I-Mab Announces Collaboration with Bristol Myers Squibb to Evaluate Givastomig in a Combination Study for Newly Diagnosed Gastric and Esophageal Cancers

Rhea-AI Summary

I-Mab (NASDAQ: IMAB), a global biotech company, has announced a clinical trial collaboration with Bristol Myers Squibb (NYSE: BMY). The focus is on evaluating the combination of givastomig, a Claudin 18.2 x 4-1BB bispecific antibody, with nivolumab and chemotherapy for treating advanced gastric and esophageal cancers. The collaboration leverages promising safety and efficacy data from givastomig's monotherapy study, presented at the European Society of Medical Oncology Congress 2023. The multi-national Phase 1 study will be conducted by I-Mab, with Bristol Myers Squibb supplying nivolumab. The aim is to explore the potential of this combination as a first-line treatment for Claudin 18.2-positive cancers.

Positive

• Collaboration with a reputable partner, Bristol Myers Squibb.
• Promising safety and efficacy data from givastomig monotherapy study.
• Potential for a new first-line treatment for advanced gastric and esophageal cancers.
• Multi-national Phase 1 study indicates robust clinical trial design.
• Supply of nivolumab by Bristol Myers Squibb ensures strategic resource allocation.

Negative

• No guaranteed success of the clinical trial outcomes.
• Potential for high research and development costs without immediate revenue.
• Dependency on the performance of both givastomig and nivolumab in combination.

Medical Research Analyst

The collaboration between I-Mab and Bristol Myers Squibb to evaluate givastomig in combination with nivolumab and chemotherapy represents a significant development in the field of oncology. Combining different mechanisms of action, this regimen aims to enhance anti-tumor responses in gastric and esophageal cancers, which are areas with high unmet medical needs. Notably, givastomig targets Claudin 18.2 and 4-1BB, offering a novel approach to treat these cancers. The choice of nivolumab, an established PD-1 inhibitor known for its efficacy in various cancers, suggests this combination could yield promising results.

For investors, the key takeaway is the potential for this combination to move through clinical trials rapidly, given the existing safety and efficacy data for givastomig as a monotherapy. The involvement of Bristol Myers Squibb, a leader in immuno-oncology, lends credibility and resources to the study, potentially accelerating its progress. Furthermore, success in early-phase trials could lead to lucrative licensing and commercialization opportunities, providing significant upside for I-Mab's stock.

Financial Analyst

From a financial perspective, this collaboration could be a pivotal move for I-Mab. Partnering with Bristol Myers Squibb mitigates some of the financial risk associated with drug development, as Bristol Myers Squibb will supply nivolumab. This agreement could potentially reduce I-Mab's development costs and expedite the clinical trial timeline. The announcement highlights that the trial will be multi-national, which may suggest a broader market target and increased potential revenue if the combination therapy proves effective.

Investors should note the strategic importance of this partnership in terms of market positioning and potential growth. If the combination therapy meets its endpoints, it could lead to a significant valuation uplift for I-Mab. Additionally, it strengthens I-Mab's pipeline, making it an attractive target for further partnerships or acquisitions.

• I-Mab enters clinical collaboration with Bristol Myers Squibb to evaluate Claudin 18.2 x 4-1BB bispecific antibody givastomig in combination with nivolumab and chemotherapy for the treatment of gastric and esophageal cancer.
• Collaboration builds on promising safety and efficacy data from the givastomig monotherapy study reported at the European Society of Medical Oncology Congress 2023.

ROCKVILLE, Md., June 5, 2024 /PRNewswire/ -- I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer, today announced that it has entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY). The collaboration will evaluate the combination of givastomig, an investigational Claudin 18.2 x 4-1BB bispecific antibody jointly developed by I-Mab and ABL Bio (KOSDAQ: 298380), with Bristol Myers Squibb's immune checkpoint inhibitor, nivolumab, and chemotherapy (FOLFOX or CAPOX), as a potential first-line treatment for patients with advanced Claudin 18.2-positive gastric and esophageal cancers.

