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Immutep Limited has been granted a new patent (number 11,680,104) by the United States Patent Office for its pre-clinical immunosuppressive product candidate IMP761, a first-in-class agonist LAG-3 antibody targeting autoimmune diseases.
The patent, owned by Immutep S.A.S., expires on 22 February 2037 and follows equivalent Japanese and European patent grants in July 2022 and October 2020, respectively.
Immutep has advanced IMP761 towards potential first-in-human clinical testing, including developing a 200L GMP-compliant manufacturing process and selecting Charles River Laboratories for a GLP toxicology study.
Immutep announces publication of new data from TACTI-002 Phase II Trial evaluating eftilagimod alpha plus pembrolizumab for 2nd line metastatic head and neck squamous cell carcinoma, showing deep and durable responses across all PD-L1 subgroups.
The overall patient population achieved a strong response rate of 29.7% and a 12-month overall survival rate of 46.0%, while patients with a PD-L1 Combined Positive Score of ≥20 had a response rate of 60% and a 12-month overall survival rate of 66.7%.
The treatment was safe, well-tolerated, and displayed no new safety signals, with more mature and final data to be presented at the ASCO 2023 Annual Meeting.
Immutep announces promising new clinical data from INSIGHT-003, a Phase I trial evaluating efti in conjunction with standard-of-care anti-PD-1 therapy and doublet chemotherapy in 1st line non-small cell lung cancer patients.
The triple combination therapy showed a 67% overall response rate and 91% disease control rate, with 81% of patients having low or negative PD-L1 expression.
Immutep is uniquely positioned to address a large portion of the non-small cell lung cancer patient population, potentially covering both chemo-free IO-IO approaches and IO-IO-chemo combinations.
Eftilagimod alpha (efti) combined with pembrolizumab achieves initial median Overall Survival of 25 months in 1st line non-small cell lung cancer patients with >1% PD-L1 expression in Phase II TACTI-002 trial.
Data Monitoring Committee recommends extending overall survival follow-up collection to show mature 3-year and potentially 5-year survival rates.
More mature Overall Survival data and additional efficacy and safety results to be presented at a major medical conference in H2 CY 2023.
Immutep receives regulatory approval from PEI to initiate INSIGHT-005, a Phase I trial evaluating eftilagimod alpha and BAVENCIO® in metastatic urothelial cancer.
The trial will focus on an area of high unmet need, targeting patients not eligible for platinum-based chemotherapy or those progressing after such treatment.
Immutep hopes to build on positive clinical data from previous trials of eftilagimod alpha and avelumab, potentially bringing a new chemo-free treatment option to patients with advanced urothelial cancer.
Immutep announces positive final data for efti plus pembrolizumab in treating 2nd line metastatic NSCLC patients refractory to anti-PD-(L)1 therapy at ELCC 2023.
The combination demonstrated a median Overall Survival (mOS) of 9.9 months and a 39% OS rate at 21 months, better than standard-of-care chemotherapy.
Eftilagimod alpha in combination with pembrolizumab was well tolerated and showed potential for further clinical investigation to help refractory 2nd line NSCLC patients revert resistance to anti-PD-X therapy.
Immutep Limited (ASX: IMM; NASDAQ: IMMP) has enrolled and randomised over 50% of the planned 154 patients in the TACTI -003 Phase IIb trial.
TACTI -003 is evaluating Immutep’s first-in-class soluble LAG-3 protein eftilagimod alpha (“efti”) in combination with MSD’s anti-PD-1 therapy KEYTRUDA® as 1st line treatment of recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC).
Marc Voigt, CEO of Immutep stated: “We are pleased to reach this important milestone and extend our sincere appreciation to our investigators, clinical team, partners, and patients for their hard work and commitment to this study.”