First Patient Receives Novel Antibody in Early-Phase Trial Assessing Safety, Efficacy of the Drug in Several Solid Tumor Types

The first patient has received a dose of NGM831 in an early-phase trial assessing the potential benefits of this novel drug in patients with advanced solid tumors, according to a press release from NGM Bio, the manufacturer of the therapy.

In particular, NGM831 is a novel antagonist antibody that blocks the interaction of ILT3 with fibronectin (a key component of the tumor stroma and plays an important role in tumor progression and resistance to chemotherapy) and other cognate ligands.

“We are proud to be one of the leaders in developing an emerging class of molecules designed to inhibit myeloid checkpoints of the anti-tumor immune response,” said David J. Woodhouse, chief executive officer at NGM Bio, in the release. “We believe this new, exciting frontier in checkpoint inhibition has the potential to enable the more effective treatment of multiple cancers, many of which elude current checkpoint inhibition approaches.”

In the phase 1/1b trial, researchers aim to determine the pharmacokinetics, safety and pharmacodynamics of NGM831 alone or in combination with Keytruda (pembrolizumab) in patients with advanced solid tumors. Researchers also want to assess preliminary antitumor activity. Enrollment into this trial may focus on adults with multiple tumor types including bladder cancer, melanoma, pancreatic cancer, mesothelioma, breast cancer, non-small cell lung cancer, gastric cancer, cholangiocarcinoma, cervical and endocervical cancer, colorectal cancer, squamous cell carcinoma of head and neck, ovarian cancer, esophageal cancer, prostate cancer and renal cell carcinoma, according to the release.

Part 1a of this trial will be focused on determining the recommended dose of NGM831 for the phase 2 trial. The recommended phase 2 dose of NGM831 with Keytruda will be determined in part 1b of the trial.

“While immunotherapy has transformed the treatment of certain types of cancer, a significant percentage of patients remain nonresponders with very poor outcomes,” said Dr. Manish R. Sharma, associate director of clinical research at START Midwest in Grand Rapids, Michigan, in the release. “The biology underpinning myeloid checkpoint inhibition with the stromal component is intriguing, as the preclinical data suggest that myeloid checkpoint inhibition deepens T-cell responses and reverses resistance mediated by the stromal component.”

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