Immutep Quarterly Activities Report Q1 FY25
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 riporta notevoli progressi nel primo trimestre dell'esercizio 2025. L'azienda ha ricevuto feedback positivi dalla FDA per il trial di fase III TACTI-004 nel cancro del polmone non a piccole cellule di prima linea. Il loro trial di fase IIb TACTI-003 ha mostrato risultati promettenti con la combinazione di efti e KEYTRUDA®, raggiungendo un tasso di risposta obiettiva del 35,5% nei pazienti negativi al PD-L1. Il primo partecipante è stato trattato nel trial di Fase I di IMP761 per malattie autoimmuni. I punti salienti finanziari includono una solida posizione di cassa di 172,3 milioni di dollari australiani a settembre 2024, con un'aspettativa di liquidità fino alla fine del 2026. L'azienda è stata aggiunta all'indice S&P ASX300, segnando una crescita significativa.
Immutep informa sobre un progreso significativo en el primer trimestre del año fiscal 2025. La empresa recibió comentarios positivos de la FDA para el ensayo de fase III TACTI-004 en cáncer de pulmón no microcítico de primera línea. Su ensayo de fase IIb TACTI-003 mostró resultados prometedores con la combinación de efti y KEYTRUDA®, logrando una tasa de respuesta objetiva del 35,5% en pacientes negativos al PD-L1. El primer participante recibió tratamiento en el ensayo de fase I de IMP761 para enfermedades autoinmunes. Los aspectos destacados financieros incluyen una sólida posición de caja de 172,3 millones de dólares australianos a septiembre de 2024, con una expectativa de llegar hasta finales de 2026. La empresa fue añadida al índice S&P ASX300, marcando un crecimiento significativo.
Immutep 는 2025 회계연도 제1분기 동안 중요한 진전을 보고합니다. 이 회사는 1차 비소세포 폐암에 대한 TACTI-004 3상 시험에 대해 FDA로부터 긍정적인 피드백을 받았습니다. TACTI-003 2b상 시험에서는 efti와 KEYTRUDA®의 조합이 목과 두경부 암에서 35.5%의 객관적 반응률을 달성하는 기대 이상의 결과를 보여주었습니다. 자가면역 질환을 위한 IMP761의 1상 시험에서 첫 번째 참가자가 투약되었습니다. 재무 하이라이트에는 2024년 9월 기준으로 1억 7230만 호주 달러의 강력한 현금 보유가 포함되며, 2026년 말까지 지속될 것으로 예상됩니다. 이 회사는 S&P ASX300 지수에 추가되어 중요한 성장을 기록했습니다.
Immutep fait état d'avancées significatives au premier trimestre de l'exercice 2025. L'entreprise a reçu des retours positifs de la FDA pour l'essai de phase III TACTI-004 dans le cancer du poumon non à petites cellules en première ligne. Leur essai de phase IIb TACTI-003 a montré des résultats prometteurs avec la combinaison d'efti et de KEYTRUDA®, atteignant un taux de réponse objective de 35,5 % chez les patients négatifs au PD-L1. Le premier participant a été traité dans l'essai de phase I d'IMP761 pour les maladies auto-immunes. Les points forts financiers incluent une solide position de trésorerie de 172,3 millions de dollars australiens en septembre 2024, avec une prévision de liquidité jusqu'à la fin de 2026. L'entreprise a été ajoutée à l'indice S&P ASX300, marquant une croissance significative.
Immutep berichtet über erhebliche Fortschritte im ersten Quartal des Geschäftsjahres 2025. Das Unternehmen erhielt positives Feedback von der FDA für die TACTI-004-Studie der Phase III bei nicht-kleinzelligem Lungenkrebs in der ersten Behandlungsreihe. Ihre TACTI-003-Studie der Phase IIb zeigte vielversprechende Ergebnisse mit der Kombination von efti und KEYTRUDA®, wobei eine objektive Ansprechrate von 35,5 % bei PD-L1-negativen Patienten erreicht wurde. Der erste Teilnehmer wurde in der Phase-I-Studie zu IMP761 für Autoimmunerkrankungen behandelt. Finanzielle Highlights umfassen eine starke Liquidität von 172,3 Millionen AUD zum September 2024, mit einer erwarteten Verfügbarkeit bis Ende 2026. Das Unternehmen wurde in den S&P ASX300-Index aufgenommen, was ein signifikantes Wachstum markiert.
- Strong cash position of A$172.3 million with extended runway through CY2026
- Positive FDA feedback received for TACTI-004 Phase III trial
- TACTI-003 trial showed 35.5% objective response rate in PD-L1 negative patients
- Addition to S&P ASX300 Index enhancing market visibility
- Received €2.19M R&D tax incentive from French Government
- Increased R&D cash burn to $9.5M in Q1 compared to $3.8M in Q4 FY24
- Higher net cash outflows of $8.6M vs $7.4M in previous quarter
Insights
The quarterly report reveals a strong financial position with
Significant clinical progress across multiple fronts:
- Positive FDA feedback for TACTI-004 Phase III NSCLC trial
- Promising TACTI-003 results showing
35.5% ORR in PD-L1 negative HNSCC patients - First human dosing of IMP761 for autoimmune diseases
- Positive feedback received from US FDA regarding the planned TACTI-004 Phase III in first-line non-small cell lung cancer successfully concluding regulatory preparations for the trial design
- Efti in combination with MSD’s KEYTRUDA® reports positive efficacy and favourable safety in first-line head and neck cancer in TACTI-003 Phase IIb trial
- First participant successfully dosed in the first-in-human Phase I trial of IMP761, a novel LAG-3 agonist antibody designed to treat autoimmune diseases
- Immutep added to the S&P ASX300 Index, recognising its considerable growth and enhancing market visibility
- Immutep has a strong aggregate cash, cash equivalent and term deposit position of A
$172.3 million as at 30 September 2024 with an expected cash reach to the end of CY2026.
