Lung

Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised

Retrieved on: 
목요일, 4월 18, 2024
Eucalyptus oil, Bronchitis, Spasm, Seizure, System, Risk, Inflammation, Patient, Lung, Monograph, Committee, Inhalation, Steam, Herbal medicine, Date, Asthma, Heart failure, Plant, Mouth, Infection, Skin, Fever, Myalgia, Water, Larynx, Medicine, Dietary supplement

Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised

Key Points: 


Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised

Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

Retrieved on: 
목요일, 4월 18, 2024
Reproduction, Particle size, Q&A, Patient, Lung, Chronic obstructive pulmonary disease, DPI, Pharmacokinetics, Child, Isocyanate, International Council, Scope, Abbreviation, Asthma, OIP, European, COPD, APSD, Absorption, Rheumatology, Risk, Draft, EMA, Safety, TE, CHMP, MDI, Pharmacodynamics, IVIVC, Documentation, Taste, Comparison, Inhalation, Charcoal, Clinical Trials Directive, The central science, Drug development, Literature, ICH, Guideline, Gastrointestinal tract, GI, Marketing, Medication package insert, Excipient, Quality, QWP, Medical device

21

Key Points: 
    • 21

      Guideline on the requirements for demonstrating
      therapeutic equivalence between orally inhaled products
      (OIP) for asthma and chronic obstructive pulmonary
      disease (COPD)

      22

      Table of contents

      23

      Executive summary ..................................................................................... 4

      24

      1.

    • Primary PK parameters to be analysed and acceptance criteria .............................. 14

      43

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      51

      6.4.

    • Definitions ........................................................................................... 18

      56

      List of Abbreviations.................................................................................. 20

      57

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      58

      Executive summary

      59

      This guideline is the 2nd revision of the CHMP Guideline formerly called ?Guideline on the requirements

      60

      for clinical documentation for orally inhaled products (OIP) including the requirements for

      61

      demonstration of therapeutic equivalence between two inhaled products for use in the treatment of

      62

      asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of

      63

      asthma in children and adolescents?.

    • It addresses the requirements for demonstration of therapeutic

      64

      equivalence (TE) between orally inhaled products containing the same active moiety(ies).

    • It is generally not recommended to aim at demonstrating TE using pharmacodynamic

      70

      or clinical endpoints as these are deemed insensitive.

    • This

      83

      guideline is directed particularly at the requirements for demonstrating TE between OIPs containing the

      84

      same active moiety(ies) and used in the management and treatment of patients with asthma and/or

      85

      COPD.

    • 86

      The guideline was first published as points to consider in 2004 and revised for the first time and

      87

      became guideline in 2009.

    • Since then, a number of Q&A documents have been published by Quality

      88

      Working Party (QWP) and former Pharmacokinetic Working Party (PKWP).

    • Scope

      93

      This document provides guidance on the requirements for demonstrating TE between OIPs, including

      94

      both, single active substance products and combination products.

    • Also, in the case that there is a need

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      98

      to confirm similarity to a product for which literature data is available (e.g., well-established use

      99

      applications), the same principles apply.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      132

      4.

    • Products for nebulisation

      177

      This guideline applies also for products for nebulisation although it is acknowledged that the

      178

      performance of these is highly dependent on the nebuliser used.

    • In vitro criteria for demonstrating TE

      206

      The test and reference products should be compared in order to conclude on TE.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      211
      212

      2.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      353

      6.2.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      392

      6.3.

    • If the
      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      432

      different strengths of the test and the reference product are not shown to be proportional in vitro, in

      433

      vivo equivalence should be demonstrated with a bracketing approach.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      471

      6.4.

    • Griffin, 1964

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      553

      which both reference product-na?ve and experienced users should be included.

    • 568

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      569

      10.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      Product strength

      Product strength may be either the delivered
      dose or the metered dose.

