ozekibart (INBRX-109) / Inhibrx Biosci, Transcenta - LARVOL DELTA

INVESTIGATION OF COMBINING MDM2 INHIBITORS WITH DR5 AGONISTS FOR BONE SARCOMA TREATMENT (CTOS 2025) - P2 | "RG7388 is cytotoxic and upregulates DR5 in bone sarcoma cell lines. Combining this agent with novelDR5 agonists may enhance cell killing and potentially survival outcomes. The phase 2 clinical trial of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients (ClinicalTrials.gov Identifier: NCT04950075) has an estimated primary completion date of September 2025."

Oncology • Osteosarcoma • Sarcoma • Solid Tumor • CASP3 • CASP7 • CDKN1A • MDM2 • TNFRSF10B

Tetravalent death receptor 5 (DR5) agonist ozekibart (INBRX-109) exhibits anti-tumor activity in GBM models as a monotherapy and in combination with TMZ (SNO 2025) - P2 | "Glioblastoma (GBM) is an aggressive brain tumor with poor outcomes due to resistance to radiation and temozolomide (TMZ)...Ozekibart (INBRX-109), a tetravalent DR5 agonist antibody, has demonstrated tolerability and clinical benefit as monotherapy in chondrosarcoma (PMID: 37265425), prompting a phase 2 trial (NCT04950075), and in combination with irinotecan and TMZ in Ewing's sarcoma...This combinatorial activity and potential for synergy with radiation/TMZ support clinical evaluation of INBRX-109 in GBM. Moreover, the established clinical safety and activity of INBRX-109 in solid tumors support its development in this indication."

Combination therapy • Monotherapy • Brain Cancer • Ewing Sarcoma • Glioblastoma • Oncology • Sarcoma • Solid Tumor • CASP3 • TNFRSF10B

THE TETRAVALENT DEATH RECEPTOR 5 AGONIST OZEKIBART (INBRX-109) IN CHONDROSARCOMA: RESULTS FROM THE RANDOMIZED, REGISTRATIONAL, PHASE 2 CHONDRAGON STUDY (CTOS 2025) - No abstract available

Clinical • P2 data • Oncology • Sarcoma • Solid Tumor • TNFRSF10B

Tetravalent death receptor 5 (DR5) agonist ozekibart (INBRX-109) exhibits anti-tumor activity in GBM models as a monotherapy and in combination with TMZ (WFNOS 2025) - P2 | "Glioblastoma (GBM) is an aggressive brain tumor with poor outcomes due to resistance to radiation and temozolomide (TMZ)...Ozekibart (INBRX-109), a tetravalent DR5 agonist antibody, has demonstrated tolerability and clinical benefit as monotherapy in chondrosarcoma (PMID: 37265425), prompting a phase 2 trial (NCT04950075), and in combination with irinotecan and TMZ in Ewing's sarcoma...This combinatorial activity and potential for synergy with radiation/TMZ support clinical evaluation of INBRX-109 in GBM. Moreover, the established clinical safety and activity of INBRX-109 in solid tumors support its development in this indication."

Combination therapy • Monotherapy • Brain Cancer • Ewing Sarcoma • Glioblastoma • Oncology • Sarcoma • Solid Tumor • CASP3 • TNFRSF10B

Research and development expenses were $28.5 million for the third quarter of 2025, as compared to $38.9 million for the third quarter of 2024 (PRNewswire) - "The decrease was primarily related to a decrease in process development and manufacturing activities performed by our CDMO partners during the prior year in connection with the Company's clinical trial for ozekibart (INBRX-109)."

Commercial • Chondrosarcoma

Inhibrx Announces Participation in Upcoming Scientific Conferences (Inhibrx Press Release)

Clinical data • Preclinical • Chondrosarcoma • Colorectal Cancer • Ewing Sarcoma

Inhibrx Biosciences…Provides Updates on…Ewing Sarcoma Expansion Cohorts (PRNewswire) - "Based on initial results from the Phase 1 trial of ozekibart in combination with irinotecan and temozolomide (IRI/TMZ) for advanced or metastatic, unresectable, relapsed, or refractory Ewing sarcoma, Inhibrx initiated an expansion cohort which is expected to enroll up to 50 patients. Of the 33 patients recruited to date, more than half were third or fourth line patients. Among the 25 evaluable patients to date, Inhibrx observed a 64% overall response rate (ORR), and a disease control rate of 92%, with the majority of patients experiencing measurable tumor reduction."

