Latest news with #EndeavorBioMedicines
Yahoo
20-05-2025
- Health
- Yahoo
Endeavor BioMedicines Presents New Clinical Findings From Post Hoc Analysis of Phase 2a Clinical Trial Evaluating ENV-101 in Patients with Idiopathic Pulmonary Fibrosis
Findings presented at the American Thoracic Society 2025 International Conference corroborate previous findings and provide important new clinical evidence supporting ENV-101 SAN DIEGO, May 20, 2025--(BUSINESS WIRE)--Endeavor BioMedicines ("Endeavor"), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today presented a post hoc analysis from the completed Phase 2a clinical trial of its lead investigational therapy, ENV-101 (taladegib). Results demonstrated a significant reduction in pulmonary vessel volume, a significant increase in lung volume, and a trend towards reduced lung fibrosis for idiopathic pulmonary fibrosis (IPF) patients treated with ENV-101 for 12 weeks vs. placebo. The analysis utilized Qureight's deep learning-based computed tomography (CT) analytics technologies and was presented in a poster presentation at the American Thoracic Society (ATS) 2025 International Conference. Lung volume, fibrotic tissue volume and pulmonary vessel volume are all volumetric lung measures that can change during IPF disease progression or in response to treatment. Each measure has been established as an independent predictor of mortality. Deep learning-based quantification of lung volume and pulmonary vascular changes may offer valuable insights that corroborate physiological improvement in lung function and measure treatment outcomes with a greater effect size than forced vital capacity (FVC), the current registrational endpoint in IPF. A new finding from this post hoc analysis demonstrated a significant reduction in pulmonary vessel volume for patients in the ENV-101 treatment arm versus placebo. A reduction in pulmonary vessel volume has been correlated with improved mortality and decreased disease burden. To date, ENV-101 is the only therapeutic that has demonstrated a reduction in pulmonary vessel volume in patients with IPF, providing further evidence that ENV-101 has the potential to reverse disease across multiple measures of IPF. "These findings provide additional evidence of clinical utility of ENV-101 in patients with IPF marking another step forward in our mission to restore hope and improve lives for those facing this otherwise devastating disease," said Lisa Lancaster, M.D., Chief Medical Officer, Endeavor BioMedicines. "We are grateful to the Qureight team for partnering with us on this important analysis." The post hoc analysis of the Phase 2a trial was conducted using novel deep learning-based CT analysis technologies developed by Qureight Ltd (Cambridge, UK). Qureight used three deep learning models developed to quantify lung volume (Lung8), pulmonary vessel volume (Vascul8), and fibrosis extent (Fibr8) on the baseline and follow-up CTs of ENV-101 treated and placebo patients (ENV-101 = 16; placebo = 18). Key Results from the Post Hoc Analysis Presented at ATS 2025 Significant increase in lung volume (Lung8) for patients in the ENV-101 treatment arm vs placebo (placebo: −113.07 mL vs ENV-101: 142.28 mL; p=0.014; effect size=0.87). Trend towards reduced fibrosis (Fibr8) for ENV-101 treated patients vs placebo (placebo: 1.32pp vs ENV-101: −1.32pp; p=0.063; effect size=−0.64). Significant reduction in normalized pulmonary vessel volume (Vascul8) for patients in the ENV-101 treatment arm vs placebo (placebo: 0.07pp vs ENV-101: -0.25pp; p=0.0007; effect size=-1.28). "We are excited to share significant findings from the post hoc analysis of the phase 2a clinical trial of ENV-101, highlighting our pulmonary vessel volume quantification model, Vascul8," said Simon Walsh, M.D., Ph.D., Chief Scientific Officer, Qureight. "Using this model, we quantified a significant treatment effect from ENV-101, with a greater effect size than forced vital capacity. Qureight's deep learning-based imaging biomarkers offer distinct advantages by capturing treatment signals from each prognostic compartment of the lung separately, optimizing for precision medicine." About the ENV-101 Phase 2a Clinical Trial Data from the post hoc analysis independently validates and builds upon the previously reported results from the Phase 