SAN DIEGO, January 13, 2021 / PRNewswire / – Inhibrx, Inc. (Inhibrx), a clinical biotechnology company with a broad line of biotherapeutic products under development, announced today that the US Food and Drug Administration (FDA) has awarded the Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma. INBRX-109 is a therapeutic candidate based on a single domain tetravalent antibody (sdAb) that agonizes the death receptor 5 (DR5) to induce selective programmed tumor cell death.
The Fast Track designation is granted by the FDA upon request from the sponsor to facilitate development and expedite the review of drugs intended for the treatment of serious or potentially fatal diseases. Depending on the stage of product development, the sponsor must also provide the FDA with non-clinical or clinical data to demonstrate the drug’s potential to meet the unmet medical needs of such a disease or condition. Research drugs under the name Fast Track can benefit from early and frequent communication with the FDA and are eligible for continuous submission and review by the FDA of its future marketing application. The designation was granted to INBRX-109 based on preliminary data from the chondrosarcoma expansion cohort of the INBRX-109 Phase 1 clinical trial.
“There are currently no approved agents for the treatment of conventional unresectable or metastatic chondrosarcoma, and we are excited about the potential of this treatment to significantly improve the outcome for patients,” he said. Mark Lappe, CEO of Inhibrx. “We look forward to working closely with the FDA during the clinical development of INBRX-109.”
A Phase 2 study that allows the registration 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 outcome. Inhibrx expects to start the dosage of patients in this study, which allows registration in the second or third trimester of this year.
About Inhibrx sdAb platform
Inhibrx uses several methods of protein engineering in the construction of therapeutic candidates that can meet the specific requirements of complex targets and disease biology. A key tool in this effort is the sdAb platform owned by Inhibrx, which allows the development of therapeutic candidates with attributes superior to other approaches to monoclonal antibodies and fusion proteins. This platform allows the combination of multiple binding units in a single molecule, allowing the creation of therapeutic candidates with defined valence or multiple specificities, potentially capable of enhanced cell signaling or conditional activation. An added benefit of this platform, these optimized and multifunctional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.
Initially, Inhibrx is looking for targets with early clinical validation, such as DR5, where other therapies have shown risks. In addition, Inhibrx is developing a portfolio of therapeutic candidates based on sdAb in a variety of indications for known and new targets.
About Inhibrx, Inc.
Inhibrx is a clinical stage biotechnology company focused on developing a wide range of biological therapeutic candidates. Inhibrx uses several protein engineering methods to therapeutically address the specific requirements of the complex target and disease biology, including its proprietary sdAb platform. Inhibrx’s pipeline is currently focused on oncology and orphan diseases. Inhibrx has collaborations with bluebird bio, Celgene and Chiesi. For more information, visit www.inhibrx.com.
Inhibrx warns that the statements contained in this press release relating to 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: judgments and beliefs of Inhibrx and its investigators regarding the safety and observed or potential effectiveness of its therapeutic candidates in clinical trials and beliefs about the future clinical development of INBRX- 109, including their ability to conduct any study that makes registration possible. Actual results may differ from those set out in this press release due to the risks and uncertainties inherent in Inhibrx’s business, including, without limitation, risks and uncertainties regarding: start, time, progress and results of your pre-clinical studies and clinical trials , and its research and development programs; its ability to present therapeutic candidates and successfully complete clinical trials; your interpretation of initial, provisional, or preliminary data from your clinical trials, including interpretations of disease control and disease response; the timing or likelihood of regulatory registrations and approvals; the successful commercialization of its therapeutic candidates, if approved; the price, coverage and reimbursement of your therapeutic candidates, if approved; its ability to use its technology platform to generate and promote additional therapeutic candidates; the implementation of its business model and 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 contract with third-party suppliers and manufacturers and its ability to perform properly; the scope of protection it can establish and maintain for the intellectual property rights that cover its therapeutic candidates; its ability to enter into strategic partnerships and the potential benefits of those partnerships; its estimates of expenses, capital requirements and additional financing needs and financial performance; their expectations regarding the impact of the COVID-19 pandemic on their business; and other risks described in Inhibrx’s filings with the United States Securities and Exchange Commission (the “SEC”), including under the heading “Risk factors” on Inhibrx Form 10-Q for the quarter ended September 30, 2020 filed with the SEC in November 13, 2020 and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this document, and Inhibrx assumes no obligation to update these statements to reflect events that occur or circumstances that exist after the date of this document. All forward-looking statements are qualified in their entirety by this precautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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SOURCE Inhibrx Inc. / Juniper Point