ordastobart (INBRX-106) / Elpiscience, Inhibrx Biosci - LARVOL DELTA

KEYNOTE A99: Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (clinicaltrials.gov) - P1/2 | N=333 | Recruiting | Sponsor: Inhibrx Biosciences, Inc | Trial completion date: May 2026 ➔ May 2027 | Trial primary completion date: Feb 2026 ➔ Oct 2026

First-in-human • Trial completion date • Trial primary completion date • Gastric 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 of Head and Neck • Urothelial Cancer • ALK • EGFR • PD-L1 • TMB

Upcoming Milestones (PRNewswire) - "Initial Phase 2 data from the INBRX-106 randomized Phase 2/3 trial in head and neck squamous cell carcinoma in combination with KEYTRUDA (pembrolizumab) are expected during the fourth quarter of 2025, as well as interim data from the Phase 1/2 checkpoint inhibitor refractory or relapsed non-small cell lung cancer trial."

P1/2 data • P2 data • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

A Study of ES102 (OX40 Agonist) in Combination With JS001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Elpiscience Biopharma, Ltd. | Recruiting ➔ Completed | N=82 ➔ 30

Enrollment change • Trial completion • Oncology • Solid Tumor • PD-L1

HexAgon-HN: Phase 2/3, randomized study of the hexavalent OX40 agonist INBRX-106 in combination with pembrolizumab vs pembrolizumab alone as first-line treatment for recurrent/metastatic head and neck cancer with a PD-L1 combined positive score of ≥20. (ASCO 2025) - P1/2, P2/3 | "Lancet. 2019; 394:1915-1928."

Clinical • Combination therapy • Metastases • P2/3 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

INBRX-106: a hexavalent OX40 agonist that drives superior antitumor responses via optimized receptor clustering. (PubMed, J Immunother Cancer) - P1/2 | "Our data establish hexavalent INBRX-106 as a differentiated and more potent OX40 agonist, showcasing its ability to overcome the limitations of conventional bivalent therapies by inducing superior receptor clustering and multimeric engagement. This unique clustering mechanism amplifies OX40 signaling, driving robust T-cell activation, proliferation, and effector function in preclinical and clinical settings. These findings highlight the therapeutic potential of INBRX-106 and its capacity to redefine OX40-targeted immunotherapy, providing a compelling rationale for its further clinical development in combination with checkpoint inhibitors."

Journal • Oncology • Solid Tumor • CD8 • TNFA

Inhibrx Reports First Quarter 2025 Financial Results (PRNewswire) - "Upcoming Milestones:...INBRX-106: (i) Initial Phase 2 data from the randomized Phase 2/3 trial in head and neck squamous cell carcinoma in combination with KEYTRUDA (pembrolizumab) are expected during the fourth quarter of 2025; and (ii) Interim data from the Phase 1/2 checkpoint inhibitor refractory or relapsed non-small cell lung cancer are expected during the fourth quarter of 2025."

Clinical data • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

INBRX-106 a novel Hexavalent OX40 agonist potentiates T-cell receptor clustering leading to improved activation and potent anti-tumor responses (IMMUNOLOGY 2025) - P1/2, P2/3 | "Thus, these data indicates that INBRX-106 induces potent agonistic OX40 activity in CD8 and CD4 T cells. Overall, our results demonstrate that INBRX-106 is a potent OX40 agonist that is biologically active in patients supporting further efficacy evaluation in clinical trials (NCT04198766/NCT06295731).Keywords: Animals Human; Cells T Cells T Cells, Cytotoxic; Processes Costimulation Signal Transduction"

IO biomarker • Oncology • CD38 • CD4 • CD8 • GZMB

A Study of ES102 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Elpiscience (Suzhou) Biopharma, Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2024 ➔ Apr 2025

Enrollment open • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

INBRX-106 + pembrolizumab: Data from P2 portion of P2/3 HexAgon-HN trial (NCT06295731) for HNSCC in H2 2025 (Inhibrx) - Investor Presentation

P2 data • Oncology • Squamous Cell Carcinoma of Head and Neck

Inhibrx Biosciences Announces Loan Agreement with Oxford Finance (PRNewswire) - "Inhibrx Biosciences...announced it entered into a loan and security agreement (the 'LSA') with Oxford Finance LLC ('Oxford', together with certain of its affiliates party thereto, the 'Lenders'), pursuant to which the Lenders provided a five-year term loan facility for up to $150 million (the 'Credit Facility'). 'This enables us strategic flexibility post data readouts expected later this year for our INBRX-109 and INBRX-106 programs'....'The INBRX-109 and INBRX-106 programs have shown highly promising clinical results, and we look forward to supporting Inhibrx as it advances its pipeline and further develops these innovative therapies'."

