terevalefim (ANG-3777) / Elicio Therap, CSL Behring - LARVOL DELTA

Development of and recovery from acute kidney injury after cardiac surgery: Randomized phase 2 trial of the hepatocyte growth factor mimetic ANG-3777. (PubMed, J Thorac Cardiovasc Surg) - "Findings from this study do not support the efficacy of ANG-3777 in preventing the development of AKI following cardiopulmonary bypass."

Journal • P2 data • Surgery • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease • HGF

The hepatocyte growth factor mimetic, ANG-3777, in kidney transplant recipients with delayed graft function: results from a randomized phase 3 trial. (PubMed, Am J Transplant) - P3 | "Although there is insufficient evidence to support an indication of ANG-3777 for patients at risk of renal dysfunction after deceased-donor kidney transplantation, these findings indicate potential biological activity that may warrant further investigation. Clinicaltrials.gov number: NCT02474667."

Clinical • Journal • P3 data • Nephrology • Transplant Rejection • Transplantation • HGF

THE EFFECT OF ANG-3777 ON THE GROWTH OF C-MET-EXPRESSING HUMAN TUMOR CELLS IN IMMUNOCOMPROMISED MICE (ESOT 2021) - "Administration of ANG-3777 in human tumor cells expressing c-MET was not associated with increased tumor volume or weight in pancreatic and colon tumor models and did not increase mortality in the glioma model in BALB/c nude mice. Keywords: ANG-3777, tumor growth, tumor weight, overall survival."

Preclinical • Brain Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Glioma • Hepatology • Nephrology • Oncology • Pancreatic Cancer • Solid Tumor • Transplantation • HGF • MET

IN VIVO PHOSPHORYLATION OF C-MET BY ANG-3777, A HEPATOCYTE GROWTH FACTOR MIMETIC (ESOT 2021) - "ANG-3777 induces phosphorylation of c-Met in normal rat liver in a time-dependent manner, and in a rat renal ischemia reperfusion model, ANG-3777 induced a robust increase in phosphorylated c-Met at 24 hours post-reperfusion."

Preclinical • Reperfusion Injury • HGF • MET

ANG-3777 TREATMENT ATTENUATES ISCHEMIA-REPERFUSION-INDUCED RENAL INJURY IN RAT AND DOG MODELS (ESOT 2021) - "ANG-3777 attenuated renal dysfunction, increased urine output, and improved survival in animals subjected to nRIR. ANG-3777 was efficacious, both when administered at onset of ischemic injury and when initiated 1d post-ischemic injury."

Preclinical • Nephrology • Renal Disease • Reperfusion Injury • HGF

[VIRTUAL] Design of the Graft Improvement Following Transplant (GIFT) Trial, a Phase 3 Study of ANG-3777 in Kidney Transplantation Patients with Delayed Graft Function (KIDNEY WEEK 2020) - "No pharmacologic intervention has been demonstrated in a rigorous trial to be effective preventing or improving the outcome of DGF. The GIFT study will generate data that are critical to advancing the treatment of DGF."

Clinical • P3 data • Acute Kidney Injury • Nephrology • Transplantation • HGF

Study to Prevent Acute Kidney Injury After Cardiac Surgery Involving Cardiopulmonary Bypass (clinicaltrials.gov) - P2; N=275; Active, not recruiting; Sponsor: Angion Biomedica Corp; Recruiting ➔ Active, not recruiting; Trial primary completion date: Mar 2021 ➔ Aug 2021

Clinical • Enrollment closed • Trial primary completion date • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease

Study to Evaluate the Pharmacokinetics of ANG-3777 in Hemodialysis Subjects (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Angion Biomedica Corp

Clinical • New P1 trial

A Study to Assess the Absorption, Metabolism and Excretion of [14C]-ANG-3777 (clinicaltrials.gov) - P1; N=6; Recruiting; Sponsor: Angion Biomedica Corp

New P1 trial

Angion Announces Results from the Phase 2 ALI-201 Study in Patients with COVID-19 Associated Pneumonia (GlobeNewswire) - P2, N=120; NCT04459676; Sponsor: Angion Biomedica Corp; "...exploratory Phase 2 ALI-201 trial of ANG-3777 in patients with severe COVID-19 related pneumonia at high risk for acute respiratory distress syndrome (ARDS) did not meet the primary or secondary efficacy endpoints. The adverse events and overall safety of the trial were consistent with previously published reports in patients hospitalized with severe COVID-19 pneumonia. 'The ALI-201 study sought to address a patient population severely ill with COVID-19, a multi-system inflammatory condition, which differs markedly from our prior and ongoing clinical trials of ANG-3777...'"

