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