I-Mab to Present Short-Talk on Updated Givastomig Monotherapy Data at the 2025 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference
I-Mab (NASDAQ:IMAB) announced that an abstract with updated Phase 1 givastomig monotherapy data in heavily pre-treated gastroesophageal carcinoma (GEC) patients was accepted as a short-talk at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference, Oct 22-26, 2025 in Boston.
The presentation, titled Updated Safety, Efficacy and Biomarker Analysis from the Phase I Study of Givastomig, will be given by Samuel J. Klempner, MD on Thursday, October 23, 2025, 6:20–6:35 PM ET (Presentation B016, Hynes Convention Center).
The company said the Phase 1b dose expansion is fully enrolled and the data support a Phase 2 randomized strategy to combine givastomig with standard of care in first-line GEC across a broad range of Claudin 18.2 expression levels.
I-Mab (NASDAQ:IMAB) ha annunciato che un abstract con dati aggiornati sul monoterapia di givastomig nella fase 1 in pazienti con carcinoma gastroesofageo fortemente pretrattati (GEC) è stato accettato come short-talk al convegno AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference, dal 22 al 26 ottobre 2025, a Boston.
La presentazione, intitolata Aggiornata analisi di sicurezza, efficacia e biomarker dallo studio di fase I di Givastomig, sarà presentata da Samuel J. Klempner, MD, giovedì 23 ottobre 2025, dalle 18:20–18:35 ET (Presentation B016, Hynes Convention Center).
L'azienda ha dichiarato che l'espansione della dose della fase 1b è pienamente arruolata e i dati supportano una strategia randomizzata di fase 2 per combinare givastomig con la cura standard nella GEC in prima linea su un'ampia gamma di livelli di espressione di Claudin 18.2.
I-Mab (NASDAQ:IMAB) anunció que un resumen con datos actualizados de la monoterapia de givastomig en pacientes con carcinoma gastroesofágico (GEC) muy pretratados fue aceptado como short-talk en la conferencia AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference, del 22 al 26 de octubre de 2025 en Boston.
La presentación, titulada Actualización de seguridad, eficacia y análisis de biomarcadores del estudio de fase I de Givastomig, será presentada por Samuel J. Klempner, MD, el jueves 23 de octubre de 2025, de 6:20 a 6:35 PM ET (Presentación B016, Hynes Convention Center).
La empresa indicó que la expansión de dosis de la fase 1b está completamente inscrita y los datos respaldan una estrategia aleatorizada de fase 2 para combinar givastomig con el estándar de atención en GEC en primera línea, abarcando un amplio rango de niveles de expresión de Claudin 18.2.
I-Mab (NASDAQ:IMAB)은 고도 이전 치료를 받은 위식도암(GEC) 환자에서의 givastomig 단독 요법의 1상 데이터를 반영한 초록이 2025년 10월 22–26일 보스턴에서 열리는 AACR-NCI-EORTC 분자 표적 및 암 치료학 회의에서 short-talk로 채택되었다고 발표했다.
발표 제목은 1상 연구의 givastomig 안전성, 유효성 및 바이오마커 분석 업데이트이며, Samuel J. Klempner 박사가 2025년 10월 23일 목요일, 동부 시간 기준 6:20–6:35 PM에 발표할 예정이다(발표 B016, 하인즈 컨벤션 센터).
회사에 따르면 1b 용량 확장 연구는 전적으로 등록되었고, 데이터는 1차 라인에서 GEC에 대해 givastomig를 표준 치료와 결합하는 2상 무작위 전략을 뒷받침하며 Claudin 18.2 발현 수치의 광범위한 범위를 포괄한다.
I-Mab (NASDAQ:IMAB) a annoncé qu’un résumé contenant des données mises à jour de la Phase 1 sur la monothérapie givastomig chez des patients atteints de carcinome gastro-oesophagien (GEC) fortement prétraités a été accepté comme short-talk lors de la conférence AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference, du 22 au 26 octobre 2025 à Boston.
La présentation, intitulée Mise à jour de la sécurité, de l’efficacité et de l’analyse des biomarqueurs de l’étude de Phase I sur Givastomig, sera présentée par le Dr Samuel J. Klempner le jeudi 23 octobre 2025, de 18h20 à 18h35 ET (Présentation B016, Hynes Convention Center).
La société a déclaré que l’expansion de dose de la Phase 1b est entièrement recrutée et que les données soutiennent une stratégie randomisée de phase 2 pour combiner givastomig avec le traitement standard en première ligne de GEC sur une large plage de niveaux d’expression de Claudin 18.2.
I-Mab (NASDAQ:IMAB) gab bekannt, dass ein Abstract mit aktualisierten Phase-1-Daten zur Monotherapie mit Givastomig bei stark vorbehandelten Gastroesophageal-Carcinom (GEC) Patienten als Short-Talk auf der AACR-NCI-EORTC Conference zu Molekularen Zielen und Krebs-Therapien vom 22. bis 26. Oktober 2025 in Boston akzeptiert wurde.
Die Präsentation mit dem Titel Aktualisierte Sicherheit, Wirksamkeit und Biomarker-Analyse aus der Phase-I-Studie von Givastomig wird von Dr. Samuel J. Klempner am Donnerstag, dem 23. Oktober 2025, von 18:20 bis 18:35 Uhr ET präsentiert (Präsentation B016, Hynes Convention Center).
