I-Mab Announces Accelerated Givastomig Phase 1b Study Progress
I-Mab (NASDAQ: IMAB) has announced accelerated progress in its Phase 1b givastomig study, with completed enrollment in the first dose expansion cohort ahead of schedule and continued momentum in the second cohort. The study evaluates givastomig, a Claudin 18.2 x 4-1BB bispecific antibody, for first-line gastric cancer treatment.
The Phase 1b program consists of a dose escalation study (n=17) and a dose expansion study (n=40). Topline data from the dose escalation study is expected in 2H 2025, while results from the 40-patient dose expansion study are anticipated in 1H 2026.
The study aims to assess givastomig's safety, preliminary efficacy, and pharmacokinetics in combination with standard care (nivolumab plus chemotherapy). Early data shows encouraging results, with the drug demonstrating activity across various CLDN18.2 expression levels and favorable tolerability when combined with chemotherapy and anti-PD-1 checkpoint inhibitors.
I-Mab (NASDAQ: IMAB) ha annunciato progressi accelerati nel suo studio di fase 1b su givastomig, con il completamento dell'arruolamento nella prima coorte di espansione della dose prima del previsto e un continuo slancio nella seconda coorte. Lo studio valuta givastomig, un anticorpo bispecifico Claudin 18.2 x 4-1BB, per il trattamento del cancro gastrico in prima linea.
Il programma di fase 1b consiste in uno studio di escalation della dose (n=17) e uno studio di espansione della dose (n=40). I dati preliminari dello studio di escalation della dose sono attesi per il secondo semestre del 2025, mentre i risultati dello studio di espansione della dose con 40 pazienti sono previsti per il primo semestre del 2026.
Lo studio ha l'obiettivo di valutare la sicurezza di givastomig, l'efficacia preliminare e la farmacocinetica in combinazione con le cure standard (nivolumab più chemioterapia). I dati preliminari mostrano risultati incoraggianti, con il farmaco che dimostra attività attraverso vari livelli di espressione di CLDN18.2 e una tollerabilità favorevole quando combinato con chemioterapia e inibitori del checkpoint anti-PD-1.
I-Mab (NASDAQ: IMAB) ha anunciado un progreso acelerado en su estudio de fase 1b sobre givastomig, con la finalización de la inscripción en la primera cohorte de expansión de dosis antes de lo previsto y un impulso continuo en la segunda cohorte. El estudio evalúa givastomig, un anticuerpo bispecífico Claudin 18.2 x 4-1BB, para el tratamiento del cáncer gástrico de primera línea.
El programa de fase 1b consiste en un estudio de escalada de dosis (n=17) y un estudio de expansión de dosis (n=40). Se esperan datos preliminares del estudio de escalada de dosis para la segunda mitad de 2025, mientras que los resultados del estudio de expansión de dosis con 40 pacientes se anticipan para la primera mitad de 2026.
El estudio tiene como objetivo evaluar la seguridad de givastomig, la eficacia preliminar y la farmacocinética en combinación con el tratamiento estándar (nivolumab más quimioterapia). Los datos iniciales muestran resultados alentadores, con el medicamento demostrando actividad a través de varios niveles de expresión de CLDN18.2 y una tolerabilidad favorable cuando se combina con quimioterapia e inhibidores de puntos de control anti-PD-1.
I-Mab (NASDAQ: IMAB)는 givastomig에 대한 1b상 연구에서 가속화된 진행 상황을 발표했으며, 첫 번째 용량 확장 집단의 등록이 예정보다 일찍 완료되었고 두 번째 집단에서도 지속적인 추진력을 보이고 있습니다. 이 연구는 위암 1차 치료를 위한 Claudin 18.2 x 4-1BB 이중 특이성 항체인 givastomig를 평가합니다.
1b상 프로그램은 용량 증가 연구(n=17)와 용량 확장 연구(n=40)로 구성되어 있습니다. 초기 데이터는 용량 증가 연구에서 2025년 하반기에 예상되며, 40명의 환자를 대상으로 한 용량 확장 연구의 결과는 2026년 상반기에 예상됩니다.
이 연구의 목표는 표준 치료(nivolumab과 화학요법)와 함께 givastomig의 안전성, 초기 효능 및 약동학을 평가하는 것입니다. 초기 데이터는 다양한 CLDN18.2 발현 수준에서 약물이 활성을 나타내고 화학요법 및 항-PD-1 체크포인트 억제제와 함께 사용 시 유리한 내약성을 보이는 등 고무적인 결과를 보여줍니다.
