First 2,000L manufacturing run of its first-in-class soluble LAG-3 protein completed by WuXi Biologics
Sydney, Australia, December 8, 2022 – 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 announces the successful scale-up of the manufacturing of its lead product candidate eftilagimod alpha (“efti” or “IMP321”), a first-in-class soluble LAG-3 protein, with the completion of a 2,000L manufacturing run.
In preparation for late-stage clinical trials and commercial production, Immutep has been working with WuXi Biologics to increase the efti manufacturing process from 200L to 2,000L capacity single-use bioreactors at the manufacturing plant in Wuxi city, China. The first 2,000L manufacturing run has been performed successfully with all predefined release criteria met.
Marc Voigt, CEO of Immutep said: “Following compelling results from the TACTI-002 Phase II trial and promising initial clinical data from INSIGHT-003 recently presented at SITC 2022, we are pleased to announce this significant achievement reaching commercial scale in efti’s manufacturing by WuXi Biologics, an important long-term partner of Immutep. With potential registrational trials in multiple indications for our first-in-class soluble LAG-3 protein, including our ongoing randomised TACTI-003 Phase IIb trial in 1st line head and neck cancer, this represents an important step towards potential commercial production of efti.”
Chris Chen, CEO of WuXi Biologics stated: “We are very pleased to be moving the scale up process forward for efti with Immutep. WuXi Biologics and Immutep have been working together for many years and we are excited to continue supporting them as they advance towards potential commercialisation of efti.”
Subject to feedback from competent authorities, Immutep plans to introduce the material manufactured by the 2,000L scale process into ongoing and future Phase II/III clinical trials.