NGM Bio Presents Updated Preliminary Findings from the Ongoing Phase 1b Dose Escalation Trial ...

• NGM120 is a novel antagonist antibody that binds GFRAL and inhibits GDF15 signaling for the potential treatment of 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

SOUTH SAN FRANCISCO, Calif., Sept. 13, 2022 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced that updated preliminary findings from its Phase 1b dose escalation trial of NGM120, a novel GFRAL antagonist antibody drug candidate, in patients with metastatic pancreatic cancer are being presented at the American Association for Cancer Research (AACR) Special Conference: Pancreatic Cancer, on Wednesday, September 14, 2022. 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.

The presentation titled “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” is available to conference attendees for the duration of the AACR Special Conference: Pancreatic Cancer and will be archived on the ‘Presentations and Publications’ page of NGM Bio’s website here.

The abstract’s first author, Andrew Hendifar, M.D., Cedars-Sinai, Samuel Oschin Cancer Center, commented, “The preliminary disease control results observed with NGM120 in combination with gemcitabine/Nab-paclitaxel in the Phase 1b cohort merit attention. Historic median progression-free survival in this patient population is approximately 5-7 months. While a small sample size, seeing two patients in this cohort exhibit partial response beyond 17 months is intriguing. I look forward to further clinical study of NGM120.”

“While preliminary, these findings encourage further study of NGM120 for the treatment of patients with advanced pancreatic cancer, a disease for which better therapeutic options are needed for patients,” said Alex DePaoli, M.D., Senior Vice President, Chief Translational Officer at NGM.

In addition to the Phase 1b dose escalation trial of NGM120 in combination with gemcitabine and Nab-paclitaxel in patients with metastatic pancreatic cancer, NGM Bio is conducting a Phase 2 randomized, single-blind (investigator-blinded), placebo-controlled, multi-center expansion trial of NGM120 in combination with gemcitabine and Nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic cancer (referred to as the PINNACLES trial), a Phase 1a trial testing NGM120 as a monotherapy for the treatment of patients with solid tumors and a recently initiated Phase 1b trial testing NGM120 in combination with one or more lines of hormone therapies in patients with metastatic castration-resistant prostate cancer (mCRPC).

NGM120 is an antagonist antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits growth differentiation factor 15 (GDF15) signaling. NGM Bio scientists have made several important discoveries related to GDF15, including identification of its cognate receptor, GFRAL. Evidence has shown that serum levels of GDF15 are elevated in patients with several tumor types, including non-small cell lung cancer, melanoma, pancreatic, prostate, colorectal, gastric, esophageal and ovarian cancer, and are associated with a worse prognosis. For more details on NGM Bio’s oncology portfolio visit NGM Bio’s website at https://www.ngmbio.com/discovery-engine/oncology/.
  
About NGM Bio

NGM Bio is focused on discovering and developing novel, life-changing medicines for people whose health and lives have been disrupted by disease. The company’s biology-centric drug discovery approach aims to seamlessly integrate interrogation of complex disease-associated biology and protein engineering expertise to unlock proprietary insights that are leveraged to generate promising product candidates and enable their rapid advancement into proof-of-concept studies. As explorers on the frontier of life-changing science, NGM Bio aspires to operate one of the most productive research and development engines in the biopharmaceutical industry. All therapeutic candidates in the NGM Bio pipeline have been generated by its in-house discovery engine, always led by biology and motivated by unmet patient need. Today, the company has seven programs in clinical development, including four in Phase 2 or 2b studies, across three therapeutic areas: cancer, retinal diseases and liver and metabolic diseases. Visit us at  www.ngmbio.com  for more information.

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