IMMUTEP
🇫🇷France
- Country
- 🇫🇷France
- Ownership
- -
- Established
- 2001-01-01
- Employees
- -
- Market Cap
- $363.8M
- Website
- http://www.immutep.com/
BMS's Opdualag Shows Strong Early Performance as First LAG-3 Checkpoint Inhibitor for Melanoma
• Bristol-Myers Squibb's Opdualag, the first FDA-approved LAG-3 inhibitor combination, generated $58 million in second-quarter sales following its March approval for metastatic melanoma.
• Clinical data shows Opdualag more than doubles progression-free survival compared to PD-1 monotherapy, positioning it as a potential new standard of care with anticipated EU approval in coming weeks.
• BMS expects Opdualag to reach $4 billion in peak sales across multiple cancer indications, strengthening its immuno-oncology portfolio as competitors including Merck develop rival LAG-3 inhibitors.
Novel Chemo-Immunotherapy Approach Shows Promise for Advanced HPV-Negative Head and Neck Cancer
• A Phase 2 clinical trial at UChicago Medicine demonstrated that combining nivolumab immunotherapy with chemotherapy led to tumor shrinkage in 53% of advanced HPV-negative head and neck cancer patients.
• The innovative treatment approach, which included response-adaptive chemo-radiation therapy, showed improved survival outcomes and reduced toxic side effects, particularly in patients who responded well to initial treatment.
• Higher PD-L1 expression levels were associated with better treatment responses, suggesting its potential as a biomarker for predicting treatment outcomes in this patient population.
LAG-3 Immunotherapies Market Poised for Explosive Growth with Next-Generation Therapies Advancing Across Major Markets
• The LAG-3 next-generation immunotherapies market is projected to grow from $463.6 million in 2024 to $5.5 billion by 2035, driven by increasing solid tumor cases and expanding treatment options.
• Bristol Myers Squibb's Opdualag (nivolumab/relatlimab) has established a foundation for LAG-3 therapies, with promising candidates from Merck, Regeneron, and Immutep advancing through clinical trials.
• Biomarker-driven precision medicine and strategic regulatory support are accelerating development of novel LAG-3 therapies, including monoclonal antibodies, bispecific antibodies, and soluble LAG-3 molecules.
Immutep's LAG-3 Agonist Shows Promise, Percheron and PYC Update on Neurological Disease Trials
• Immutep's IMP-761, a LAG-3 agonist, demonstrates a favorable safety profile in Phase I trials, potentially addressing autoimmune diseases like rheumatoid arthritis.
• Percheron Therapeutics anticipates Phase 2b trial results for ATL-1102 in Duchenne muscular dystrophy, a genetic condition affecting muscle protein production.
• PYC Therapeutics reports positive pre-clinical data for PYC-002, targeting the underlying cause of Phelan-McDermid syndrome, with human trials expected in 2026.
Immutep Initiates Phase III Trial of Eftilagimod Alfa for First-Line Non-Small Cell Lung Cancer
• Immutep has commenced its Phase III TACTI-004 trial to evaluate eftilagimod alfa in combination with pembrolizumab and chemotherapy for first-line metastatic non-small cell lung cancer.
• The global study will enroll approximately 750 patients across 150+ clinical sites in over 25 countries, with first patient enrollment expected in Q1 2025.
• The trial's dual primary endpoints are progression-free survival and overall survival, aiming to establish a new standard of care for patients with metastatic NSCLC.
• Regulatory approval has been granted by the Australian Therapeutic Goods Administration, with further approvals anticipated in the UK and other countries.
Aulos Bioscience Doses First Patient in Phase 2 NSCLC Trial of AU-007, Avelumab, and Aldesleukin Combination
• Aulos Bioscience has dosed the first patient in a Phase 2 trial evaluating AU-007, avelumab, and low-dose aldesleukin for non-small cell lung cancer (NSCLC).
