NGM438 / NGM Biopharma - LARVOL DELTA

Combination targeting of myeloid cell stromal checkpoints (IMMUNOLOGY 2025) - "When both ECM ligands were present, dual blockade of ILT3 and LAIR1 had synergistic effects on myeloid cell activation and repolarization. Thus, blockade of both “stromal checkpoints” may be required to fully overcome the immunosuppressive effects of the tumor stroma. These data provide support for combination targeting of stromal checkpoint inhibitors."

Stroma • Oncology • LAIR1

KEYNOTE-E13: Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=130 | Active, not recruiting | Sponsor: NGM Biopharmaceuticals, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Anti-tumor activity of a novel LAIR1 antagonist in combination with anti-PD-1 to treat collagen-rich solid tumors. (PubMed, Mol Cancer Ther) - "Further, a mouse-reactive NGM438 surrogate antibody sensitized refractory KP mouse lung tumors to anti-PD-1 therapy and resulted in increased intratumoral CD8+ T cell content and inflammatory gene expression. These data place LAIR1 at the intersection of stroma and suppressive myeloid cells and support the notion that blockade of the LAIR1/collagen axis can potentially address resistance to checkpoint inhibitor therapy in the clinic."

Combination therapy • IO biomarker • Journal • Lung Cancer • Oncology • Solid Tumor • CD8 • LAIR1

KEYNOTE-E20: Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=71 | Active, not recruiting | Sponsor: NGM Biopharmaceuticals, Inc | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Mar 2024 ➔ Apr 2025

Combination therapy • Enrollment closed • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • CD163 • CD8 • MMP9

NGM Bio Provides Recent Business Highlights and Reports Fourth Quarter and Full Year 2023 Financial Results (GlobeNewswire) - "Enrollment ongoing for patients with microsatellite stability (MSS) colorectal cancer (CRC) in Phase1/2 trial of NGM707, a dual ILT2/ILT4 antagonist antibody product candidate, in combination with KEYTRUDA (pembrolizumab) with expected completion of enrollment in the second quarter of 2024....Initiated an ongoing Phase 1, Part 1c dose finding cohort evaluating the triplet combination of NGM831, NGM438 and pembrolizumab. This cohort is anticipated to complete enrollment in the first half of 2024."

Enrollment status • Colorectal Cancer

KEYNOTE-E13: Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: NGM Biopharmaceuticals, Inc | N=79 ➔ 130 | Trial completion date: Dec 2024 ➔ Mar 2026 | Trial primary completion date: Feb 2024 ➔ Jul 2025

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

NGM Bio Reports First Quarter 2023 Financial Results and Provides Business Highlights, Including Topline ALPINE 4 Data (Yahoo Finance) - "Initiated the first two Phase 2b expansion cohorts in the Phase 1/2 trial evaluating NGM707, an ILT2/ILT4 antagonist antibody product candidate, in combination with KEYTRUDA® (pembrolizumab)...Continued enrollment in the Phase 1/1b trial evaluating NGM438...Continued enrollment in the Phase 1/1b trial evaluating NGM831..."

Trial status • Oncology • Solid Tumor

NGM Bio Provides Business Highlights and Reports Fourth Quarter and Full Year 2022 Financial Results (GlobeNewswire) - "Research and development (R&D) expenses were $46.7 million and $181.1 million for the quarter and year ended December 31, 2022, respectively, compared to $38.7 million and $161.7 million for the same periods in 2021. R&D expenses increased $8.0 million in the quarter ended December 31, 2022 as compared to the prior year period and $19.4 million in 2022 as compared to 2021 primarily due to costs related to our ongoing clinical trials of NGM707, NGM438, NGM831 and NGM120, our completed Phase 2 trial of NGM621, and personnel-related expenses, partially offset by decreased expenses for our manufacturing activities and our clinical trials of aldafermin."

Commercial • Oncology • Solid Tumor

NGM Bio Outlines Corporate Strategy and Provides Guidance on Key Priorities (GlobeNewswire) - "2023 Strategic Priorities - Oncology: Advance the ongoing Phase 1/2 signal-seeking trial of NGM707 and the ongoing Phase 1 signal-seeking trials of NGM831 and NGM438, all being studied in patients with advanced solid tumors."

