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Inhibrx Biosciences Announces Preliminary Data from the Phase 1 Trial of ozekibart (INBRX-109) for the Treatment of Colorectal Cancer

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Inhibrx Biosciences (NASDAQ: INBX) has released preliminary data from its Phase 1 trial of ozekibart (INBRX-109) combined with FOLFIRI for treating advanced colorectal cancer. The trial showed promising results among 10 evaluated patients, including one complete response, three partial responses, and six stable disease cases. The study demonstrated durable disease control lasting ≥180 days in 46.2% of patients, with a median progression-free survival of 7.85 months.

Treatment-emergent adverse events related to ozekibart were reported in 84.6% of patients, mostly grade 1 or 2 in severity, with grade ≥3 events in 30.8% of patients. Common side effects included nausea, increased alanine aminotransferase, diarrhea, and fatigue. Based on these encouraging results, Inhibrx has initiated an expansion cohort to enroll up to 50 patients, with data expected in Q3 2025.

Inhibrx Biosciences (NASDAQ: INBX) ha rilasciato dati preliminari dal suo trial di Fase 1 di ozekibart (INBRX-109) combinato con FOLFIRI per il trattamento del cancro colorettale avanzato. Il trial ha mostrato risultati promettenti tra 10 pazienti valutati, inclusi una risposta completa, tre risposte parziali e sei casi di malattia stabile. Lo studio ha dimostrato un controllo della malattia duraturo della durata di ≥180 giorni nel 46,2% dei pazienti, con una sopravvivenza libera da progressione mediana di 7,85 mesi.

Eventi avversi emergenti dal trattamento legati a ozekibart sono stati segnalati nell'84,6% dei pazienti, per lo più di grado 1 o 2 di gravità, con eventi di grado ≥3 nel 30,8% dei pazienti. Gli effetti collaterali comuni includevano nausea, aumento dell'alanina aminotransferasi, diarrea e affaticamento. Sulla base di questi risultati incoraggianti, Inhibrx ha avviato una coorte di espansione per arruolare fino a 50 pazienti, con dati attesi nel terzo trimestre del 2025.

Inhibrx Biosciences (NASDAQ: INBX) ha publicado datos preliminares de su ensayo de Fase 1 de ozekibart (INBRX-109) combinado con FOLFIRI para el tratamiento del cáncer colorrectal avanzado. El ensayo mostró resultados prometedores entre 10 pacientes evaluados, que incluyeron una respuesta completa, tres respuestas parciales y seis casos de enfermedad estable. El estudio demostró un control duradero de la enfermedad, que se mantuvo ≥180 días en el 46,2% de los pacientes, con una mediana de supervivencia libre de progresión de 7,85 meses.

Se informaron eventos adversos emergentes del tratamiento relacionados con ozekibart en el 84,6% de los pacientes, la mayoría de grado 1 o 2 en severidad, con eventos de grado ≥3 en el 30,8% de los pacientes. Los efectos secundarios comunes incluyeron náuseas, aumento de alanina aminotransferasa, diarrea y fatiga. Basado en estos resultados alentadores, Inhibrx ha iniciado una cohorte de expansión para inscribir hasta 50 pacientes, con datos esperados en el tercer trimestre de 2025.

인히브릭스 바이오사이언스(NASDAQ: INBX)오제키바르트(INBRX-109)와 FOLFIRI를 결합한 진행성 대장암 치료를 위한 1상 시험의 초기 데이터를 발표했습니다. 이 시험은 10명의 평가된 환자 중 완전 반응 1건, 부분 반응 3건, 질병 안정 사례 6건을 포함하여 유망한 결과를 보여주었습니다. 연구는 환자의 46.2%에서 ≥180일 동안 지속적인 질병 조절을 입증했으며, 중간 무진행 생존 기간은 7.85개월이었습니다.

오제키바르트와 관련된 치료 유래의 부작용은 환자의 84.6%에서 보고되었으며, 대부분은 1도 또는 2도의 심각도로, 3도 이상의 사건은 환자의 30.8%에서 발생했습니다. 흔한 부작용으로는 메스꺼움, 알라닌 아미노 전이 효소 증가, 설사 및 피로가 포함됩니다. 이러한 고무적인 결과를 바탕으로, 인히브릭스는 최대 50명의 환자를 모집하기 위한 확장 집단을 시작했으며, 데이터는 2025년 3분기에 예상됩니다.

Inhibrx Biosciences (NASDAQ: INBX) a publié des données préliminaires de son essai de Phase 1 sur ozekibart (INBRX-109) combiné avec FOLFIRI pour le traitement du cancer colorectal avancé. L'essai a montré des résultats prometteurs parmi 10 patients évalués, y compris une réponse complète, trois réponses partielles et six cas de maladie stable. L'étude a démontré un contrôle durable de la maladie durant ≥180 jours chez 46,2 % des patients, avec une survie médiane sans progression de 7,85 mois.

