Immutep Limited American Depositary Shares - IMMP STOCK NEWS

Immutep has announced the successful dosing of the first participant in the Phase I clinical trial of IMP761, a first-in-class agonist LAG-3 antibody.

This trial aims to restore immune system balance by enhancing the LAG-3 brake function to address autoimmune diseases. Conducted by the Centre for Human Drug Research (CHDR) in Leiden, Netherlands, the study plans to enroll 49 healthy volunteers. The trial will assess safety, pharmacokinetics, and pharmacodynamics of IMP761 with initial safety data expected by year-end and further data by the first half of CY2025.

Preclinical studies have shown IMP761 to significantly reduce inflammatory cytokines and suppress antigen-specific T cell–mediated immune responses. The trial targets conditions like rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis.

Immutep (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotech company focused on LAG-3 immunotherapies for cancer and autoimmune diseases, has announced its participation in two upcoming investor conferences. The company will present at the Canaccord Genuity 44th Annual Growth Conference in Boston on August 14, 2024, and the Baird 2024 Global Healthcare Conference in New York on September 10, 2024.

At the Canaccord event, Immutep's presentation is scheduled for 8:30-8:55 AM ET, while at the Baird conference, it will present from 1:25-1:55 PM ET. A live webcast and replay of the Canaccord presentation will be available on Immutep's website and through a provided link.

Immutep (ASX: IMM; NASDAQ: IMMP) reported significant developments in Q4 FY24:

Key highlights:

• Entered a pivotal Phase III trial collaboration with MSD for eftilagimod alfa in 1L NSCLC
• Reported positive results from TACTI-003 Phase IIb trial in 1L HNSCC
• Presented encouraging data from AIPAC-003 and EFTISARC-NEO trials
• Signed an exclusive license with Cardiff University for oral LAG-3 therapy
• Completed A$100.2 million equity financing

Immutep's cash position totaled A$181.8 million, extending runway to end of 2026. The company continues to advance its clinical programs for efti in various cancer indications and IMP761 for autoimmune diseases.

Immutep (NASDAQ: IMMP) has successfully concluded regulatory preparations for its TACTI-004 Phase III trial design, following positive feedback from the FDA. The trial will evaluate eftilagimod alfa (efti) in combination with KEYTRUDA® (pembrolizumab) and standard chemotherapy for first-line metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression.

Key points:

• Trial will enroll ~750 patients
• Targets entire 1L NSCLC market eligible for anti-PD-1 therapy
• Based on positive data from TACTI-002 Phase II and INSIGHT-003 trials
• Dual primary endpoints: progression-free and overall survival
• 1:1 randomized, double-blind, multinational, controlled design
• Includes both squamous and non-squamous NSCLC subtypes

Immutep (ASX: IMM; NASDAQ: IMMP) has received regulatory clearance in the Netherlands to initiate a Phase I study of IMP761, the world's first therapeutic LAG-3 agonist antibody for autoimmune diseases. The study, expected to enroll 49 healthy volunteers starting Q3 CY2024, will assess safety, pharmacokinetics, and pharmacodynamics.

IMP761 aims to restore immune system balance by enhancing LAG-3's 'brake' function to silence self-antigen-specific memory T cells, which cause many autoimmune diseases. The antibody has shown promise in preclinical studies for suppressing T cell-mediated immune responses and reducing inflammatory cytokines.

The trial, conducted by the Centre for Human Drug Research in Leiden, will use a unique KLH challenge model to evaluate IMP761's pharmacological activity. First data is anticipated before the end of 2024.

Immutep has announced positive results from Cohort B of their TACTI-003 Phase IIb trial, which evaluates the combination of eftilagimod alfa (efti) and KEYTRUDA® (pembrolizumab) as a first-line treatment for head and neck squamous cell carcinoma (HNSCC) patients with negative PD-L1 expression. The combination achieved a 35.5% response rate and a 58.1% disease control rate, significantly higher than historical controls for anti-PD-1 monotherapy.

Additionally, the combination showed a high complete response rate of 9.7%, with over 50% of patients receiving treatment for at least six months. No new safety signals were observed, making the treatment favorable in terms of safety.

Immutep will discuss the path forward with regulatory agencies based on these promising results. The company has received FDA Fast Track designation for efti in 1L HNSCC regardless of PD-L1 expression.

A webcast to discuss the clinical data will be held on July 12, 2024, at 9am AEST.

Immutep, a biotechnology company specializing in LAG-3 immunotherapies for cancer and autoimmune diseases, will present new clinical data at the European Society for Medical Oncology (ESMO) Virtual Plenary session on July 11, 2024. The presentation will feature results from the TACTI-003 Phase IIb trial, focusing on Cohort B with negative PD-L1 expression in first-line head and neck squamous cell carcinoma patients. Dr. Robert Metcalf from The Christie NHS Foundation Trust will present the data, which shows a substantially improved overall response rate. Additionally, Immutep will host a webcast to discuss these clinical results on July 12, 2024, at 9am AEST.

Immutep has signed an exclusive License Agreement with Cardiff University to develop and commercialize anti-LAG-3 small molecules for cancer treatment. Under this collaboration, several promising compounds have been identified that block LAG-3, a key immune checkpoint. These small molecules could offer a more convenient and cost-effective oral treatment for cancer patients compared to existing monoclonal and bi-specific antibodies. The agreement builds on a relationship that began in 2019 and includes upfront and milestone payments, as well as royalties on future sales.

Immutep has announced the successful completion of its institutional placement and the institutional component of its 1 for 16 pro rata accelerated non-renounceable entitlement offer, raising approximately A$89.6 million. The offer price was A$0.38 per new share, and it saw strong support from institutional investors, achieving a 100% take-up rate. The total expected to be raised by the offer is A$100.2 million, including the upcoming retail entitlement offer set to open on June 7, 2024. New shares are expected to be issued and commence trading by mid-June 2024. The funds raised will support Immutep's late-stage clinical programs in lung, breast, and head and neck cancers.