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Biopharma Co. Begins Dosing in Ph. 1 Solid Tumor Trial
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NGM Biopharmaceuticals Inc. shares rose 14.75% after the company reported it dosed the first group of patients in its Phase 1/1b clinical trial of NGM831 for use in treating advanced solid tumors.

Yesterday afternoon, biotech firm NGM Biopharmaceuticals Inc. (NGM:NASDAQ), which is focused on discovering and developing transformative therapeutics for patients based upon scientific understanding of key biological pathways underlying cancer, retinal diseases and liver and metabolic diseases, announced "it has dosed the first patient in a Phase 1/1b clinical trial of NGM831 for the treatment of patients with advanced solid tumors."

The company explained that "NGM831 is an antagonist antibody product candidate designed to block the interaction of ILT3 (also known as LILRB4) with fibronectin, a key component of the tumor stroma, as well as other cognate ligands."

NGM Biopharmaceuticals added that ILT3 is just one of many receptors in the LILR family that is believed may serve a core role in creating an immune suppressive state in the tumor microenvironment. The firm stated that NGM831 represents the second of three programs in its myeloid reprogramming and checkpoint inhibition portfolio to move forward into clinical trials. In addition to NGM831, the company's NGM707 and NGM438 have also been designed to target certain LILR suppressive receptors with the primary objective of enhancing and stimulating anti-tumor immunity.

NGM Biopharmaceuticals' CEO David J. Woodhouse, Ph.D. commented, "We are proud to be among the leaders in developing an emerging class of molecules designed to inhibit myeloid checkpoints of the anti-tumor immune response. 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…NGM831's entry into the clinic is another important milestone in our myeloid and stromal checkpoint development strategy. By mid-2022, we expect all three programs, which are directed at multiple and distinct targets, to be in the clinic."

The firm advised that it is now enrolling around 180 participants in an ongoing Phase 1/2 trial of its dual ILT2/ILT4 antagonist antibody, NGM707, in patients with advanced solid tumors and expects to move its LAIR1 antagonist antibody, NGM438, into the clinic in Q2/22.

START Midwest's Associate Director of Clinical Research Manish R. Sharma, M.D. remarked, "While immunotherapy has transformed the treatment of certain types of cancer, a significant percentage of patients remain non-responders, with very poor outcomes. 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."

"I look forward to enrolling patients in the NGM831 Phase 1/1b trial and seeing how the science and preclinical findings translate in the clinic in both a monotherapy and combination setting," Dr. Sharma added.

The company indicated that the Phase 1/1b multicenter, dose-escalation study is structured to test the safety, pharmacokinetics and pharmacodynamics of NGM831 in treating patients with advanced solid tumors as both a stand-alone monotherapy and in combination therapy with Merck & Co. Inc.'s (MRK:NYSE) KEYTRUDA®.

The trial is designed with the objective of evaluating preliminary antitumor activity in adult patients across numerous tumor types including breast, cervical, esophageal, gastric, mesothelioma, NSCLC, pancreatic, ovarian, prostate cancer along with melanoma and several additional forms of cancer.

The company advised that it also presently conducting another Phase 2 oncology study of its anti-GFRAL antagonist antibody, NGM120, for use in treating patients diagnosed with metastatic pancreatic cancer.

NGM is a biopharmaceutical company based in So. San Francisco, Calif. The firm is engaged in the discovery and development of medicines for treating cancer, retinal, liver, and metabolic diseases. The company claims that "it leverages its biology-centric drug discovery approach to uncover novel mechanisms of action and generate proprietary insights that enable it to move biologic drug candidates rapidly into proof-of-concept clinical studies." The company noted that all of the therapeutic candidates in its pipeline were generated via its in-house discovery engine using a disease-agnostic mindset to meet significant unmet patient needs.

NGM Biopharmaceuticals began the day with a market cap of around $1.2 billion with approximately 78.05 million shares outstanding and a short interest of about 3.1%. NGM shares opened slightly higher today at $15.40 (+$0.15, +0.98%) over yesterday's $15.25 closing price. The stock has traded today between $15.40 and $17.79 per share and closed for trading at $17.50 (+$2.25, +14.75%).



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