enristomig (INBRX-105) / Inhibrx Biosci, Elpiscience - LARVOL DELTA

Inhibrx Reports Fourth Quarter and Fiscal Year 2024 Financial Results (PRNewswire) - "Research and development expenses were $203.7 million during the fiscal year 2024 as compared to $191.6 million during the fiscal year 2023, primarily due to the following factors: an increase in clinical trial expenses primarily due to the ongoing registration-enabling Phase 2 trial for ozekibart (INBRX-109) for the treatment of unresectable or metastatic conventional chondrosarcoma and due to the expansion of the INBRX-106 Phase 1/2 trial and initiation of the Phase 2/3 trial for HNSCC, including expenses for in-house clinical trial support. These increases were offset in part by a decrease in clinical trial expenses as a result of the termination of the INBRX-105 program."

Commercial • Chondrosarcoma • Squamous Cell Carcinoma of Head and Neck

Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (clinicaltrials.gov) - P1 | N=160 | Terminated | Sponsor: Inhibrx Biosciences, Inc | Trial completion date: Dec 2025 ➔ Oct 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Aug 2025 ➔ Oct 2024; Program terminated due to lack of meaningful efficacy signal.

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Trial termination • Cutaneous Melanoma • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • TMB

Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (clinicaltrials.gov) - P1 | N=160 | Active, not recruiting | Sponsor: Inhibrx Biosciences, Inc | Phase classification: P2 ➔ P1 | N=300 ➔ 160

Combination therapy • Enrollment change • Metastases • Phase classification • Cutaneous Melanoma • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • TMB

Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (clinicaltrials.gov) - P2 | N=300 | Active, not recruiting | Sponsor: Inhibrx Biosciences, Inc | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Cutaneous Melanoma • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • TMB

Inhibrx Inc. Stockholders Approve Sale of INBRX-101 to Sanofi (PRNewswire) - " Inhibrx...announced that, at a special meeting (the 'Special Meeting'), the Company's stockholders approved the sale to Sanofi of all the assets and liabilities primarily related to INBRX-101, an optimized, recombinant alpha-1 antitrypsin ('AAT') augmentation therapy currently in a registrational trial for the treatment of patients with alpha-1 antitrypsin deficiency ('AATD'). Immediately prior to the closing of the merger, all non-101 assets and liabilities, including INBRX-105, INBRX-106, INBRX-109, Inhibrx's non-101 discovery pipeline and its corporate infrastructure, will be spun out from the Company into a new publicly traded company, Inhibrx Biosciences, Inc. ('New Inhibrx')."

Commercial • Alpha-1 Antitrypsin Deficiency • Solid Tumor

Inhibrx Reports Fourth Quarter and Fiscal Year 2023 Financial Results (PRNewswire) - "INBRX-105: The Company decided to terminate its INBRX-105 program after evaluation of the totality of data from the expansion cohorts, in which it determined the initial signal was not sufficiently validated to support the continuation of the program. The Company is in the process of winding down the clinical trial and expects it to be completed within the first half of 2024."

Discontinued • Trial status • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Renal Cell Carcinoma • Solid Tumor

Inhibrx Announces Sale of INBRX-101 to Sanofi for an aggregate value of up to $2.2B (PRNewswire) - "Inhibrx, Inc...and Sanofi...today announced that the companies have entered into a definitive agreement under which Aventis Inc., a Pennsylvania corporation (a subsidiary of Sanofi) will acquire all the assets and liabilities associated with INBRX-101, an optimized, recombinant alpha-1 antitrypsin ('AAT') augmentation therapy currently in a registrational trial for the treatment of patients with alpha-1 antitrypsin deficiency ('AATD'). Immediately prior to the closing of the merger, all non-101 assets and liabilities, including INBRX-105, INBRX-106, INBRX-109, Inhibrx's non-101 discovery pipeline and its corporate infrastructure, will be spun out from the Company into a new publicly traded company, Inhibrx Biosciences, Inc. ('New Inhibrx')....New Inhibrx will continue to own Inhibrx's other clinical therapeutic candidates, INBRX-105, INBRX-106, and INBRX-109..."

Commercial • Licensing / partnership • Alpha-1 Antitrypsin Deficiency • Immunology • Oncology • Solid Tumor

Inhibrx Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights (PRNewswire) - "...the Company's payments to its contract research organizations, or CRO, partners continue to increase as the registration-enabling Phase 2 trials progress for both INBRX-101 for the treatment of emphysema due to AATD and INBRX-109 for the treatment of unresectable or metastatic conventional chondrosarcoma, and additional cash outlay to its CRO partners for the INBRX-105 and INBRX-106 Phase 1/2 trials...Research and development expenses were $38.1 million during the third quarter of 2023, compared to $24.9 million during the third quarter of 2022...an increase in clinical trial expenses, primarily related to the registration-enabling Phase 2 trial for INBRX-101 for the treatment of emphysema due to AATD, which was initiated during the current year, as well as the progression of its INBRX-109 registration-enabling Phase 2 trial for the treatment of unresectable or metastatic conventional chondrosarcoma."

