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

• 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 1a study with no dose-limiting toxicities
• Two of five prostate cancer patients in the Phase 1a trial demonstrated disease control with one partial response (PR) ongoing at 62 weeks
• Two patients experienced reductions in prostate-specific antigen (PSA) levels, one with a >30% reduction and one patient with reduction of PSA to undetectable levels
• NGM recently initiated an additional Phase 1b cohort testing NGM120 in combination with one or more lines of hormone therapies in patients with metastatic castration resistant prostate cancer (mCRPC)

SOUTH SAN FRANCISCO, Calif., Sept. 06, 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 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.

The poster titled “Initial Results of a Cohort of Advanced Prostate Cancer Patients in a Phase 1a Study of NGM120, a First-in-class Anti-GDNF Family Receptor Alpha Like (GFRAL) Antibody” (publication number: 1402P) is available to conference attendees for the duration of the ESMO Annual Congress and will be archived on the ‘Presentations and Publications’ page of NGM Bio’s website here.

“We are pleased to share these updated findings from the Phase 1a dose escalation trial of NGM120,” said Alex DePaoli, M.D., Senior Vice President, Chief Translational Officer at NGM Bio. “While still preliminary, these findings provide an interesting signal that encourages further study of NGM120 for the treatment of patients with advanced prostate cancer.”

The poster’s first author, Igor Medic, M.D., Cancer Center Oncology Medical Group, Sharp Grossmont Hospital, commented, “While a small sample size, the durable response and reduction of PSA to undetectable levels seen in this study in a patient with prostate cancer refractory to multiple lines of treatment is intriguing. I look forward to further clinical study of NGM120.”

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 in multiple cancers. For more details on NGM Bio’s oncology portfolio visit NGM Bio’s website at https://www.ngmbio.com/discovery-engine/oncology/.

In addition to the Phase 1a trial testing NGM120 as a monotherapy for the treatment of patients with solid tumors and the recently initiated Phase 1b trial testing NGM120 in combination with one or more lines of hormone therapies in patients with mCRPC, NGM Bio is conducting a Phase 1b dose escalation trial of NGM120 in combination with gemcitabine and Nab-paclitaxel in patients with metastatic pancreatic cancer and 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).

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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Investor Contact: Brian Schoelkopf ir@ngmbio.com

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