2a randomized, double-blind, multi-center, placebo-controlled clinical trial of ENV-101 (NCT04968574). In the trial, ENV-101 demonstrated significant improvements in lung function and total lung volume, while also showing a reduction in key measures of lung fibrosis versus placebo with a manageable safety profile. About the WHISTLE-PF Trial Endeavor continues to study ENV-101 and has initiated the Phase 2b WHISTLE-PF (Wound-remodeling Hedgehog-Inhibitor ILD Study Testing Lung Function Endpoints-PF) clinical trial, a global, randomized, placebo-controlled study evaluating the therapeutic potential of ENV-101 in individuals with IPF (NCT06422884). The WHISTLE-PF trial will evaluate the efficacy of a range of ENV-101 doses through 24 weeks of treatment, characterize the investigational compound's safety, assess its effect on patient reported outcomes and its effects on lung capacity and lung fibrosis as measured by chest HRCT. About Idiopathic Pulmonary Fibrosis IPF is a chronic, progressive lung disease that affects more than 150,000 adults in the United States. Although the exact cause of IPF is unknown, various environmental factors can deliver repeated injuries to lung cells that trigger abnormal wound-healing processes and life-threatening lung scarring. IPF is a chronic disease with limited treatment options and a very poor prognosis: the average life expectancy is only three to five years after diagnosis. About ENV-101 Endeavor BioMedicines' investigational medicine ENV-101 (taladegib) is a Hedgehog signaling pathway inhibitor. By binding to and inhibiting a key receptor in the Hedgehog pathway, ENV-101 stops the abnormal accumulation of the myofibroblasts that cause fibrosis. This may resolve the excessive wound-healing process seen in pulmonary fibrosis, improving lung volume and function. About Endeavor BioMedicines Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor's lead candidate, ENV-101 (taladegib), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). The company's second candidate, ENV-501, is a HER3 antibody-drug conjugate (ADC) in development for the treatment of HER3-positive solid tumors. More information is available at and on LinkedIn or X. View source version on Contacts Media: Audra Friis Sam Brown, Inc.917-519-9577audrafriis@ Sign in to access your portfolio
Business Wire
20-05-2025
- Business
- Business Wire
Endeavor BioMedicines Presents New Clinical Findings From Post Hoc Analysis of Phase 2a Clinical Trial Evaluating ENV-101 in Patients with Idiopathic Pulmonary Fibrosis
SAN DIEGO--(BUSINESS WIRE)-- Endeavor BioMedicines ('Endeavor'), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today presented a post hoc analysis from the completed Phase 2a clinical trial of its lead investigational therapy, ENV-101 (taladegib). Results demonstrated a significant reduction in pulmonary vessel volume, a significant increase in lung volume, and a trend towards reduced lung fibrosis for idiopathic pulmonary fibrosis (IPF) patients treated with ENV-101 for 12 weeks vs. placebo. The analysis utilized Qureight's deep learning-based computed tomography (CT) analytics technologies and was presented in a poster presentation at the American Thoracic Society (ATS) 2025 International Conference. Lung volume, fibrotic tissue volume and pulmonary vessel volume are all volumetric lung measures that can change during IPF disease progression or in response to treatment. Each measure has been established as an independent predictor of mortality. Deep learning-based quantification of lung volume and pulmonary vascular changes may offer valuable insights that corroborate physiological improvement in lung function and measure treatment outcomes with a greater effect size than forced vital capacity (FVC), the current registrational endpoint in IPF. A new finding from this post hoc analysis demonstrated a significant reduction in pulmonary vessel volume for patients in the ENV-101 treatment arm versus placebo. A reduction in pulmonary vessel volume has been correlated with improved mortality and decreased disease burden. To date, ENV-101 is the only therapeutic that has demonstrated a reduction in pulmonary vessel volume in patients with IPF, providing further evidence that ENV-101 has the potential to reverse disease across multiple measures of IPF. 