Pharmacodynamics

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

Retrieved on: 
Thursday, April 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: 
Thursday, April 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

Alumis Announces Late-Breaker Psoriasis Phase 2 Data Presentation for Allosteric TYK2 Inhibitor ESK-001 at the American Academy of Dermatology 2024 Annual Meeting

Retrieved on: 
Monday, March 4, 2024
SAN, Dermatology, High, Safety, AAD, Patient, Pharmacodynamics, Phase 1, American Academy, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Alumis Inc., a clinical stage biopharmaceutical company developing oral therapies using a precision approach to transform the lives of patients with immune-mediated diseases, today announced two clinical data presentations at the American Academy of Dermatology Annual Meeting taking place March 8-12, 2024, in San Diego, CA.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Alumis Inc., a clinical stage biopharmaceutical company developing oral therapies using a precision approach to transform the lives of patients with immune-mediated diseases, today announced two clinical data presentations at the American Academy of Dermatology Annual Meeting taking place March 8-12, 2024, in San Diego, CA.
  • Details regarding the presentations are as follows:
    Title: Efficacy and Safety of ESK-001, a Highly Selective Oral TYK2 Inhibitor, in a Phase 2 Study in
    Title: Pharmacokinetic and Pharmacodynamic Characteristics of ESK-001, an Oral Allosteric TYK2 Inhibitor, in Phase 1 Healthy Volunteer Trials
    Alumis will also host a virtual investor event to review the ESK-001 Phase 2 clinical data being presented at AAD on March 9 at 5:00 p.m. PT.
  • To access the live webcast, please register by visiting the Events page on the Alumis website.

Adicet Bio Highlights ADI-001 Expansion, Persistence and Pharmacodynamic Profile from Ongoing Phase 1 Study at the 65th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Sunday, December 10, 2023
Research, FDA, Clinical Trials, Stem Cells, Biotechnology, Health, Pharmaceutical, Science, Oncology, Cytokine, PST, ASH, AUC, ACET, PD, Stem cell factor, Patient, CD19, Tmax, Allele, HLA, Cancer, Cmax, NHL, Pharmacodynamics, Investigator's brochure, Pharmaceutical industry, Vaccine, Medical imaging, Generic drug, Persistence

The data will be provided during a poster presentation at the ASH Annual Meeting on Sunday, December 10, 2023.

Key Points: 
  • The data will be provided during a poster presentation at the ASH Annual Meeting on Sunday, December 10, 2023.
  • “Historically, expansion and persistence of cell therapy products and release of functional cytokines have correlated with patient outcomes.
  • We remain on track to provide a clinical update from the Phase 1 study in NHL patients in the second half of 2024."
  • Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
    Date/Time: Sunday, December 10, 2023, from 6:00 - 8:00 p.m. PST

Astria Therapeutics Reports Third Quarter Financial Results and Provides a Corporate Update

Retrieved on: 
Monday, November 13, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Webcast, Interest, Plasma kallikrein, Safety, D, Therapy, First Nations Summit, IND, Investment, PD, Experiment, Patient, Allergy, Journal, Atopic dermatitis, Hereditary angioedema, Investigational New Drug, HAE, Half-life, YTE, OX40, Pharmacodynamics, ACAAI, Pharmaceutical industry, Cryptocurrency, Asteria, Pharmacology

Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for rare and niche allergic and immunological diseases, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for rare and niche allergic and immunological diseases, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.
  • We now expect to deliver initial proof-of-concept results in Q1 2024 from the Phase 1b/2 ALPHA-STAR trial in HAE patients.
  • STAR-0215 achieved potentially therapeutic levels in less than one day and showed an estimated half-life of up to 127 days.
  • Additional preclinical results were shared in the Journal of Pharmacology and Experimental Therapeutics that support STAR-0215’s potential as a best-in-class plasma kallikrein inhibitor.

Astria Therapeutics Presents New Phase 1a Data Confirming Potential for STAR-0125 to Prevent Hereditary Angioedema Attacks with Dosing 2 or 4 Times Per Year at the 2023 American College of Allergy, Asthma, and Immunology Annual Scientific Meeting

Retrieved on: 
Friday, November 10, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Plasma kallikrein, Therapy, University, Asthma, PD, Patient, Allergy, American College, Internal medicine, Hereditary angioedema, HAE, Half-life, Pharmacodynamics, ACAAI, Pharmaceutical industry

These data confirm the potential for STAR-0215 to be dosed once every three months and every six months.

Key Points: 
  • These data confirm the potential for STAR-0215 to be dosed once every three months and every six months.
  • “These new data, including long-term follow-up from the original cohorts and initial data from new, higher dose cohorts, support our vision for STAR-0215 as a first-choice therapy for HAE.
  • These data confirm our approach to administer STAR-0215 once every three and every six months in future trials.
  • These results demonstrate early proof-of-concept in healthy subjects for STAR-0215 as a potential HAE therapy with favorable safety profile, long half-life, and durable PD.