    • 570

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      571

      List of Abbreviations
      APSD

      Aerodynamic Particle Size Distribution

      AUC

      Area Under the Curve

      CHMP

      Committee for Medicinal Products for Human
      Use

      CI

      Confidence Interval

      Cmax

      Peak concentration

      COPD

      Chronic Obstructive Pulmonary Disease

      DPI

      Dry Powder Inhaler

      FPD

      Fine Particle Dose

      GI

      Gastrointestinal

      ICH

      International Conference on Harmonisation

      IVIVC

      In vitro in vivo correlation

      MDI

      Metered Dose Inhaler

      OIP

      Orally Inhaled Product

      PD

      Pharmacodynamic

      PK

      Pharmacokinetic

      pMDI

      Pressurised Metered Dose Inhaler

      QWP

      Quality Working Party

      SmPC

      Summary of Product Characteristics

      TE

      Therapeutic equivalence

      tmax

      Time to peak concentration

      572

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

Retrieved on: 
목요일, 4월 18, 2024
Reproduction, Particle size, Q&A, Patient, Lung, Chronic obstructive pulmonary disease, DPI, Pharmacokinetics, Child, Isocyanate, International Council, Scope, Abbreviation, Asthma, OIP, European, COPD, APSD, Absorption, Rheumatology, Risk, Draft, EMA, Safety, TE, CHMP, MDI, Pharmacodynamics, IVIVC, Documentation, Taste, Comparison, Inhalation, Charcoal, Clinical Trials Directive, The central science, Drug development, Literature, ICH, Guideline, Gastrointestinal tract, GI, Marketing, Medication package insert, Excipient, Quality, QWP, Medical device

21

Key Points: 
    • 21

      Guideline on the requirements for demonstrating
      therapeutic equivalence between orally inhaled products
      (OIP) for asthma and chronic obstructive pulmonary
      disease (COPD)

      22

      Table of contents

      23

      Executive summary ..................................................................................... 4

      24

      1.

    • Primary PK parameters to be analysed and acceptance criteria .............................. 14

      43

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      51

      6.4.

    • Definitions ........................................................................................... 18

      56

      List of Abbreviations.................................................................................. 20

      57

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      58

      Executive summary

      59

      This guideline is the 2nd revision of the CHMP Guideline formerly called ?Guideline on the requirements

      60

      for clinical documentation for orally inhaled products (OIP) including the requirements for

      61

      demonstration of therapeutic equivalence between two inhaled products for use in the treatment of

      62

      asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of

      63

      asthma in children and adolescents?.

    • It addresses the requirements for demonstration of therapeutic

      64

      equivalence (TE) between orally inhaled products containing the same active moiety(ies).

    • It is generally not recommended to aim at demonstrating TE using pharmacodynamic

      70

      or clinical endpoints as these are deemed insensitive.

    • This

      83

      guideline is directed particularly at the requirements for demonstrating TE between OIPs containing the

      84

      same active moiety(ies) and used in the management and treatment of patients with asthma and/or

      85

      COPD.

    • 86

      The guideline was first published as points to consider in 2004 and revised for the first time and

      87

      became guideline in 2009.

    • Since then, a number of Q&A documents have been published by Quality

      88

      Working Party (QWP) and former Pharmacokinetic Working Party (PKWP).

    • Scope

      93

      This document provides guidance on the requirements for demonstrating TE between OIPs, including

      94

      both, single active substance products and combination products.

    • Also, in the case that there is a need

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      98

      to confirm similarity to a product for which literature data is available (e.g., well-established use

      99

      applications), the same principles apply.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      132

      4.

    • Products for nebulisation

      177

      This guideline applies also for products for nebulisation although it is acknowledged that the

      178

      performance of these is highly dependent on the nebuliser used.

    • In vitro criteria for demonstrating TE

      206

      The test and reference products should be compared in order to conclude on TE.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      211
      212

      2.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      353

      6.2.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      392

      6.3.

    • If the
      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      432

      different strengths of the test and the reference product are not shown to be proportional in vitro, in

      433

      vivo equivalence should be demonstrated with a bracketing approach.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      471

      6.4.

    • Griffin, 1964

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      553

      which both reference product-na?ve and experienced users should be included.