I-Mab (NASDAQ: IMAB) a annoncé des progrès accélérés dans son étude de phase 1b sur le givastomig, avec un recrutement achevé dans la première cohorte d'expansion de dose avant la date prévue et un élan continu dans la deuxième cohorte. L'étude évalue le givastomig, un anticorps bispécifique Claudin 18.2 x 4-1BB, pour le traitement du cancer gastrique de première ligne.
Le programme de phase 1b se compose d'une étude d'escalade de dose (n=17) et d'une étude d'expansion de dose (n=40). Les données préliminaires de l'étude d'escalade de dose sont attendues pour la deuxième moitié de 2025, tandis que les résultats de l'étude d'expansion de dose avec 40 patients sont anticipés pour la première moitié de 2026.
L'étude vise à évaluer la sécurité du givastomig, son efficacité préliminaire et sa pharmacocinétique en combinaison avec le traitement standard (nivolumab plus chimiothérapie). Les données préliminaires montrent des résultats encourageants, le médicament démontrant une activité à travers divers niveaux d'expression de CLDN18.2 et une tolérabilité favorable lorsqu'il est associé à la chimiothérapie et aux inhibiteurs de point de contrôle anti-PD-1.
I-Mab (NASDAQ: IMAB) hat einen beschleunigten Fortschritt in seiner Phase 1b-Studie zu givastomig angekündigt, mit einem vorzeitigen Abschluss der Rekrutierung in der ersten Dosis-Erweiterungsgruppe und anhaltendem Schwung in der zweiten Gruppe. Die Studie bewertet givastomig, einen bispezifischen Antikörper Claudin 18.2 x 4-1BB, zur Erstlinienbehandlung von Magenkrebs.
Das Phase 1b-Programm besteht aus einer Dosissteigerungsstudie (n=17) und einer Dosis-Erweiterungsstudie (n=40). Erste Daten aus der Dosissteigerungsstudie werden für die zweite Hälfte 2025 erwartet, während die Ergebnisse der Dosis-Erweiterungsstudie mit 40 Patienten für die erste Hälfte 2026 antizipiert werden.
Die Studie zielt darauf ab, die Sicherheit, die vorläufige Wirksamkeit und die Pharmakokinetik von givastomig in Kombination mit der Standardbehandlung (nivolumab plus Chemotherapie) zu bewerten. Erste Daten zeigen ermutigende Ergebnisse, wobei das Medikament in verschiedenen CLDN18.2-Expressionsniveaus aktiv ist und eine günstige Verträglichkeit in Kombination mit Chemotherapie und Anti-PD-1-Checkpoint-Inhibitoren zeigt.
- Enrollment completed ahead of schedule in first dose expansion cohort
- Strong recruitment momentum in second expansion cohort
- Early data shows encouraging results
- Drug demonstrates activity across various CLDN18.2 expression levels
- Good tolerability with standard chemotherapy and checkpoint inhibitors
- Final results not expected until 1H 2026
- Still in early Phase 1b stage
- Efficacy data not yet available
Insights
I-Mab's Phase 1b study for givastomig in gastric cancer is advancing more rapidly than anticipated, with enrollment completed ahead of schedule in the first dose expansion cohort and momentum continuing with the first patient dosed in the second cohort. This acceleration in clinical development suggests strong investigator interest and patient eligibility, which are positive indicators for a clinical program.
The study design spans both dose escalation (n=17) and dose expansion (n=40), with the former already fully enrolled and data expected in 2H 2025. The bispecific antibody targeting Claudin 18.2 x 4-1BB is being evaluated in combination with standard of care chemotherapy plus nivolumab (anti-PD-1) in first-line gastric cancer – a strategic positioning that could maximize market potential if successful.
What's particularly noteworthy is that givastomig reportedly shows activity across varying CLDN18.2 expression levels, potentially addressing a limitation of other Claudin 18.2-targeted therapies that typically require high expression. This broader applicability could significantly expand the eligible patient population, a important differentiator in a competitive landscape.
While the absence of interim efficacy signals limits our ability to assess clinical value, the commentary from both the company's CMO and an external academic expert (MGH's Dr. Klempner) suggests optimism about the drug's tolerability profile and potential efficacy. However, investors should note that meaningful clinical data is still distant, with topline results not expected until 1H 2026.