Medicenna Announces Promising Single-Agent Response and Durability of MDNA11 in the Phase 1/2 ABILITY Study During Dose Escalation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

Retrieved on: 
Monday, November 6, 2023
Hypertelorism, PD, VLS, Trae tha Truth, BCC, MSI-H, MDNA, MCC, Poster, Pharmacodynamics, SITC, Immunotherapy, Radiation, SD, RDE, PK, DLT, Safety, Society, CSCC, PDAC, Patient, Combination therapy, Toxicity, TSX, LFT, Nevus, Medical imaging, Pharmaceutical industry, Vaccine

MDNA11 with uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors.

Key Points: 
  • MDNA11 with uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors.
  • Following return from a 7 week vacation, a single new lesion was observed and MDNA11 treatment was resumed.
  • Monotherapy expansion part of ABILITY-1 is enrolling patients with metastatic melanoma, non-melanoma skin cancers (CSCC, MCC, and BCC) and MSI-H/dMMR tumors.
  • A copy of the poster and a related slide deck have been posted to the “ Events and Presentations ” page of Medicenna’s website.

Synthekine Presents Preclinical Data at SITC 38th Annual Meeting Demonstrating its IL-12 Partial Agonist, STK-026, Significantly Expands Therapeutic Window

Retrieved on: 
Friday, November 3, 2023
Oncology, Health, Hospitals, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Pharmacology, Inc., T helper cell, Society for Immunotherapy of Cancer, Poster, Pharmacodynamics, SITC, Immunotherapy, IL-12, NK, Biology, Neoplasm, The Boy in the Bubble (novel), Annual general meeting, Toxicity, CRS, Society, Pharmaceutical industry, Vaccine, Cancer

Synthekine Inc ., an engineered cytokine therapeutics company, today presented new data from preclinical studies of STK-026, its biased IL-12 partial agonist program, during the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego.

Key Points: 
  • Synthekine Inc ., an engineered cytokine therapeutics company, today presented new data from preclinical studies of STK-026, its biased IL-12 partial agonist program, during the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego.
  • STK-026 is designed to retain the potent antitumor activity of IL-12 while avoiding its systemic toxicities and is currently in IND-enabling studies.
  • Notably, compared to wild-type IL-12 treatment, STK-026 monotherapy demonstrated a substantial improvement in therapeutic window which was associated with reduced NK activation and systemic cytokine induction.
  • The poster will be available on Synthekine’s website following presentation at the meeting.

Adicet Bio Announces Poster Presentation Highlighting ADI-001 Data at the 65th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
Oncology, Health, Clinical Trials, Research, Science, Biotechnology, ASH, Pharmacodynamics, ACET, Patient, Cancer, PDT, Bio, American Society for Investigative Pathology, Society, Pharmaceutical industry

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today announced the acceptance of a poster presentation at the upcoming 65th American Society of Hematology (ASH) Annual Meeting to be held in San Diego, CA from December 9-12, 2023.

Key Points: 
  • Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today announced the acceptance of a poster presentation at the upcoming 65th American Society of Hematology (ASH) Annual Meeting to be held in San Diego, CA from December 9-12, 2023.
  • Details of the poster presentation are as follows:
    Title: Expansion, Persistence and Pharmacodynamic Profile of ADI-001, a First-in-Class Allogeneic CD20-Targeted CAR Gamma Delta T Cell Therapy, in Patients with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma
    Session Name: 704.
  • Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
    Date/Time: Sunday, December 10, 2023, from 6:00 - 8:00 p.m. PDT

Bolt Biotherapeutics Presents Updated Clinical Data from Phase 1 Dose-Escalation Trial of BDC-1001 as Monotherapy and in Combination with Nivolumab in HER2-Expressing Tumors at ESMO 2023 Congress

Retrieved on: 
Monday, October 23, 2023
CR, Memorial Sloan Kettering Cancer Center, PRS, Trastuzumab, Plasma, Cholangiocarcinoma, Aes, ESMO, ISAC, MPH, Nivolumab, Publication, HER2, Congress, LVEF, Salivary gland tumour, European Society for Medical Oncology, MSK, Phenotype, Pharmacodynamics, Bolt, Oncology, SDS, Cancer, Therapy, Patient, Breast, Toxicity, ASCO, TLR, Pharmaceutical industry, Vaccine

BDC-1001 comprises a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to a proprietary TLR7/8 agonist.

Key Points: 
  • BDC-1001 comprises a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to a proprietary TLR7/8 agonist.
  • The Phase 1 dose-escalation trial enrolled 131 patients with 16 different HER2-expressing solid tumor types across 18 dose levels in two arms, monotherapy and in combination with nivolumab.
  • The response rate at the RP2D was 29% in evaluable patients with HER2-positive tumors, both in monotherapy (2/7, 29%) and in combination with nivolumab (2/7, 29%).
  • Additionally, a copy of the presentation is available on the Publications page of the Bolt Therapeutics website.