Inhibrx Launches Potential Phase 2 Study Enabling INBRX-109 Registration in Patients With Conventional Chondrosarcoma, Updates Data From Ongoing Phase 1 Study, Announces Amended Loan Agreement With Oxford
SAN DIEGO, June 21, 2021 / PRNewswire / – InhibRx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development, announced the launch of a potential Phase 2 study to register INBRX-109 in chondrosarcoma conventional.
INBRX-109 is a precisely engineered tetravalent death receptor 5 (DR5) agonist antibody designed to exploit tumor-biased cell death induced by activation of DR5.
Chondrosarcoma is an orphan bone cancer with approximately 2,800 new patients diagnosed each year in United States and the European Union. There is currently no approved therapy for the treatment of chondrosarcoma.
In January 2021The United States Food and Drug Administration (FDA) has granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma.
Inhibrx provided updated results from an ongoing Phase 1 clinical trial evaluating the efficacy and safety of INBRX-109 in patients with conventional chondrosarcoma. Additional data will be presented at the Connective Tissue Oncology Society (CTOS) annual conference to be held on November 10-13, 2021.
- Disease control was observed in 14 of 16 patients (87.5%). Two patients (12.5%) achieved partial responses and 12 of 16 patients (75%) had stable disease as measured by RECISTv1.1.
- Based on the preliminary results of the ongoing phase 1 study, the median progression-free survival (PFS) is 7.6 months and the median overall survival has not been reached.
- Three patients exceeded 52 weeks of treatment with INBRX-109, 62 weeks being the longest duration of stable disease observed to date, with the patient still in the study.
- The safety and tolerability profile in conventional chondrosarcoma was favorable with only 1 in 16 patients presenting a transient sign of low grade and fully reversible hepatotoxicity.
- The trial is ongoing with 12 additional locations added for patients with IDH1 or IDH2 mutations to support ongoing biomarker discovery efforts.
A randomized, blinded, placebo-controlled, potentially registrable phase 2 trial of INBRX-109 in conventional chondrosarcoma began this month. The main objective of this trial is to assess the anticancer efficacy of INBRX-109, as measured by PFS according to RECISTv1.1 and evaluated by an independent central radiological review. Patients with disease progression on placebo may be able to switch to INBRX-109. An interim analysis will take place after 50% of the planned PHC events have been observed.
In addition, at the start of this study, Inhibrx’s loan agreement with Oxford Finance was amended and $ 40 million additional principal was received by Inhibrx on June 18, 2021.
About Inhibrx, Inc.
Inhibrx is a clinical-stage biotechnology company focused on the development of a broad portfolio of novel biological therapeutic candidates in oncology and orphan diseases. Inhibrx uses a variety of protein engineering methods to meet the specific requirements of complex target and disease biology, including its proprietary sdAb platform. Inhibrx has collaborations with bluebird bio, Bristol-Myers Squibb and Chiesi. For more information, please visit www.inhibrx.com.
Inhibrx cautions you that statements in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx’s current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding: the judgments and beliefs of Inhibrx and its investigators regarding the safety and efficacy observed to date of its therapeutic candidate, INBRX-109, discussions with the United States Food and Drug Administration, and statements and beliefs regarding the future clinical development of INBRX-109, including statements that the phase 2 trial allows for the registration and presumption of positive results Phase 1 clinical trials. Actual results may differ from those presented in this press release due to the risks and uncertainties inherent in Inhibrx’s business, including, without limitation, risks and uncertainties relating to: the launch , the timing, progress and results of its preclinical studies and clinical trials, and its research and development programs; its ability to advance and complete therapeutic candidates in clinical trials; its interpretation of initial, interim or preliminary data from its clinical trials, including interpretations regarding disease control and disease response; the timing or likelihood of regulatory filings and approvals; the successful commercialization of its therapeutic candidates, if approved; the pricing, coverage and reimbursement of its therapeutic candidates, if approved; its ability to use its technology platform to generate and advance additional therapeutic candidates; the implementation of its business model and its strategic plans for its business and therapeutic candidates; its ability to successfully manufacture therapeutic candidates for clinical trials and commercial use, if approved; its ability to enter into contracts with third party suppliers and manufacturers and their ability to function properly; the extent of the protection it is able to establish and maintain for intellectual property rights covering its therapeutic candidates; its ability to enter into strategic partnerships and the potential benefits of such partnerships; its estimates of expenditures, capital requirements, and additional funding and financial performance requirements; its expectations regarding the impact of the COVID-19 pandemic on its business; and other risks described in documents filed by Inhibrx with the United States Securities and Exchange Commission (the “SEC”), including under the heading “Risk Factors” in Inhibrx’s Annual Report on Form 10 -K for the fiscal year ended December 31, 2020, as filed with the second. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx makes no commitment to update such statements to reflect events that occur or circumstances that occur. exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release contains estimates and other statistical data produced. by independent parties and by Inhibrx. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.
Investor and media contact:
Kelly Bridge, CFO
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