Des événements indésirables liés au traitement avec ozekibart ont été signalés chez 84,6 % des patients, principalement de grade 1 ou 2 en gravité, avec des événements de grade ≥3 chez 30,8 % des patients. Les effets secondaires courants comprenaient des nausées, une augmentation de l'alanine aminotransférase, des diarrhées et de la fatigue. Sur la base de ces résultats prometteurs, Inhibrx a lancé une cohorte d'expansion pour recruter jusqu'à 50 patients, avec des données attendues au troisième trimestre 2025.

Inhibrx Biosciences (NASDAQ: INBX) hat vorläufige Daten aus seiner Phase-1-Studie zu ozekibart (INBRX-109) in Kombination mit FOLFIRI zur Behandlung von fortgeschrittenem kolorektalem Krebs veröffentlicht. Die Studie zeigte vielversprechende Ergebnisse bei 10 bewerteten Patienten, einschließlich einer kompletten Antwort, drei teils vollständigen Antworten und sechs stabilen Krankheitsfällen. Die Studie zeigte eine nachhaltige Krankheitskontrolle, die ≥180 Tage bei 46,2% der Patienten andauerte, mit einer medianen progressionsfreien Überlebenszeit von 7,85 Monaten.

Behandlungsbedingte Nebenwirkungen, die mit ozekibart in Zusammenhang stehen, wurden bei 84,6% der Patienten berichtet, wobei die meisten von Grad 1 oder 2 waren, während Ereignisse der Schwere Grad ≥3 bei 30,8% der Patienten auftraten. Häufige Nebenwirkungen waren Übelkeit, erhöhte Alanin-Aminotransferase, Durchfall und Müdigkeit. Basierend auf diesen ermutigenden Ergebnissen hat Inhibrx eine Erweiterungsgruppe begonnen, um bis zu 50 Patienten zu rekrutieren, wobei Daten im dritten Quartal 2025 erwartet werden.

Positive
  • Complete response achieved in one heavily pretreated patient
  • 40% overall response rate (4 out of 10 evaluated patients)
  • 7.85 months median progression-free survival
  • 46.2% of patients showed durable disease control lasting ≥180 days
  • Majority of adverse events were low-grade (grade 1 or 2)
Negative
  • 84.6% of patients experienced treatment-related adverse events
  • 30.8% of patients experienced grade ≥3 adverse events
  • Small initial patient sample size (only 10 evaluated patients)

Insights

The Phase 1 trial results for ozekibart (INBRX-109) represent a potentially significant development in the challenging landscape of advanced colorectal cancer treatment. The observed 40% objective response rate (4/10 patients showing complete or partial responses) is particularly impressive given the heavily pretreated patient population, where response rates to subsequent therapies typically fall below 20%.

The median progression-free survival of 7.85 months compares favorably to historical data for later-line treatments, where PFS typically ranges from 2-4 months. Most notably, the complete response in a patient who had failed three prior therapy lines and partial responses in FOLFIRI-refractory patients suggest ozekibart may overcome traditional resistance mechanisms.

For investors, several key aspects warrant attention:

  • The expansion cohort of 50 patients could provide validation data by Q3 2025, representing a significant near-term catalyst
  • The manageable safety profile, with predominantly grade 1-2 adverse events, supports potential combination strategies
  • Success in colorectal cancer, a major market with effective late-line options, could substantially increase INBX's market potential

The strategic decision to focus on patients with 2-3 prior therapy lines in the expansion cohort appears well-calculated, potentially positioning ozekibart in a more defined treatment setting where positive data could lead to accelerated development pathways. However, investors should note that these are early-stage results from a small patient population and larger studies will be needed for definitive efficacy assessment.

The preliminary efficacy signals from ozekibart merit attention from a clinical perspective. In colorectal cancer, where resistance to standard therapies remains a major challenge, achieving a complete response in a third-line setting is particularly noteworthy. The ability to elicit responses in FOLFIRI-refractory patients suggests a potentially complementary mechanism of action that could overcome existing resistance pathways.

The observed adverse event profile is encouraging:

  • The 84.6% TEAE rate with predominantly grade 1-2 events suggests acceptable tolerability
  • The specific adverse events (nausea, ALT elevation, diarrhea, fatigue) are generally manageable
  • The 30.8% grade ≥3 TEAE rate is within acceptable ranges for cancer therapeutics

The expansion cohort's design focusing on a more uniform patient population with 2-3 prior therapy lines is strategically sound. This could provide more definitive evidence of efficacy in a specific treatment setting where new options are urgently needed. The anticipated Q3 2025 data readout could be pivotal for determining the drug's potential in this indication.

SAN DIEGO, Jan. 21, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases, today announced preliminary efficacy and safety data from the Phase 1 trial of ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma (CRC). 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, based on RECIST v1.1 criteria. 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. All patients had received at least one prior line of systemic therapy (median: two; range: 1–6). 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.

Ozekibart-related treatment-emergent adverse events (TEAEs) were reported in 84.6% of patients, with most being grade 1 or 2 in severity. Grade ≥3 TEAEs were observed in 30.8% of patients. The most common ozekibart-related TEAEs included nausea, increased alanine aminotransferase, diarrhea, and fatigue, with the majority being low-grade.

