IMP761 / Immutep - LARVOL DELTA

Immutep Receives A$4.6 million R&D Tax Incentive from French Government (Immutep Limited Press Release) - "Immutep qualifies for the CIR tax incentive through its subsidiary Immutep S.A.S. due to the research and development conducted in its laboratory in France. The cash payment is provided in respect of expenditure incurred on eligible R&D activities conducted in the European Union in the 2024 calendar year....The funds will be used to support the ongoing and planned global clinical development of eftilagimod alfa and IMP761."

Commercial • Immunology • Oncology

The Israel and New Zealand Patent Office each granted a new patent protecting Immutep’s intellectual property for a binding assay for determining MHC Class II binding activity of LAG-3 protein used in characterisation of efti in GMP-grade manufacturing (The Manila Times) - "A new patent was also granted for IMP761 in New Zealand."

Patent • Immunology

IMP761 - Phase I Trial (The Manila Times) - "...additional data from the Phase I study is expected to follow in Q4 CY2025."

P1 data • Immunology

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE (GlobeNewswire) - "Immutep is progressing with the ongoing Phase I trial of its autoimmune candidate IMP761....Immutep is continuing with single ascending dose levels of 2.5, 7 and 14 mg/kg. Additional data from the Phase I is expected to follow later in CY 2025."

P1 data • Immunology

A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy Volunteers (clinicaltrials.gov) - P1 | N=79 | Recruiting | Sponsor: Immutep S.A.S. | N=49 ➔ 79 | Trial completion date: Aug 2025 ➔ Apr 2026 | Trial primary completion date: Aug 2025 ➔ Apr 2026

Enrollment change • Trial completion date • Trial primary completion date

Immutep Announces Positive Update from Phase I Study of IMP761, a First-in-Class LAG-3 Agonist Antibody for Autoimmune Diseases (GlobeNewswire) - P1 | N=49 | NCT06637865 | Sponsor: Immutep S.A.S. | "Immutep Limited...announces positive initial efficacy data and continued favourable safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases. Through the highest dosing level to date (0.9 mg/kg of IMP761), there have been no treatment-related adverse events in healthy participants. Additionally, pharmacodynamic data at this dosing level show that the inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge has already reached 80%. Given the encouraging efficacy and safety, Immutep is continuing with single ascending dose levels of 2.5, 7 and 14 mg/kg....Additional data from the Phase I to follow in second half of CY2025."

P1 data • Rheumatoid Arthritis

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE (GlobeNewswire) - "Immutep is progressing with the ongoing Phase I trial of its autoimmune candidate IMP761. IMP761 is a first-in-class agonist LAG-3 antibody designed to restore balance to the immune system by enhancing the 'brake' function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases. Following previously reported favourable initial safety data in December 2024, additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships are expected to be reported in CY2025."

P1 data • PK/PD data • Immunology

Immutep Quarterly Activities Report Q2 FY25 (GlobeNewswire) - "During the quarter, Immutep continued to advance its clinical trial programs for efti and for IMP761. The Company is well funded with a strong cash, cash equivalent and term deposit balance as at 31 December 2024 of approximately A$159.26 million in total, which gives Immutep an expected cash reach to the end of CY2026. The A$159.26 million total balance consists of: a cash and cash equivalent balance of A$73.89 million and; bank term deposits totalling A$85.37 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months."

Commercial • HER2 Negative Breast Cancer • Lung Non-Squamous Non-Small Cell Cancer • Soft Tissue Sarcoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Immutep Announces Initial Safety Data from First-in-Human Phase I Trial Evaluating IMP761 (GlobeNewswire) - "Immutep Limited...today announces favourable initial safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761. Through the first three of five single ascending dose cohorts in healthy participants, there have been no treatment related adverse events....The trial in up to 49 participants is being conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands. In addition to the safety analysis, CHDR is implementing its keyhole limpet haemocyanin (KLH) challenge model to evaluate IMP761’s pharmacological activity. Additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships to follow in the first half of CY2025."

P1 data • Immunology • Inflammatory Bowel Disease • Multiple Sclerosis • Rheumatoid Arthritis

Immutep Quarterly Activities Report Q1 FY25 (GlobeNewswire) - "During the quarter, Immutep continued to advance its clinical trial programs for efti and preclinical program for IMP761 to create value for shareholders. The Company is well funded with a strong cash and cash equivalent balance as at 30 September 2024 of approximately A$120.3 million. In addition to this cash balance, Immutep has an A$52.0 million bank term deposit, which has been recognised as a short-term investment due to the maturity date of 5-12 months. This aggregate position of A$172.3 million as at 30 September 2024 gives Immutep an expected cash reach to the end of CY2026."