• The trial is a collaboration with Merck KGaA and focuses on second-line treatment for PD-L1+ NSCLC patients who have progressed after first-line checkpoint inhibitor therapy.
• Preclinical data showed the combination of AU-007 with avelumab and IL-2 resulted in strong anti-cancer activity, including complete tumor eradication.
• Aulos Bioscience plans to share preliminary data from this Phase 2 cohort in the first half of 2025.
Immutep's Efti Shows Promise Across Multiple Cancer Trials; Enters Phase III for NSCLC
• Immutep's pivotal TACTI-004 trial of eftilagimod alfa (efti) in first-line non-small cell lung cancer (1L NSCLC) has received regulatory approval, marking the company's transition to Phase III.
• INSIGHT-003 trial data in 1L NSCLC demonstrates a 32.9-month median overall survival and an 81.0% 24-month overall survival rate, significantly outperforming historical controls.
• TACTI-003 trial in first-line head & neck cancer (PD-L1 CPS <1) reported at ESMO IO 2024 shows a 67% 12-month overall survival rate, exceeding historical controls.
• EFTISARC-NEO Phase II trial in soft tissue sarcoma shows a three-fold increase in tumor hyalinization, the trial's primary endpoint, compared to historical radiotherapy data.
Immutep's Eftilagimod Alpha Shows Promise in Phase II Sarcoma Trial
• Immutep's eftilagimod alpha, combined with pembrolizumab and radiotherapy, demonstrates a significant increase in tumor hyalinization in soft tissue sarcoma patients.
• Tumor hyalinization, a key predictor of overall survival, was notably increased compared to standard treatments, suggesting a potential breakthrough.
• The Phase II trial results indicate a promising new therapeutic approach for this aggressive cancer, warranting further investigation.
• The combination therapy represents a potential advancement in the treatment landscape for soft tissue sarcoma, addressing an unmet medical need.
Immutep's Phase II Sarcoma Trial Shows Promising Results
• Immutep reported encouraging Phase II trial results for its sarcoma treatment, potentially offering a new option for patients with this challenging cancer.
• The trial assessed the safety and efficacy of Immutep's drug in combination with another therapy, demonstrating a manageable safety profile.
• These findings suggest a potential advancement in sarcoma treatment, warranting further investigation in larger studies to confirm the benefits.
• The positive outcome could lead to improved outcomes for sarcoma patients, addressing a significant unmet need in oncology.
Eftilagimod Alpha Plus Pembrolizumab/Chemo Shows Survival Benefit in Advanced NSCLC
• The INSIGHT-003 trial demonstrated that adding eftilagimod alpha to pembrolizumab and chemotherapy improved overall survival in metastatic nonsquamous NSCLC patients.
• Patients treated with the combination therapy experienced a median overall survival of 32.9 months, compared to 22.0 months in historical controls.
• The 24-month overall survival rate was 81.0% with the eftilagimod alpha combination, indicating a substantial improvement in long-term survival.
• The combination therapy showed a manageable safety profile, supporting its potential as a first-line treatment option for NSCLC, especially in patients with low PD-L1 expression.
Novel HER2-Targeted Therapies Show Promise in Advanced Breast Cancer
• Trastuzumab duocarmazine significantly improves progression-free survival compared to physician's choice in pretreated HER2-positive metastatic breast cancer patients.
• Combining eribulin with trastuzumab and pertuzumab demonstrates non-inferior progression-free survival versus taxanes in first-line HER2-positive advanced breast cancer.
• Pertuzumab retreatment with trastuzumab and chemotherapy shows a significant overall survival benefit in HER2-positive locally advanced/metastatic breast cancer.
Immutep's Efti Shows Promise in Lung and Head & Neck Cancers, Advances Autoimmune Program
• Immutep's eftilagimod alfa (efti) in combination with pembrolizumab (KEYTRUDA®) receives positive FDA feedback for a Phase III trial in first-line non-small cell lung cancer (NSCLC).