The accelerated enrollment in I-Mab's Phase 1b givastomig program represents a modest positive operational development for this micro-cap biotech (
Financially, this acceleration could modestly improve I-Mab's capital efficiency by potentially shortening the development timeline, though the impact on cash runway is likely minimal given that topline results remain scheduled for 1H 2026. The company hasn't revealed burn rate details in this release, but micro-cap oncology biotechs typically require significant capital to advance clinical programs.
Strategically, givastomig's first-line positioning in combination with standard care represents an ambitious but potentially high-reward approach. Success in this setting would maximize commercial potential, but also elevates clinical hurdles compared to later-line development. The dual-targeting mechanism (CLDN18.2 x 4-1BB) differentiates it from competing single-target Claudin 18.2 antibodies currently in development.
The commentary from an external expert (Dr. Klempner) adds credibility to the program's potential advantages, particularly regarding activity across broader CLDN18.2 expression levels. This could represent a meaningful commercial advantage if validated in larger studies.
While today's announcement lacks efficacy data, the dose escalation readout expected in 2H 2025 will provide the first meaningful efficacy and safety signal for this asset, representing the next significant catalyst for investor assessment of givastomig's potential.
- Enrollment completed ahead of schedule in the first dose expansion cohort
- Momentum continues with first patient dosed in the second expansion cohort
- Topline results from the 40-patient dose expansion study expected in 1H 2026
- Phase 1b dose escalation data expected to be presented in 2H 2025
ROCKVILLE, Md., March 07, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced that enrollment has been completed ahead of schedule in the first dose expansion cohort in the Phase 1b givastomig combination study, with continued momentum in the second dose expansion cohort. The Phase 1b study is evaluating givastomig, a potential best-in-class, Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, targeting CLDN18.2-expressing tumor cells for the treatment of gastric cancer in the first-line (1L) setting. The Phase 1b program includes a dose escalation study (n=17) and a dose expansion study (n=40). Enrollment in the dose escalation study is complete, and topline data are expected in the second half of 2025.
“The Phase 1b clinical program continues to show encouraging early data, with strong recruitment momentum. Enrollment in the first dose expansion cohort was completed months ahead of schedule and we are observing a similar rate of recruitment in the second expansion cohort,” said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. “We hope that the data from these studies will help to establish the optimal dosing regimen and demonstrate givastomig’s potential to provide improved efficacy in the first-line treatment of patients with gastric cancers.”
Sam Klempner, MD, Associate Professor of Medicine, Massachusetts General Hospital commented, “I believe the addition of novel Claudin 18.2-targeted therapies to existing standards has the potential to improve treatment outcomes for patients with gastric and gastroesophageal cancers. Givastomig’s activity across a range of CLDN18.2 expression levels and its overall tolerability in combination with standard chemotherapy and anti-PD-1 checkpoint inhibitors is encouraging and offers hope that we may be able to expand the population of patients benefitting from CLDN18.2-directed approaches. I look forward to ongoing participation in the Phase 1b clinical program and hope results of the study will validate the activity of a CLDN18.2 x 4-1BB bispecific strategy in gastroesophageal cancers.”
The Phase 1b program is designed to evaluate givastomig’s safety, preliminary efficacy and pharmacokinetics as a potential first-line treatment for gastric cancer in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy.
About Givastomig
Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting CLDN18.2-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first-line metastatic gastric cancers, with additional potential in other solid tumors. In a Phase 1 monotherapy study, reported at the European Society for Medical Oncology in September 2024 (ESMO 2024), givastomig was observed to maintain a strong tumor-binding property and anti-tumor activity, attributable to a potential synergistic effect of proximal interaction with CLDN18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents.
This program is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.
About I-Mab
I-Mab (NASDAQ: IMAB) is a US-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. I-Mab has established operations in Rockville, Maryland, and Short Hills, New Jersey. For more information, please visit https://www.i-mabbiopharma.com and follow us on LinkedIn and X.
I-Mab Forward Looking Statements
This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company’s pipeline and clinical development of I-Mab’s drug candidates, including givastomig, the projected advancement of the Company’s portfolio and anticipated milestones and related timing, the potential benefits of givastomig, and the availability of data and information from ongoing studies and trials. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab’s drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab’s reliance on third parties to conduct drug development, manufacturing and other services; and I-Mab’s limited operating history and I-Mab’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the “Risk Factors” section in I-Mab’s most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.
I-Mab Investor & Media Contacts
PJ Kelleher
LifeSci Advisors
+1-617-430-7579
pkelleher@lifesciadvisors.com
IR@imabbio.com
FAQ
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