GSK2831781 / Immutep - LARVOL DELTA

Immutep Quarterly Activities Report Q3 FY24 (GlobeNewswire) - "Further updates from AIPAC-003 will be provided in CY2024....As detailed in Immutep’s half year report in February 2024, Immutep received from GSK a written notice of termination of its exclusive License and Research Collaboration Agreement with GSK entered into in 2010 for the development of GSK2831781, a LAG-3 depleting antibody derived from Immutep’s IMP731 antibody, targeting autoimmune disease, with an effective termination date of 30 May 2024. The Company expects no material impact on the financial statements due to the termination."

Licensing / partnership • P2/3 data • Breast Cancer • Oncology • Solid Tumor

A randomised, double-blind, placebo-controlled study of the LAG-3-depleting monoclonal antibody GSK2831781 in patients with active ulcerative colitis. (PubMed, Aliment Pharmacol Ther) - P2 | "Despite evidence of target cell depletion in blood, GSK2831781 failed to reduce inflammation in the colonic mucosa suggesting no pharmacological effect. The study was terminated early (NCT03893565)."

Journal • Gastroenterology • Gastrointestinal Disorder • Immune Modulation • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • LAG3

Randomized Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2831781 in Healthy Japanese and White Participants. (PubMed, Clin Pharmacol Drug Dev) - "Following IV and SC administration, GSK2831781 depleted circulating LAG3 T cells with no interethnic difference observed. There were no major impacts on circulating regulatory T cells."

Journal • PK/PD data • CD4 • FOXP3 • IL2RA • IL7R

Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis (clinicaltrials.gov) - P2; N=104; Terminated; Sponsor: GlaxoSmithKline; N=61 ➔ 104; Active, not recruiting ➔ Terminated; The trial was stopped based on the assessment of clinical data as part of a planned interim analysis

Clinical • Enrollment change • Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis (clinicaltrials.gov) - P1; N=63; Not yet recruiting; Sponsor: GlaxoSmithKline

Clinical • New P1 trial • Dermatology • Immunology • Psoriasis • CXCL8 • IFNG • IL6 • LAG3 • TNFA

A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis (clinicaltrials.gov) - P1; N=18; Completed; Sponsor: GlaxoSmithKline; Active, not recruiting ➔ Completed; N=67 ➔ 18

Clinical • Enrollment change • Trial completion • Dermatology • Immunology • Psoriasis • CXCL8 • IFNG • IL6 • LAG3 • TNFA

A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis (clinicaltrials.gov) - P1; N=67; Recruiting; Sponsor: GlaxoSmithKline; Trial primary completion date: Mar 2018 ➔ Jun 2018

Clinical • Trial primary completion date • Dermatology • Immunology • Psoriasis • CXCL8 • IFNG • IL6 • LAG3 • TNFA

A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis (clinicaltrials.gov) - P1; N=67; Active, not recruiting; Sponsor: GlaxoSmithKline; Recruiting ➔ Active, not recruiting; Trial primary completion date: Aug 2018 ➔ Mar 2018

Clinical • Enrollment closed • Trial primary completion date • Dermatology • Immunology • Psoriasis • CXCL8 • IFNG • IL6 • LAG3 • TNFA

A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: GlaxoSmithKline; N=32 ➔ 64

Clinical • Enrollment change • Dermatology • Immunology • Psoriasis • CXCL8 • IFNG • IL6 • LAG3 • TNFA

A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: GlaxoSmithKline; Trial primary completion date: May 2017 ➔ Feb 2018

Clinical • Trial primary completion date • Dermatology • Immunology • Psoriasis • CXCL8 • IFNG • IL6 • LAG3 • TNFA

A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis (clinicaltrials.gov) - P1; N=63; Recruiting; Sponsor: GlaxoSmithKline; Not yet recruiting ➔ Recruiting; Trial primary completion date: Aug 2016 ➔ May 2017

Clinical • Enrollment open • Trial primary completion date • Dermatology • Immunology • Psoriasis • CXCL8 • IFNG • IL6 • LAG3 • TNFA

Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis (clinicaltrials.gov) - P2; N=61; Active, not recruiting; Sponsor: GlaxoSmithKline; N=242 ➔ 61; Trial completion date: May 2023 ➔ May 2021; Trial primary completion date: Jul 2022 ➔ May 2021

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis (clinicaltrials.gov) - P2; N=242; Active, not recruiting; Sponsor: GlaxoSmithKline; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

"$IMMP Ulcerative Colitis Phase II Study of GSK2831781 Discontinued https://t.co/CmFooZE9kq" (@otcdynamics)

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Ulcerative Colitis Phase II Study of GSK2831781 Discontinued (GlobeNewswire) - "Immutep Limited...advises that one of its licensing partners, GSK, has discontinued its Phase II clinical trial evaluating an anti-LAG3 cell depleting monoclonal antibody, GSK2831781 (derived from Immutep’s IMP731 antibody), in patients with active ulcerative colitis....The trial was stopped by GSK based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial’s Data Review Committee."

Trial termination • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Depletion of LAG-3 T Cells Translated to Pharmacology and Improvement in Psoriasis Disease Activity: A Phase I Randomized Study of mAb GSK2831781. (PubMed, Clin Pharmacol Ther) - P1 | "Psoriasis disease activity improved up to day 43 at all GSK2831781 doses (0.5, 1.5 and 5 mg/kg) compared with placebo. Depletion of LAG-3-expressing activated T cells is a novel approach, and this first clinical study shows that GSK2831781 is pharmacologically active and provides encouraging early evidence of clinical effects in psoriasis, which warrants further investigation in T-cell-mediated inflammatory diseases."

Clinical • Journal • P1 data • Dermatology • Immunology • Inflammation • Psoriasis • CD8 • CDH1 • IL17A • LAG3

GSK2831781: Regulatory submission for psoriasis between 2021-2025 (Immutep) - Corporate Presentation

Regulatory • Immunology • Psoriasis

GSK2831781: Proof-of-concept data from P1 trial (NCT03965533) for psoriasis in H2 2020 (Immutep) - NWR Virtual Small Cap Health Conference

P1 data • Immunology • Psoriasis

GSK2831781: Expiry of patents related to composition-of-matter and methods of treatment in 2036 (Immutep) - Investor Presentation

Patent • Immunology • Psoriasis

Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2831781 After an Intravenous (IV) Dose in Healthy Japanese and Caucasian Subjects, and a Subcutaneous (SC) Dose in Healthy Caucasian Subjects (clinicaltrials.gov) - P1; N=37; Completed; Sponsor: GlaxoSmithKline; Active, not recruiting ➔ Completed

Clinical • Trial completion

Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis (clinicaltrials.gov) - P2; N=280; Recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Apr 2022 ➔ Mar 2023

Clinical • Trial completion date

Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2831781 After an Intravenous (IV) Dose in Healthy Japanese and Caucasian Subjects, and a Subcutaneous (SC) Dose in Healthy Caucasian Subjects (clinicaltrials.gov) - P1; N=36; Active, not recruiting; Sponsor: GlaxoSmithKline; Recruiting ➔ Active, not recruiting

Enrollment closed

Immutep to Receive £4M Milestone Payment From GSK (GlobeNewswire, Immutep Limited) - "Immutep Limited...announces that it will receive a milestone payment from GSK of £4 million (~US$5.02 million) related to the first patient being dosed in GSK’s Phase II clinical trial evaluating GSK2831781 in ulcerative colitis. GSK2831781 is derived from Immutep’s IMP731 antibody, a depleting anti-LAG antibody technology that was exclusively licensed to GSK. About IMP731 and GSK2831781."

Clinical

"@Immutep will receive a £4m (~A$7.39m/US$5.02m) milestone payment from its partner, @GSK Eligible to receive up to £64m (~A$118m) in payments plus royalties, if GSK2831781 (from $IMM's IMP731) is commercialised. ASX: https://t.co/2gOYRnBEOZ #biotechnology" (@Immutep)

Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2831781 After an Intravenous (IV) Dose in Healthy Japanese and Caucasian Subjects, and a Subcutaneous (SC) Dose in Healthy Caucasian Subjects (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: GlaxoSmithKline; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open