Trial status • Oncology • Solid Tumor

NGM Bio Announces Initiation of Phase 1/1b Clinical Study of NGM438 for the Treatment of Patients with Advanced Solid Tumors (GlobeNewswire) - "NGM Biopharmaceuticals...announced it has initiated a Phase 1/1b clinical study of NGM438 for the treatment of patients with advanced solid tumors....The Phase 1/1b open-label, multicenter, dose-escalation and dose-expansion trial is designed to determine the safety, pharmacokinetics and pharmacodynamics of NGM438 when given alone and in combination with KEYTRUDA to patients across a spectrum of advanced solid tumors, and to evaluate preliminary antitumor activity. The trial will enroll up to approximately 80 adult patients with multiple tumor types..."

Trial status • Biliary Cancer • Biliary Tract Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Urothelial Cancer

Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=71 | Recruiting | Sponsor: NGM Biopharmaceuticals, Inc | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Monotherapy • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • CD163 • CD8 • MMP9

Preclinical development of NGM438, a novel anti-LAIR1 antagonist monoclonal antibody for the treatment of collagen-rich solid tumors (AACR 2022) - "NGM438 was tested using several immune cell-based functional assays, alone and in combination with the anti-PD1 mAb, pembrolizumab. NGM438 is a novel LAIR1 antagonist mAb that reverses collagen-based immune suppression. LAIR1 was expressed on cancer patient circulating and intratumoral immune cells, and LAIR1-expressing cells were often found in collagen-rich tumor stroma. Preclinical data demonstrated that LAIR1 antagonism sensitized a resistant mouse tumor model to respond to anti-PD1 mAb treatment."

IO biomarker • Late-breaking abstract • Preclinical • Oncology • Solid Tumor • LAIR1

Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=71 | Not yet recruiting | Sponsor: NGM Biopharmaceuticals, Inc

Combination therapy • Monotherapy • New P1 trial • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • CD163 • CD8 • MMP9

NGM Bio to Present Late-Breaking Preclinical Research at 2022 AACR Annual Meeting Supporting Development of its Myeloid Reprogramming Portfolio (GlobeNewswire) - "NGM Biopharmaceuticals...provided additional detail today on two late-breaking poster presentations it will give on Wednesday, April 13, 2022, at the American Association for Cancer Research (AACR) Annual Meeting....NGM Bio will also give an oral presentation on April 10, 2022 at the AACR meeting featuring preclinical data for the lead program in its myeloid checkpoint inhibitor portfolio, NGM707, a dual ITL2/ILT4 antagonist antibody....The late-breaking presentations will feature preclinical data supporting the development of NGM831, an ILT3 antagonist antibody product candidate, and NGM438, a LAIR1 antagonist product candidate....NGM438 is anticipated to enter the clinic this quarter.... An initial data readout from the Phase 1a monotherapy dose escalation portion of Phase 1/2 clinical trial of NGM707 is expected in the second half of 2022."

Late-breaking abstract • New trial • P1 data • Preclinical • Oncology • Solid Tumor

NGM Bio Announces Initiation of Phase 1/1b Clinical Trial of NGM831 for the Treatment of Patients with Advanced Solid Tumors (GlobeNewswire) - "NGM Biopharmaceuticals...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....NGM707, a dual ILT2/ILT4 antagonist antibody, is currently enrolling patients in an ongoing Phase 1/2 trial for the treatment of patients with advanced solid tumors and is expected to enroll approximately 180 patients. NGM438, a LAIR1 antagonist antibody, is anticipated to enter the clinic in the second quarter of 2022."

