ORIC Pharmaceuticals Announces Clinical Supply Agreement to Evaluate ORIC-114 in Combination with Amivantamab for the First-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations
ORIC Pharmaceuticals announced a clinical supply agreement with Janssen Research & Development to evaluate ORIC-114 in combination with amivantamab for the first-line treatment of non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This Phase 1b trial is expected to begin in Q1 2025, with initial data anticipated by mid-2026.
The trial aims to assess the safety and tolerability of the combination therapy and determine the recommended Phase 2 dose (RP2D). ORIC will sponsor the trial, while Johnson & Johnson will supply amivantamab.
ORIC retains the development and commercial rights to ORIC-114 and may expand its use with other agents. The company highlighted that ORIC-114 has shown promising systemic and intracranial activity in heavily pre-treated patients with EGFR/HER2 mutated NSCLC. The trial will further explore its efficacy in the first-line setting, both as a monotherapy and in combination with amivantamab.
In 2024, ORIC completed the monotherapy dose escalation portion of the Phase 1b trial for ORIC-114 in patients with advanced solid tumors. Based on these data, two provisional RP2D levels (80 mg and 120 mg QD) were selected for further evaluation.
ORIC Pharmaceuticals ha annunciato un accordo di fornitura clinica con Janssen Research & Development per valutare ORIC-114 in combinazione con amivantamab per il trattamento in prima linea del cancro polmonare non a piccole cellule (NSCLC) con mutazioni di inserzione dell'esone 20 dell'EGFR. Questo trial di Fase 1b è previsto per iniziare nel primo trimestre del 2025, con dati iniziali attesi entro la metà del 2026.
Lo studio mira a valutare la sicurezza e la tollerabilità della terapia combinata e a determinare la dose raccomandata per la Fase 2 (RP2D). ORIC sponsorizzerà il trial, mentre Johnson & Johnson fornirà amivantamab.
ORIC mantiene i diritti di sviluppo e commercializzazione di ORIC-114 e potrebbe espandere il suo utilizzo con altri agenti. L'azienda ha sottolineato che ORIC-114 ha mostrato un'attività sistemica e intracranica promettente in pazienti pesantemente pre-trattati con mutazioni di EGFR/HER2 nel NSCLC. Lo studio esplorerà ulteriormente la sua efficacia in setting di prima linea, sia come monoterapia che in combinazione con amivantamab.
Nel 2024, ORIC ha completato la parte di escalation della dose di monoterapia del trial di Fase 1b per ORIC-114 in pazienti con tumori solidi avanzati. Sulla base di questi dati, sono stati selezionati due livelli provvisori di RP2D (80 mg e 120 mg QD) per ulteriori valutazioni.
ORIC Pharmaceuticals anunció un acuerdo de suministro clínico con Janssen Research & Development para evaluar ORIC-114 en combinación con amivantamab para el tratamiento de primera línea del cáncer de pulmón no microcítico (NSCLC) con mutaciones de inserción en el exón 20 del EGFR. Este ensayo de fase 1b se espera que comience en el primer trimestre de 2025, con datos iniciales anticipados para mediados de 2026.
El ensayo tiene como objetivo evaluar la seguridad y tolerabilidad de la terapia combinada y determinar la dosis recomendada para la fase 2 (RP2D). ORIC patrocinará el ensayo, mientras que Johnson & Johnson suministrará amivantamab.
ORIC retiene los derechos de desarrollo y comercialización de ORIC-114 y puede ampliar su uso con otros agentes. La compañía destacó que ORIC-114 ha mostrado una actividad sistémica e intracraneal prometedora en pacientes tratados en exceso con mutaciones de EGFR/HER2 en NSCLC. El ensayo explorará aún más su eficacia en el tratamiento de primera línea, tanto como monoterapia como en combinación con amivantamab.
En 2024, ORIC completó la parte de escalado de dosis de monoterapia del ensayo de fase 1b para ORIC-114 en pacientes con tumores sólidos avanzados. Con base en estos datos, se seleccionaron dos niveles provisionales de RP2D (80 mg y 120 mg QD) para una evaluación adicional.
ORIC 제약회사는 Janssen Research & Development와 협력하여 ORIC-114를 amivantamab와 병용하여 비소세포 폐암(NSCLC)에서 EGFR 엑손 20 삽입 변이를 가진 환자를 치료하기 위한 임상 공급 계약을 발표했습니다. 이 1b 단계 임상시험은 2025년 1분기에 시작될 예정이며, 초기 데이터는 2026년 중반에 예상됩니다.
이 시험의 목표는 병용 요법의 안전성 및 내약성을 평가하고 2상 권장 용량(RP2D)을 결정하는 것입니다. ORIC이 시험을 후원하며, Johnson & Johnson이 amivantamab를 공급할 것입니다.