Das Unternehmen berichtete, dass die Phase-1b-Dosis-Expansion vollständig eingeschrieben ist und die Daten eine randomisierte Phase-2-Strategie unterstützen, Givastomig mit Standard of Care in der Erstlinienbehandlung von GEC über einen breiten Bereich von Claudin 18.2-Expressionsniveaus zu kombinieren.
I-Mab (NASDAQ:IMAB) أعلنت أن ملخصًا يحتوي على بيانات محدثة من المرحلة 1 لعلاج givastomig أحادي العلاج لدى مرضى سرطان المعدة والمريء الذين تلقوا علاجات سابقة بشكل كبير قد تم قبوله كـ حديث قصير في مؤتمر AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference، في الفترة من 22 إلى 26 أكتوبر 2025 في بوسطن.
سيُقدِّم العرض المسمى تحديث الأمان والفعالية وتحليل العلامات الحيوية من دراسة المرحلة الأولى لـ Givastomig البروفيسور Samuel J. Klempner، يوم الخميس 23 أكتوبر 2025، من الساعة 6:20 إلى 6:35 مساءً بالتوقيت الشرقي (العرض B016، Hynes Convention Center).
قالت الشركة إن التوسع في جرعة المرحلة 1b قد تم تسجيله بالكامل وأن البيانات تدعم استراتيجية عشوائية من المرحلة 2 لدمج givastomig مع الرعاية القياسية في الخط الأول من GEC عبر نطاق واسع من مستويات تعبير Claudin 18.2.
I-Mab（纳斯达克股票代码：IMAB）宣布，一项包含更新的 givastomig 一阶段单药治疗数据的摘要，针对经大量前期治疗的胃食管癌（GEC）患者，被接受为在 AACR-NCI-EORTC 分子靶点与癌症治疗会议（2025年10月22–26日，波士顿）上的< b>短讲。
题为“来自 givastomig 一期研究的安全性、有效性及生物标志物分析更新”的演讲，将由 Samuel J. Klempner 医学博士于 2025 年 10 月 23 日（美国东部时间）下午 6:20–6:35 发布（演讲 B016，Hynes Convention Center）。
公司表示，1b 期剂量扩展已完全招募，数据支持在 GEC 一线将 givastomig 与标准治疗相结合的二期随机策略，覆盖 Claudin 18.2 表达水平的广泛范围。
- None.
- None.
- The AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics to be held October 22-26 in Boston, Massachusetts
ROCKVILLE, Md., Oct. 14, 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 an abstract related to updated data from the Phase 1 study of givastomig as a monotherapy in heavily pre-treated patients with gastroesophageal carcinoma (GEC) has been accepted as a “short-talk” at the AACR-NCI-EORTC conference which will be held October 22-26 in Boston, Massachusetts.
“As we follow patients in the fully enrolled givastomig Phase 1b dose expansion study and advance the program towards the initiation of a randomized Phase 2 study in gastric cancers, we appreciate the opportunity to present additional Phase 1 data demonstrating givastomig’s monotherapy activity and engage with the oncology community. These data support our Phase 2 strategy to combine givastomig with standard of care in first line GEC patients with a broad range of Claudin 18.2 expression levels,” said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab.
AACR-NCI-EORTC Conference Information:
Title: Updated Safety, Efficacy and Biomarker Analysis from the Phase I Study of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Claudin 18.2 Positive Advanced Gastroesophageal Carcinoma (GEC)
Session: Concurrent Session 2: Bispecifics/T-cell Engagers
Speaker: Samuel J. Klempner, MD, Associate Professor of Medicine, Massachusetts General Hospital
Presentation Number: B016
Date and Time: Thursday, October 23, 6:20 – 6:35 PM ET
Location: Hynes Convention Center
About Givastomig
Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (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 (1L) metastatic gastric cancers, with further exploratory studies in other CLDN18.2-positive gastrointestinal tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.
Givastomig 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 U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB) designed to treat Claudin 18.2-positive gastric cancers. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for first-line metastatic gastric cancers and other Claudin 18.2-positive gastrointestinal tumors. Additionally, I-Mab is collaborating with its partner, ABL Bio, for the development of ragistomig, a bispecific antibody integrating PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator, in solid tumors.
For more information, please visit https://www.i-mabbiopharma.com and follow us on LinkedIn.
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. 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 potential benefits of I-Mab’s drug candidates, including givastomig; anticipated clinical milestones and results, including the timing of initiating clinical studies and reporting data from clinical 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; 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; and those risks more fully discussed in the “Risk Factors” section in I-Mab’s annual report on Form 20-F filed with the SEC on April 3, 2025 as well as the 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
When will I-Mab (IMAB) present givastomig Phase 1 data at AACR-NCI-EORTC 2025?
What topic will I-Mab (IMAB) cover in the AACR-NCI-EORTC short-talk on October 23, 2025?
Who is the speaker for I-Mab's (IMAB) givastomig presentation at AACR-NCI-EORTC 2025?
What development plans did I-Mab (IMAB) describe for givastomig after the Phase 1 update?
Where and how can investors see I-Mab's (IMAB) givastomig short-talk at AACR-NCI-EORTC 2025?
