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  • ||||||||||  DEL-30 / NGM Biopharma
    GENETIC ANALYSIS OF GLUT10 (SLC2A10) GENE IN PAKISTANI PATIENTS WITH DIABETES MELLITUS () -  Mar 10, 2025 - Abstract #ADPD2025ADPD_2427;    
    Six single nucleotide variations were detected in 5 of the patients in which two similar deletion variations (c.T>del24, c.A>del31) were found within the region of Exon 3 (111bp) in three diabetic individuals whereas the other four variations (c.T>del23, c.A>del30, c.T>del30, c.A>del37) were detected in two affected individuals. To conclude, our research emphasizes the importance of finding DNA variations using DNA sequencing in the molecular diagnosis of diverse genetic diseases.
  • ||||||||||  MASH 2B TRIALS- A SYSTEMATIC REVIEW () -  Oct 15, 2024 - Abstract #AASLD2024AASLD_2363;    
    Lanifibranor and icosabutate showed promise, especially in T2D patients. FGF21 analogues like efruxifermin improved fibrosis, while FGF19 trials had variable results.
  • ||||||||||  aldafermin (NGM282) / NGM Biopharma
    Journal, Heterogeneity:  Genetic heterogeneity of engineered Escherichia coli Nissle 1917 strains during scale-up simulation. (Pubmed Central) -  Sep 17, 2024   
    Whole genome short-read sequencing revealed the genetic instability of the pMUT-based production plasmid after serial passaging for approximately 150 generations using an automated platform for high-throughput microbial evolution in five independent lineages for six distinct strains. While a reduction of the number of mutations of 12%-43% could be observed after the deletion of the error-prone DNA polymerases, the interruption of production-relevant genes could not be prevented, highlighting the need for additional strategies to improve the stability of advanced microbiome therapeutics.
  • ||||||||||  aldafermin (NGM282) / NGM Biopharma
    Preclinical, Review, Journal:  THE ROLE OF FGF19 IN METABOLIC REGULATION: INSIGHTS FROM PRECLINICAL MODELS TO CLINICAL TRIALS. (Pubmed Central) -  Aug 22, 2024   
    Moreover, we provide a comprehensive overview of clinical trials involving a FGF19 analog called aldafermin, emphasizing promising results in diseases such as non-alcoholic steatohepatitis and diabetes. Therefore, we aim to foster a deeper understanding of FGF19 role and encourage further exploration of its clinical applications, thereby advancing the field and offering innovative approaches to address the escalating global health challenge of obesity and related metabolic conditions.
  • ||||||||||  aldafermin (NGM282) / NGM Biopharma, efruxifermin (AKR-001) / Akero Therap, pegozafermin (BIO89-100) / 89Bio
    Fibroblast Growth Factor Analogues in Metabolic Dysfunction Associated Steatotic Liver Disease: A Network Meta-Analysis (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_3435;    
    Twelve RCTs comprising 1,420 patients with MASLD were included, involving four FGF agonists: efruxifermin, aldafermin, pegbelfermin, and pegozafermin at various doses. Most significant mean reduction in hepatic fat fraction (HFF) [MD = -67.98, 95% CI [-102.12; -33.84], P 30% [RR=4.68, 95% CI [2.57; 7.97], P1 stage without MASH worsening followed by efruxifermin at 50 mg ( P =0.04).
  • ||||||||||  NGM120 / NGM Biopharma
    Trial completion, Trial completion date, Trial primary completion date, Combination therapy, Metastases:  PINNACLES: Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy (clinicaltrials.gov) -  Jul 8, 2024   
    P1/2,  N=90, Completed, 
    These data may help inform the design and sample size calculation of future clinical trials and assist selection of combination therapy. Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> Jan 2024 | Trial primary completion date: Jul 2024 --> Sep 2023
  • ||||||||||  NGM438 / NGM Biopharma
    Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker:  Anti-tumor activity of a novel LAIR1 antagonist in combination with anti-PD-1 to treat collagen-rich solid tumors. (Pubmed Central) -  Apr 22, 2024   
    Further, a mouse-reactive NGM438 surrogate antibody sensitized refractory KP mouse lung tumors to anti-PD-1 therapy and resulted in increased intratumoral CD8+ T cell content and inflammatory gene expression. These data place LAIR1 at the intersection of stroma and suppressive myeloid cells and support the notion that blockade of the LAIR1/collagen axis can potentially address resistance to checkpoint inhibitor therapy in the clinic.
