REVIEW OF OPERATIONS AND ACTIVITIES (CONTINUED)
Efti Manufacturing
During the financial year 2020, Immutep commenced some of the steps towards upscaling the manufacturing process of efti from 200L to 2,000L single-use bioreactors at the WuXi Biologics manufacturing plant (Wuxi, China). This work program prepares for potential commercial manufacturing and additional registration trials in multiple indications. It is planned to recommence as Immutep advances its clinical development program for efti.
Separately, Immutep’s partner in China, EOC Pharma, has also started upscaling manufacturing to 2,000L.
IMP761 – preclinical development
IMP761 is an immunosuppressive agonist antibody to LAG-3. It is the first agonist antibody that targets the immune checkpoint LAG-3 for the treatment of autoimmune diseases, such as inflammatory bowel diseases, rheumatoid arthritis, and multiple sclerosis.
Immutep continued cell line development and the manufacturing steps for IMP761 during the financial year. The Company’s manufacturing partner for IMP761, Batavia Biosciences, made significant progress in the cell line development, delivering a pharmaceutical-grade, stable CHO cell line that produces sufficient yields for the clinical development of IMP761. The program is now working on the completion of cell line development.
IMP761 preclinical research results were published in the peer reviewed Journal of Immunology during the financial year.
Clinical Development by Immutep’s Partners
Novartis – IMP701 – Phase II
Novartis is Immutep’s partner for the development of LAG525, which is a humanised LAG-3 antagonist antibody derived from its IMP701 antibody.
In total, Novartis has five clinical trials ongoing for LAG525 in multiple cancer indications, including a Phase II clinical trial in triple negative breast cancer. Across the five trials, LAG525 will be evaluated in a total of more than 1,000 patients, significantly enhancing the value of this product candidate.
GlaxoSmithKline (GSK) – IMP731 – Phase I
GSK is Immutep’s partner for GSK2831781, which is derived from the Company’s IMP731 antibody.
GSK is conducting a Phase II clinical study evaluating GSK2831781 in 242 ulcerative colitis patients. The first patient being dosed September 2019 prompted a milestone payment of GBP4m (AU$7.4m). The study is expected to be fully completed in August 2022 with clinical proof of concept expected in the first half of calendar year 2021.
GSK also completed a Phase I study in 36 healthy Japanese and Caucasian volunteers in December 2019.
CYTLIMIC – Phase I
Immutep continued to collaborate with CYTLIMIC to prepare for clinical trials evaluating efti as part of a cancer peptide vaccine, called CYT001, in patients with advanced or metastatic solid cancer. The cancer vaccine is comprised of the combination immunotherapy of a HSP70 derived peptide, a GPC3 derived peptide, Immutep’s IMP321 (efti) and Hiltonol.
CYTLIMIC reported positive results from its YNP01 Phase I clinical trial of CYT001 in early 2020, showing that approximately 70% of patients showed an immune response to each peptide. The results were published in the scientific peer-reviewed journal, Cancer Immunology, Immunotherapy.
In addition, in June 2020 interim results from a second Phase I study of CYT001, called YCP02, showed that tumour cell death and infiltration of T cells into tumour regions was observed in 6 out of 9 patients.
CYTLIMIC is also collaborating with Chiba University in Japan to start a new Phase I trial of CYT001, called CRESCENT1.
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