'These findings provide additional evidence of clinical utility of ENV-101 in patients with IPF marking another step forward in our mission to restore hope and improve lives for those facing this otherwise devastating disease,' said Lisa Lancaster, M.D., Chief Medical Officer, Endeavor BioMedicines. 'We are grateful to the Qureight team for partnering with us on this important analysis.' The post hoc analysis of the Phase 2a trial was conducted using novel deep learning-based CT analysis technologies developed by Qureight Ltd (Cambridge, UK). Qureight used three deep learning models developed to quantify lung volume (Lung8), pulmonary vessel volume (Vascul8), and fibrosis extent (Fibr8) on the baseline and follow-up CTs of ENV-101 treated and placebo patients (ENV-101 = 16; placebo = 18). Key Results from the Post Hoc Analysis Presented at ATS 2025 Significant increase in lung volume (Lung8) for patients in the ENV-101 treatment arm vs placebo (placebo: −113.07 mL vs ENV-101: 142.28 mL; p=0.014; effect size=0.87). Trend towards reduced fibrosis (Fibr8) for ENV-101 treated patients vs placebo (placebo: 1.32pp vs ENV-101: −1.32pp; p=0.063; effect size=−0.64). Significant reduction in normalized pulmonary vessel volume (Vascul8) for patients in the ENV-101 treatment arm vs placebo (placebo: 0.07pp vs ENV-101: -0.25pp; p=0.0007; effect size=-1.28). 'We are excited to share significant findings from the post hoc analysis of the phase 2a clinical trial of ENV-101, highlighting our pulmonary vessel volume quantification model, Vascul8,' said Simon Walsh, M.D., Ph.D., Chief Scientific Officer, Qureight. 'Using this model, we quantified a significant treatment effect from ENV-101, with a greater effect size than forced vital capacity. Qureight's deep learning-based imaging biomarkers offer distinct advantages by capturing treatment signals from each prognostic compartment of the lung separately, optimizing for precision medicine.' About the ENV-101 Phase 2a Clinical Trial Data from the post hoc analysis independently validates and builds upon the previously reported results from the Phase 2a randomized, double-blind, multi-center, placebo-controlled clinical trial of ENV-101 (NCT04968574). In the trial, ENV-101 demonstrated significant improvements in lung function and total lung volume, while also showing a reduction in key measures of lung fibrosis versus placebo with a manageable safety profile. About the WHISTLE-PF Trial Endeavor continues to study ENV-101 and has initiated the Phase 2b WHISTLE-PF (W ound-remodeling H edgehog-Inhibitor I LD S tudy T esting L ung Function E ndpoints- PF) clinical trial, a global, randomized, placebo-controlled study evaluating the therapeutic potential of ENV-101 in individuals with IPF (NCT06422884). The WHISTLE-PF trial will evaluate the efficacy of a range of ENV-101 doses through 24 weeks of treatment, characterize the investigational compound's safety, assess its effect on patient reported outcomes and its effects on lung capacity and lung fibrosis as measured by chest HRCT. About Idiopathic Pulmonary Fibrosis IPF is a chronic, progressive lung disease that affects more than 150,000 adults in the United States. Although the exact cause of IPF is unknown, various environmental factors can deliver repeated injuries to lung cells that trigger abnormal wound-healing processes and life-threatening lung scarring. IPF is a chronic disease with limited treatment options and a very poor prognosis: the average life expectancy is only three to five years after diagnosis. About ENV-101 Endeavor BioMedicines' investigational medicine ENV-101 (taladegib) is a Hedgehog signaling pathway inhibitor. By binding to and inhibiting a key receptor in the Hedgehog pathway, ENV-101 stops the abnormal accumulation of the myofibroblasts that cause fibrosis. This may resolve the excessive wound-healing process seen in pulmonary fibrosis, improving lung volume and function. About Endeavor BioMedicines Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor's lead candidate, ENV-101 (taladegib), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). The company's second candidate, ENV-501, is a HER3 antibody-drug conjugate (ADC) in development for the treatment of HER3-positive solid tumors. More information is available at and on LinkedIn or X.
