Immutep Quarterly Activities Report Q2 FY25
Rhea-AI Summary
Immutep (ASX: IMM; NASDAQ: IMMP) reported significant progress in Q2 FY25, marking its transition to a Phase III biotech company. Key highlights include:
The company's TACTI-004 Phase III trial in first-line non-small cell lung cancer received its first regulatory approval. Mature data from INSIGHT-003 showed impressive results with 32.9-month median overall survival and 81.0% 24-month OS rate. The TACTI-003 trial in head & neck cancer demonstrated promising outcomes with 67% 12-month OS rate.
The Phase II soft tissue sarcoma trial showed a three-fold increase in tumor hyalinization compared to historical data. The company's IMP761 Phase I trial reported favorable initial safety results.
Financially, Immutep maintains a strong position with A$159.26 million in cash, cash equivalents, and term deposits, providing an expected cash reach until the end of CY2026. The quarter saw increased R&D spending of A$16.2 million, primarily due to the Phase III trial commencement.
Positive
- Transition to Phase III company with TACTI-004 trial approval
- Exceptional INSIGHT-003 trial results with 32.9-month median overall survival
- Strong cash position of A$159.26M with runway through end of 2026
- Triple improvement in tumor hyalinization in Phase II sarcoma trial
- Favorable safety results from IMP761 Phase I trial
Negative
- Increased R&D cash burn to A$16.2M from A$9.5M in previous quarter
- Higher total net cash outflows of A$19.0M vs A$8.6M in Q1
- Departure of Chief Medical Officer announced for April 2025
News Market Reaction – IMMP
On the day this news was published, IMMP gained 0.97%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Media Release
- Marking Immutep’s transition to a Phase III biotech, the Company’s pivotal TACTI-004 trial in first-line non-small cell lung cancer (1L NSCLC) received first regulatory approval
- Mature data from INSIGHT-003 in 1L NSCLC demonstrates an excellent 32.9-month median overall survival (OS) and
81.0% 24-month OS rate, significantly outperforming historical controls - Promising new results in first line head & neck cancer with PD-L1 CPS <1 reported at ESMO IO 2024, with median OS not reached and
67% 12-month OS rate well above historical controls - Phase II in soft tissue sarcoma shows three-fold increase in tumour hyalinization (trial’s primary endpoint, also associated with survival) compared to historical data from radiotherapy
- Phase I trial of IMP761 reported favourable initial safety results advancing the first-in-class agonist LAG-3 antibody program
- Publication in Science Immunology by Monash University & Immutep first to resolve how human LAG-3 binds to MHC II and show crystal structure human LAG-3/MHC II complex
- Strong aggregate cash, cash equivalent and term deposit position of A
$159.26 million , providing Immutep with an expected cash reach to the end of CY2026
SYDNEY, AUSTRALIA, Jan. 31, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, provides an update on its activities for the quarter ended 31 December 2024 (Q2 FY25).
EFTI DEVELOPMENT PROGRAM FOR CANCER
TACTI-004 – Start of Phase III Trial in 1L NSCLC
In December 2024, Immutep initiated its pivotal TACTI-004 Phase III clinical trial of eftilagimod alfa (“efti”) for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC). The receipt of regulatory approval from the Australian Therapeutic Goods Administration means that Immutep has transitioned into a Phase III company; a significant milestone for the Company.
Immutep has successfully completed regulatory submissions in the vast majority of the more than 25 countries that will be part of the global TACTI-004 trial. Additional approvals from multiple countries are expected in the weeks and months ahead. The Company expects to enrol the first patient in Q1 of CY2025.
TACTI-003 (KEYNOTE-C34) – Phase IIb Trial in 1L HNSCC
In December 2024, Immutep reported further positive results from Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. Cohort B is evaluating efti in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with PD-L1 negative tumours (CPS <1) who typically do not respond well to anti-PD-1 therapy alone. The results were presented by Martin Forster, M.D., Ph.D., at the ESMO Immuno-Oncology (IO) Annual Congress 2024.
