Immutep Stock Price, News & Analysis

Immutep (ASX: IMM; NASDAQ: IMMP) has completed patient enrolment in the randomised Phase II portion of the AIPAC-003 clinical trial. The trial enrolled 65 metastatic breast cancer patients who have exhausted endocrine therapy including CDK4/6 inhibitors. Patients were recruited from 22 clinical sites in Europe and the United States.

The study is designed to determine the optimal biological dose of eftilagimod alpha ('efti') in combination with paclitaxel, aligning with the FDA's Project Optimus initiative. Patients were randomised 1:1 to receive either 30mg or 90mg dosing of efti. The company will provide further updates after data collection, cleaning, and analysis.

Immutep (ASX: IMM; NASDAQ: IMMP) has received a €2,194,918 (~A$3,627,980) R&D tax incentive payment from the French Government under its Crédit d'Impôt Recherche (CIR) scheme. This cash payment is for eligible R&D activities conducted in the European Union during the 2023 calendar year. The CIR allows French companies to be reimbursed 30% of their eligible R&D expenditure.

Immutep qualifies for this incentive through its subsidiary Immutep S.A.S., which conducts research in its French laboratory. The company also qualifies for cash rebates from the Australian Federal Government's R&D tax incentive program for eligible activities in Australia. These funds will support the ongoing and planned global clinical development of eftilagimod alpha and IMP761.

Immutep (ASX: IMM; NASDAQ: IMMP) announced new data from the EFTISARC-NEO Phase II trial will be presented at the Connective Tissue Oncology Society 2024 Annual Meeting. The trial evaluates a novel triple combination of eftilagimod alpha (efti), radiotherapy, and KEYTRUDA® (pembrolizumab) for soft tissue sarcoma (STS) patients. This is the first trial to assess efti in a neoadjuvant setting, providing access to tumor tissue before and after treatment.

Initial efficacy data from May 2024 showed promising results, with most of the first six patients experiencing deep responses rarely seen in STS. STS is an orphan disease with high unmet medical need, affecting ~23,400 cases annually in Europe and an estimated 13,590 new cases in the US in 2024. The open-label study will treat up to 40 patients and is primarily funded by a Polish government grant.

Immutep (ASX: IMM; NASDAQ: IMMP) announced positive results from the TACTI-003 Phase IIb trial evaluating eftilagimod alpha (efti) in combination with KEYTRUDA® for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma. Key findings include:

1. Higher objective response rates (ORR) in patients with any PD-L1 expression (CPS ≥1): 32.8% for efti+KEYTRUDA vs 26.7% for KEYTRUDA alone.

2. Strongest outperformance in high PD-L1 expressing patients (CPS ≥20): 31.0% ORR (34.5% including post-cutoff data) vs 18.5% for KEYTRUDA alone.

3. High durability of response of 17.5 months in the combination arm.

4. Favorable safety profile with no new safety signals observed.

5. Statistically significant increase in absolute lymphocyte count, indicating efti's biological activity.

Immutep (ASX: IMM; NASDAQ: IMMP) announces a late-breaking abstract for oral presentation at the 2024 ESMO Congress in Barcelona. The presentation will detail results from the randomized TACTI-003 Phase IIb trial evaluating eftilagimod alpha (efti) in combination with pembrolizumab versus pembrolizumab alone in first-line head and neck squamous cell carcinoma patients with any PD-L1 expression (CPS >1).

The presentation, titled 'Primary Results from TACTI-003,' will be delivered by Dr. Claus Andrup Kristensen on September 15, 2024. This selection as a Proffered Paper indicates high-quality research with potential implications for clinical practice or disease understanding.

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