• Phase IIb trial (TACTI-003) results show efti plus KEYTRUDA® demonstrates efficacy and favorable safety in first-line head and neck cancer, particularly in PD-L1 negative tumors.
• Immutep doses first participant in Phase I trial of IMP761, a novel LAG-3 agonist antibody, targeting autoimmune diseases, marking a significant milestone.
• The company's strong financial position, with A$172.3 million, extends its cash reach to the end of CY2026, supporting ongoing clinical programs.
Immutep Reports Positive FDA Feedback and Clinical Advancements in Q1 FY25
• Immutep received positive FDA feedback for its TACTI-004 Phase III trial in first-line non-small cell lung cancer, marking a crucial step in regulatory preparations.
• The TACTI-003 Phase IIb trial demonstrated a 35.5% objective response rate in PD-L1 negative head and neck cancer patients treated with efti and KEYTRUDA.
• Immutep initiated a Phase I trial of IMP761 for autoimmune diseases, with the first participant successfully dosed, signaling progress in novel LAG-3 therapies.
• With A$172.3 million in cash, Immutep is financially secure through CY2026 and has been added to the S&P ASX300 Index, enhancing market visibility.
LAG-3 Inhibitors Show Promise in Cancer Immunotherapy, Market Expected to Surge
• The LAG-3 inhibitors market is poised for substantial growth, projected to exceed USD 3 billion by 2029, driven by increasing adoption in cancer therapy.
• Opdualag, the first approved LAG-3 therapy, has demonstrated significant commercial success, generating substantial revenue and paving the way for further drug development.
• Clinical trials are actively evaluating LAG-3 inhibitors in combination with other therapies, showing potential across various cancers, autoimmune disorders, and inflammatory diseases.
• Several LAG-3 inhibitor candidates are in late-stage clinical trials, indicating a robust pipeline and growing interest from major pharmaceutical companies.
Immutep Completes Enrollment in Phase II AIPAC-003 Trial for Metastatic Breast Cancer
• Immutep has completed patient enrollment in the Phase II portion of the AIPAC-003 trial, which is evaluating eftilagimod alpha (efti) in metastatic breast cancer.
• The trial enrolled 65 patients with metastatic breast cancer who had exhausted endocrine therapy, including CDK4/6 inhibitors, across 22 sites in Europe and the US.
• The study aims to determine the optimal biological dose of efti in combination with paclitaxel, aligning with the FDA's Project Optimus initiative.
• Patients were randomized 1:1 to receive either 30mg or 90mg of efti, and further updates will be provided after data collection and analysis.
Immutep's Efti Shows Promise in Neoadjuvant Soft Tissue Sarcoma Treatment
• Immutep's EFTISARC-NEO Phase II trial evaluates eftilagimod alpha (efti) with radiotherapy and pembrolizumab in soft tissue sarcoma patients.
• Initial data from the trial shows encouraging results, with deep responses observed in the majority of the first six patients.
• The EFTISARC-NEO trial is the first to assess efti in a neoadjuvant setting, allowing for assessment of its impact on the tumor microenvironment.
• The trial is being conducted at the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw and is funded by a Polish government grant.
Immutep's INSIGHT-003 Trial Reaches Enrollment Target in First-Line NSCLC
• The INSIGHT-003 trial, evaluating eftilagimod alpha in combination with anti-PD-1 therapy and chemotherapy, has reached its enrollment target of 20 patients with 1L NSCLC.
• Initial results from the triple combination therapy showed a 72.7% objective response rate and a 90.9% disease control rate in 1L NSCLC patients.
• The study is evaluating the safety, tolerability, and initial efficacy of the triple combination in patients with previously untreated non-small cell lung cancer.
• Additional data from the INSIGHT-003 trial is expected throughout 2023, which will further guide the development of eftilagimod alpha in 1L NSCLC.
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