Commercial • Alpha-1 Antitrypsin Deficiency • Head and Neck Cancer • Immunology • Oncology • Sarcoma • Solid Tumor

Phase 1/2 study of the bispecific 4–1BB and PD-L1 antibody INBRX-105 alone and in combination with pembrolizumab in select solid tumors (SITC 2023) - P2 | "Primary objectives are safety and determination of the maximum tolerated dose and/or RP2D of INBRX-105 as monotherapy and with pembrolizumab. Secondary objectives include pharmacokinetics, immunogenicity, and preliminary antitumor activity per RECIST."

Combination therapy • IO biomarker • P1/2 data • Tumor mutational burden • Cutaneous Melanoma • Head and Neck Cancer • Lung Cancer • Melanoma • Microsatellite Instability • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • MSI • PD-1 • TMB

Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Inhibrx, Inc. | Phase classification: P1 ➔ P2

Combination therapy • Metastases • Phase classification • Cutaneous Melanoma • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • TMB

Key pharmacokinetic and pharmacodynamic parameters that correlate with the anti-tumor activity of a bispecific PD-L1 conditional 4-1BB agonist (SITC 2021) - P1 | "Early efforts to develop 4-1BB targeted agonists were limited by poor tolerability (Urelumab) or insufficient efficacy (Utomilumab). INBRX-105 is currently being evaluated in patients with advanced solid tumors in a first-in-human trial (NCT03809624). Trial Registration INBRX-105 is currently being evaluated in patients with advanced solid tumors in a first-in-human trial (NCT03809624)."

IO biomarker • PK/PD data • Oncology • Solid Tumor • CD8 • PD-L1

Inhibrx Reports Fourth Quarter and Fiscal Year 2022 Financial Results (PRNewswire) - "Key Highlights:...INBRX-105: To date, we have observed a therapeutic window for our targeted 4-1BB agonist in the checkpoint refractory population, with responses both as a single agent and in combination with Keytruda®. We expect to announce clinical data from these cohorts during the second half of 2023."

P1 data • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Urothelial Cancer

Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=300 | Recruiting | Sponsor: Inhibrx, Inc. | N=170 ➔ 300 | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Aug 2023 ➔ Aug 2025

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • TMB

Study of INBRX-105 in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=170 | Recruiting | Sponsor: Inhibrx, Inc. | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Nov 2022 ➔ Aug 2023

Combination therapy • Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • ALK • EGFR

Inhibrx Announces Completion of Phase 1 Combination Dose Escalation for INBRX-105, a Novel Targeted 4-1BB Agonist, and Draws an Additional $60 Million from Oxford Finance (PRNewswire) - "Inhibrx, Inc...announced the completion of Phase 1 dose escalation of INBRX-105, a novel targeted 4-1BB agonist, in combination with Keytruda®. It also reported the funding of an additional $60 million from its Loan and Security Agreement, as amended (the 'Loan Agreement'), with Oxford Finance, LLC ('Oxford'), to bring its cash balance to approximately $176 million as of June 30, 2022....Part 4, dose expansion cohorts of INBRX-105 in combination with Keytruda®, initiated enrollment in May 2022. This will include a total of approximately 90 patients in five separate cohorts and we expect to announce initial data from these cohorts in the first half of 2023"

Financing • P1 data • Trial status • Oncology • Solid Tumor

A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=22 | Terminated | Sponsor: Elpiscience Biopharma, Ltd. | N=180 ➔ 22 | Recruiting ➔ Terminated | Trial primary completion date: Nov 2021 ➔ Apr 2022; Sponsor's clinical development strategy adjustment

Enrollment change • Trial primary completion date • Trial termination • Oncology • Solid Tumor • PD-L1

A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Malignant Thoracic Tumors (clinicaltrials.gov) - P1b/2 | N=0 | Withdrawn | Sponsor: Elpiscience Biopharma, Ltd. | N=276 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • IO biomarker • Trial withdrawal • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer • ALK • EGFR • PD-L1 • ROS1

Inhibrx Announces Amended Loan Agreement with Oxford (PRNewswire) - "Inhibrx...announced that it has amended its loan and security agreement with Oxford Finance LLC ('Oxford')....The amendment provides for four additional tranches of term loans for up to an additional $130 million as follows: $40 million principal amount funded upon the closing of the amendment; $30 million, funded upon initiation of Part 4 of the Phase 1 clinical trial of INBRX-105, our PD-L1x4-1BB tetravalent conditional agonist;..."

