Registration-enabling study expected to begin dosing in the second or third quarter of this year
SAN DIEGO, Jan. 13, 2021 /PRNewswire/ -- Inhibrx, Inc. (Inhibrx), a clinical-stage biotechnology company with a broad pipeline of biotherapeutics in development, announced today the U.S. Food and Drug Administration (FDA) granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma. INBRX-109 is a precisely engineered tetravalent single domain antibody (sdAb)-based therapeutic candidate that agonizes death receptor 5 (DR5) to induce tumor selective programmed cell death.
Fast Track designation is granted by the FDA upon the request of the sponsor to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening diseases. Depending upon the stage of the product's development, the sponsor must also provide FDA with nonclinical or clinical data to demonstrate the drug's potential to address unmet medical needs for such a disease or condition. Investigational drug products with Fast Track designation may benefit from early and frequent communication with the FDA, and are eligible for rolling submission and FDA review of its future marketing application. The designation was granted to INBRX-109 based on preliminary data from the chondrosarcoma expansion cohort of the Phase 1 clinical trial of INBRX-109.
"There are currently no approved agents for the treatment of unresectable or metastatic conventional chondrosarcoma, and we are excited about the potential of this treatment to meaningfully improve the outcome for patients," said Mark Lappe, CEO of Inhibrx. "We look forward to working closely with the FDA throughout the clinical development of INBRX-109."
A potential registration-enabling Phase 2 study of INBRX-109 has been discussed with the FDA and will be designed as a randomized, blinded, placebo-controlled study in unresectable or metastatic conventional chondrosarcoma with progression-free survival as the primary endpoint. Inhibrx expects to start dosing patients in this potentially registration-enabling study in the second or third quarter of this year.
About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities, potentially capable of enhanced cell signaling or conditional activation. An additional benefit of this platform, these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.
Initially, Inhibrx is pursuing targets with early clinical validation, such as DR5, where other therapeutics have demonstrated liabilities. In addition, Inhibrx is developing a portfolio of sdAb based therapeutic candidates in a variety of indications for both known and novel targets.
About Inhibrx, Inc.
Inhibrx is a clinical-stage biotechnology company focused on developing a broad pipeline of biologic therapeutic candidates. Inhibrx utilizes diverse methods of protein engineering to therapeutically address the specific requirements of complex target and disease biology, including its proprietary sdAb platform. The Inhibrx pipeline is currently focused on oncology and orphan diseases. Inhibrx has collaborations with bluebird bio, Celgene and Chiesi. For more information, please visit www.inhibrx.com.
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