    • 568

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      569

      10.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      Product strength

      Product strength may be either the delivered
      dose or the metered dose.

    • 570

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      571

      List of Abbreviations
      APSD

      Aerodynamic Particle Size Distribution

      AUC

      Area Under the Curve

      CHMP

      Committee for Medicinal Products for Human
      Use

      CI

      Confidence Interval

      Cmax

      Peak concentration

      COPD

      Chronic Obstructive Pulmonary Disease

      DPI

      Dry Powder Inhaler

      FPD

      Fine Particle Dose

      GI

      Gastrointestinal

      ICH

      International Conference on Harmonisation

      IVIVC

      In vitro in vivo correlation

      MDI

      Metered Dose Inhaler

      OIP

      Orally Inhaled Product

      PD

      Pharmacodynamic

      PK

      Pharmacokinetic

      pMDI

      Pressurised Metered Dose Inhaler

      QWP

      Quality Working Party

      SmPC

      Summary of Product Characteristics

      TE

      Therapeutic equivalence

      tmax

      Time to peak concentration

      572

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

Quanta Presents Preclinical Data for QTX3544, a Potent and Selective G12V-preferring Multi-KRAS Inhibitor, in Late-Breaking Session at Annual AACR Meeting 2024

Retrieved on: 
월요일, 4월 8, 2024
Discovery, MAPK, Patient, Lung, Doctor of Philosophy, MD, IND, AACR, Therapy, Stomach

RADNOR, Pa. & SOUTH SAN FRANCISCO, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Quanta Therapeutics, a privately-held biopharmaceutical company leading innovative development of direct, oral therapeutics for RAS-driven cancers, announced the presentation of QTX3544, a multi-KRAS inhibitor with G12V-preferring activity (G12V+ multi-KRAS), in a late-breaking poster presentation session at the American Association of Cancer Research (AACR) Annual Meeting.

Key Points: 
  • QTX3544 demonstrated a favorable preclinical profile, including high selectivity and potent activity against multiple KRAS mutations with preference for the G12V mutation.
  • Additionally, QTX3544 significantly inhibited KRASG12V tumor growth in preclinical animal models and exhibited promising oral bioavailability and pharmacokinetic properties.
  • “We continue to advance our pipeline of candidates against KRAS-driven cancer mutations focusing on the most prevalent drivers, G12D and G12V,” said Perry Nisen, MD, PhD, Chief Executive Officer of Quanta.
  • We look forward to completing IND-enabling studies for QTX3544 this year to support future clinical studies in patients with G12V-mutated solid tumors, a population without targeted treatment options.”
    Data from the presentation are summarized below.

Elicio Therapeutics to Present Updated Clinical T Cell and Antigen Spreading Response Data from the Ongoing AMPLIFY-201 Phase 1 Study of ELI-002 and Preclinical Data on ELI-007 and ELI-008 at the AACR Annual Meeting

Retrieved on: 
금요일, 4월 5, 2024
CD4, CD8, AMP, Development, Antigen, Immunotherapy, Colorectal cancer, Memory, Patient, Lung, GM-CSF, Biomarker, DNA, Epitope, Cancer, Granzyme B, BRAF, Lymph, IL2, Circulating tumor DNA, Phenotype, Neoplasm, Research and development, Immunization, Therapy, Vaccination, CRC, V600E, Immune system, Melanoma, Granzyme, Phase 1, Amphetamine, Nature Medicine, Annual general meeting, Vaccine

Preclinical data on vaccine candidates, ELI-007 and ELI-008, investigational peptide vaccines targeting BRAF and p53-driven cancers, respectively, will also be shared.

Key Points: 
  • Preclinical data on vaccine candidates, ELI-007 and ELI-008, investigational peptide vaccines targeting BRAF and p53-driven cancers, respectively, will also be shared.
  • A majority of patients who received the booster immunizations maintained or increased mKRAS-specific T cell responses relative to baseline.
  • The mKRAS-specific CD4 and CD8 T cells generated by ELI-002 exhibited increased cytotoxic function and development of favorable memory phenotype.
  • "Earlier data published in Nature Medicine demonstrate that our off-the-shelf lymph node-targeted cancer vaccine candidate, ELI-002, induces memory T cell responses.