Financing • Oncology

Inhibrx Announces Presentations at SITC 2021 (PRNewswire) - "Inhibrx, Inc...announced today that the Company will be presenting three poster presentations at the Society for Immunotherapy of Cancer's (SITC) annual meeting, to be held in Washington, D.C. and in a virtual platform, on November 10-14, 2021....'We are excited to share some of the preclinical data related to our clinical candidates, INBRX-105 and INBRX-106, which inform the selection of pharmacodynamic biomarkers, dosing and clinical strategy,'...'Additionally, we will be introducing the first emerging pipeline candidate from our targeted cytokine platform, INBRX-121, which specifically expands and enhances the cytotoxic capacity of NK cells.'"

Preclinical • Oncology • Solid Tumor

Study of INBRX-105 in Patients With Solid Tumors (clinicaltrials.gov) - P1; N=170; Recruiting; Sponsor: Inhibrx, Inc.; N=90 ➔ 170; Trial completion date: Dec 2021 ➔ Mar 2023; Trial primary completion date: Jul 2021 ➔ Nov 2022

Clinical • Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • ALK • EGFR

Inhibrx Reports Fourth Quarter and Fiscal Year 2020 Financial Results and Announces Phase 1 Single Agent Dose Escalation Results for INBRX-105, a Novel Targeted 4-1BB Agonist (PRNewswire) - P1, N=90; NCT03809624; Sponsor: Inhibrx, Inc; "We observed dose-limiting toxicities, which were consistent with immune related adverse events...at several dose levels and determined the 1 mg/kg dose level as the MTD of INBRX-105...Eight out of 18 evaluable patients (44%) receiving INBRX-105 at dose levels equal to or greater than 0.1 mg/kg achieved stable disease, with the greatest reduction in tumor volume observed to be 20% by RECISTv1.1...a dose escalation cohort of INBRX-105 in combination with Keytruda® is targeted to initiate enrollment during the second quarter of 2021 and we expect to announce initial data during the fourth quarter of 2021....Research and development expense was $73.5 million during the fiscal year 2020, as compared to $47.9 million during the fiscal year 2019. These increases were primarily due to an increase in contract manufacturing expense for...its INBRX-109 and INBRX-101 programs."

Commercial • P1 data • Trial status • Oncology

Inhibrx Reports Financial Results for the Third Quarter 2020 and Announces Amended Loan Agreement with Oxford (PRNewswire) - "First registration-enabling study for INBRX-109 in chondrosarcoma anticipated to start Q2 2021 and additional clinical data read-outs expected through 2021 for INBRX-106, INBRX-105, INBRX-109, and INBRX-101....Research and development expense was $19.8 million during the third quarter of 2020, as compared to $12.8 million during the third quarter of 2019. This increase was primarily due to an increase in contract manufacturing expense for scale-up activities performed by Inhibrx's CDMO partners for its INBRX-109 and INBRX-101 programs. Additionally, CRO costs increased due to the progression of its Phase 1 trials."

Clinical data • Commercial • New trial • Alpha-1 Antitrypsin Deficiency • Oncology • Sarcoma

A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=180; Recruiting; Sponsor: Elpiscience Biopharma, Ltd.

Clinical • New P1 trial

Elpiscience doses first patient with PD-L1/4-1BB bispecific antibody (GBI Health) - "China-based Elpiscience Biopharma Ltd announced dosing of a first patient with ES101, a first-in-class bispecific antibody targeting programmed cell death-ligand 1 (PD-L1) and 4-1BB, in a Phase I trial. The study is being led by Shanghai East Hospital with indication not disclosed...ES101, also known as INBRX-105, was originally developed by US biotech Inhibrx, with Elpiscience in-licensing China rights."

Enrollment open

Inhibrx announces dosing of first patient in phase 1 dose-escalation study of INBRX-105, a novel multispecific PD-L1 and 4-1BB antibody (PRNewswire) - “Inhibrx...announced...that dosing has begun in a Phase 1 dose-escalation clinical trial of INBRX-105. INBRX-105 is a novel, multispecific antibody therapeutic candidate that is both an antagonist of PD-L1 and a conditional agonist of 4-1BB in development for the treatment of PD-L1 expressing tumors, including those that are resistant to approved checkpoint inhibitor therapies. The clinical trial aims to determine the safety profile of INBRX-105 in humans, as well as the recommended therapeutic dose level for future clinical development."

Enrollment open