors independently of PD-L1. The Phase 1a/1b open-label, multi-center study...consists of a dose escalation and an expansion stage to evaluate the tolerability, pharmacokinetics, immunogenicity and biomarker strategy of NPX267 in patients with metastatic solid tumors including epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) and other indications."

Trial status • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Osteosarcoma • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer • Urothelial Cancer • Uterine Cancer

Treatment With NPX267 for Subjects With Solid Tumors Known to Express HHLA-2 (clinicaltrials.gov) - P1a/1b | N=131 | Not yet recruiting | Sponsor: NextPoint Therapeutics, Inc.

New P1 trial • Breast Cancer • Cholangiocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • HHLA2

NPX267, a first-in-class monoclonal antibody targeting KIR3DL3, blocks HHLA2-mediated immunosuppression and potentiates T and NK cell-mediated antitumor immunity (SITC 2022) - "Conclusions Collectively, these data demonstrate that the KIR3DL3-HHLA2 pathway is a novel immune checkpoint axis that facilitates tumor escape by attenuating both innate and adaptive antitumor immune responses. NPX267, a first-in-class KIR3DL3 blocking antibody, potentiates anti-tumor immunity against HHLA2 + tumors and may represent a promising approach to treat certain cancers."

IO biomarker • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8 • HHLA2 • KIR2DS2 • PD-L1