CDR-Life Unveils Results on T-Cell Engagers Targeting Hard-to-Treat Solid Tumors at AACR 2024

Retrieved on: 
금요일, 4월 5, 2024
Cell, Trichloroethylene, Patient, Lung, Epitope, Breast, KK, Allele, AACR, Cancer, Antibody, TCE, Therapy, Peptide, Vaccine

Identifying a TCE against the KK-LC-1 peptide on HLA-A*01 will provide an option for patients that do not benefit from the more common HLA-A*02 targeting therapeutics currently in development.

Key Points: 
  • Identifying a TCE against the KK-LC-1 peptide on HLA-A*01 will provide an option for patients that do not benefit from the more common HLA-A*02 targeting therapeutics currently in development.
  • However, high levels of similar off-target peptides presented in healthy tissues make targeting the KK-LC-1/HLA-A*01 challenging.
  • CDR-Life’s data gathered on pMHC TCE antibodies with high specificity towards HLA-A*01 restricted KK-LC-1 epitopes demonstrate the antibodies’ promising anti-tumor activity and specificity for KK-LC-1/HLA-A*01 positive tumors.
  • In vitro studies showed significantly higher TCE-dependent T-cell activation towards cells presenting the target peptide compared to the risk peptides.

New Survey Reveals Present-Day Risks of Asbestos Exposure in America - 38% in High-Risk Jobs, 47% Vulnerable through Second-Hand Exposure

Retrieved on: 
목요일, 4월 4, 2024
Law, Asbestos, Risk, Education, Lung, Public, PLLC, Cancer, Mesothelioma, EPA, Sickness, Gen

These findings, released today, underscore the urgent necessity for Asbestos Cancer Risk Awareness and routine testing.

Key Points: 
  • These findings, released today, underscore the urgent necessity for Asbestos Cancer Risk Awareness and routine testing.
  • They emphasize the crucial importance of proactive measures to mitigate the pervasive risks associated with asbestos exposure in the United States.
  • Awareness about the risks of asbestos exposure appears to be widespread, with 45% of respondents acknowledging the potential dangers.
  • For more information on asbestos risks and testing, including an infographic, podcast, and video, visit this page .

Surrozen Publishes Study in 'Respiratory Research' Demonstrating the Promise of a Wnt Mimetic Antibody in Treating Pulmonary Fibrosis

Retrieved on: 
수요일, 4월 3, 2024
Research, Extracellular matrix, B cell, ECM, Regeneration, Idiopathic pulmonary fibrosis, AT2, Inflammation, Lung, SWAP, Respiratory Research, Macrophage, IPF, Pulmonary fibrosis, Fibrosis, Therapy, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., April 03, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively modulate the Wnt pathway for tissue repair and regeneration, announced today publication of data in Respiratory Research highlighting the potential for Surrozen’s Wnt mimetic technologies to treat serious lung diseases like idiopathic pulmonary fibrosis (IPF) https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-0.... The results observed with systemic administration of Surrozen’s Wnt mimetic antibody in an acute bleomycin model of pulmonary fibrosis demonstrate a Wnt pathway mediated decrease in inflammation and fibrosis and improvement in lung function.

Key Points: 
  • The results observed with systemic administration of Surrozen’s Wnt mimetic antibody in an acute bleomycin model of pulmonary fibrosis demonstrate a Wnt pathway mediated decrease in inflammation and fibrosis and improvement in lung function.
  • Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by areas of myofibroblast accumulation and extracellular matrix (ECM) deposition, disruption of alveolar architecture, and restricted lung physiology.
  • In pulmonary fibrosis, multiple cell types may need to be targeted to provide a regenerative environment facilitating repair.
  • “This work published in Respiratory Research represents a breakthrough in understanding the role of the Wnt pathway in lung fibrosis and the potential for Wnt mimetics to reduce fibrosis and improve lung function.”

