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NGM Biopharmaceuticals (NGM) Outlines Corporate Strategy and Provides Guidance on Key Priorities

January 9, 2023 9:03 AM EST

NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today is providing an overview of highlights from 2022 and outlining its 2023 corporate priorities.

“In 2022, NGM Bio sharpened its focus on oncology solid-tumor clinical development. We reported promising preliminary data from our first myeloid checkpoint inhibitor program, NGM707, and advanced our additional myeloid checkpoint inhibitor programs, NGM438 and NGM831, into the clinic,” said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio.

Dr. Woodhouse continued, “Our strategy in 2023 is to focus our clinical development efforts on our portfolio of four clinical-stage oncology programs while operating our prolific drug discovery engine to generate next-generation biologic therapeutics. For our programs outside this area of focus, in retinal disease and NASH, we will seek development partners with relevant domain expertise. We’re committed to developing transformative therapeutics for patients and energized by the opportunities we see in this next chapter of the NGM Bio story.”

Key 2022 Activities

Oncology

Myeloid Checkpoint Inhibitor Portfolio

  • Presented preliminary data from the Phase 1a monotherapy portion of the Phase 1/2 trial of NGM707, an ILT2/ILT4 antagonist antibody product candidate, in patients with advanced or metastatic solid tumors at the 2022 European Society of Medical Oncologists (ESMO) I-O Annual Congress in Q4 2022. NGM707 was generally well tolerated, potential proof-of-mechanism (myeloid reprogramming) was observed in peripheral blood and tumor biopsies and early signals of anti-tumor activity were demonstrated across multiple tumor types. As of a November 23, 2022 cut-off there were 24 response-evaluable patients and best overall responses were partial response in one patient, stable disease in one patient and non-complete response/non-progressive disease in one patient.
  • Initiated a Phase 1 trial of NGM831, an ILT3 antagonist antibody product candidate, in Q1 2022 as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors.
  • Initiated a Phase 1 trial of NGM438, a LAIR1 antagonist antibody product candidate, in Q2 2022 as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors.

Other Oncology Programs

  • Presented updated preliminary findings from ongoing Phase 1a and Phase 1b cohorts evaluating NGM120, an antagonist antibody that binds GFRAL and inhibits GDF15 signaling, for the treatment of cancer at the 2022 ESMO Annual Congress and at the 2022 American Association for Cancer Research (AACR) Special Conference: Pancreatic Cancer in Q3 2022.
  • Presented preclinical data on NGM Bio’s first disclosed bispecific program, NGM936, an ILT3 x CD3 bispecific antagonist antibody product candidate designed for the treatment of AML and multiple myeloma, at the 2022 American Society of Hematology (ASH) Annual Meeting in Q4 2022.

Retinal Diseases

  • Completed the Phase 2 CATALINA trial of NGM621, a monoclonal antibody product candidate engineered to potently inhibit complement C3 for patients with geographic atrophy (GA) secondary to advanced macular degeneration, which did not meet its primary endpoint of a statistically significant rate of change using slope analysis in GA lesion area over 52 weeks for NGM621 versus sham. Presented additional findings from post-hoc analyses from the CATALINA trial at The Retina Society Annual Scientific Meeting in Q4 2022.

NASH

  • Completed enrollment in ALPINE 4, the Phase 2b trial of aldafermin, an engineered FGF19 analog product candidate, in patients with compensated NASH cirrhosis (F4 NASH) in Q1 2022.
  • Received notification from Merck of its decision to terminate the Phase 2b trial of MK-3655 in patients with NASH and liver fibrosis stage 2 or 3 and pursue other priorities. This decision was based on the results of an interim analysis of safety and reduction in liver fat at Week 24. Although it was not the primary endpoint of the trial, the percent reduction from baseline in liver fat for MK-3655, while greater than placebo across multiple dose arms, did not reach Merck’s threshold for continuing the trial. The trial was not discontinued for safety concerns.

Corporate

  • Cash runway is expected to be sufficient to fund operations into the fourth quarter of 2024.

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

NASH

  • Read out topline data from ALPINE 4, the Phase 2b trial of aldafermin in patients with F4 NASH, in Q2 2023

Business Development

  • Consistent with NGM Bio’s business model since inception, business development will remain a key priority to allow the company to focus development and financial resources on oncology clinical development and new molecule generation. NGM Bio will seek partners for the following programs:
    • Aldafermin, an engineered FGF19 analog product candidate, designed for the treatment of patients with NASH and/or diseases related to bile acid dysregulation
    • NGM621, a monoclonal antibody product candidate engineered to potently inhibit complement C3, designed for the treatment of patients with GA secondary to advanced macular degeneration
    • NGM936, an ILT3 x CD3 bi-specific antagonist antibody product candidate, designed for the treatment of patients with AML and multiple myeloma

Visit www.ngmbio.com/discovery-engine/publications/ to view all of NGM Bio’s posters and presentations.



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