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

Emerging therapeutic strategies and clinical development of investigational agents for conventional chondrosarcoma. (PubMed, Expert Opin Investig Drugs) - "Multi-targeted TKIs remain the most commonly used systemic therapies for advanced cCS; however, recent advances in DR5 agonism and IDH1 inhibition provide proof of concept that biologically informed therapeutic strategies can achieve meaningful clinical benefit. Continued progress will require comprehensive molecular profiling, rational combination strategies, and innovative clinical trial designs to accelerate drug development in this rare malignancy."

Journal • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • BCL2 • IDH1 • IDH2 • MTAP

Phase I study of the tetravalent death receptor 5 (DR5) agonist ozekibart (INBRX-109) combined with irinotecan (I) and temozolomide (T) in adolescents and adults with Ewing sarcoma (Sarcoma-RC 2026) - P1 | "Legal entity responsible for the study Inhibrx Biosciences, Inc. Funding Inhibrx Biosciences, Inc."

Clinical • P1 data • Ewing Sarcoma • Hematological Disorders • Hepatology • Sarcoma • Solid Tumor • EWSR1 • TNFRSF10B

The tetravalent death receptor 5 (DR5) agonist ozekibart (INBRX-109) in conventional chondrosarcoma (CS): Secondary efficacy endpoints from the randomized, registrational, phase 2 ChonDRAgon study. (ASCO 2026) - P2 | "In addition to a PFS benefit, ozekibart significantly improved DCR and delayed QOL deterioration vs PBO in advanced CS. Ozekibart has the potential to become the first standard of care for a population with high unmet need."

Clinical • P2 data • Sarcoma • Solid Tumor • TNFRSF10B

Preclinical Characterization and Phase 1 Trial Results of INBRX-109, a Third-Generation, Recombinant, Humanized, Death Receptor 5 Agonist Antibody, in Chondrosarcoma. (PubMed, Clin Cancer Res) - P1, P2 | "INBRX-109 demonstrated encouraging antitumor activity with a favorable safety profile in patients with unresectable/metastatic chondrosarcoma. A randomized, placebo-controlled, phase 2 trial (ChonDRAgon, NCT04950075) will further evaluate INBRX-109 in conventional chondrosarcoma."

Journal • P1 data • Preclinical • Hepatology • Oncology • Sarcoma • Solid Tumor • IDH1 • IDH2 • TNFRSF10B

Upcoming Milestones:…ozekibart (INBRX-109) (PRNewswire) - "(i) During the second quarter of 2026, Inhibrx initiated two additional Phase 1 cohorts in colorectal cancer (CRC): (1) a second line study investigating ozekibart in combination with Folfiri and Avastin, and (2) a third/fourth line study investigating ozekibart in combination with Lonsurf and Avastin. The Company expects to announce interim results from these cohorts during the first quarter of 2027; (ii) The Company plans to meet with the FDA in the fourth quarter of 2026 to discuss plans to initiate a first-line registrational trial in CRC as well as the potential for an accelerated regulatory pathway for ozekibart in fourth-line CRC."

FDA event • P1 data • Trial status • Colorectal Adenocarcinoma

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

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

Metastases • 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=240 | Recruiting | Sponsor: Inhibrx, Inc. | Trial completion date: Dec 2024 ➔ Jul 2026 | Trial primary completion date: Aug 2024 ➔ Dec 2025

Metastases • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Ewing Sarcoma • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Sarcoma • Solid Tumor

Study of INBRX-109 in Conventional Chondrosarcoma (clinicaltrials.gov) - P2; N=201; Recruiting; Sponsor: Inhibrx, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • 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=240 | Recruiting | Sponsor: Inhibrx, Inc. | Trial completion date: Dec 2022 ➔ Dec 2024 | Trial primary completion date: Aug 2022 ➔ Aug 2024

Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Ewing Sarcoma • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Sarcoma • Solid Tumor

Inhibrx Biosciences, Inc…announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) seeking approval of ozekibart (INBRX-109) for the treatment of patients with unresectable or metastatic conventional chondrosarcoma. (PRNewswire) - "The FDA has not identified any filing review issues at this time and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027...The BLA is supported by positive results from the ChonDRAgon study, a randomized, blinded, placebo-controlled, registrational trial of ozekibart in patients with metastatic or unresectable conventional chondrosarcoma, which met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival (PFS) for patients treated with ozekibart compared to placebo."

