Immutep Limited American Depositary Shares - IMMP STOCK NEWS

Immutep announced positive data from EFTISARC-NEO, a Phase II trial evaluating eftilagimod alpha (efti) combined with radiotherapy and KEYTRUDA® in soft tissue sarcoma (STS) patients. The preliminary analysis of 21 patients showed the triple combination achieved a three-fold increase in tumor hyalinization/fibrosis (median 50%) compared to standard radiotherapy's historical 15%. 71.4% of patients achieved pathologic response (≥35% hyalinization/fibrosis) and 9.5% achieved complete pathologic response. The treatment demonstrated safety with no grade ≥3 toxicities related to efti and pembrolizumab. The study aims to enroll 40 patients by Q1 2025.

Immutep reports significant progress in Q1 FY25. The company received positive FDA feedback for TACTI-004 Phase III trial in first-line non-small cell lung cancer. Their TACTI-003 Phase IIb trial showed promising results with efti and KEYTRUDA® combination in head and neck cancer, achieving 35.5% objective response rate in PD-L1 negative patients. The first participant was dosed in Phase I trial of IMP761 for autoimmune diseases. Financial highlights include strong cash position of A$172.3 million as of September 2024, with expected reach until end of CY2026. The company was added to the S&P ASX300 Index, marking significant growth.

Immutep (NASDAQ: IMMP) announces upcoming presentation of new Phase IIb data from TACTI-003 trial's Cohort B at ESMO Immuno-Oncology Congress 2024. The study focuses on first-line recurrent/metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression (CPS <1), evaluating the combination of eftilagimod alpha and pembrolizumab. Dr. Martin Forster from UCL Cancer Institute will present the findings on December 12, 2024, in Geneva, Switzerland. The abstract will be available on December 5, with the complete poster released on Immutep's website after the presentation.

Immutep (ASX: IMM; NASDAQ: IMMP) has announced progress in its first-in-human Phase I study of IMP761, a novel LAG-3 immunotherapy for autoimmune diseases. The study, conducted at the Centre for Human Drug Research in Leiden, Netherlands, has completed Part A (single dose) with no safety issues. It has now advanced to Part B, the dose escalation phase, where single dosing will increase from 0.03 mg/kg to 0.90 mg/kg.

The trial will assess both safety and pharmacokinetic/pharmacodynamic (PK/PD) modeling in 30 healthy volunteers. Pending safety clearance, it will proceed to Part C, involving multiple ascending doses in 14 subjects. The study incorporates a unique keyhole limpet haemocyanin (KLH) challenge model to evaluate IMP761's pharmacodynamic activity early in clinical development.

Immutep expects to release initial safety data before the end of the year, with PK/PD relationship assessments following in the first half of 2025.

Immutep (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company focused on developing LAG-3 immunotherapies for cancer and autoimmune diseases, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. The company's CEO, Marc Voigt, will engage in a fireside chat on Wednesday, October 16, 2024, at 9:30 am ET.

The event will be streamed live on M-Vest, and interested parties can reserve their seats through a provided link. This participation underscores Immutep's commitment to engaging with the investment community and sharing insights about their innovative immunotherapy research and development efforts.

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.