ORIC는 ORIC-114에 대한 개발 및 상업적 권리를 보유하며, 다른 약물과 병용하여 사용을 확대할 수 있습니다. 이 회사는 ORIC-114가 EGFR/HER2 변이가 있는 비소세포 폐암 환자에서 유망한 전신 및 두개 내 활성을 보였다고 강조했습니다. 이 시험은 1차 치료에서의 단독 요법 및 amivantamab와의 병용 요법의 효능을 추가로 탐색할 것입니다.
2024년에 ORIC는 진행성 고형 종양 환자를 대상으로 한 ORIC-114의 단독 요법 용량 상승 부분을 완료했습니다. 이러한 데이터를 기반으로 두 개의 임시 RP2D 수준(80 mg 및 120 mg QD)이 추가 평가를 위해 선택되었습니다.
ORIC Pharmaceuticals a annoncé un accord de fourniture clinique avec Janssen Research & Development pour évaluer ORIC-114 en combinaison avec amivantamab pour le traitement de première ligne du cancer du poumon non à petites cellules (NSCLC) avec mutations d'insertion de l'exon 20 de l'EGFR. Cet essai de phase 1b devrait commencer au premier semestre 2025, avec des données initiales attendues d'ici mi-2026.
L'essai vise à évaluer la sécurité et la tolérance de la thérapie combinée et à déterminer la dose recommandée pour la phase 2 (RP2D). ORIC parrainera l'essai, tandis que Johnson & Johnson fournira amivantamab.
ORIC conserve les droits de développement et de commercialisation de ORIC-114 et peut élargir son utilisation avec d'autres agents. La société a souligné que ORIC-114 a montré une activité systémique et intracrânienne prometteuse chez les patients ayant subi de nombreux traitements avec mutations de l'EGFR/HER2 dans le NSCLC. L'essai explorera davantage son efficacité en première ligne, tant en monothérapie qu'en combinaison avec amivantamab.
En 2024, ORIC a terminé la partie d'escalade de dose de monothérapie de l'essai de phase 1b pour ORIC-114 chez des patients atteints de tumeurs solides avancées. Sur la base de ces données, deux niveaux provisoires de RP2D (80 mg et 120 mg QD) ont été sélectionnés pour une évaluation supplémentaire.
ORIC Pharmaceuticals gab eine klinische Versorgungsvereinbarung mit Janssen Research & Development bekannt, um ORIC-114 in Kombination mit amivantamab zur Erstlinienbehandlung von nicht-kleinzelligem Lungenkrebs (NSCLC) mit EGFR Exon 20 Einfügemutationen zu evaluieren. Diese Phase-1b-Studie soll im ersten Quartal 2025 beginnen, wobei erste Daten Mitte 2026 erwartet werden.
Die Studie zielt darauf ab, die Sicherheit und Verträglichkeit der Kombinationstherapie zu bewerten und die empfohlene Phase-2-Dosis (RP2D) zu bestimmen. ORIC wird die Studie unterstützen, während Johnson & Johnson amivantamab liefern wird.
ORIC behält die Entwicklungs- und Vertriebsrechte an ORIC-114 und könnte dessen Einsatz mit anderen Wirkstoffen erweitern. Das Unternehmen betonte, dass ORIC-114 in stark vorbehandelten Patienten mit EGFR/HER2 mutiertem NSCLC vielversprechende systemische und intrakraniellen Aktivitäten gezeigt hat. Die Studie wird die Wirksamkeit im Erstlinieneinsatz sowohl als Monotherapie als auch in Kombination mit amivantamab weiter untersuchen.
Im Jahr 2024 schloss ORIC den Teil der Dosissteigerung zur Monotherapie der Phase-1b-Studie für ORIC-114 bei Patienten mit fortgeschrittenen soliden Tumoren ab. Basierend auf diesen Daten wurden zwei vorläufige RP2D-Niveaus (80 mg und 120 mg QD) für weitere Bewertungen ausgewählt.
- ORIC Pharmaceuticals has entered into a clinical supply agreement with Janssen Research & Development.
- The Phase 1b trial will evaluate ORIC-114 in combination with amivantamab for first-line treatment of NSCLC with EGFR exon 20 insertion mutations.
- Initial data from the trial is expected by mid-2026.
- ORIC retains development and commercial rights to ORIC-114.
- The trial initiation is not expected until Q1 2025, with initial data not available until mid-2026, potentially leading to delays in market impact.
Insights
This clinical supply agreement marks a strategic move in the NSCLC treatment landscape. The combination of ORIC-114 with amivantamab targets a important unmet need in EGFR exon 20 insertion mutations, particularly significant given ORIC-114's demonstrated brain penetrance - a critical factor as brain metastases are common in EGFR-mutated NSCLC.
