Clinical stage biotechnology company Immutep (ASX:IMM) reports it has successfully achieved the commercial scale in manufacturing of its lead product candidate Eftilagimod (efti) Alpha.
The company which specialises in developing LAG-3 immunotherapies for cancer and autoimmune diseases says the ‘first-in-class’ soluble LAG-3 protein has been manufactured in a 2,000L run.
In preparation for late-stage clinical trials and commercial production, Immutep states it 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.
It also notes the first 2,000L manufacturing run has been performed ‘successfully’ with all predefined release criteria met.
“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”
Immutep Chief Executive Officer Marc Voight says: “Following compelling results from the TACTI-002 phase two 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 registration trials in multiple indications for our first-in-class soluble LAG-3 protein, including our ongoing randomised TACTI-003 phase two B trial in first line head and neck cancer, this represents an important step towards potential commercial production of efti.”
WuXi Biologics Chief Executive Officer Chris Chen comments: “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.”
Eftilagimod Alpha is Immutep’s soluble LAG-3 clinical stage candidate that is a ‘first-in-class’ antigen presenting cell (APC) activator for the treatment of cancer, capitalising on LAG-3’s unique characteristics to stimulate both innate and adaptive immunity.
Efti binds to and activates antigen presenting cells via MHC II molecules leading to expansion and proliferation of CD8+ (cytotoxic) T cells, CD4+ (helper) T cells, dendritic cells, NK cells, and monocytes.
The company says it also upregulates the expression of key biological molecules like CXLC10 that further boost the immune system’s ability to fight cancer.
Efti is currently under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and HER2–/HR+ metastatic breast cancer. The company states its ‘favourable’ safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and chemotherapy.
Efti has also received Fast Track Designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).
WuXi Biologics is a leading global Contract Research, Development and Manufacturing Organisation (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics from concept to commercialisation for the benefit of patients worldwide.
Immutep is a clinical-stage biotechnology company leading the development of LAG-3 related immunotherapy products for the treatment of cancer and autoimmune disease.
The company is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximise value to shareholders.
Additional LAG-3 product candidates, including antibodies for immune response modulation, are licensed to, and being developed by Immutep’s large pharmaceutical partners.