Commercial • Immunology • Non Small Cell Lung Cancer • Soft Tissue Sarcoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

INTELLECTUAL PROPERTY (GlobeNewswire) - "During the quarter, Immutep was granted seven new patents for efti, IMP761 and LAG525 (ieramilimab) in various territories...Two patents were granted for efti in combination with a PD-1 pathway inhibitor in South Korea and Brazil and one patent was granted in Mexico for a binding assay for determining MHC Class II binding activity...New patents were also granted for IMP761 in India and Israel. For LAG525, which is exclusively licensed to Novartis by Immutep, two new patents were granted in Australia and Taiwan."

Patent • Breast Cancer • Colorectal Cancer • Inflammatory Bowel Disease • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Ovarian Cancer • Prostate Cancer • Rheumatoid Arthritis

Immutep Announces First-in-Human Phase I Study of IMP761 Progresses to Dose Escalation Portion of Trial (GlobeNewswire) - "Immutep Limited...announces that the first part (Part A, single dose) of the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761 has been fully recruited and the drug has been administered with no safety issues....Immutep anticipates the first safety data from the trial to be available before year end with assessment of PK/PD relationships to follow in the first half of CY2025."

Enrollment status • P1 data • Immunology

A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy Volunteers (clinicaltrials.gov) - P1 | N=49 | Recruiting | Sponsor: Immutep S.A.S.

New P1 trial

Immutep Receives A$3.6 million R&D Tax Incentive from French Government (Immutep Limited Press Release) - "Immutep Limited...is pleased to announce it has received a €2,194,918 (~ A$3,627,980 ) research and development (R&D) tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme (CIR). The 'Crédit d’Impôt Recherche' (CIR), meaning 'Research Tax Credit', is a French government tax incentive by which French companies conducting research and development activities in Europe can be reimbursed 30% of their eligible expenditure....The funds will be used to support the ongoing and planned global clinical development of eftilagimod alpha and IMP761."

Commercial • Oncology

Immutep Announces First Participant Dosed in Phase I Study of IMP761, a First in Class Agonist LAG-3 Antibody (GlobeNewswire) - "Immutep Limited...announces that the first participant has been successfully dosed in the first-in-human Phase I trial of IMP761....Immutep anticipates the first safety data from the Phase I study to be available before end of the year with assessment of PK/PD relationships to follow in the first half of CY2025."

P1 data • Trial status • Immunology

Immutep Receives Regulatory Clearance for Phase I Study of First-in-Class LAG-3 Agonist Antibody Designed to Treat Autoimmune Diseases (GlobeNewswire) - "Immutep Limited...announces it has received regulatory clearance from the ethics and competent authority in the Netherlands to initiate the first-in-human Phase I study of IMP761....Immutep anticipates that CHDR will enrol first participants into the Phase I study during Q3 of CY2024 with first data being available before end of the year."

New P1 trial • Immunology

Immutep Appoints Leading Research Institute to Conduct First-in-Human Phase I Study of IMP76 (Immutep Limited Press Release) - "Immutep Limited...announces it has entered into an agreement with the Centre for Human Drug Research (CHDR), a world-class institute in Leiden, the Netherlands specializing in cutting-edge early-stage clinical drug research, to perform a first-in-human clinical study of IMP761....Subject to the relevant ethic and regulatory approvals, the single and multiple ascending dose, placebo-controlled, double-blind, Phase I study will enrol approximately 49 healthy volunteers, with the objective of assessing safety, pharmacokinetics (PK) and pharmacodynamics (PD)....Trial expected to begin mid-CY2024."

Licensing / partnership • New P1 trial • Immunology

Immutep Receives A$2.6 million R&D Tax Incentive from French Government (Immutep Limited Press Release) - "Immutep Limited...is pleased to announce it has received a €1,595,475 (~ A$2,628,354 ) research and development (R&D) tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme (CIR)....The cash payment is provided in respect of expenditure incurred on eligible R&D activities conducted in the European Union in the 2022 calendar year. Immutep also qualifies for cash rebates from the Australian Federal Government’s R&D tax incentive program in respect of expenditure incurred on eligible R&D activities conducted in Australia....The funds will be used to support the ongoing and planned global clinical development of eftilagimod alpha and the preclinical development of IMP761."