The two-pronged mechanism combining ORIC-114's EGFR/HER2 inhibition with amivantamab's EGFR-MET targeting could potentially provide superior efficacy compared to monotherapy approaches. The selection of 80 mg and 120 mg QD as provisional RP2D levels suggests a manageable safety profile, important for first-line treatment consideration.
For simpler understanding: Imagine a dual-action approach - ORIC-114 acts like a precise key that fits into specific locks (EGFR/HER2) in cancer cells, while amivantamab works like a targeted missile system. Together, they might provide a more comprehensive attack on cancer cells, including those that have spread to the brain.
This agreement represents significant value creation potential for ORIC Pharmaceuticals without substantial financial risk. The deal structure is particularly favorable as Johnson & Johnson provides the combination drug while ORIC maintains full development and commercial rights to ORIC-114. This arrangement preserves ORIC's flexibility to pursue additional combination studies with other agents.
The market cap of
Think of this like getting a free test drive of a premium vehicle (amivantamab) to showcase your own car's (ORIC-114) capabilities, with the potential to attract more partners and market opportunities while keeping all the benefits.
Phase 1b combination trial of ORIC-114 and subcutaneous amivantamab in patients with 1L NSCLC with EGFR exon 20 insertion mutations expected to initiate in Q1 2025, with initial data in mid-2026
SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Jan. 13, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that the company has entered into a supply agreement with Janssen Research & Development, LLC, a Johnson & Johnson company, to evaluate ORIC-114, a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor, in combination with subcutaneous (SC) amivantamab, Johnson & Johnson’s fully-human EGFR-MET bispecific antibody, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
Under the terms of the agreement, ORIC® will conduct and sponsor the trial and Johnson & Johnson will provide SC amivantamab. ORIC maintains development and commercial rights to ORIC-114 and is free to expand the program in combination with other agents.
“ORIC-114 has already demonstrated encouraging systemic and intracranial activity in heavily pre-treated patients with EGFR/HER2 mutated NSCLC,” said Jacob M. Chacko, MD, chief executive officer. “Given the prevalence of brain metastases across all lines of EGFR exon 20 NSCLC, we aim to further explore ORIC-114’s emerging profile in the first-line setting both as a monotherapy and in combination with SC amivantamab.”
ORIC expects to initiate the combination Phase 1b trial to evaluate the safety and tolerability of ORIC-114 in combination with SC amivantamab for the first-line treatment of patients with advanced NSCLC with EGFR exon 20 insertion mutations in the first quarter of 2025. The primary objectives are to determine the provisional recommended Phase 2 dose (RP2D) for the combination, and additional objectives include assessment of efficacy and further characterization of the safety profile of ORIC-114 in combination with SC amivantamab. The company expects to report initial data from the trial in mid-2026.
In 2024, the company announced the completion of the monotherapy dose escalation portion of the Phase 1b trial of ORIC-114 in patients with advanced solid tumors with EGFR and HER2 exon 20 alterations or HER2 amplifications. Based upon these data, ORIC selected the two provisional RP2D levels of ORIC-114 at 80 mg and 120 mg QD, which are being further evaluated in three dose expansion cohorts for dose optimization and final RP2D selection in patients with NSCLC with EGFR exon 20 (EGFR exon 20 inhibitor naïve), HER2 exon 20, or EGFR atypical mutations as well as an extension cohort for the treatment of patients with first-line, treatment-naïve EGFR exon 20 mutated NSCLC.
About ORIC-114
ORIC-114 is a highly selective, brain penetrant, orally bioavailable, irreversible inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, making it a promising therapeutic candidate to address the unmet medical need of having both meaningful systemic as well as CNS antitumor activity.
About ORIC Pharmaceuticals, Inc.
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-114, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers, and (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the continued clinical development of ORIC-114, including in combination with SC amivantamab; ORIC-114 clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; the development plans and timelines for ORIC-114 and ORIC’s other product candidates; the potential advantages of ORIC-114 and ORIC’s other product candidates and programs; plans underlying ORIC’s clinical trials and development; anticipated program milestones, including timing of program and data updates and the initiation of a Phase 1b trial evaluating ORIC-114 in combination with SC amivantamab; and statements by the company’s chief executive officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC’s plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC’s product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements or its clinical trial collaboration and supply agreements; the potential market for ORIC’s product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section titled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2024, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
Contact:
Dominic Piscitelli, Chief Financial Officer
dominic.piscitelli@oricpharma.com
info@oricpharma.com
FAQ
What is the focus of the clinical supply agreement announced by ORIC Pharmaceuticals?
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What are the objectives of the ORIC-114 and amivantamab combination trial?
What rights does ORIC Pharmaceuticals retain regarding ORIC-114?
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