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Immutep Operational Update
Sydney, AUSTRALIA, May 07, 2021 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, provides an update on its clinical and preclinical programs. Eftilagimod alpha (“efti”) Update AIPAC - Phase IIb clinical trial TACTI-002 (also designated KEYNOTE-798) - Phase II clinical trial Recruitment is also ongoing for patients with 2nd line NSCLC (Part B) which was expanded under the study’ Simon’s two-stage clinical trial design. Currently, 27 patients of a total of 36 patients have received the first treatment. In 2nd line head and neck squamous cell carcinoma (HNSCC, Part C) the recruitment of patients is complete. Currently the recruitment of TACTI-002 is tracking well and new clinical data from TACTI-002 is planned to be presented at the American Society of Clinical Oncology Annual Meeting (ASCO) 2021 (4-8 June). TACTI-003 – a Phase IIb Clinical Trial in 1st line Head and Neck Cancer The study will evaluate the safety and efficacy of efti in combination with pembrolizumab, compared to pembrolizumab alone in 1st line metastatic or recurrent HNSCC patients with PD-L1 positive (CPS =1) tumors (cohort A), and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors (CPS <1) (cohort B). According to the current plans about 130 patients in cohort A will be randomized 1:1 to receive either efti plus pembrolizumab or pembrolizumab alone. Subjects in cohort B (up to 24 patients) will receive a combination of efti and pembrolizumab. The primary endpoint of the study is the Overall Response Rate (ORR) according to RECIST 1.1. and iRECIST will be used for treatment decisions. Secondary endpoints include OS and Progression Free Survival (PFS). Following the grant of Fast Track designation for efti to treat 1st line HNSCC patients by the US FDA in early April 2021 and the appointment of a Contract Research Organisation (CRO), Immutep is on track to start the study in mid-2021. INSIGHT-004 - Phase I clinical trial IMP761 Update The Company has completed the selection of a high-producing CHO cell line for its IMP761 IgG4 mAb and is in the process of selecting a contract manufacturing organization (CMO) for GMP manufacturing of its preclinical candidate IMP761. Financial Update Immutep continues to be in a robust financial position with a cash runway into calendar year 2023, beyond the expected timing for several significant data read-outs from its trials. About Immutep Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC) activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Additional LAG-3 products, including antibodies for immune response modulation, are being developed by Immutep’s large pharmaceutical partners. Further information can be found on the Company’s website www.immutep.com or by contacting: Australian Investors/Media: U.S. Media:
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