Business Wire
01-05-2025
- Health
- Business Wire
Endeavor BioMedicines Announces Upcoming Presentations at the 2025 American Thoracic Society International Conference
SAN DIEGO--(BUSINESS WIRE)-- Endeavor BioMedicines ('Endeavor'), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, announced that two posters have been accepted for presentation at the American Thoracic Society 2025 (ATS 2025) International Conference. ATS 2025 will take place May 16-21, 2025, in San Francisco. Following are details about the Endeavor poster presentations at ATS 2025: Title: Deep Learning-based Disease Severity Biomarkers on CT; Posthoc Analysis in a Phase 2a Placebo-controlled Study of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis Abstract Session: C23 – On The Horizon: Imaging and Molecular Biomarkers in Fibrotic ILD Presenter: Simon Walsh, M.D., Ph.D., Thoracic Radiologist, Qureight Ltd. Date and Time: Location: Room 2002/2004 (West Building, Level 2), Moscone Center Title: WHISTLE-PF: Study Design of A Phase 2b, Multi-center, Randomized, Double-blind, Controlled Trial of ENV-101 (Taladegib) In Patients With Idiopathic Pulmonary Fibrosis Abstract Session: A74 – Fibrotic Lung Disease Revisited Presenter: Toby M. Maher, M.D., Ph.D., Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California, Los Angeles Date and Time: May 18, 2025, 9:15-4:15 p.m. PT Location: Area G, Hall F, (North Building, Exhibition Level), Moscone Center For more information about Endeavor BioMedicines and the company's activities at ATS 2025, visit About Idiopathic Pulmonary Fibrosis IPF is a chronic, progressive lung disease that affects more than 150,000 adults in the United States. Although the exact cause of IPF is unknown, various environmental factors can deliver repeated injuries to lung cells that trigger abnormal wound-healing processes and life-threatening lung scarring. IPF is a chronic disease with limited treatment options and a very poor prognosis: the average life expectancy is only three to five years after diagnosis. About ENV-101 Endeavor BioMedicines' investigational medicine ENV-101 is a Hedgehog signaling pathway inhibitor. By binding to and inhibiting a key receptor in the Hedgehog pathway, ENV-101 stops the abnormal accumulation of the myofibroblasts that cause fibrosis. This may resolve the excessive wound-healing process seen in pulmonary fibrosis, improving lung volume and function. About Endeavor BioMedicines Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor's lead candidate, ENV-101 (taladegib), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). The company's second candidate, ENV-501, is a HER3 antibody-drug conjugate (ADC) in development for the treatment of HER3-positive solid tumors. More information is available at and on LinkedIn or X.
Yahoo
01-05-2025
- Business
- Yahoo
Endeavor BioMedicines Announces Upcoming Presentations at the 2025 American Thoracic Society International Conference
SAN DIEGO, May 01, 2025--(BUSINESS WIRE)--Endeavor BioMedicines ("Endeavor"), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, announced that two posters have been accepted for presentation at the American Thoracic Society 2025 (ATS 2025) International Conference. ATS 2025 will take place May 16-21, 2025, in San Francisco. Following are details about the Endeavor poster presentations at ATS 2025: Title: Deep Learning-based Disease Severity Biomarkers on CT; Posthoc Analysis in a Phase 2a Placebo-controlled Study of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis Abstract Session: C23 – On The Horizon: Imaging and Molecular Biomarkers in Fibrotic ILD Presenter: Simon Walsh, M.D., Ph.D., Thoracic Radiologist, Qureight Ltd. Date and Time: May 20, 2025, 9:15-11:15 a.m. PT Location: Room 2002/2004 (West Building, Level 2), Moscone Center Title: WHISTLE-PF: Study Design of A Phase 2b, Multi-center, Randomized, Double-blind, Controlled Trial of ENV-101 (Taladegib) In Patients With Idiopathic Pulmonary Fibrosis Abstract Session: A74 – Fibrotic Lung Disease Revisited Presenter: Toby M. Maher, M.D., Ph.D., Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California, Los Angeles Date and Time: May 18, 2025, 9:15-4:15 p.m. PT Location: Area G, Hall F, (North Building, Exhibition Level), Moscone Center For more information about Endeavor BioMedicines and the company's activities at ATS 2025, visit About Idiopathic Pulmonary FibrosisIPF is a