Enrollment status • New trial • Trial status • Oncology • Solid Tumor

NGM Bio to Host the First of Four Virtual R&D Events on March 30, 2022 (GlobeNewswire) - "NGM Biopharmaceuticals...announced it will host the first of four virtual R&D events on Wednesday, March 30, 2022, from 11:00 am – 12:15 pm ET...During the presentations, NGM Bio will introduce a previously undisclosed preclinical program as a new example of its discovery engine in action....Future sessions will cover four NGM Bio-discovered programs – NGM707 (a dual ILT2/ILT4 antagonist antibody product candidate), NGM831 (an ILT3 antagonist antibody product candidate), NGM438 (a LAIR1 antagonist antibody product candidate) and NGM621 (an anti- complement C3 antibody product candidate)."

Preclinical • Oncology

NGM Bio Announces Oral and Late-Breaking Poster Presentations Supporting Its Myeloid Reprogramming Portfolio at Upcoming 2022 AACR Annual Meeting (GlobeNewswire) - "Oral presentation to showcase NGM Bio’s in vitro and in vivo research demonstrating potential advantages of dual ILT2/ILT4 inhibition with NGM707....Late-breaking poster presentations to highlight preclinical research supporting development of NGM831, an ILT3 antagonist antibody, anticipated to initiate Phase 1 trial in first quarter of 2022, and NGM438, a LAIR1 antagonist antibody, anticipated to initiate Phase 1 trial in second quarter of 2022....An initial data readout from the Phase 1a portion (monotherapy dose escalation) of the...Phase 1/2 study evaluating the potential of NGM707 in patients with advanced solid tumors...is expected in the second half of 2022."

Late-breaking abstract • New P1 trial • P1 data • Preclinical • Oncology • Solid Tumor

NGM Bio Outlines 2022 Strategic Priorities Across Its Portfolio of Clinical-Stage Oncology, Retinal and Liver and Metabolic Programs (GlobeNewswire) - "2022 Strategic Priorities and Anticipated Clinical Milestones...Initiation of a Phase 1 trial of NGM831 for the treatment of patients with advanced solid tumors expected in the first quarter of 2022; Initiation of a Phase 1 trial of NGM438, a LAIR1 antagonist antibody, for the treatment of patients with advanced solid tumors expected in the second quarter of 2022; Initial data from the Phase 1a trial of NGM707 monotherapy in patients with advanced solid tumors expected in the second half of 2022; Additional data from the ongoing Phase 1a/1b trial of NGM120 in patients with cancer and cancer-related cachexia expected in the second half of 2022"

New P1 trial • P1 data • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Glioblastoma • Gynecologic Cancers • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

NGM Bio Discloses Fourth Oncology Development Candidate, NGM831, an ILT3 Antagonist Antibody, Coinciding with Publication in Cancer Immunology Research (GlobeNewswire) - “NGM Biopharmaceuticals, Inc…disclosed its fourth oncology development candidate, NGM831, an antagonist antibody designed to block the interaction of ILT3 with fibronectin, as well as with other ligands. The announcement coincides with a publication in Cancer Immunology Research, a journal of the American Association for Cancer Research, describing NGM’s discovery of ILT3’s functional ligand, fibronectin, an extracellular matrix protein that forms a fibrillar network within the tumor stroma….NGM plans to initiate first-in-human testing of NGM831 in the first half of 2022...NGM also plans to initiate a Phase 1 study of NGM438 in advanced solid tumors in the first half of 2022.”

New P1 trial • New trial • Pipeline update • Oncology • Solid Tumor

NGM Discloses Third Oncology Development Candidate, NGM438, a Novel Antagonist Antibody Inhibiting LAIR1 for the Treatment of Advanced Solid Tumors (GlobeNewswire) - "NGM Biopharmaceuticals...disclosed its third oncology development candidate, NGM438, a novel antagonist antibody that inhibits Leukocyte-associated immunoglobulin-like receptor 1 (LAIR1). NGM438 was featured earlier today during NGM’s first R&D Day....NGM438 joins NGM707 as the second myeloid reprogramming product candidate in the NGM oncology portfolio. NGM707 is a novel dual antagonist antibody that inhibits Immunoglobulin-like transcript 2 (ILT2) and Immunoglobulin-like transcript 4 (ILT4). First-in-human testing for NGM707 is expected to begin in mid-2021."

Clinical • New molecule • New trial • Oncology • Solid Tumor