Under the terms of the agreement, the study will be a multi-national Phase 1 study conducted by I-Mab. Bristol Myers Squibb will supply nivolumab. Nivolumab is an immune checkpoint inhibitor that is designed to block the PD-L1 protein on cancer cells from binding to PD-1, enhancing T-cell function and resulting in improved anti-tumor responses.

"We are pleased to enter into this clinical collaboration agreement with Bristol Myers Squibb as we embark on the next stage of givastomig's development to explore the significant promise of this bispecific antibody in a triple-therapy regimen," said Raj Kannan, CEO of I-Mab. "The study builds on the encouraging single-agent activity and safety we have observed with givastomig as presented at ESMO 2023. We remain optimistic that givastomig in combination with nivolumab and chemotherapy will drive potent anti-tumor activity in specific tumors, and we look forward to accelerating progress in the clinic."

About Givastomig

Givastomig, also known as TJ-CD4B/ABL111 or TJ033721, is a bispecific antibody designed to bind to Claudin 18.2 (CLDN18.2) as a tumor engager and 4-1BB as a conditional T-Cell activator. Givastomig uniquely binds to tumor cells expressing various levels of CLDN18.2, including gastric cancer and pancreatic cancer cells, and conditionally activates intra-tumoral T-cells at the tumor site through 4-1BB. Givastomig appears to effectively maintain a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both CLDN18.2 antibody and 4-1BB antibody while avoiding or minimizing liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. Developed through a collaboration between I-Mab and ABL Bio, a clinical-stage biotechnology company in South Korea, givastomig is currently being investigated in a Phase 1 clinical study in the U.S. and China. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for givastomig for the treatment of gastric cancer, including cancer of the gastroesophageal junction.

About I-Mab

I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer.

I-Mab has established operations in the U.S. in Rockville, Maryland, and in San Diego, California. For more information, please visit https://www.i-mabbiopharma.com and follow us on LinkedIn and X.

I-Mab Forward Looking Statements

This press release 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", "plan", "promise", "potential", "estimate", "confident", "explore", "optimistic about", "look forward to" 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. The forward-looking statements in this press release include, without limitation, statements regarding: the anticipated terms, objectives, and potential of the clinical collaboration with Bristol Myers Squibb, including in the evaluation of Claudin 18.2 x 4-1BB bispecific antibody givastomig in combination with nivolumab and chemotherapy as a potential first-line treatment of gastric and esophageal cancer; the potential of nivolumab to enhance T-cell function and improve anti-tumor responses; the plan to explore the promise of givastomig in a triple-therapy regimen through the clinical collaboration; the potential implications of givastomig for patients; and I-Mab's anticipated clinical development and potential commercialization of givastomig. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such forward-looking statements. These risks and uncertainties include, but are 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 not support further development or New Drug Application/Biologics License Application 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 discussions of potential risks, uncertainties, and other important factors in I-Mab's most recent annual report on Form 20-F and I-Mab's subsequent filings with the U.S. Securities and Exchange Commission (the "SEC"). I-Mab may also make written or oral forward-looking statements in its periodic reports to 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. 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 Contacts

Investors & Media

Tyler Ehler

Senior Director, Investor Relations

IR@imabbio.com

 

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SOURCE I-Mab Biopharma

FAQ

What is the new collaboration between I-Mab and Bristol Myers Squibb about?

The collaboration aims to evaluate the combination of givastomig, nivolumab, and chemotherapy for treating advanced gastric and esophageal cancers.

What is givastomig?

Givastomig is a Claudin 18.2 x 4-1BB bispecific antibody developed by I-Mab and ABL Bio.

What cancers are being targeted in the I-Mab and Bristol Myers Squibb study?

The study targets advanced Claudin 18.2-positive gastric and esophageal cancers.

What kind of study will I-Mab conduct for the new treatment?

I-Mab will conduct a multi-national Phase 1 study.

Who will supply nivolumab for the I-Mab and Bristol Myers Squibb collaboration?

Bristol Myers Squibb will supply nivolumab for the study.