P2 data • Infectious Disease • Novel Coronavirus Disease

Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney (clinicaltrials.gov) - P3; N=253; Active, not recruiting; Sponsor: Angion Biomedica Corp; Trial completion date: Dec 2021 ➔ Sep 2021

Clinical • Trial completion date • Nephrology • Transplantation

Study Developed to Evaluate the Effect of ANG-3777 on the Baseline-adjusted, Placebo-controlled QT/QTc Interval (clinicaltrials.gov) - P1; N=48; Not yet recruiting; Sponsor: Angion Biomedica Corp

Clinical • New P1 trial

Study to Assess Efficacy and Safety Relative to Standard of Care in Patients With COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Angion Biomedica Corp; Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Pneumonia • PCR

Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney (clinicaltrials.gov) - P3; N=253; Active, not recruiting; Sponsor: Angion Biomedica Corp; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Nephrology • Transplantation

Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function. (PubMed, Kidney Int Rep) - "Preclinical and phase 2 data indicate that treatment with ANG-3777 (formerly BB3), a hepatocyte growth factor (HGF) mimetic, may improve long-term kidney function and reduce health care resource use and cost, but these data require validation in a phase 3 randomized controlled trial...Adverse events are assessed throughout the study. GIFT will generate data that are important to advancing treatment of DGF in this medically complex population."

Clinical • Journal • Acute Kidney Injury • Nephrology • Transplantation • HGF

ANG-3777: Data from P3 trial (NCT02474667) for transplant-associated acute kidney injury (delayed graft function) at the end of 2021 (Vifor Pharma) - Investor Presentation: Data from P2 trial (NCT02771509) for acute kidney injury after cardiac surgery in Q2 2021

P2 data • P3 data • Renal Disease

Phase 3 biotech Angion Biomedica files for a $75 million IPO (Nasdaq) - "The company's lead candidate, ANG-3777...is currently in a Phase 3 registrational trial to improve kidney function and reduce the severity of DGF following deceased-donor kidney transplantation in patients showing evidence of early kidney dysfunction, with topline data expected by the end of 2021."

P3 data: top line • Renal Disease

Hepatocyte Growth Factor Mimetic ANG-3777 for Cardiac Surgery-Associated Acute Kidney Injury. (PubMed, Kidney Int Rep) - "Safety will include adverse events and laboratory measures. This phase 2 study of ANG-3777 provides data to develop a phase 3 registrational study in this medically complex condition."

Journal • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease • Reperfusion Injury • Transplantation • HGF

ANG-3777: Top-line data from P2 trial (NCT02771509) for acute kidney injury after cardiac surgery in mid-2021 (Angion Biomedica) - Corporate Presentation: Top-line data from P3 trial (NCT02474667) for transplant-associated acute kidney injury (delayed graft function) in H2 2021

P2 data • P3 data: top line • Renal Disease

ANG-3777: NDA submission for transplant-associated acute kidney injury (delayed graft function) in 2022 (Angion Biomedica) - Corporate Presentation

NDA • Renal Disease

"Vifor Pharma and Angion Sign License Agreement for ANG-3777 in Nephrology Indications https://t.co/0TIdLGWBt2" (@NewsFromBW)

M&A • Nephrology

[VIRTUAL] The Effect of ANG-3777 on the Growth of c-MET-Expressing Human Tumor Cells in Immunocompromised Mice (KIDNEY WEEK 2020) - "Administration of ANG-3777 in human tumor cells expressing c-MET was not associated with increased tumor volume or weight in pancreatic and colon tumor models and did not increase mortality in the glioma model in BALB/c nude mice."

Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Glioma • Hepatology • Nephrology • Oncology • Pancreatic Cancer • Solid Tumor • Transplantation • HGF • MET

[VIRTUAL] The Effect of ANG-3777 on In Vitro Cell Proliferation (KIDNEY WEEK 2020) - "In vitro cell-based proliferation assays confirmed that the activity of ANG-3777 is comparable to that of HGF in inducing cell proliferation in HUVECs and rat Schwann cells with neither agent stimulating proliferation in mouse fibroblasts."

Preclinical

Sorocabanos will test new medication in the treatment of Covid-19 [Google translation] (Jornal Cruzeiro do Sul) - "Sorocaba coronavirus patients will volunteer in a clinical research study to test the efficacy or otherwise of leading-edge drugs in the treatment of Covid-19. The unprecedented scientific work is being carried out in at least 40 hospitals worldwide....Of the five drugs that patients will receive, three already exist....They are: Ruxolitinib, Acalabrutinib and Lenzilumab (Humanigen). Two other drugs do not yet exist on the market and are called ANG-3777 (Angion) and BLD-2660 (Blade)."

Trial status • Infectious Disease • Novel Coronavirus Disease

Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney (clinicaltrials.gov) - P3; N=262; Recruiting; Sponsor: Angion Biomedica Corp; Trial primary completion date: Dec 2020 ➔ Sep 2021

Clinical • Trial primary completion date • Transplantation