Commercial • Oncology

Immutep completes AUD 80 million capital raise (PharmiWeb) - "Immutep Limited...announces the successful completion of an AUD 80 million capital raise to support its late-stage and expanding clinical development pipeline. With this new capital, Immutep believes it is fully funded for its current and expanded clinical program through to Q1 CY2026 with a pro-forma cash balance of AUD 135.2 million (USD 90.6 million)....'These funds will help us further our mission to unlock the power of the immune system to fight cancer and autoimmune disease, including advancing eftilagimod alpha into a new registrational Phase III trial in lung cancer, and supporting its late-stage trials in head and neck cancer and metastatic and triple-negative breast cancer, to final data and Phase II read-outs, respectively. We’ll also be able to expand eftilagimod alpha into new settings and potentially conduct a first-in-human Phase I trial for IMP761, the world’s first and only LAG-3 agonist, for autoimmune diseases...]"

Financing • Breast Cancer • Head and Neck Cancer • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Lung Cancer • Multiple Sclerosis • Non Small Cell Lung Cancer • Oncology • Rheumatoid Arthritis • Rheumatology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer

Immutep Granted United States Patent for IMP761, a First-in-Class Agonist Antibody Targeting LAG-3 (Immutep Limited Press Release) - "Immutep Limited...announced the grant of a new patent (number 11,680,104) by the United States Patent Office. The granted claims are composition-of-matter type claims covering Immutep’s pre-clinical immunosuppressive product candidate IMP761....The patent is owned by Immutep S.A.S. and will expire on 22 February 2037 (including 174 days of patent term adjustment). This new United States patent follows the grant of the equivalent Japanese and European patents announced in July 2022 and October 2020, respectively. A divisional application has also been filed to pursue claims drawn to methods of treating T-cell mediated immune disorders, such as inflammatory or autoimmune diseases, by administration of IMP761."

Patent • Immunology • Inflammation • Inflammatory Arthritis • Rheumatology

Immutep Selects Charles River Laboratories for IMP761’s GLP Toxicology Study (GlobeNewswire) - "Immutep Limited...announces it has entered into an agreement with Charles River under which Charles River will conduct a GLP toxicology study for IMP761, Immutep's proprietary preclinical candidate for autoimmune diseases. IMP761 is a first-in-class LAG-3 agonist antibody that aims to address the underlying cause of many autoimmune diseases, namely the overactivation of self-antigen-specific memory T cells expressing LAG-3. Preclinical toxicology studies are an essential part of drug development as they help to evaluate the potential safety and toxicity of a drug candidate before it is tested in humans."

Licensing / partnership • Immunology • Inflammatory Bowel Disease

"Not sure what it means...but The bottom of the announcement also says "DJ Immutep: Achievement Allows IND-enabling Studies in 1H'2023 and Subsequent Clinical Testing of IMP761 to Address Root Cause of Autoimmune Diseases >IMMP Tuesday, December 06, 2022 01:08:53 PM (GMT)"" (@Rukul2GP)

Clinical • Immunology

Immutep Receives A$2.7 million R&D Tax Incentive from French Government (GlobeNewswire) - "Immutep Limited...is pleased to announce it has received a €1,804,341 (~ A$2,693,046 ) research and development (R&D) tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme (CIR)....The funds will be used to support the ongoing and planned global clinical development of eftilagimod alpha and the preclinical development of IMP761."

Commercial • Immunology • Inflammatory Bowel Disease

Immutep Quarterly Activities Report (GlobeNewswire) - "CYTLIMIC has been conducting studies of CYT001...Using artificial intelligence from the HSP70 and GPC-3 proteins, plus two adjuvants, efti and Hiltonol. Based on a comprehensive business evaluation, CYTLIMIC has determined to dissolve the company and to transfer its own patents and licensing rights to NEC accordingly....The net cash used in Research and Development activities in the quarter was $7.62 million, compared to $8.13 million in Q3 FY22. The lower cash outflows in Q4 FY22 were mainly due to the decrease of efti and IMP761 contract manufacturing payments. The cash outflow for clinical trial activities increased compared with Q3 FY 22 and were in line with increased activity in TACTI-003. Total net cash outflows used in operating activities in the quarter was $9.28 million compared to $10.95 million in Q3 FY22."

Financing • Patent • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Immutep Quarterly Activities Report (GlobeNewswire) - "Immutep Limited...provides an update on the ongoing development of its product candidates...IMP761 for the quarter ended 30 June 2022 (Q4 FY22)....Preclinical development steps are continuing for IMP761, prior to advancing the candidate into clinical trials. This includes development of a GMP-compliant manufacturing process for IMP761. The GMP manufacturing at 200 litre scale is ongoing. IMP761 is Immutep’s immunosuppressive agonist antibody to LAG-3 which will be tested to treat the causes of autoimmune disease, such as inflammatory bowel disease, rheumatoid arthritis, and multiple sclerosis, rather than merely treating the symptoms."

Commercial • Preclinical • Immunology • Inflammatory Bowel Disease • Multiple Sclerosis • Rheumatoid Arthritis • Rheumatology