Commercial • Solid Tumor

Treatment with a novel hexavalent OX40 agonist enhances activation of circulating T cells to favor anti-tumor immunity (SITC 2024) - P1/2, P2/3 | "Two clinical studies are currently evaluating hexavalent aOX40 (INBRX-106) alone and with pembrolizumab (Phase 1/2: NCT04198766; Phase 2/3: NCT06295731). Ethics Approval Experimental procedures were performed according to the National Institutes of Health Guide for the Care and Use of Laboratory Animals and in accordance with the Earle A. Chiles Research Institute (EACRI) Institutional Animal Care and Use Committee (Animal Welfare Assurance No. A3913–01)."

IO biomarker • Oncology • CD8

Phase 2/3 study of the hexavalent OX40 agonist INBRX-106 as an add-on to pembrolizumab in first-line recurrent/metastatic PD-L1+ (combined positive score ≥20) head and neck cancer (SITC 2024) - P1/2, P2/3 | "INBRX-106 and pembro to be administered every 3 weeks. 1L, first line; CBR, clinical benefit rate; CPS, combined positive score; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; HNSCC, head and neck squamous cell carcinoma; HPV, human papillomavirus; ORR, objective response rate; OS, overall survival; PD-L1, programmed cell death 1 ligand 1; pembro, pembrolizumab; PFS, progression-free survival; PFS6mo progression-free survival rate at 6 months; PRO, patient-reported outcome; R, randomized; R/M, recurrent/metastatic; TTCx, time to chemotherapy; Tx, treatment"

Clinical • Metastases • P2/3 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Inhibrx Biosciences Reports Third Quarter 2024 Financial Results (PRNewswire) - "Inhibrx Biosciences...the biopharmaceutical company now has two programs in ongoing clinical trials, with data readouts for each expected within the next 12 months...R&D Expense. Research and development expenses were $38.9 million during the third quarter of 2024, compared to $38.1 million during the third quarter of 2023. The increase in research and development expenses was primarily due to: an increase in clinical trial expenses due to the expansion of the Company's ongoing registration-enabling Phase 2 trial for ozekibart (INBRX-109) for the treatment of unresectable or metastatic conventional chondrosarcoma. Clinical trial expenses also increased as a result of the expansion of the INBRX-106 Phase 1/2 trial and the initiation of the Phase 2/3 trial in head and neck squamous cell carcinoma, including expenses for in-house clinical trial support."

Clinical data • Commercial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC (Triple Negative Breast Cancer) Patients (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Providence Health & Services | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jun 2026 ➔ Jun 2027

Combination therapy • Enrollment open • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A Study of ES102 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Elpiscience (Suzhou) Biopharma, Ltd.

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

KEYNOTE A99: Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (clinicaltrials.gov) - P1/2 | N=333 | Recruiting | Sponsor: Inhibrx Biosciences, Inc | Phase classification: P1 ➔ P1/2

Combination therapy • Metastases • Phase classification • Gastric Cancer • 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 of Head and Neck • Urothelial Cancer • ALK • EGFR • PD-L1 • TMB

Press Release: Sanofi completes acquisition of Inhibrx, Inc. (GlobeNewswire) - "Sanofi announced today the completion of its acquisition of Inhibrx, Inc...The acquisition adds SAR447537 (formerly INBRX-101) to Sanofi’s rare disease pipeline, underscoring the company’s commitment to pursuing differentiated and potential best-in-class medicines that build upon our existing strengths and capabilities...The former holders of shares of Inhibrx common stock voted to approve the acquisition at a special meeting of stockholders on May 24, 2024. Upon the closing of the acquisition, former shareholders of Inhibrx became entitled to receive $30.00 per share in cash, which represents a total equity value of approximately $1.7 billion (on a fully diluted basis), as well as one contingent value right per share to receive $5.00 upon the achievement of a regulatory milestone....'Inhibrx Biosciences, which was a wholly owned subsidiary of Inhibrx prior to the distribution, acquired all of the assets of Inhibrx not related to SAR447537, which include INBRX-109 and INBRX-106...'"

M&A • Alpha-1 Antitrypsin Deficiency • Oncology • Rare Diseases • Solid Tumor

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

INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC (clinicaltrials.gov) - P2/3 | N=410 | Recruiting | Sponsor: Inhibrx, Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of ES102 (OX40 Agonist) in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Elpiscience Biopharma, Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Mar 2024

Metastases • Trial completion • Trial completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC (Triple Negative Breast Cancer) Patients (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: Providence Health & Services

Combination therapy • New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

KEYNOTE A99: Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (clinicaltrials.gov) - P1 | N=333 | Recruiting | Sponsor: Inhibrx, Inc. | Phase classification: P1/2 ➔ P1

Combination therapy • Metastases • Phase classification • Gastric Cancer • 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 of Head and Neck • Urothelial Cancer • ALK • EGFR • PD-L1 • TMB

INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC (clinicaltrials.gov) - P2/3 | N=410 | Not yet recruiting | Sponsor: Inhibrx, Inc.

Combination therapy • Metastases • New P2/3 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of ES102 (OX40 Agonist) in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Elpiscience Biopharma, Ltd. | Trial completion date: Mar 2024 ➔ Jun 2024

Metastases • Trial completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1