  • ||||||||||  aldafermin (NGM282) / NGM Biopharma
    Efficacy and safety of FGF-analogs for the treatment of MASH: a systematic review and meta-analysis (Poster Area) -  Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_2098;    
    Notably, only Aldafermin 1 mg displayed an increase in MASH resolution with no worsening of fibrosis and no significant side effects compared to placebo. Further studies with larger sample size and extended follow-up are essential for comprehensively assessing the sustained efficacy and safety of the drug.
  • ||||||||||  NGM438 / NGM Biopharma
    Enrollment closed, Trial completion date, Trial primary completion date, Monotherapy:  KEYNOTE-E20: Study of NGM438 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) -  Apr 1, 2024   
    P1,  N=71, Active, not recruiting, 
    Further studies with larger sample size and extended follow-up are essential for comprehensively assessing the sustained efficacy and safety of the drug. Recruiting --> Active, not recruiting | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Mar 2024 --> Apr 2025
  • ||||||||||  aldafermin (NGM282) / NGM Biopharma
    Journal:  FGF19 and its analog Aldafermin cooperate with MYC to induce aggressive hepatocarcinogenesis. (Pubmed Central) -  Feb 19, 2024   
    In particular, even a short systemic treatment with recombinant proteins triggered rapid appearance of proliferative foci of MYC-expressing hepatocytes. The fact that FGF19 analog Aldafermin is not fully devoid of the hormone's oncogenic properties raises concerns in the context of its potential use for patients with damaged, mutation-prone liver.
  • ||||||||||  Comparative efficacy of pharmacologic therapies in MASH: Systematic review and meta-analysis (New Hall) -  Jan 6, 2024 - Abstract #APASL2024APASL_707;    
    For MRI-PDFF response, Aldafermin (SUCRA = 92.61), Efruxifermin (SUCRA = 81.00) and Resmetirom (SUCRA = 55.54) had the highest probability of being ranked the most effective intervention for achieving MRI-PDFF response at week 12. These data provide relative rank-order efficacy of various MASH therapies in terms of improvements in MRI-PDFF.
  • ||||||||||  NGM621 Intravitreal / NGM Biopharma
    Trial completion, Trial completion date, Trial primary completion date:  CATALINA: A Study of NGM621 in Participants With Geographic Atrophy (clinicaltrials.gov) -  Jun 18, 2023   
    P2,  N=320, Completed, 
    Ultimately, 9 studies involving 232 patients were included in qualitative review and summarized in the Table . Active, not recruiting --> Completed | Trial completion date: Apr 2023 --> Aug 2022 | Trial primary completion date: Dec 2022 --> Aug 2022
  • ||||||||||  aldafermin (NGM282) / NGM Biopharma
    Trial completion:  Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4) (clinicaltrials.gov) -  Jun 13, 2023   
    P2b,  N=160, Completed, 
    Active, not recruiting --> Completed | Trial completion date: Apr 2023 --> Aug 2022 | Trial primary completion date: Dec 2022 --> Aug 2022 Active, not recruiting --> Completed
  • ||||||||||  aldafermin (NGM282) / NGM Biopharma
    Fibroblast growth factor 19 cooperates with Myc to promote liver carcinogenesis (Poster Area) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_2305;    
    Moreover, we suggest that aldafermin might keep oncogenic properties in this context. Since Myc pathway is often deregulated in patients with NASH or cirrhosis, our results suggest a precautionary approach with regard to the potential adverse effects of FGF analogs in these patients.
  • ||||||||||  resmetirom (MGL-3196) / Madrigal Pharma, aldafermin (NGM282) / NGM Biopharma
    Hepatic fat and liver volume reductions  (Poster Area) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1914;    
    P2
    The impact of SC and LV correction is great on the concomitant fibrosis around steatosis, but minimal on the concomitant fibrosis around ballooning. Therefore, concomitant analyses with digital pathology can augment the interpretation of the mechanism of action of drugs in NASH as well as allow for a better understanding of the impact these drugs have on histopathology and should be considered in future trials.