NGM707 / NGM Biopharma - LARVOL DELTA

KEYNOTE-D25: Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - P1/2 | N=179 | Active, not recruiting | Sponsor: NGM Biopharmaceuticals, Inc | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Monotherapy • Biliary Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • CNS Tumor • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Phase 1/2 study of NGM707, an ILT2/ILT4 dual antagonist antibody, in advanced solid tumors: Interim results from dose-escalation. (ASCO 2024) - P1/2 | "NGM707 as monotherapy and in combination with pembrolizumab was safe and well tolerated at all dose levels. In heavily pretreated advanced and metastatic solid tumor malignancies, we observed early efficacy and biomarker signals, including in tumors considered unresponsive to anti-PD(L)1. These results support further evaluation of NGM707."

Metastases • P1/2 data • Fatigue • Lung Cancer • Melanoma • Musculoskeletal Pain • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor

Sixteen Researchers from Florida Cancer Specialists & Research Institute Share Cancer Care Discoveries at 2024 ASCO Annual Meeting (PRNewswire) - "Florida Cancer Specialists & Research Institute, LLC (FCS) physicians will present findings from multiple clinical studies that are contributing to global advancements in cancer care at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Clinical research originating from trials conducted at the three FCS Phase 1 Drug Development Units and late-phase studies at FCS clinics throughout Florida are among those being published or presented during the five-day international gathering of oncology physicians and professionals."

Clinical data • P1 data • P1/2 data • Breast Cancer • Liver Cancer • Non Small Cell Lung Cancer • Solid Tumor

NGM707 in combination with pembrolizumab in advanced or metastatic solid tumors: Preliminary results from dose escalation (AACR 2024) - P1/2 | "BACKGROUND: NGM707-IO-101 (NCT04913337) is a Phase 1/2, dose escalation/expansion study evaluating NGM707, a humanized monoclonal antibody that blocks ILT2 and ILT4 receptors, as monotherapy or in combination with pembrolizumab. NGM707 in combination with pembrolizumab appears to be safe and well tolerated at all dose levels. In this advanced and metastatic solid tumor cohort, early efficacy signals have been observed. Preliminary evidence of myeloid cell reprogramming was observed in paired tumor biopsies."

Combination therapy • IO biomarker • Metastases • Oncology • Solid Tumor

Pharmacodynamic and predictive biomarker results from the phase I dose escalation study of NGM707, an ILT2/ILT4 dual antagonist antibody, in patients with advanced solid tumors (AACR 2024) - P1/2 | "NGM707-IO-101 (NCT04913337) is a first-in-human Phase 1/2 clinical trial of NGM707 monotherapy and combination with pembrolizumab. Baseline gene expression signatures have shown an encouraging association with clinical benefit from NGM707 and merit further investigation as promising predictive biomarkers. Protein and gene expression changes reflecting the expected modes of action of NGM707 and pembrolizumab were observed in both peripheral blood and tumor biopsies following treatment."

Biomarker • Clinical • Metastases • P1 data • PK/PD data • Oncology • Solid Tumor • CD163 • CD4 • CD8 • CXCL9 • LILRB1

NGM Bio to Present Two Posters Highlighting Clinical Data from the Ongoing Phase 1/2 Clinical Trial of NGM707, a Dual ILT2/ILT4 Antagonist Antibody Product Candidate, at AACR 2024 Annual Meeting (GlobeNewswire) - "NGM Biopharmaceuticals...announced that two abstracts highlighting clinical data from the ongoing Phase 1/2 clinical trial of NGM707, a dual ILT2/ILT4 antagonist antibody product candidate, have been selected for presentation at the American Association for Cancer Research (AACR) Annual Meeting....This presentation will provide more detailed findings from the Phase 1 Part 1b dose escalation cohort of the ongoing Phase 1/2 trial evaluating NGM707 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with advanced or metastatic solid tumors than as originally reported by NGM Bio in January 2024."

P1 data • Solid Tumor

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

NGM Bio Announces New Clinical Data from Ongoing Trial of NGM707 in Advanced Solid Tumors and Outlines Evolved Strategy for Aldafermin and NGM120 to Focus on Rare Conditions with Significant Unmet Need (GlobeNewswire) - P1 | N=179 | NCT04913337 | Sponsor: NGM Biopharmaceuticals, Inc | "Announced encouraging new findings from the Phase 1 Part 1b dose escalation cohort of the ongoing Phase 1/2 trial evaluating NGM707 in combination with pembrolizumab for the treatment of patients with advanced or metastatic solid tumors. The combination of NGM707 and pembrolizumab was generally well tolerated at all four dose levels of NGM707. The maximum tolerated dose was not reached...there were four confirmed partial responses (PRs) across multiple indications, including one pathological complete response (CR), and 12 stable disease (SD) (11% overall response rate [ORR] and 43% disease control rate [DCR])....NGM Bio is completing enrollment in the Phase 1 Part 1b cohort and anticipates providing an update in mid-2024 on the completed cohort and subsequent next steps, including the potential for additional cohorts, which may include MSS CRC patients."

Enrollment status • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Preclinical characterization of LAE111, a potent anti-LILRB1/LILRB2 antagonist bispecific antibody (SITC 2023) - "Lead bispecific antibodies were characterized in a panel of functional assays together with the competitor’s anti-LILRB1 mAb (15G8), anti-LILRB2 mAb (MK4830 and J19) and anti-LILRB1/LILRB2 dual mAb (NGM707), which are currently being tested in the clinical trials. Combination of LAE111 and PD1/PDL1 inhibitor markedly activated T cell response. These results support further development of LAE111 as a therapeutic for cancer."

