NEW YORK – I-Mab said Monday that it is focusing its resources on developing its investigational agent givastomig for certain patients with gastric cancers and other solid tumors.
Rockville, Maryland-based I-Mab is developing the claudin 18.2 (CLDN18.2)- and 4-1BB-directed bispecific antibody as a first-line treatment for advanced solid tumors, including gastric cancers.
According to I-Mab, Phase I data suggests that givastomig, which the firm is codeveloping with ABL Bio, has encouraging anti-tumor activity and minimal toxicities, relative to other 4-1BB agents. In an initial monotherapy portion of the ongoing Phase I trial, givastomig alone led to a 16.3 percent overall response rate among advanced solid cancer patients, none of whom experienced dose-limiting toxicities.
In the Phase Ib dose-escalation portion of the same trial, I-Mab is evaluating givastomig plus Bristol Myers Squibb's checkpoint inhibitor Opdivo (nivolumab) and chemotherapy in patients whose tumors express CLDN18.2 in at least 1 percent of cells with an immunohistochemistry staining intensity of 1+. The firm has added two dose cohorts to the trial and will evaluate a total of 40 patients. It expects to present data from the dose-escalation portion of its trial during the second half of 2025 and the dose-expansion portion in early 2026.
In prioritizing givastomig's development, I-Mab has decided to pause development of the CD73-directed antibody uliledlimab. I-Mab said it will wait for data to mature within a uliledlimab trial that its partner, drugmaker TJ Biopharma, is conducting in China. TJ Biopharma is evaluating uliledlimab in CD73-high non-small cell lung cancer patients. Even though I-Mab is putting further uliledlimab investments on hold, the firm said it may potentially resume development contingent on positive data.
The firm also said it has streamlined its operational model and shifted its focus to the US. And as of Sept. 30, 2024, it reported a $184.4 million cash balance, which it expects will fund the full Phase I givastomig trial as well as additional development initiatives through 2027.
"I-Mab made excellent progress executing its corporate strategy in 2024, including the establishment of a new operating model as a US-based global biotech company," I-Mab CEO and board member Sean Fu said in a statement. This included divesting its operations in China and building out its leadership team with US-based executives.