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Integrated Phase II/III trial design incorporates feedback from the FDA and EMA and will help inform a BLA and MAA
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HR+/HER2-neg/low metastatic breast cancer (MBC) patient population has been expanded to include triple-negative breast cancer, which together account for ~78% of breast cancer cases
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Approval for study start received in US and IRB approval in Spain, with more countries to follow shortly
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First patient expected to be enrolled in early Q2 CY2023
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As a first-in-class APC activator, efti is well positioned to enhance standard-of-care chemotherapy in MBC
SYDNEY, AUSTRALIA – 14 March 2023 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announced the initiation of AIPAC-003 (Active Immunotherapy, Eftilagimod Alpha, and PAClitaxel), an integrated Phase II/III trial to evaluate eftilagimod alpha (“efti”) in combination with paclitaxel for the treatment of metastatic HER2-neg/low breast cancer (MBC). Regulatory approval has been received in the US and Institutional Review Board (IRB) approval has been received in Spain, with approvals in additional countries anticipated to follow shortly. The first patient is expected to be enrolled in early Q2 CY2023.
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