FDA filing • PDUFA • Chondrosarcoma

Phase 1 study of the tetravalent death receptor 5 agonist ozekibart (INBRX-109) combined with chemotherapy in locally advanced or metastatic, unresectable colorectal adenocarcinoma (CRC). (ASCO 2026) - P1 | "Clinical Trial Registration Number: NCT03715933 Background: Patients with metastatic CRC are typically treated with fluorouracil-based chemotherapy in combination with leucovorin and irinotecan (FOLFIRI) or oxaliplatin (FOLFOX). Ozekibart + FOLFIRI demonstrated encouraging preliminary efficacy in a heavily pretreated patient population with metastatic, unresectable CRC. The safety profile of ozekibart + FOLFIRI was manageable, with most AEs being low grade. Our findings support further evaluation of ozekibart + FOLFIRI in advanced CRC."

Metastases • P1 data • Alopecia • Colorectal Adenocarcinoma • Colorectal Cancer • Hematological Disorders • Hepatology • Immunology • Oncology • Sarcoma • Solid Tumor • TNFRSF10B

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas (clinicaltrials.gov) - P1 | N=411 | Recruiting | Sponsor: Inhibrx Biosciences, Inc | Trial completion date: Dec 2026 ➔ Jun 2029 | Trial primary completion date: Jun 2026 ➔ Dec 2028

First-in-human • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Ewing Sarcoma • Gastric Cancer • Mesothelioma • Oncology • Sarcoma • Solid Tumor

Recent Corporate Highlights and Upcoming Milestones (Financial Times) - "We plan to meet with the FDA in the second half of 2026 to discuss plans to initiate a first-line registrational trial in CRC. We also plan to discuss with the FDA the potential for accelerated regulatory pathways for ozekibart in fourth-line colorectal cancer and in refractory Ewing sarcoma."

FDA event • Colorectal Cancer

Inhibrx’s cancer duo could be pharma’s next big takeout target: report (Firstwordpharma Press Release) - "Inhibrx Biosciences may be close to spinning off another portion of its pipeline. Its shares jumped about 37% on Wednesday after a report from Reuters detailed interest from several pharmas, including Merck & Co., in buying a pair of experimental cancer drugs from the biotech. According to people familiar with the matter, the deal could be worth $9 billion, including a $1-billion price tag for ozekibart (INBRX-109) and $8 billion for INBRX-106, a hexavalent OX40 agonist....In addition to Merck, the German drugmaker Merck KGaA and Japanese firm Ono Pharmaceuticals are also reportedly interested in Inhibrx's cancer assets."

Commercial • Oncology

Inhibrx Biosciences…announced that it will host a live webcast presentation on Tuesday, April 21, 2026 at 1:30 p.m. Pacific Time to provide a clinical update from its Phase 1/2 study evaluating ozekibart (INBRX-109) in combination with FOLFIRI in patients with locally advanced or metastatic, unresectable colorectal cancer (CRC) (PRNewswire)

P1/2 data • Colorectal Cancer

Inhibrx Provides Clinical Update on Ozekibart (INBRX-109) in Late Line Colorectal Cancer (PRNewswire) - "Efficacy was assessed in 45 evaluable patients, resulting in an ORR of 20% per RECIST v1.1 criteria. Historically, the current standard of care has yielded limited response rates (ORR of 1-6% per RECIST v1.1 criteria). Nearly half of responses were durable with a duration of response exceeding 6 months....The median PFS for the evaluable population was 5.5 months. Notably, 42% of patients remained progression-free at the 6-month landmark, with 9 patients remaining on therapy....The overall disease control rate (partial responses and stable disease as best response) remained robust at 87%, further supporting the potential of ozekibart to control tumor growth in a heavily pre-treated population."