chronic, progressive lung disease that affects more than 150,000 adults in the United States. Although the exact cause of IPF is unknown, various environmental factors can deliver repeated injuries to lung cells that trigger abnormal wound-healing processes and life-threatening lung scarring. IPF is a chronic disease with limited treatment options and a very poor prognosis: the average life expectancy is only three to five years after diagnosis. About ENV-101Endeavor BioMedicines' investigational medicine ENV-101 is a Hedgehog signaling pathway inhibitor. By binding to and inhibiting a key receptor in the Hedgehog pathway, ENV-101 stops the abnormal accumulation of the myofibroblasts that cause fibrosis. This may resolve the excessive wound-healing process seen in pulmonary fibrosis, improving lung volume and function. About Endeavor BioMedicinesEndeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor's lead candidate, ENV-101 (taladegib), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). The company's second candidate, ENV-501, is a HER3 antibody-drug conjugate (ADC) in development for the treatment of HER3-positive solid tumors. More information is available at and on LinkedIn or X. View source version on Contacts Media: Audra Friis Sam Brown, Inc.917-519-9577audrafriis@
Yahoo
02-04-2025
- Health
- Yahoo
Endeavor BioMedicines Appoints Internationally Renowned ILD Expert Lisa Lancaster, M.D., as Chief Medical Officer
SAN DIEGO, April 02, 2025--(BUSINESS WIRE)--Endeavor BioMedicines, a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today announced the appointment of Lisa Lancaster, M.D., as Chief Medical Officer. A renowned pulmonologist and clinical researcher focused on interstitial lung disease (ILD), Dr. Lancaster will lead the company's clinical development program for ENV-101 (taladegib), an inhibitor of the Hedgehog signaling pathway for the treatment of pulmonary fibrosis. "Dr. Lancaster is a highly experienced and respected physician with extensive expertise in interstitial lung diseases, including idiopathic pulmonary fibrosis," said John Hood, Ph.D., Co-founder, CEO and Chairman, Endeavor BioMedicines. "Her background, in addition to her deep relationships within the pulmonology community, make her the ideal candidate to fill the chief medical officer role. We are thrilled to have her join the Endeavor team." Dr. Lancaster has 25 years of pulmonology experience, serving as Interstitial Lung Disease Program Director at Vanderbilt University Medical Center since 2000, as well as Professor of Medicine in the Division of Allergy, Pulmonary and Critical Care Medicine within the Department of Medicine at Vanderbilt University Medical Center. Since Dr. Lancaster joined Vanderbilt University Medical Center in 1999, the Vanderbilt Idiopathic Pulmonary Fibrosis and ILD Research Program has participated in and/or completed over 80 clinical trials and registries. This included Dr. Lancaster serving as a principal investigator for pivotal clinical trials evaluating the two currently approved idiopathic pulmonary fibrosis therapies. Dr. Lancaster has also served on numerous ILD steering committees and advisory boards and has authored or coauthored over 100 publications on ILD. Her national leadership roles have included membership in the Steering Committee for the Diffuse Lung Disease Network of the American College of Chest Physicians and the Steering Committee for the Pulmonary Fibrosis Foundation Registry. "As a physician who has spent my entire career treating patients and leading clinical research programs, it is profoundly important to me to work among colleagues who share my passion for restoring hope for patients and their families living with IPF," said Dr. Lancaster. "At Endeavor, I have found just that – a team who strives to push the boundaries of medical innovation to create meaningful new therapeutic options for these patients." About Endeavor BioMedicines Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor's lead candidate, ENV-101 (taladegib), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). The company's second candidate, ENV-501, is a HER3 antibody-drug conjugate (ADC) in development for the treatment of HER3-positive solid tumors. More information is available at and on LinkedIn or X. View source version on Contacts Media Contact: Audra Friis Sam Brown, Inc.917-519-9577audrafriis@ Sign in to access your portfolio