Encouraged by these preliminary results, 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.

"We believe these interim results underscore the potential of ozekibart to provide meaningful clinical benefit for patients with advanced solid tumors, even in heavily pretreated populations. We are particularly encouraged by the durable disease control observed and look forward to further evaluating these findings in our expansion cohort," commented Josep Garcia, Chief Clinical Development Officer at Inhibrx.

About Colorectal Adenocarcinoma

Colorectal adenocarcinoma is the third most frequent cancer globally and the second leading cause of cancer-related death. According to the WHO, there were nearly 2,000,000 new cases of CRC in 2020, with nearly 1,000,000 deaths. Effective therapies beyond the second-line setting are limited. In the U.S., the five-year relative survival rate in patients with metastatic CRC is 15.7%, underscoring the need for better treatments.

About ozekibart (INBRX-109)

Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation.
In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, registration-enabling Phase 2 trial of ozekibart in metastatic, unresectable conventional chondrosarcoma, which is currently ongoing and expected to read out in the middle of this year. Additionally, in a Phase 1 trial, Inhibrx is investigating ozekibart in Ewing sarcoma in combination with irinotecan/temozolomide.

About Inhibrx Biosciences, Inc.

Inhibrx Biosciences is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates. Inhibrx Biosciences utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx Biosciences was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx Biosciences acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of Inhibrx Biosciences. Following such transactions, Inhibrx Biosciences' current clinical pipeline of therapeutic candidates includes ozekibart (INBRX-109) and INBRX-106, both of which utilize multivalent formats where the precise valency can be optimized in a target-centric way to mediate what we believe to be the most appropriate agonist function. Both programs have key data readouts expected in 2025. For more information, please visit www.inhibrx.com.

Forward-Looking Statements

Inhibrx cautions you that statements contained 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: Inhibrx's judgments and beliefs regarding the strength of Inhibrx's pipeline any future potential safety and efficacy of its therapeutic candidate, ozekibart; the clinical development of ozekibart, including expected enrollment in the expansion cohort and data readouts and the timing thereof; the potential demand for ozekibart and any presumption that preliminary data will be representative of final data or data in later clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: the initiation, timing, progress and results of its preclinical studies and clinical trials, and its research and development programs; its ability to advance therapeutic candidates into, and successfully complete, clinical trials; its interpretation of initial, interim or preliminary data from its clinical trials, including interpretations regarding disease control and disease response; results from preclinical studies or early clinical trials not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of its therapeutic candidates that may limit their development, regulatory approval and/or commercialization; the potential for its programs and prospects to be negatively impacted by developments relating to its competitors, including the results of studies or regulatory determinations relating to its competitors; the timing or likelihood of regulatory filings and approvals and regulatory developments in the U.S. and foreign countries; the successful commercialization of its therapeutic candidates, if approved; an accelerated development or approval pathway may not be available for ozekibart or other therapeutic candidates and any such pathway may not lead to a faster development process; it may not realize the benefits associated with orphan drug designation, including that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained; the pricing, coverage and reimbursement of its therapeutic candidates, if approved; its ability to utilize its technology platform to generate and advance additional therapeutic candidates; and other risks described from time to time in the "Risk Factors" section of its filings with the U.S. Securities and Exchange Commission, including those described in its Registration Statement on Form 10, as amended (File No. 001-42031), its Registration Statement on Form S-1, as amended and supplemented from time to time (File No. 333-280127), and its Quarterly Reports on Form 10-Q, and supplemented from time to time by its Current Reports on Form 8-K as filed from time to time. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx undertakes no obligation to update these statements to reflect events that occur or circumstances that 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.

Investor and Media Contact:

Kelly Deck, CFO
ir@inhibrx.com
858-795-4260

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SOURCE Inhibrx Biosciences, Inc.

FAQ

What are the key results from INBX's Phase 1 trial of ozekibart in colorectal cancer?

The trial showed one complete response, three partial responses, and six stable disease cases among 10 evaluated patients, with 46.2% achieving durable disease control lasting ≥180 days and a median progression-free survival of 7.85 months.

What are the main side effects reported in INBX's ozekibart Phase 1 trial?

The most common side effects included nausea, increased alanine aminotransferase, diarrhea, and fatigue. 84.6% of patients experienced treatment-related adverse events, mostly grade 1 or 2, with 30.8% experiencing grade ≥3 events.

When will INBX release data from the ozekibart expansion cohort?

Inhibrx expects to release data from the expansion cohort, which will enroll up to 50 patients, in Q3 2025.

How many patients were evaluated in INBX's Phase 1 trial of ozekibart?

The efficacy was assessed in 10 of 13 patients who received at least one dose of ozekibart in combination with FOLFIRI.

What is the significance of INBX's ozekibart trial results in previously treated patients?

The results are significant as responses were observed in heavily pretreated patients, including one complete response in a patient with three prior therapy lines and partial responses in patients who had failed prior FOLFIRI-based treatments.

Inhibrx Biosciences, Inc.

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