P1 data • Trial status • Ewing Sarcoma

Inhibrx Biosciences…Provides Updates on Colorectal Cancer…Expansion Cohorts (PRNewswire) - "Based on initial results from the Phase 1 trial of ozekibart in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal cancer (CRC), Inhibrx initiated an expansion cohort enrolling 44 patients, as a fourth line of therapy for approximately 70% of patients and as a third line of therapy for approximately 30% of patients. 80% of patients had been previously treated with regimens containing irinotecan. Efficacy, based on RECIST v1.1 criteria, was assessed in 26 evaluable patients to date who had at least one post-baseline scan. The results show a 23% overall response rate (ORR) and an overall disease control rate of 92%."

P1 data • Trial status • Colorectal Adenocarcinoma

Inhibrx Biosciences Reports Positive Topline Results from its Registrational Trial of Ozekibart (INBRX-109) in Chondrosarcoma… (PRNewswire) - "The ChonDRAgon study met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival (PFS) for patients with advanced or metastatic chondrosarcoma treated with ozekibart compared to placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio [HR] 0.479; 95% CI: 0.33, 0.68); P<0.0001), more than doubling median PFS to 5.52 months versus 2.66 months for placebo....Detailed results from this trial will be presented at the Connective Tissue Oncology Society (CTOS) Annual Meeting on November 14, 2025....Inhibrx plans to file a BLA in Q2 of 2026."

FDA filing • P2 data • Chondrosarcoma

Upcoming Milestones (PRNewswire) - "The ozekibart (INBRX-109) registration-enabling Phase 2 trial in unresectable or metastatic conventional chondrosarcoma completed full enrollment in July 2025. The completion of 151 progression free survival events are required to unblind the study. The Company expects to announce these results by late October 2025. The Company plans to announce interim data from the Ewing sarcoma and colorectal cancer expansion cohorts at that time as well."

Clinical data • Enrollment closed • Chondrosarcoma • Colorectal Cancer • Ewing Sarcoma

Inhibrx Reports First Quarter 2025 Financial Results (PRNewswire) - "Upcoming Milestones: INBRX-109: (i) Data from the registration-enabling Phase 2 trial in unresectable or metastatic conventional chondrosarcoma are expected during the third quarter of 2025; and (ii) Initial data on the colorectal cancer expansion cohort are anticipated in the third quarter of 2025 with interim data from the Ewing sarcoma expansion cohort expected in the second half of 2025."

Clinical data • Chondrosarcoma • Colorectal Cancer • Ewing Sarcoma

Recent Advances in Succinate Dehydrogenase Deficient Gastrointestinal Stromal Tumor Systemic Therapies. (PubMed, Curr Treat Options Oncol) - "In our current practice we typically treat advanced symptomatic SDH-Def GIST with the anti-angiogenic TKIs, sequentially treating with sunitinib, regorafenib and pazopanib...Olverembatinib and rogaratinib have shown promising activity in pre-clinical models and small SDH-Def GIST cohorts. Other agents whose benefits are explored here include the immune checkpoint inhibitors (ICI) ipilimumab and nivolumab and temozolomide, whether as monotherapy or in combination with INBRX-109 (a pro-apoptotic antibody) or olaparib. Additional research into TKI agents with anti-vascular endothelial growth factor receptor (VEGFR) and anti-fibroblast growth factor receptor (FGFR) activity in this clinical setting is needed. Patients with SDH-Def will benefit more broadly from ongoing explorations of treatments with alternative mechanisms of action, especially those that exploit cellular pathways involved in SDH-Def GIST tumorigenesis."

Journal • Review • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Metabolic Disorders • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • FGFR

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

Tetravalent death receptor 5 (DR5) agonist ozekibart (INBRX-109) + FOLFIRI in 2L+ colorectal adenocarcinoma (CRC): Preliminary results from a phase 1 study. (ASCO-GI 2025) - P1, P2 | "Pts with locally advanced or metastatic, unresectable CRC who received oxaliplatin-based chemo were eligible for part 3... Ozekibart + FOLFIRI showed encouraging preliminary efficacy, including PRs and durable disease control, as 2L+ therapy in pts with CRC. Given these promising data, a new expansion cohort (C4d) is open to validate these findings in a more homogeneous population. Eligible pts will have had 2 or 3 prior lines of systemic therapy (irinotecan allowed but not in the immediately prior line) and must have archival or fresh biopsy tissue."

