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
NGM Biopharmaceuticals reported encouraging preliminary results from its Phase 1a trial of NGM120, an antibody targeting GFRAL to treat advanced prostate cancer. The study showed good tolerability, with no dose-limiting toxicities. Notably, two out of five patients exhibited disease control, including one partial response at 62 weeks and PSA reductions. NGM is expanding its research with a Phase 1b cohort testing NGM120 in combination with hormone therapies for metastatic castration-resistant prostate cancer. Further details will be presented at the ESMO Annual Congress on September 11, 2022.
- NGM120 demonstrated good tolerability with no dose-limiting toxicities in the Phase 1a study.
- Two out of five prostate cancer patients showed disease control, with one ongoing partial response at 62 weeks.
- Two patients had significant PSA level reductions; one patient achieved undetectable levels.
- The sample size in the trial was small, which may limit the strength of the findings.
- 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.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “will,” “look forward,” “potential,” “promising,” “preliminary,” “encouraging,” “goal,” “aspires,” “aims” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to: NGM Bio’s product candidates, including the potential of NGM Bio’s oncology product candidate, NGM120 to treat cancer; potential outcomes suggested by preliminary findings regarding NGM120; NGM Bio’s aspiration to operate one of the most productive research and development engines in the biopharmaceutical industry and other statements that are not historical fact. Because such statements deal with future events and are based on NGM Bio’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of NGM Bio could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating, enrolling, reporting data from or completing clinical studies, as well as the risks that results obtained in preclinical or clinical trials to date may not be indicative of results obtained in ongoing or future trials, that preliminary results will differ from final results and that NGM Bio’s product candidates may otherwise not be tolerable and effective treatments in their planned indications; the ongoing COVID-19 pandemic, which has adversely affected, and could materially and adversely affect in the future, NGM Bio’s business and operations, including NGM Bio’s ability to timely supply, initiate, enroll and complete its ongoing and future clinical trials; the time-consuming and uncertain regulatory approval process; NGM Bio’s reliance on third-party manufacturers for its product candidates and the risks inherent in manufacturing and testing pharmaceutical products; the sufficiency of NGM Bio’s cash resources, including to fund its wholly-owned programs, and NGM Bio’s need for additional capital; and other risks and uncertainties affecting NGM Bio and its development programs, including those discussed in the section titled “Risk Factors” in NGM Bio’s annual report on Form 10-Q for the quarter ended June 30, 2022 filed with the United States Securities and Exchange Commission (SEC) on August 4, 2022 and future filings and reports that NGM Bio makes from time to time with the SEC. Except as required by law, NGM Bio assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.
| Investor Contact: Brian Schoelkopf ir@ngmbio.com | Media Contact: media@ngmbio.com |
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