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IMUGENE LIMITED — Capital/Financing Update 2018
Sep 20, 2018
65124_rns_2018-09-20_f78a96ce-a59d-414e-8810-29f482015868.pdf
Capital/Financing Update
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ASX Announcement
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Imugene commences cGMP manufacture of PD-1 cancer vaccine
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Appoints cGMP peptide manufacturer AmbioPharm Inc. in South Carolina USA to supply clinical grade KEY-Vaxx PD-1 cancer vaccine
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KEY-Vaxx manufacture commenced after pilot batch successfully completed
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Protection of PD-1 B-cell cancer vaccines strengthened with filing of new patent
Sydney, Australia - 21 September 2018 – Imugene Limited (ASX:IMU) a clinical stage immuno-oncology company today announced it has formally commenced cGMP manufacture of the clinical batch of cancer vaccine KEY-Vaxx for the proposed Phase 1 PD-1 clinical trial, after successfully completing pilot studies.
The cGMP batch is part of the pre-clinical development for the proposed PD-1 Phase 1 clinical trial to be conducted in 2019.
AmbioPharm Inc. (APi), a US-based cGMP manufacturer has been appointed. APi is a full-service peptide manufacturing company headquartered in North Augusta, SC, USA.
The protection of Imugene’s global position in PD-1 B-cell cancer vaccines was also strengthened today with the filing of a new provisional patent titled “ A vaccine Composition and Uses Thereof ” (Australian Patent Office: 2018903518).
This new filing protects innovative new PD-1 vaccine candidates designed to generate an antibody immune response against PD-1, and greatly expands the number of candidates protected in the highly valued checkpoint inhibitor landscape. The patent filing augments the PD-1 method of treatment patent filed in February 2018 (Australian Patent Office: 2018900368).
Imugene’s Managing Director Leslie Chong said, “Maintaining and strengthening our already strong international intellectual property position is a key area of focus in maintaining the competitive advantage of KEY-Vaxx and any future improvements, vaccine formulations and clinical uses. We are extremely pleased with the progress made from our expert scientific team.”
KEY-Vaxx is a B-cell peptide cancer vaccine which aims to induce the body to produce polyclonal antibodies that block PD-1 signalling, and potentially produce an anticancer effect similar to Keytruda, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming treatment of a range of cancers.
IMUGENE LIMITED ACN 009 179 551 Phone +61 3 9824 5254 Fax +61 3 9822 7735 Website www.imugene.com
KEY-Vaxx has shown potential in preclinical studies. It outperformed an industrystandard mouse anti-PD-1 antibody in a mouse model of HER2+ colorectal cancer. Developed by Professor Pravin Kaumaya at the Ohio State University in Columbus OH, the immnotherapy is constructed from a single B cell epitope derived from the extracellular domain of PD-1.
For further information please contact:
Leslie Chong Managing Director and Chief Executive Officer T: 0458 040 433 Follow us on Twitter @TeamImugene
About Imugene (ASX:IMU)
Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors. Our unique platform technology seeks to harness the body’s immune system to generate antibodies against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody therapies. Our product pipeline includes multiple immunotherapy B-cell vaccine candidates aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies. We are supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets.
Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Imugene is well funded and resourced, to deliver on its commercial and clinical milestones. Together with leading specialists and medical professionals, we believe Imugene’s immuno-oncology therapies will become a foundation treatment for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market.
IMUGENE LIMITED ACN 009 179 551 Phone +61 3 9824 5254 Fax +61 3 9822 7735 Website www.imugene.com
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