Immunome Doses First Patient in Phase 1 Trial of IM-1021, a ROR1-Targeted ADC
Immunome (NASDAQ: IMNM) has initiated patient dosing in its Phase 1 clinical trial of IM-1021, a ROR1-targeted ADC (Antibody-Drug Conjugate). The first-in-human trial is designed as an open-label, multicenter study focusing on dose escalation and expansion to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1021.
The study will include patients with advanced B-cell lymphomas and advanced solid tumors. IM-1021 is an optimized ADC incorporating Immunome's proprietary TOP1 inhibitor, HC74, targeting patients with high unmet medical needs.
Immunome (NASDAQ: IMNM) ha avviato la somministrazione ai pazienti nel suo studio clinico di Fase 1 per IM-1021, un ADC (Coniugato Anticorpo-Farmaco) mirato a ROR1. Lo studio, il primo sui soggetti umani, è progettato come uno studio multicentrico e in aperto, focalizzato sull'aumento e l'espansione della dose per valutare la sicurezza, la tollerabilità, la farmacocinetica e l'attività antitumorale preliminare di IM-1021.
Lo studio includerà pazienti con linfomi a cellule B avanzati e tumori solidi avanzati. IM-1021 è un ADC ottimizzato che incorpora l'inibitore proprietario TOP1 di Immunome, HC74, destinato a pazienti con elevate esigenze mediche insoddisfatte.
Immunome (NASDAQ: IMNM) ha iniciado la dosificación de pacientes en su ensayo clínico de Fase 1 para IM-1021, un ADC (Conjugado Anticuerpo-Fármaco) dirigido a ROR1. El ensayo de primera en humanos está diseñado como un estudio multicéntrico y abierto, centrado en la escalación y expansión de dosis para evaluar la seguridad, tolerabilidad, farmacocinética y la actividad antitumoral preliminar de IM-1021.
El estudio incluirá pacientes con linfomas de células B avanzados y tumores sólidos avanzados. IM-1021 es un ADC optimizado que incorpora el inhibidor TOP1 de propiedad de Immunome, HC74, dirigido a pacientes con altas necesidades médicas insatisfechas.
Immunome (NASDAQ: IMNM)은 IM-1021의 1상 임상 시험에서 환자 투약을 시작했습니다. ROR1을 표적으로 하는 ADC(항체-약물 접합체)입니다. 이 첫 번째 인간 대상 시험은 개방형 다기관 연구로 설계되어 있으며, IM-1021의 안전성, 내약성, 약동학 및 초기 항종양 활성을 평가하기 위해 용량 증량 및 확장에 중점을 두고 있습니다.
이 연구는 진행성 B세포 림프종 및 진행성 고형 종양 환자를 포함합니다. IM-1021은 Immunome의 독점 TOP1 억제제 HC74를 포함한 최적화된 ADC로, 높은 의료적 요구가 있는 환자를 대상으로 하고 있습니다.
Immunome (NASDAQ: IMNM) a commencé l'administration de patients dans son essai clinique de Phase 1 pour IM-1021, un ADC (Conjugé Anticorps-Médicament) ciblant ROR1. Cet essai de première sur l'homme est conçu comme une étude multicentrique et ouverte, axée sur l'escalade et l'expansion des doses pour évaluer la sécurité, la tolérance, la pharmacocinétique et l'activité antitumorale préliminaire de IM-1021.
L'étude inclura des patients atteints de lymphomes à cellules B avancés et de tumeurs solides avancées. IM-1021 est un ADC optimisé incorporant l'inhibiteur TOP1 propriétaire d'Immunome, HC74, ciblant les patients ayant de grands besoins médicaux non satisfaits.
Immunome (NASDAQ: IMNM) hat die Patientenbehandlung in seiner Phase-1-Studie zu IM-1021, einem ROR1-zielgerichteten ADC (Antikörper-Wirkstoff-Konjugat), aufgenommen. Die erste klinische Studie am Menschen ist als offene, multizentrische Studie konzipiert, die sich auf die Dosissteigerung und -erweiterung konzentriert, um die Sicherheit, Verträglichkeit, Pharmakokinetik und die vorläufige antitumorale Aktivität von IM-1021 zu bewerten.
Die Studie wird Patienten mit fortgeschrittenen B-Zell-Lymphomen und fortgeschrittenen soliden Tumoren umfassen. IM-1021 ist ein optimiertes ADC, das Immunomes proprietären TOP1-Inhibitor HC74 integriert und sich an Patienten mit hohen ungedeckten medizinischen Bedürfnissen richtet.
- First patient dosed in Phase 1 trial, marking clinical development milestone
- Trial addresses high unmet medical needs in both blood cancers and solid tumors
- Proprietary technology platform with TOP1 inhibitor HC74
- Early-stage Phase 1 trial with no efficacy data yet
- Long development timeline ahead before potential commercialization
“Immunome is developing differentiated ADCs that we believe can greatly benefit cancer patients,” said Bob Lechleider, M.D., Chief Medical Officer at Immunome. “The dosing of our first patient with IM-1021 advances that mission, as we work to establish safety and explore efficacy of IM-1021 in patients with high unmet need in B-cell lymphomas and solid tumors.”
IM-1021 is an optimized, ROR1-targeted ADC that incorporates Immunome’s proprietary TOP1 inhibitor, HC74. The Phase 1 trial is an open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1021. The study is expected to include participants with advanced B-cell lymphomas and advanced solid tumors.
About Immunome
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors. For more information, visit www.immunome.com.
Cautionary Statement Regarding Forward-Looking Statements
Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “developing,” “believe,” “work to,” “explore,” “expected” and similar expressions to identify these forward-looking statements. These forward-looking statements include Immunome’s expectations regarding progress of its pipeline, the benefits and safety of its clinical programs, the timeline for regulatory filings, and other statements regarding forecasts for the future. These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, the risks and uncertainties described in Immunome’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 13, 2024, and in Immunome’s other filings with the SEC. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release.
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Investor Contact
Max Rosett
Chief Financial Officer
investors@immunome.com
Source: Immunome, Inc.
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