P1 data • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • TNFRSF10B

Inhibrx Biosciences Announces Preliminary Data from the Phase 1 Trial of ozekibart (INBRX-109) for the Treatment of Colorectal Cancer (PRNewswire) - P1 | N=321 | NCT03715933 | Sponsor: Inhibrx Biosciences, Inc | "These results were presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Annual Cancers Symposium. Efficacy was assessed in 10 of the 13 patients who received at least one dose of ozekibart....Results demonstrated one complete response (CR), three partial responses (PR), and six cases of stable disease (SD). Durable disease control lasting ≥180 days was observed in 46.2% of patients, with a median progression-free survival (PFS) of 7.85 months.....Notably, the patient achieving a CR had undergone three prior lines of therapy, and two PRs occurred in patients who had failed prior FOLFIRI-based treatments....Inhibrx has initiated a new expansion cohort to validate these findings in a more uniform patient population. The cohort is expected to enroll up to 50 patients, each with two to three prior lines of systemic therapy, and data are anticipated in Q3 2025."

P1 data • Trial status • Colorectal Adenocarcinoma

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

ChonDRAgon: Study of INBRX-109 in Conventional Chondrosarcoma (clinicaltrials.gov) - P2 | N=201 | Recruiting | Sponsor: Inhibrx Biosciences, Inc | Trial completion date: Jul 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Oncology • Sarcoma • Solid Tumor

Phase 1 Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including Sarcomas (clinicaltrials.gov) - P1 | N=321 | Recruiting | Sponsor: Inhibrx Biosciences, Inc | N=240 ➔ 321 | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Ewing Sarcoma • Gastric Cancer • Mesothelioma • Oncology • Sarcoma • Solid Tumor

Advancing Systemic Therapy in Chondrosarcoma: New Horizons. (PubMed, Oncol Ther) - "Among new approaches, DR5 agonists such as INBRX-109 have shown single-agent efficacy, with minimal toxicity, opening possibilities for use in combination therapies to improve outcomes...The integration of multi-targeted approaches could enhance efficacy, address tumour heterogeneity, and overcome resistance, presenting a hopeful direction for systemic therapy in this challenging cancer. The investigation of combination regimens with IDH inhibitors, immunotherapy and DR5 agonists hold promise for transforming the management of advanced chondrosarcoma."

IO biomarker • Journal • Immune Modulation • Immunology • Oncology • Sarcoma • Solid Tumor • TNFRSF10B

THE TETRAVALENT DEATH RECEPTOR 5 AGONIST OZEKIBART INBRX-109) IN PATIENTS WITH CHONDROSARCOMA: UPDATED RESULTS FROM A PHASE 1 STUDY (CTOS 2024) - P1, P2 | "Consistent with the prior analysis, INBRX-109 was found to be well tolerated, and no new safety signals were observed. INBRX-109 continued to demonstrate encouraging clinical efficacy in patients with unresectable or metastatic CS, regardless of IDH mutation status, and median PFS remained greater compared to historical data ( < 4 months). These results are being confirmed in a randomized, blinded, placebo-controlled, phase 2 trial of INBRX-109 in unresectable or metastatic conventional CS (ChonDRAgon, NCT04950075), which is currently enrolling in the US, Europe, and Australia."

Clinical • P1 data • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor • IDH1 • IDH2 • TNFA • TNFRSF10B

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

Targeting Death Receptor 5 (DR5) for imaging and treatment of primary bone and soft tissue tumors: an update of the literature. (PubMed, Front Mol Biosci) - "The combination of DR5 agonists and commonly used chemotherapeutic agents, such as doxorubicin, can promote cell death...There are currently two ongoing clinical trials focusing on the activation of DR5, namely, IGM-8444 and INBRX-109, which have progressed to phase 2. Further modifications of TRAIL delivery with fusion to single-chain variable fragments (scFv-TRAIL), directed against tumor-associated antigens (TAAs), and in the use of stem cells focus on targeted TRAIL delivery to cancer cells using bi-functional strategies. In vitro, in vivo, and clinical trials, as well as advances in imaging and theranostics, indicate that targeting DR5 remains a valid strategy in the treatment of some relapsed and refractory cancers."

Journal • Review • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • TNFRSF10B

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

A role for the oncogenic driver fusion protein EWS-FLI1 in the targeting of DR5 by INBRX-109 in Ewing sarcoma (AACR 2024) - "INBRX-109 is an exciting candidate for ES as a single agent in subsets of tumors or in combination with irinotecan, which is currently being evaluated in the clinic. Investigation of the exact relationship between EWS-FLI1 and sensitivity to DR5 targeting is ongoing. Initial findings suggest EWS-FLI1, combined with other disease modifying mutations, is a key mediator of this sensitivity."

Ewing Sarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • EWSR1 • FLI1 • TNFA • TNFRSF10B