Preclinical • Oncology • CD34 • LILRB1 • TNFA

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

First-in-human Study of NGM707, An ILT2/ILT4 Dual Antagonist Antibody in Advanced or Metastatic Solid Tumors: Preliminary Monotherapy Dose Escalation Data (ESMO-IO 2022) - P1/2 | "Methods NGM707-IO-101 is a phase 1/2, dose escalation/expansion study evaluating NGM707 as a monotherapy and in combination with pembrolizumab. Preliminary evidence of myeloid reprogramming was seen in tumor biopsies. Monotherapy tx is ongoing and enrollment of pembrolizumab combination cohorts has been initiated."

Monotherapy • P1 data • Oncology • Solid Tumor • CD163

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 Presents Preliminary Data from Phase 1 Monotherapy Dose Escalation Trial of NGM707 in Patients with Advanced or Metastatic Solid Tumors at 2022 ESMO-IO Annual Meeting (GlobeNewswire) - P1/2 | N=179 | NCT04913337 | Sponsor: NGM Biopharmaceuticals, Inc | "NGM Biopharmaceuticals...announced the presentation of preliminary data from the Phase 1 Part 1a monotherapy dose escalation arm of the ongoing Phase 1/2 trial of NGM707 in patients with advanced or metastatic solid tumors at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Annual Congress....As of a November 23, 2022 data cut-off, 34 patients have been enrolled in the monotherapy dose escalation. Of 24 response-evaluable patients (those completing at least one on-treatment scan), best overall responses are partial response (PR) in one patient, stable disease in six patients and non-complete response/non-progressive disease in one patient. Six of the 24 response-evaluable patients experienced target lesion reduction."

P1 data • Oncology • Solid Tumor

NGM Bio Announces Poster Presentation Featuring Initial Findings from Ph1a Trial of NGM707 in Patients with Advanced Solid Tumors at Upcoming 2022 ESMO-IO Annual Meeting (GlobeNewswire) - "NGM707 is part of NGM Bio’s wholly-owned portfolio of immuno-oncology programs, including NGM831, an ILT3 antagonist antibody product candidate, and NGM438, a LAIR1 antagonist antibody product candidate, focused on blocking myeloid checkpoints to reprogram suppressive myeloid cells in the tumor microenvironment. NGM Biopharmaceuticals, Inc....announced that an abstract related to the Company’s lead myeloid reprogramming and checkpoint inhibition program, NGM707, has been accepted for presentation at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Annual Congress, which will take place December 7 – 9, 2022 at the Palexpo Exhibition Centre in Geneva, Switzerland."

P1 data • Hematological Malignancies • Oncology • Solid Tumor

Immune inhibitory receptors ILT2 and ILT4 exhibit both distinct and overlapping biology in vitro and in vivo (AACR 2022) - "Despite high expression of ILT2 and ILT4 on myeloid cell populations, evidence from standard in vitro assays suggested that ILT2 and ILT4 have distinct functional activities. Here, we provide evidence that both ILT2 and ILT4 play key roles in myeloid immune suppression, and that blockade of these two receptors can be additive or synergistic. ILT2 blockade additionally enhanced T cell and NK cell function."

IO biomarker • Preclinical • Oncology • CD34 • CD8

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 Announces Clinical Trial Collaboration with Merck Related to Ongoing Phase 1/2 Trial of NGM707, an ILT2/ILT4 Dual Antagonist Antibody, in Combination with Merck’s KEYTRUDA (pembrolizumab) (GlobeNewswire) - "NGM Biopharmaceuticals, Inc...announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada) to evaluate NGM707, NGM’s wholly-owned novel ILT2/ILT4 dual antagonist antibody, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA. NGM is currently enrolling patients in the Phase 1/2 trial, initiated in June 2021, to evaluate the potential of NGM707 as a monotherapy and in combination with KEYTRUDA in adult patients with advanced or metastatic solid tumors with elevated expression of ILT2 and ILT4."

Enrollment status • Licensing / partnership • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Glioblastoma • Gynecologic Cancers • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - P1/2; N=179; Recruiting; Sponsor: NGM Biopharmaceuticals, Inc; Not yet recruiting ➔ Recruiting

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

NGM Bio Announces Initiation of Phase 1/2 Clinical Study of NGM707 for the Treatment of Advanced Solid Tumors (GlobeNewswire) - “NGM Biopharmaceuticals…announced it has dosed the first patient in a Phase 1/2 study to evaluate the efficacy, safety and pharmacokinetics/pharmacodynamics of NGM707 when given alone or in combination with KEYTRUDA® (pembrolizumab), an anti- PD-1 antibody…NGM707 originated from NGM’s in-house discovery engine. The program follows NGM120, a glial cell-derived neurotrophic factor alpha-like (GFRAL) antagonistic antibody, which is currently in a Phase 2 study in patients with metastatic pancreatic cancer, as the second NGM wholly owned oncology candidate in the clinic…‘We look forward to enrolling patients in this Phase 1/2 study and understanding how NGM707’s preclinical benefits may translate to patients in the clinical setting.”

Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - P1/2; N=179; Not yet recruiting; Sponsor: NGM Biopharmaceuticals, Inc

Combination therapy • Monotherapy • New P1/2 trial • Biliary Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck