NGM120 / NGM Biopharma - LARVOL DELTA

Decoding GDF15: Impact on prostate cancer metabolism, chemoresistance, and clinical applications. (PubMed, Chin Med J (Engl)) - "Clinically, GDF15 has shown potential as a biomarker, offering diagnostic precision and prognostic value, particularly when combined with established markers such as prostate-specific antigen. The review concludes with a discussion on several monoclonal antibodies targeting GDF15 in clinical trials, such as AV-380, NGM120, Visugromab, and AZD8853, highlighting promising strategies for novel therapies and precision medicine."

Journal • Cachexia • Genito-urinary Cancer • Metabolic Disorders • Oncology • Prostate Cancer • Solid Tumor • GDF15

Advancements of investigational agents for cancer cachexia: what clinical progress have we seen in the last 5 years? (PubMed, Expert Opin Investig Drugs) - "This review covers key investigational therapies developed over the past five years, with a focus on agents targeting Growth Differentiation Factor 15 (GDF-15), including ponsegromab, AV-380, and NGM120. Additional agents include ghrelin receptor agonists (e.g. anamorelin), anabolic/catabolic modulators (ACM-001), and cannabinoids (ART27.13). The evolving role of low-dose olanzapine is also discussed in the 2023 ASCO guideline update...The lack of standardized endpoints, heterogeneity of the syndrome, and absence of FDA-approved treatments remain major barriers to treatment implementation. Multimodal strategies combining pharmacological treatment with nutritional and rehabilitative support are likely to define future therapeutic success."

Journal • Cachexia • Oncology • GDF15

An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia. (clinicaltrials.gov) - P2 | N=136 | Not yet recruiting | Sponsor: NGM Biopharmaceuticals, Inc

New P2 trial • Cachexia • Colorectal Cancer • Oncology • Solid Tumor

An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia. (clinicaltrials.gov) - P2 | N=136 | Recruiting | Sponsor: NGM Biopharmaceuticals, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Cachexia • Colorectal Cancer • Oncology • Solid Tumor

A Research Study Testing NGM120 in Pregnant Women with Severe Nausea and Vomiting (Hyperemesis Gravidarum) (ANZCTR) - P2 | N=30 | Not yet recruiting | Sponsor: NGM Biopharmaceuticals, Inc.

New P2 trial • Rare Diseases

NGM Bio Announces $122 Million Series A Financing to Initiate Registrational Trial in Primary Sclerosing Cholangitis and Fund Phase 2 Trial in Hyperemesis Gravidarum (GlobeNewswire) - "NGM Biopharmaceuticals, Inc...announced a $122 million Series A financing led by TCG with participation from a select group of investors. NGM Bio will use the proceeds from the Series A financing to initiate a planned registrational trial of aldafermin, an engineered FGF19 analog, for the treatment of PSC, and to complete a planned Phase 2 trial of NGM120, a GDF15/GFRAL antagonist, for the treatment of HG. Both trials are expected to begin in the fourth quarter of 2024."

Financing • New P2 trial • Metabolic Disorders • Primary Biliary Cholangitis

PINNACLES: Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy (clinicaltrials.gov) - P1/2 | N=90 | Completed | Sponsor: NGM Biopharmaceuticals, Inc | Active, not recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Jan 2024 | Trial primary completion date: Jul 2024 ➔ Sep 2023

Combination therapy • Metastases • Trial completion • Trial completion date • Trial primary completion date • Bladder Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Melanoma • Metastatic Castration-Resistant Prostate Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • GDF15

PINNACLES: Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy (clinicaltrials.gov) - P1/2 | N=75 | Active, not recruiting | Sponsor: NGM Biopharmaceuticals, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • GDF15

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

Initial results of a cohort of advanced prostate cancer patients in a phase Ia study of NGM120, a first-in-class anti-GDNF family receptor alpha like (GFRAL) antibody (ESMO 2022) - P1/2 | "The negative effects of GDF15 on body weight and immune modulation could potentially be blocked by NGM120 through GFRAL, a GDF15 receptor. A phase 1b trial has been initiated to confirm these findings in pts with PC, including those with MSI-H tumors."

Clinical • P1 data • Genito-urinary Cancer • Microsatellite Instability • Oncology • Prostate Cancer • Solid Tumor • CD8 • GDF15 • MSI

[VIRTUAL] Initial results of a phase Ia/Ib study of NGM120, a first-in-class anti-GDNF family receptor alpha like (GFRAL) antibody in patients (pts) with advanced solid tumors (ESMO 2021) - P1/2 | "We present the data from Ph1a/1b dose finding study (NCT04068896) of NGM120 and NGM120 + gemcitabine (Gem)/nab-paclitaxel (nab-P) in advanced cancer pts. NGM120 (30 or 100 mg) was given to pts with advanced solid tumors Q3W SC as monotherapy (Ph1a), or to pts with metastatic pancreatic cancer in a 1st line setting Q4W SC in combination with Gem/nab-P (Ph1b). NGM120 given as monotherapy or with Gem/nab-P was well tolerated and showed potential pathway engagement evidenced by increased LBM and BW. Disease control at wk 16 in evaluable Ph1b patients was encouraging. A Ph2a study is ongoing to further evaluate NGM120 in the 1st line setting of pancreatic cancer, with pts randomized to either NGM120 or placebo in combination with Gem/nab-P."

Clinical • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • GDF15

NGM Bio Presents Updated Preliminary Findings from the Ongoing Phase 1b Dose Escalation Trial of NGM120 in Combination with Gemcitabine and Nab-paclitaxel in Patients with Metastatic Pancreatic Cancer at AACR Special Conference: Pancreatic Cancer (GlobeNewswire) - "These results demonstrate that treatment with the drug was well tolerated to date in the study with no dose-limiting toxicities and provided encouraging signals of anti-cancer activity in patients with metastatic pancreatic cancer. NGM120 has been well tolerated to date in patients in the Phase 1b combination cohort (NGM120 + gemcitabine + Nab-paclitaxel) with no dose-limiting toxicities. As of the March 15, 2022 abstract data cut-off date, among the six evaluable patients in the Phase 1b combination cohort, a disease control rate of 100% was observed, median progression-free survival had not been reached and the 12-month survival rate was 83.3%. Three of the six evaluable patients experienced partial responses (PR) extending more than 32 weeks as of the abstract cut-off date, including one patient with a PR that was ongoing at 90 weeks as of August 15, 2022."

P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Initial results of a cohort of advanced pancreatic cancer patients in a phase 1b Study of NGM120, a first-in-class anti-GDNF Family Receptor Alpha Like (GFRAL) antibody (AACRPanCa 2022) - No abstract available.

NGM Bio Presents Updated Preliminary Findings for a Subgroup of Patients with Advanced Prostate Cancer from the Ongoing Phase 1a Dose Escalation Trial of NGM120 in Patients with Advanced Solid Tumors at the ESMO Annual Congress (GlobeNewswire) - P1 | N=75 | NCT04068896 | Sponsor: NGM Biopharmaceuticals, Inc | "NGM Biopharmaceuticals, Inc...announced that updated preliminary findings from its open-label Phase 1a dose escalation study of NGM120, a novel GFRAL antagonist antibody drug candidate, in a subset of patients with advanced prostate cancer will be presented at the European Society for Medical Oncology (ESMO) Annual Congress on Sunday, September 11, 2022. These results demonstrate that treatment with NGM120 was well tolerated to date in the study with no dose-limiting toxicities and provide encouraging signals of anti-cancer activity in patients with advanced prostate cancer."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

NGM Bio Announces Presentations Featuring Updated Findings from the Ongoing Phase 1a Dose Escalation Trial of NGM120 in Patients with Advanced Solid Tumors at the European Society of Medical Oncology (ESMO) Annual Congress and the Ongoing Phase 1b Trial of NGM120 in Patients with Advanced Pancreatic Cancer at the American Association for Cancer Research (AACR) Special Conference: Pancreatic Cancer (GlobeNewswire) - "NGM Biopharmaceuticals...announced that abstracts related to NGM120...have been accepted for presentation at the ESMO Annual Congress, which will take place September 9 - 13, 2022...and at the AACR Special Conference: Pancreatic Cancer, which will take place September 13 - 16, 2022....Poster presentation at upcoming ESMO Annual Congress to highlight analysis of subgroup of patients with prostate cancer in NGM120 Phase 1a trial. Short-talk presentation at upcoming AACR Special Conference: Pancreatic Cancer to highlight analysis of patients with advanced pancreatic cancer in NGM120 Phase 1b trial."

P1 data • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy (clinicaltrials.gov) - P1/2 | N=75 | Recruiting | Sponsor: NGM Biopharmaceuticals, Inc | Trial completion date: Nov 2023 ➔ Jan 2025 | Trial primary completion date: Jan 2023 ➔ Jul 2024

Combination therapy • Trial completion date • Trial primary completion date • Bladder Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

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 Presents Preliminary Findings from Ongoing Phase 1a/1b Dose Escalation Study of NGM120 in Patients with Advanced Solid Tumors at the ESMO Virtual Congress 2021 (GlobeNewswire) - P1a/b, N=90; NCT04068896; Sponsor: NGM Biopharmaceuticals; “NGM Biopharmaceuticals…announced that preliminary findings from its ongoing, open-label Phase 1a/1b dose escalation study of NGM120, a novel GFRAL antagonist antibody, in patients with advanced solid tumors are being presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2021, being held September 16 - 21. These preliminary results demonstrated that treatment with the drug was well tolerated to date in the study with no dose-limiting toxicities and provided encouraging initial signals of anti-cancer activity in patients with metastatic pancreatic cancer…Secondary endpoints include pharmacokinetics (PK), overall response rate1, progression-free survival (PFS) and changes in lean body mass and body weight. Entry criteria for both cohorts included elevated serum levels of GDF15.”

P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

NGM Bio Provides Business Highlights and Reports Second Quarter 2021 Financial Results (GlobeNewswire) - “The Phase 1a/1b dose-finding portion of the study is still ongoing, and NGM expects to report interim results from that portion of the study at the European Society for Medical Oncology in the third quarter of 2021.”

P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy (clinicaltrials.gov) - P1/2; N=90; Recruiting; Sponsor: NGM Biopharmaceuticals, Inc; Phase classification: P1 ➔ P1/2

Clinical • Combination therapy • Phase classification • Bladder Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy (clinicaltrials.gov) - P1; N=90; Recruiting; Sponsor: NGM Biopharmaceuticals, Inc; Trial completion date: Dec 2021 ➔ Nov 2023; Trial primary completion date: Feb 2021 ➔ Jan 2023

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Bladder Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

NGM Bio Initiates Expansion of Ongoing Phase 1b Proof-of-Concept Study of NGM120 in Patients with Metastatic Pancreatic Cancer (GlobeNewswire) - "NGM Biopharmaceuticals, Inc...announced it has dosed the first patient in an expansion of its ongoing Phase 1b proof-of-concept study of NGM120 in patients with metastatic pancreatic cancer...This placebo-controlled study will evaluate the effect of NGM120 on both cancer and cancer-related cachexia....This proof-of-concept expansion represents a pre-planned progression of an ongoing Phase 1a/1b dose-finding clinical trial NGM is conducting in patients with select advanced solid tumors and metastatic pancreatic cancer."

Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

NGM Bio announces initiation of phase 1a/1b clinical study of NGM120 for the potential treatment of cancer and cancer anorexia/cachexia syndrome (CACS) (GlobeNewswire) - "NGM Biopharmaceuticals, Inc...announced the initiation of a Phase 1a/1b clinical study of NGM120, a first-in-class antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits growth differentiation factor 15 (GDF15) signaling, for the potential treatment of cancer and cancer anorexia/cachexia syndrome (CACS)....'This study will provide insights into the drug candidate’s anti-CACS and anti-cancer activity in patients with solid tumors, including pancreatic cancer'"

Trial status

Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy (clinicaltrials.gov) - P1; N=90; Recruiting; Sponsor: NGM Biopharmaceuticals, Inc; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open