I-Mab Completes Enrollment Ahead of Schedule in | U.S. Markets

I-Mab experiences early completion of enrollment in a Part 1b examine evaluating givastomig for gastric most cancers therapy.

Quiver AI Abstract

I-Mab has accomplished enrollment forward of schedule within the first cohort of its Part 1b dose growth examine, which evaluates the bispecific antibody givastomig for treating gastric most cancers. The examine targets CLDN18.2-expressing tumor cells and is progressing with the dosing of the primary affected person within the second cohort. Topline outcomes from the 40-patient dose growth examine are anticipated within the first half of 2026, whereas information from a dose escalation examine involving 17 sufferers are anticipated within the second half of 2025. I-Mab’s Chief Medical Officer famous encouraging preliminary information and speedy affected person recruitment, which suggests the potential for improved outcomes with givastomig together with customary chemotherapy and nivolumab. General, the scientific program goals to determine the security and efficacy of givastomig as a first-line therapy option.

Potential Positives

• Enrollment within the first dose growth cohort was accomplished forward of schedule, indicating sturdy curiosity and engagement within the examine.
• The momentum within the second dose growth cohort suggests ongoing progress within the scientific trial, doubtlessly accelerating development timelines.
• Topline outcomes from the continuing examine are anticipated within the first half of 2026, offering a timeline for future information disclosure that will improve investor confidence.
• The participation and optimistic remarks from a notable exterior professional, Dr. Sam Klempner, lend credibility to the efficacy and potential affect of givastomig on gastric most cancers therapy.

Potential Negatives

• Future scientific outcomes for givastomig stay unsure and will not help additional development or regulatory approval, posing a risk to investor confidence and project viability.
• There may be a reliance on third events for drug development, which introduces dangers associated to execution and timeline delays.
• The company acknowledges potential challenges in reaching business success, which can restrict the financial sustainability of its operations.

FAQ

What’s the current announcement from I-Mab concerning its Part 1b examine?

I-Mab introduced that enrollment was accomplished forward of schedule within the first dose growth cohort of its Part 1b examine.

What’s Givastomig and its function within the examine?

Givastomig is a bispecific antibody focusing on CLDN18.2-expressing tumor cells, developed for treating gastric most cancers within the first-line setting.

When are the topline outcomes from the Part 1b examine anticipated?

Topline outcomes from the 40-patient dose growth examine are anticipated within the first half of 2026.

What does the Part 1b program intention to guage?

This system goals to guage the security, preliminary efficacy, and pharmacokinetics of Givastomig mixed with customary take care of gastric most cancers.

How is I-Mab working with ABL Bio on Givastomig?

I-Mab is developing Givastomig in a world partnership with ABL Bio, sharing worldwide rights excluding Higher China and South Korea.

Disclaimer: That is an AI-generated abstract of a press release distributed by GlobeNewswire. The model used to summarize this release might make errors. See the total release right here.

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Full Launch

• 
  Enrollment accomplished forward of schedule within the first dose growth cohort
  
• 
  Momentum continues with first affected person dosed within the second growth cohort
  
• 
  Topline outcomes from the 40-patient dose growth examine anticipated in 1H 2026
  
• 
  Part 1b dose escalation information anticipated to be introduced in 2H 2025
  

ROCKVILLE, Md., March 07, 2025 (GLOBE NEWSWIRE) — I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, world biotech company, targeted on the development of precision immuno-oncology brokers for the therapy of most cancers, right now introduced that enrollment has been accomplished forward of schedule within the first dose growth cohort within the Part 1b givastomig mixture examine, with continued momentum within the second dose growth cohort. The Part 1b examine is evaluating givastomig, a potential best-in-class, Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, focusing on CLDN18.2-expressing tumor cells for the therapy of gastric most cancers within the first-line (1L) setting. The Part 1b program consists of a dose escalation examine (n=17) and a dose growth examine (n=40). Enrollment within the dose escalation examine is full, and topline information are anticipated within 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,” stated

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, Affiliate Professor of Medication, Massachusetts Normal 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 Part 1b program is designed to guage givastomig’s security, preliminary efficacy and pharmacokinetics as a potential first-line therapy for gastric most cancers together with customary of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy.

