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IMP-761

Generic Name
IMP-761
Clinical Trials
Related News

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'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 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.

Immutep's IMP761 Phase I Trial Advances to Dose Escalation After Demonstrating Initial Safety

• Immutep's Phase I study of IMP761, a novel LAG-3 immunotherapy, has completed the single-dose portion with no reported safety concerns, allowing progression to dose escalation. • The trial, conducted by CHDR in the Netherlands, will now evaluate single IMP761 doses ranging from 0.03 mg/kg to 0.90 mg/kg in healthy volunteers. • Subsequent phases will assess multiple ascending doses and further evaluate pharmacokinetic/pharmacodynamic (PK/PD) relationships using a KLH challenge model. • Initial safety data is expected by year-end, with PK/PD assessments anticipated in the first half of 2025, offering insights into IMP761's activity.
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