P1/2 data • Colorectal Cancer

Inhibrx plans to meet with the U.S. Food and Drug Administration (FDA) in the second half of 2026 to discuss plans to initiate a first-line registrational trial in CRC (PRNewswire) - "The Company also plans to discuss with the FDA the potential for accelerated regulatory pathways for ozekibart in fourth-line colorectal cancer and in refractory Ewing sarcoma."

FDA event • New trial • Colorectal Cancer • Ewing Sarcoma

A DR5-targeting ADC exhibits superior anti-tumor activity and potentially better therapeutic window (AACR 2026) - "Later in a study of advanced Ewing sarcoma, Ozekibart combined with irinotecan and temozolomide demonstrated improved clinical benefit with an ORR of 64% and a DCR of 92%. Finally, this ADC showed better in vivo safety profile: lower on-target off-tumor apoptosis, longer half-life and better tolerability in comparison with that of INBRX109,suggesting a potentially wider therapeutic window. These results may support progression of this novel DR5-tageting ADC into clinical development as a potentially more potent and safer DR5-targeted therapy."

ADC • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor

Additionally, the Company submitted a Biologics License Application (BLA) to the FDA for ozekibart in conventional chondrosarcoma in April 2026 (PRNewswire)

FDA filing • Chondrosarcoma

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

Upcoming Milestones: ozekibart (INBRX-109) (PRNewswire) - "(i) We expect to submit the Biologics License Application ('BLA') for ozekibart for the treatment of unresectable or metastatic conventional chondrosarcoma to the U.S. Food and Drug Administration ('FDA') early in the second quarter of 2026; (ii) We plan to announce progression-free survival ('PFS') data for the Phase 1/2 colorectal cancer expansion cohort in the second quarter of 2026; and (iii) We plan to meet with the FDA to discuss accelerated approval for Ewing Sarcoma and fourth line colorectal cancer in the second half of 2026."

FDA event • FDA filing • P1/2 data • Chondrosarcoma • Colorectal Cancer • Ewing Sarcoma

Results from a phase I trial with ozekibart added to standard chemotherapy indicate encouraging efficacy and safety in adolescents and adults with Ewing sarcoma, according to a presentation at the ESMO Sarcoma and Rare Cancers Congress 2026 (Lugano, 12–14 March) (Abstract 84MO) (Daily Reporter) - "As presented at the Congress, treatment with ozekibart added to irinotecan and temozolomide resulted in an objective response rate (ORR) of 64.5% (all partial responses) in 31 evaluable patients with relapsed/refractory classical Ewing sarcoma, including those who had disease progression on prior irinotecan–temozolomide regimens. The disease control rate was 87.1% and one patient remained progression free after more than 2 years of treatment."

P1 data • Ewing Sarcoma

Inhibrx Announces Participation in Upcoming Scientific Conference (PRNewswire) - "ESMO Sarcoma and Rare Cancers Congress; March 12th- 14th, 2026; Lugano Switzerland; Title: Phase 1 Study of the Tetravalent Death Receptor 5 (DR5) Agonist Ozekibart (INBRX-109) Combined With Irinotecan (I) and Temozolomide (T) in Adolescents and Adults With Ewing Sarcoma; Abstract number: 84MO."

P1 data • Ewing Sarcoma

ChonDRAgon: Study of INBRX-109 in Conventional Chondrosarcoma (clinicaltrials.gov) - P2 | N=206 | Active, not recruiting | Sponsor: Inhibrx Biosciences, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Sarcoma • Solid Tumor