I-Mab said the measure ensures cash reserves to keep the company operational until 2027. Image credit: Brian A Jackson / Shutterstock

Cancer immunotherapy biotech I-Mab, has paused the development of uliledlimab in favour of its now lead candidate givastomig.

The Maryland, US-based company saw an uptick in its stock price on 6 January upon the announcement, closing 17.89% higher than the market close on Friday.

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As part of the reshuffle, I-Mab will prioritise the advancement of givastomig, a CLDN18.2 x 4-1BB bispecific antibody, targeting the first-line treatment of metastatic gastric cancers with further potential in other solid tumours.

Uliledlimab is an antibody designed to target CD73. The development pause will also allow I-Mab to allow data from an ongoing China-only randomised study conducted by its partner TJ Biopharma, to mature. The study is evaluating uliledlimab in combination with a checkpoint inhibitor toripalimab in CD73-high non-small cell lung cancer (NSCLC) patients. Depending on the trial’s outcome, the development of uliledlimab could continue, said the company.

Givastomig has been evaluated in a Phase I trial (NCT04900818) in patients with advanced or metastatic solid tumours. As per topline data from the monotherapy cohort, the overall response rate (ORR) was 16.3%, including seven partial responses at doses between 5mg/kg and 18mg/kg. Of the seven who responded, five had received prior checkpoint inhibitor therapy. The data was presented at the European Society for Medical Oncology (ESMO) Annual Meeting in 2024.

The therapy also boasted a favourable safety profile with mainly grade 1 or 2 treatment-related adverse events (TRAEs) reported. No dose-limiting toxicities were observed, and a maximum tolerated dose was not identified.

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The trial is also investigating the therapy in combination with Opdivo (nivolumab) and chemotherapy as part of a collaboration agreement with Bristol Myers Squibb. This cohort has now been fully enrolled with data expected in H2 2025.

Dr. Phillip Dennis, CMO of I-Mab, said: “Data arising from this [givastomig] study will not only help establish the breadth of patients who might respond to this novel regimen, such as those with low levels of CLDN18.2 expression that would not qualify for approved CLDN18.2 therapies, but also help establish the recommended dose of givastomig for subsequent studies.”

As a result of the pipeline reshuffle, I-Mab estimates it has enough cash to fund the Phase I givastomig  study through dose expansion data readouts and further development initiatives into 2027.

Givastomig is being jointly developed through a global partnership with ABL Bio, with I-Mab as the lead party in most countries worldwide. In China and South Korea, ABL Bio and I-Mab share joint rights.