Adding to the high response rates and favourable safety data previously reported in July 2024, the new data showed that, encouragingly, median overall survival (OS) has not yet been reached and the 12-month OS rate is
AIPAC-003 – Phase II/III Trial in Metastatic Breast Cancer
In October 2024, Immutep completed patient enrolment in the Phase II portion of the AIPAC-003 trial. The randomised Phase II portion of the trial enrolled 65 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30mg or 90mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative and prior regulatory interaction with FDA. Data cleaning and analysis is ongoing.
INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC
In November 2024, first overall survival results were reported from the investigator-initiated INSIGHT-003 trial evaluating efti in combination with KEYTRUDA® (pembrolizumab) and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC).
Mature data from patients with a minimum follow-up of 22 months (N=21) demonstrated results significantly exceeding historical controls and expectations. Data included a median OS of 32.9 months, median PFS of 12.7 months, and a 24-month OS rate of
Subsequent to quarter end, patient enrolment was completed for INSIGHT-003 in January 2025. The trial reached its enrolment target of approximately 50 evaluable patients across multiple clinical sites in Germany led by the Frankfurt Institute of Clinical Cancer Research IKF. Additional data updates are expected in 2025 and beyond.
EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma
Also in November, new data from the EFTISARC-NEO Phase II investigator-initiated trial of efti in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma (STS) were presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting.
Based on preliminary analysis, the triple combination therapy demonstrates significant efficacy in the neoadjuvant setting for resectable STS. The combination achieved a greater than three-fold increase in tumour hyalinization/fibrosis (median
The EFTISARC-NEO trial, with a data cut-off of 20 October 2024, also showed
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE
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.
In December 2024, Immutep reported favourable initial safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761. There have been no treatment related adverse events in the first three of five single ascending dose cohorts in healthy participants. Additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships to follow in the first half of CY2025.
PARTNER ACTIVITY
Collaboration with Monash University
In December 2024, new findings that resolve how human lymphocyte activation gene 3 (LAG-3) binds to its main ligand MHC Class II (MHC-II), also known as HLA Class II (HLA-II) in humans, were published in Science Immunology. The work by Monash University and Immutep, is also the first to show the crystal structure of a human LAG-3/MHC-II complex and provides a better foundation for development of blocking LAG-3 therapeutics, including Immutep’s anti-LAG-3 small molecule program.
INTELLECTUAL PROPERTY
During the quarter, Immutep was granted three new patents for efti and IMP761 in various territories. In particular, Immutep was granted a new patent for efti in combination with a PD-1 pathway inhibitor for the treatment of infection from the Brazilian Patent Office and a new patent for the same combination for the treatment of cancer or infection by the Japan Patent Office. In addition, a new patent was granted for IMP761 by the Malaysian Patent Office.
CORPORATE & FINANCIAL SUMMARY
Board & Senior Management Changes
Independent Non-Executive Director, Anne Anderson, tendered her resignation from the role, effective from 4 October 2024. The Board thanked her for her contribution to Immutep and wished her every success with her next endeavours.
As Immutep’s efti program has advanced into Phase III development, the Company has continued to grow and evolve its team. As part of this, Christian Mueller, who has been with Immutep for over eight years, most recently as SVP Regulatory and Strategy has been promoted to Chief Development Officer. In addition, Dr Florian Vogl, Immutep’s Chief Medical Officer will depart the Company in April 2025. The Company’s current Medical Affairs Advisor, who has been working in different roles closely with Immutep for over nine years, Dr Stephan Winckels, has been appointed acting CMO and taken over all related responsibilities.
Cash Flow Summary
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
In Q2 FY25, cash receipts from customers were A
The net cash used in R&D activities during the quarter was A
Total net cash outflows used in operating activities in the quarter were A
Total cash flow used in investing activities for the quarter was A
About Immutep
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
Australian Investors/Media:
Catherine Strong, Sodali & Co
+61 (0)406 759 268; catherine.strong@sodali.com
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ
What are the key results from Immutep's INSIGHT-003 trial for NSCLC (IMMP)?
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