Avacta Group Regulatory News (AVCT)

20 June 2019

Avacta Group plc

("Avacta", the "Company" or the "Group")

Avacta and Selexis Partner to Develop Cell Line for Clinical Manufacturing

Avacta's first Affimer clinical candidate is a potent PD-L1 antagonist under development for solid tumour indications as the basis of bispecific and combination therapies

Cambridge, UK, and Geneva, Switzerland, 20 June 2019 - Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and research reagents, and Selexis, a pioneering life sciences company and global leader in mammalian cell line generation technology, have partnered to develop the Chinese hamster ovary (CHO) cell line that will be used to manufacture Avacta's first Affimer clinical candidate for first-time-in-human clinical trials. This major milestone means that Avacta remains on track to submit an IND/CTA application for an Affimer PD-L1 inhibitor by the end of 2020.

Avacta's first clinical candidate will be against PD-L1, a clinically validated immune checkpoint that plays an important role in the tumour escape mechanism in cancer. The lead molecule (AVA004) is a potent PD-L1 antagonist that has been engineered with an Fc domain for half-life extension. Avacta has demonstrated the preclinical efficacy of AVA004 in syngeneic and xenograft mouse models and it compares favourably to approved monoclonal antibodies such as Imfinzi®, Tecentriq® and Bavencio® at the doses administered.

Alastair Smith, Avacta Group Chief Executive Officer, commented:

"The strategic partnership with Selexis allows Avacta to access the technology and know-how to develop high-expressing CHO cell lines as well as the extensive experience of developing a range of Fc fusion proteins for clinical manufacturing. These cell lines are the essential basis of clinical manufacturing of AVA004 and this partnership supports Avacta's strategy to demonstrate safety and tolerability of the Affimer platform in humans with a planned IND/CTA by the end of 2020.

The ultimate aim is to combine AVA004 with other Affimer checkpoint modulators in bispecific cancer immunotherapies, and with novel chemotherapies as drug conjugates and combination therapies utilising proprietary tumour microenvironment targeting chemistry. These approaches seek to combine modulation of the adaptive immune response with stimulation of the innate immune system, with the aim of improving the clinical outcome for the sizeable proportion of solid tumour patients having "cold" tumours that do not respond to checkpoint inhibitors alone."

Marco Bocci, PhD, Dpharm, Selexis Senior Vice President, Licensing and Business Development commented:

"Our agreement with Avacta is a result of Selexis' leadership in bringing an innovative technology solution to our partners and the capability to enhance speed in drug development, including for those developing therapeutics that are beyond traditional monoclonal antibodies. It is rewarding for us to play a role as Avacta prepares to advance its first Affimer clinical candidate into the clinic."

- Ends -

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About Avacta Group plc - https://www.avacta.com

Avacta's principal focus is on its proprietary Affimer® technology which is a novel engineered alternative to antibodies that has wide application in Life Sciences for diagnostics, therapeutics and general research and development.

Antibodies dominate markets worth in excess of $100bn despite their shortcomings. Affimer technology has been designed to address many of these negative performance issues, principally; the time taken to generate new antibodies, the reliance on an animal's immune response, poor specificity in many cases, and batch to batch variability. Affimer technology is based on a small protein that can be quickly generated to bind with high specificity and affinity to a wide range of protein targets.

Avacta has a pre-clinical biotech development programme with an in-house focus on immuno-oncology as well as partnered development programmes. Avacta is commercialising non-therapeutic Affimer reagents through licensing to developers of life sciences research tools and diagnostics.

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About Selexis SA

Selexis SA, a JSR Life Sciences Company, is the global leader in cell line development with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop and commercialize innovative medicines and vaccines. Our global partners are utilizing Selexis technologies to advance more than 121 drug products in clinical development and the manufacture of five commercial products. As part of a comprehensive drug development process, the Company's technologies shorten development timelines and reduce manufacturing risks. JSR's CDMO service offering leverages the full capabilities of Selexis' proprietary SUREtechnology Platform™ to offer an end-to-end solution to the industry.

Selexis' SUREtechnology Platform is based on Selexis SGE® (Selexis Genetic Elements) - novel human DNA-based elements that control the dynamic organization of chromatin across mammalian cells. These elements increase transcription rates of transgenes by rendering the expression cassette independent of the locus of integration and thus allowing higher and more stable expression of any recombinant proteins. SUREtechnology improves the way cells are used in the discovery, development and manufacturing of recombinant proteins and immune checkpoint inhibitors.

More information is available at www.selexis.com. 

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