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody focusing on CLDN18.2-positive tumor cells. It conditionally prompts T cells by way of the 4-1BB signaling pathway within the tumor microenvironment the place CLDN18.2 is expressed. Givastomig is being developed for first-line metastatic gastric cancers, with extra potential in different stable tumors. In a

Part 1

monotherapy examine, reported on the European Society for Medical Oncology in September 2024 (ESMO 2024), givastomig was noticed to take care of a sturdy tumor-binding property and anti-tumor exercise, attributable to a potential synergistic impact of proximal interplay with CLDN18.2 and 4-1BB, whereas minimizing toxicities generally seen with different 4-1BB brokers.

This program is being collectively developed by way of a world partnership with ABL Bio, wherein I-Mab is the lead occasion and shares worldwide rights, excluding Higher China and South Korea, equally with ABL Bio.

About I-Mab

I-Mab (NASDAQ: IMAB) is a US-based, world biotech company, targeted on the development of precision immuno-oncology brokers for the therapy of most cancers. I-Mab has established operations in Rockville, Maryland, and Brief Hills, New Jersey. For more data, please go to

https://www.i-mabbiopharma.com

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I-Mab Ahead Trying Statements

This announcement incorporates forward-looking statements. These statements are made beneath the “safe harbor” provisions of the U.S. Personal Securities Litigation Reform Act of 1995. These forward-looking statements might be recognized by terminology corresponding to “will”, “expects”, “believes”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and comparable phrases or the detrimental thereof. I-Mab may make written or oral forward-looking statements in its periodic experiences to the U.S. Securities and Change Fee (the “SEC”), in its annual report to shareholders, in press releases and different written supplies and in oral statements made by its officers, administrators or staff to 3rd events. Statements that aren’t historic info, together with statements about I-Mab’s beliefs and expectations, are forward-looking statements. Ahead-looking statements on this press release embody, with out limitation, statements concerning: the Firm’s pipeline and scientific development of I-Mab’s drug candidates, together with givastomig, the projected development of the Firm’s portfolio and anticipated milestones and associated timing, the potential advantages of givastomig, and the provision of information and data from ongoing research and trials. Ahead-looking statements contain inherent dangers and uncertainties that will trigger precise outcomes to vary materially from these contained in these forward-looking statements, together with however not restricted to the next: I-Mab’s potential to exhibit the security and efficacy of its drug candidates; the scientific outcomes for its drug candidates, which can or might not help additional development or New Drug Utility/Biologics License Utility (NDA/BLA) approval; the content material and timing of choices made by the related regulatory authorities concerning regulatory approval of I-Mab’s drug candidates; I-Mab’s potential to attain business success for its drug candidates, if authorized; I-Mab’s potential to acquire and keep safety of mental property for its technology and medicines; I-Mab’s reliance on third events to conduct drug development, manufacturing and different providers; and I-Mab’s restricted working historical past and I-Mab’s potential to acquire extra funding for operations and to finish the development and commercialization of its drug candidates, in addition to these dangers more absolutely mentioned within the “Risk Factors” part in I-Mab’s most up-to-date annual report on Kind 20-F, in addition to discussions of potential dangers, uncertainties, and different important elements in I-Mab’s subsequent filings with the SEC. All forward-looking statements are primarily based on data at present obtainable to I-Mab. I-Mab undertakes no obligation to publicly replace or revise any forward-looking statements, whether or not as a end result of new data, future occasions, or in any other case, besides as could also be required by law.

I-Mab Investor & Media Contacts

PJ Kelleher

LifeSci Advisors

+1-617-430-7579

[email protected]

[email protected]

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