Full Press Release Details
Immutep Advances IMP761 Manufacturing
SYDNEY, AUSTRALIA 16 December 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or
the Company ), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, is pleased to announce it has signed a Manufacturing Service
Agreement (MSA) with Northway Biotech, an end-to-end biopharmaceutical contract development and manufacturing organisation (CDMO), to manufacture IMP761 ahead of
IMP761, Immutep s preclinical candidate for autoimmune diseases is an immunosuppressive agonist antibody to LAG-3. It has now been tested in a Th1-driven autoimmune disease setting, oligoarticular juvenile idiopathic arthritis, as a proof of concept which has been published in the
peer-reviewed Pediatric Journal in Oct 2021.1
Northway Biotech is a European specialist
manufacturer of recombinant proteins and monoclonal antibodies, with manufacturing sites in Lithuania and the United States. Under the agreement, Northway has already started developing a GMP-compliant
manufacturing process of IMP761 and will manufacture IMP761 in large scale bioreactors. The process is based on a pharmaceutical-grade, stable GS knockout CHO K1 cell line system that has been shown to produce product yields of IMP761 in small scale
setup. The work is undertaken at Northway s Vilnius, Lithuania facility with the potential to expand the agreement to include further process scale up and cover commercial supply in the future.
After completion of the required preclinical development, the material produced will be used for Immutep s clinical trials of IMP761. Planning for
further pre-clinical and clinical development is ongoing.
Commenting on the agreement, Marc Voigt said:
We are very excited to be partnering with Northway Biotech to develop a GMP manufacturing process for IMP761. As a targeted immunosuppressive antibody, IMP761 has the potential to address the root cause of autoimmune diseases by specifically
silencing the autoimmune memory T cells accumulating at the disease site, known to express LAG-3. We are very pleased to be moving IMP761 towards clinical trials.
Vladas Algirdas Bumelis, CEO of Northway Biotech said: We have a long and successful history of developing processes to facilitate
efficient and scalable production for new and promising products. Our team in Vilnius is looking forward to applying their world-class skills and
state-of-the-art equipment to develop a manufacturing process including GMP manufacturing for Immutep s IMP761.
Andr Markmann, VP Business Development of Northway Biotech, added: We are proud to be selected by Immutep as CDMO to support
Immutep s fight against autoimmune diseases which impair so many patients globally.
Level 33, Australia Square
264 George Street, Sydney NSW 2000
IMP761 is Immutep s preclinical autoimmune product candidate. It is an immunosuppressive agonist antibody to
LAG-3. Immutep reported encouraging preclinical results from its in vivo studies of IMP761 in early 2019, showing it decreases inflammatory T cell infiltration induced by intra-dermal injection of an
antigen. As a targeted immunosuppressive antibody, IMP761 has the potential to address the root cause of autoimmune diseases by specifically silencing the autoimmune memory T cells accumulating at the disease site which express LAG-3 as an exhaustion marker after being repeatedly stimulated with dominant self-peptides at the disease site. These findings were published in the Journal of Immunology in January 2020.
About Northway Biotech
Northway Biotech is a leading
contract development and manufacturing organisation (CDMO) supporting customers worldwide. Its highly experienced, professional team executes projects at any stage, from cell line construction and process development to cGMP manufacturing of
biopharmaceutical products. The company s wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its
state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development and
commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and located in Vilnius, Lithuania, London, United Kingdom, and in Waltham, MA, US.
Further information can be found on Northway s website www.northwaybiotech.com or by contacting:
Vladas Algirdas Bumelis, Ph.D.
CEO, Executive Chairman of
BoD & Advisory Board
Immutep is a globally active biotechnology
company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to
bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.
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:
Catherine Strong, Citadel-MAGNUS
Level 33, Australia Square
264 George Street, Sydney NSW 2000
Tim McCarthy, LifeSci Advisors
915.2564; tim@lifesciadvisors.com
This announcement was authorised for release by the Board of Immutep Limited.
Level 33, Australia Square
264 George Street, Sydney NSW 2000