Dr. Marra Francis Joins Genece Health as Chief Medical Officer

Retrieved on: 
수요일, 4월 3, 2024
Health, Obstetrics, Faculty, Gynaecology, Physician, FACOG, DEL, Memorial Hermann–Texas Medical Center, Lung, Breast, University, MD, Biology, Ovary, Cancer, Liquid biopsy, GeneDx, Occidental College

DEL MAR, Calif., April 03, 2024 (GLOBE NEWSWIRE) -- Genece Health, a molecular testing company focused on improving cancer detection for lung, breast, ovarian and other cancers, today announced that Marra Francis, MD, FACOG, has joined the company as its chief medical officer.

Key Points: 
  • DEL MAR, Calif., April 03, 2024 (GLOBE NEWSWIRE) -- Genece Health, a molecular testing company focused on improving cancer detection for lung, breast, ovarian and other cancers, today announced that Marra Francis, MD, FACOG, has joined the company as its chief medical officer.
  • Dr. Francis’ past experience also includes serving as head of medical affairs for women's health of Sema4 (now GeneDx); as executive medical director of EverlyWell; and as chief medical officer of Aspira Women's Health.
  • Dr. Francis holds a medical degree from the University of Connecticut Health Center and a bachelor of arts degree in biology from Occidental College.
  • “We are delighted to have Marra join our team at a very exciting time for Genece,” said Greg Gosch, CEO of Genece Heath.

Diagonal Therapeutics Launches with $128 Million in Financing to Pioneer a New Approach to Discovering and Developing Agonist Antibodies to Tackle the Underlying Causes of Severely Debilitating Diseases

Retrieved on: 
수요일, 4월 3, 2024
Hereditary hemorrhagic telangiectasia, Telangiectasia, Biotechnology, Blood, Disease, Atlas, Patient, Lung, Stroke, Viking Global Investors, Death, Artery, Chiari malformation, Rupture, Intraparenchymal hemorrhage, Heart failure, Lightspeed Venture Partners, Therapy, TGF, Antibody, Bleeding, Heart, Pharmacology, Unified school district, HHT, PAH, Atlas Venture, Pulmonary hypertension, Pharmaceutical industry

CAMBRIDGE, Mass., April 03, 2024 (GLOBE NEWSWIRE) -- Diagonal Therapeutics, a biotechnology company pioneering a new approach to discovering and developing agonist antibodies, launched today with $128 million in financing. The Series A was co-led by BVF Partners and Atlas Venture, with participation from Lightspeed Venture Partners, RA Capital Management, Frazier Life Sciences, Viking Global Investors, Velosity Capital, and Checkpoint Capital. Diagonal was co-founded by Chief Executive Officer, Alex Lugovskoy, Ph.D., and Atlas and previously seeded by Atlas, Lightspeed Venture Partners, and Velosity Capital. The financing will support further advancement of the company’s proprietary DIAGONAL platform and pipeline of novel therapeutics to value-creating milestones, including its lead program for the treatment of hereditary hemorrhagic telangiectasia (HHT), a severely debilitating bleeding disorder with limited therapeutic options, through clinical proof-of-concept. Diagonal's agonist antibody activates a receptor complex in the TGF-β superfamily genetically impaired in HHT patients. In preclinical models of HHT, Diagonal's agonist antibodies prevent and reverse the formation of pathological vascular malformations.

Key Points: 
  • Diagonal was co-founded by Alex Lugovskoy, Ph.D., and Atlas and previously seeded by Atlas, Lightspeed Venture Partners, and Velosity Capital.
  • CAMBRIDGE, Mass., April 03, 2024 (GLOBE NEWSWIRE) -- Diagonal Therapeutics, a biotechnology company pioneering a new approach to discovering and developing agonist antibodies, launched today with $128 million in financing.
  • Diagonal was co-founded by Chief Executive Officer, Alex Lugovskoy, Ph.D., and Atlas and previously seeded by Atlas, Lightspeed Venture Partners, and Velosity Capital.
  • In preclinical models of HHT, Diagonal's agonist antibodies prevent and reverse the formation of pathological vascular malformations.