NPX372 / NextPoint - LARVOL DELTA

NPX372, a B7-H7:CD3 Bispecific Antibody, in Selected Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=81 | Recruiting | Sponsor: NextPoint Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Tract Cancer • Esophageal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

NPX372, a B7-H7:CD3 Bispecific Antibody, in Selected Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=81 | Not yet recruiting | Sponsor: NextPoint Therapeutics, Inc.

New P1 trial • Biliary Tract Cancer • Esophageal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • HHLA2

Safety and tolerability of NPX372, a novel B7-H7:CD3 bispecific T cell engaging antibody (AACR 2025) - "These data demonstrate on-target activity of NXP372 in monkeys, with doses tolerated up to 1000 µg/Kg, which covers a dose range that is effective in preclinical models. The totality of the data suggests that NXP372 may be a safe and effective drug to further develop toward human clinical studies."

Bispecific • Clinical • Oncology • CCL4 • CRP • CXCL8 • HHLA2 • IFNG • IL1R1 • IL2RA

B7-H7-CD3 bispecific T cell engaging antibodies demonstrate potent anti-tumor activity in B7-H7+ preclinical tumor models (AACR 2025) - "These data demonstrate that B7-H7 represents a novel tumor associated antigen for CD3 bispecific T cell engagement that can induce potent T cell-mediated anti-tumor immunity."

Bispecific • Preclinical • Oncology • HHLA2

NextPoint Therapeutics…announced the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate clinical development of NPX372, a first-in-class T cell engager (TCE) for the treatment of patients with solid tumors (Businesswire) - "Initiates first-in-human clinical studies of an IgG-like CD3 bispecific designed with a wide therapeutic index to selectively redirect T cells to B7-H7–expressing tumors, including lung adenocarcinoma, renal cell carcinoma and pancreatic adenocarcinoma. Clinical trial design with efficient dose escalation algorithm and biomarker strategy allows rapid data readout and enables optimized dosing and response."

First-in-human • IND • Lung Adenocarcinoma • Pancreatic Adenocarcinoma • Renal Cell Carcinoma

NextPoint Therapeutics to Showcase Pioneering Preclinical Data on NPX125, a Novel B7-H7 Targeted Antibody-Drug Conjugate (ADC) at AACR Annual Meeting 2025 (Businesswire) - "NPX125, which utilizes NextPoint's proprietary linker technology paired with a clinically validated topoisomerase 1 inhibitor payload in a DAR8 (drug-antibody ratio) format, is initiating IND-enabling work with an anticipated IND filing in mid-2026....NPX125 via its interaction with B7-H7 demonstrated efficient internalization across many different tumor cell lines; Showed both direct and bystander cytotoxic activity, critical for addressing tumor heterogeneity; NPX125 demonstrated superior serum stability in rat pharmacokinetic studies; Robust developability profile due to antibody selection and unique linker properties....NextPoint will also present three additional posters at AACR showcasing its comprehensive approach to targeting the B7-H7 axis."

IND • Preclinical • Solid Tumor

NextPoint Therapeutics to Highlight Antibody-Drug Conjugate (ADC) and T Cell Engager (TCE) Preclinical Findings Targeting Novel B7-H7 Pathway at AACR Annual Meeting (Businesswire) - "NextPoint Therapeutics...announced the company will present four posters highlighting its B7-H7-targeted oncology pipeline at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2025, to be held in Chicago, from April 25-30, 2025. NextPoint's presentations will showcase its advanced therapeutic approaches, including its B7-H7-targeted antibody-drug conjugate (ADC) with proprietary linker technology and B7-H7-CD3 bispecific T cell engager with wide therapeutic window....The studies will present preclinical evaluation of these first-in-class candidates across multiple solid tumor types expressing B7-H7, complemented by comprehensive tumor expression analyses that support NextPoint's clinical biomarker strategy for identifying the right patient populations for each B7-H7-directed therapy."

Preclinical • Oncology • Solid Tumor

B7-H7-CD3 bispecific T cell engaging antibodies demonstrate potent anti-tumor activity against B7-H7+ preclinical tumor models (SITC 2024) - "NPX387 showed superior in vivo activity compared to NPX372. Conclusions These data demonstrate that B7-H7 represents a novel tumor associated antigen for CD3 bispecific T cell engagement that can induce potent T cell-mediated anti-tumor immunity."

Preclinical • Oncology • HHLA2

NextPoint Therapeutics Announces Upcoming Poster Presentation on a B7-H7 Directed T Cell Engager Therapy at SITC2024 (Businesswire) - "These BsAbs are designed to bind both B7-H7 expressed on the surface of tumors cells and CD3 on the surface of T cells to induce potent T cell-mediated cytotoxicity toward B7-H7+ tumors independent of existing ADC/IO approaches. NextPoint’s B7-H7xCD3 BsAb 2:1 bispecific antibody design provides optimized target:CD3 affinity ratio, inactivated Fc effector function and ability to fully evaluate safety preclinically. Due to very limited normal tissue expression, B7-H7xCD3 is safe to administer in a wide dose range. Efficacy data presented at SITC demonstrates potent T cell-mediated cytotoxicity against multiple B7-H7+ tumor cell lines with sub-nanomolar EC50s in addition to induction of complete regressions in most of B7-H7+ tumor bearing mice....'Armed with tolerability data, NextPoint is rapidly advancing the Investigational New Drug (IND) application for our T cell engager, NPX372.'"

Preclinical • Oncology • Solid Tumor

NextPoint Therapeutics Announces First-in-class T Cell Engager NPX372 As New Drug Candidate Targeting B7-H7 in Solid Tumors (Businesswire) - "NextPoint Therapeutics...has unveiled NPX372, a novel T cell engager. NPX372 further expands NextPoint’s multi-modal focus on the emerging B7-H7 axis in cancer therapy....Preclinical data highlight NPX372’s potent anti-tumor responses and a favorable safety profile at clinically relevant doses with no indication of cytokine release syndrome. This asset is part of NextPoint's diverse portfolio of immunotherapies designed to target various tumor types. NextPoint is rapidly advancing the Investigational New Drug (IND) application for NPX372."

New molecule • Preclinical • Solid Tumor