Clinical Trials
33
16 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2001
Active, not recruiting
15
45.5%
Completed
8
24.2%
Not yet recruiting
1
3.0%
Recruiting
7
21.2%
Terminated
1
3.0%
Withdrawn
1
3.0%
No approval data available
- Immutep will narrow registration-directed development of eftilagimod alfa to head and neck squamous cell carcinoma with CPS below one and neoadjuvant soft tissue sarcoma. - The pivot follows early discontinuation of TACTI-004 and a root cause analysis identifying subtle N-glycan structural differences between 200-litre and 2,000-litre efti batches. - Immutep has contracted a new 200-litre manufacturing run, the scale used for ten GMP batches in earlier successful Phase I and Phase II studies. - New studies are targeted to begin in the second half of 2027, subject to trial design, regulatory discussions, manufacturing timelines, partnering and resources.
- Immutep discontinued its pivotal Phase III TACTI-004 trial evaluating eftilagimod alfa in first-line non-small cell lung cancer after an independent interim analysis concluded the study was unlikely to meet its primary endpoints. - The trial discontinuation triggered one of the most dramatic share price reactions in the ASX biotech sector, with Immutep stock plunging around 88% and erasing the vast majority of the company's market value in a single trading session. - The global Phase III study was designed to enroll roughly 756 patients across more than 150 clinical sites in over 25 countries, testing efti in combination with chemotherapy and Keytruda. - Despite the setback, efti continues to be evaluated in other tumor types including head and neck cancer, breast cancer and soft-tissue sarcoma, with Fast Track designation from the FDA in certain settings.
- Dr Reddy's has signed an exclusive licensing agreement with Australia's Immutep worth up to $370 million to develop and distribute eftilagimod alfa, a first-in-class cancer immunotherapy. - The deal grants Dr Reddy's distribution rights for all regions except North America, Europe, Japan and Greater China, with Immutep receiving $20 million upfront and potential milestone payments up to $349.5 million. - Eftilagimod alfa is currently being tested in a Phase III trial for first-line treatment of advanced non-small cell lung cancer in combination with pembrolizumab and chemotherapy. - The partnership represents Dr Reddy's strategic diversification beyond generics into innovative cancer therapies as the company faces pricing pressures in its largest North American market.
- Immutep's AIPAC-003 Phase II trial demonstrated strong objective response rates of 41.9% and 48.5% for eftilagimod alfa combined with paclitaxel in heavily pretreated metastatic breast cancer patients. - The study successfully established 30 mg as the optimal biological dose for eftilagimod alfa, completing FDA's Project Optimus requirements for dose optimization. - Both dosing levels showed substantial immune activation with increases in biomarkers including absolute lymphocyte count and interferon-gamma, supporting the drug's mechanism of action. - The findings will inform ongoing Phase III trials, including the TACTI-004 study evaluating eftilagimod alfa with pembrolizumab and chemotherapy in first-line non-small cell lung cancer.
- Immutep received positive FDA feedback on eftilagimod alfa development for first-line treatment of head and neck squamous cell carcinoma patients with PD-L1 expression below 1. - The FDA agreed on the potential of efti combined with KEYTRUDA to address high unmet need in this patient segment, representing up to 20% of first-line HNSCC patients. - FDA outlined potential accelerated approval pathways including a randomized registrational trial or smaller single-arm study under Project FrontRunner initiative. - Current treatment options for PD-L1 CPS <1 patients are limited to chemotherapy, as anti-PD-1 therapy alone is only approved for patients with CPS >1.
- Immutep's first-in-class LAG-3 agonist antibody IMP761 demonstrated 80% inhibition of T cell infiltration at 0.9 mg/kg dose with no treatment-related adverse events in healthy participants. - The placebo-controlled Phase I study will continue with higher single ascending doses of 2.5, 7, and 14 mg/kg to evaluate the drug's potential for treating autoimmune diseases. - IMP761 targets the LAG-3 immune checkpoint to silence dysregulated memory T cells, offering a potentially more targeted approach for rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis. - Additional Phase I data are expected in the second half of 2025 from the trial being conducted at the Centre for Human Drug Research in the Netherlands.
- 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.
• 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 EFTISARC-NEO Phase II trial, evaluating eftilagimod alpha with radiotherapy and Keytruda, has completed enrollment of 40 patients with resectable soft tissue sarcoma. - Early data presented at CTOS 2024 showed the triple combination significantly increased tumor hyalinization/fibrosis compared to radiotherapy alone, suggesting improved survival. - The treatment combination demonstrated a favorable safety profile, with no grade ≥3 toxicities related to eftilagimod alpha and pembrolizumab reported. - Further data updates from the EFTISARC-NEO trial are anticipated in 2025, offering potential advancements in soft tissue sarcoma treatment strategies.
- The INSIGHT-003 trial, evaluating eftilagimod alpha (efti) with pembrolizumab and chemotherapy, has completed enrollment with approximately 50 patients. - Initial overall survival data from INSIGHT-003 showed a median OS of 32.9 months and a 24-month OS rate of 81.0% in treated patients. - The trial is being conducted across multiple sites in Germany, led by the Frankfurt Institute of Clinical Cancer Research IKF. - Further data updates from the INSIGHT-003 trial are anticipated in 2025 and beyond, offering potential advancements in NSCLC treatment.