SYDNEY, AUSTRALIA, Oct. 29, 2024 (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 30 September 2024 (Q1 FY25).
EFTI DEVELOPMENT PROGRAM FOR CANCER
TACTI-004 (KEYNOTE-PNC91) – 1L NSCLC Phase III Clinical Collaboration with MSD
In July, Immutep received positive feedback from the US Food and Drug Administration (FDA) regarding its planned TACTI-004 Phase III trial of eftilagimod alfa (efti) in combination with KEYTRUDA® (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, and histology-based platinum doublet chemotherapy for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression.
The FDA feedback builds on previously received guidance from the Paul-Ehrlich-Institut and the Spanish Agency for Medicines and Health Products, successfully concluding the preparatory regulatory interactions for the design of this registrational trial. The study will enrol ~750 patients regardless of PD-L1 expression in order to address the entire 1L NSCLC market eligible for anti-PD-1 therapy.
TACTI-003 (KEYNOTE-C34) – Phase IIb clinical trial in 1L HNSCC
TACTI-003 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). The randomized Cohort A portion of the study is evaluating efti in combination with KEYTRUDA as compared to KEYTRUDA monotherapy in patients with PD-L1 positive (Combined Positive Score [CPS] ≥1) tumours, whereas Cohort B is evaluating efti in combination with KEYTRUDA in patients with PD-L1 negative tumours (CPS <1).
In July, Immutep reported updated positive efficacy and safety results from Cohort B of the TACTI-003 Phase IIb trial at an ESMO Virtual Plenary session. In patients with negative PD-L1 expression (CPS <1) in Cohort B, efti in combination with KEYTRUDA® achieved a
In September, further data was reported from Cohort A of the TACTI-003 trial in a late-breaking abstract and prestigious Proffered Paper oral presentation at ESMO Congress 2024. At ESMO, late-breaking abstracts are generally reserved for high-quality, new research findings from randomised phase II or phase III trials with implications for clinical practice or understanding of disease processes. Proffered Papers are oral presentations of original data of superior quality, followed by expert discussion and perspectives.
In patients with PD-L1 positive tumours (CPS ≥1), efti in combination with KEYTRUDA outperformance was largest in CPS ≥20 with
Immutep will continue to follow the maturing data from TACTI-003, with the most relevant endpoint of Overall Survival expected in 2025 and engage with regulatory authorities regarding potential paths forward.
TACTI-002 (KEYNOTE-PN798) – Phase II clinical trial in 1L NSCLC
Immutep continues to follow patients with first-line non-small cell lung cancer (1L NSCLC), in Part A of the TACTI-002 trial, where excellent median Overall Survival (mOS) rates were seen across all levels of PD-L1 expression. Immutep has previously reported final data from the other parts of the TACTI-002 trial.
AIPAC-003 – Integrated Phase II/III trial in MBC
Subsequent to quarter end, Immutep completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in October. The Phase II portion enrolled 65 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who had exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The patients have been enrolled across 22 clinical sites in Europe and the United States and have been randomised 1:1 to receive either 30mg or 90mg dosing of efti in combination with paclitaxel to determine the optimal biological dose of efti consistent with the FDA’s Project Optimus initiative. Further updates will be provided after data collection, data cleaning and analysis.
INSIGHT-003 – Phase I in non-squamous 1L NSCLC
The investigator-initiated INSIGHT-003 trial continued to enrol patients throughout the quarter and they have been safely dosed across six sites in Germany. Further updates from the trial are anticipated in Q 4 CY2024.
INSIGHT-005 – Phase I trial in Urothelial Carcinoma
The INSIGHT-005 trial is evaluating efti and the anti-PD-L1 therapy BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial cancer. The study is jointly funded with Merck KGaA, Darmstadt, Germany.
EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma
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) will be presented on 14 November at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting taking place in San Diego, California.
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE
In August, Immutep successfully dosed the first participant in the first-in human Phase I trial of IMP761 after receiving regulatory clearance from the ethics and competent authority in the Netherlands to initiate the study. Safety data from this first-in-human study is anticipated by the end of the calendar year 2024, with pharmacokinetics and pharmacodynamics data in first half CY2025.
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.
INTELLECTUAL PROPERTY
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. The assay is used in the characterisation of efti in GMP-grade manufacturing.
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.
CORPORATE & FINANCIAL SUMMARY
Immutep enters the ASX300
Following the September quarterly review of the S&P Dow Jones Indices, Immutep was added to the S&P/ASX 300 index. Joining the ASX300 recognises the Company's considerable growth over the years, enhances its market visibility and supports investor confidence.
Cash Flow Summary
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
Cash receipts from customers in Q1 FY25 were
The net cash used in G&A activities in the quarter was
The net cash used in R&D activities during the quarter was
Total net cash outflows used in operating activities in the quarter were
For the cash flow used in investing activities, the company invested
Net cash outflow from financing activities for the quarter was approximately
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
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