6. November 2016

AdAlta and XL-protein announce collaboration to develop a long

acting version of its lead fibrosis drug candidate AD-114 using
PASylation® Technology
MELBOURNE, Australia and FREISING, Germany, 7 November 2016: AdAlta Ltd (ASX:
1AD), the biotechnology company advancing its lead i-body candidate towards clinical
development, and XL-protein GmbH, a privately owned German biopharmaceutical company
specialized in the design of biobetters with extended half-life, announced today that they have
entered into a collaboration on the development and commercialization of a long acting form of
AD-114, a novel first-in-class drug candidate for fibrosis therapy.
Under this collaboration agreement, XL-protein will apply its proprietary PASylation® technology
to AD-114 to extend its circulation half-life and, thus, duration of therapeutic action. AD-114 is
AdAlta’s lead i-body drug candidate being developed for the treatment of idiopathic pulmonary
fibrosis (IPF) and a variety of other fibrotic and inflammatory diseases. In preclinical studies of
IPF, the initial indication for AD-114, the i-body has shown both anti-fibrotic activity as well as
anti-inflammatory activity, which are important for the treatment and prevention of this disease.
A long-acting form of AD-114 that has a significantly extended plasma half-life would allow less
frequent administration and lower dosing, making it ideal for treating chronic indications such as
IPF.
XL-protein’s PASylation® technology offers a biological alternative to PEGylation, an established
chemistry procedure that is used to modify and tailor residence time of protein drugs in blood
plasma.
The PASylation® technology utilizes genetic engineering to fuse a polymer of natural amino
acids (Proline, Alanine and/or Serine) with a protein-based therapeutic such as AD-114, thereby
enabling manufacture of a fully active protein in various host organisms, including the laboratory
bacterium Escherichia coli. The PASylation® approach not only provides a tunable plasma halflife
that is related to the length of the PAS polymer but also offers traceless metabolization.
“XL-protein is providing a smart, biological approach to enable precise modifications to AD-114
that are designed to prolong its circulation time in the body and therefore window of activity. We
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are excited to be working with the XL-protein team as we aim to progress AD-114 towards the
clinic by early 2018” said Sam Cobb, CEO of AdAlta.
“We are pleased to report that preliminary data from pilot studies in animal models look
promising as this shows that the plasma half-life of AD-114 has been dramatically extended. In
terms of manufacturing, this modification is easily incorporated into AD-114, allowing facile
scale-up and downstream purification” commented Claus Schalper, CEO of XL-protein.
Financial terms have not been disclosed.
About AdAlta LImited
AdAlta Limited (ASX:1AD) is an Australian based drug development company headquartered in
Melbourne. The Company is focused on using its proprietary technology platform to generate ibodies,
a new class of protein therapeutics, with applications as therapeutic drugs to treat
diseases.
AdAlta is developing its lead i-body candidate, AD-114, for the treatment of idiopathic pulmonary
fibrosis (IPF) and other human fibrotic diseases, for which current therapies are sub-optimal and
there is a high-unmet medical need. AD-114 has strong pre-clinical results for IPF,
demonstrating both anti-fibrotic and anti-inflammatory activity in human lung tissue and
indicating greater efficacy than existing approved IPF drugs.
The i-body is a human analogue of the antigen binding domain of the shark antibody, which
combines the advantages of monoclonal antibodies (high target specificity and affinity) with the
beneficial stability features of small molecules. In addition to stability, the i-body has a long
binding loop that is a feature of shark antibodies not present in either human or next generation
antibodies. This feature enables the i-body to recognise and bind to a diverse range of different
therapeutically-relevant drug targets, including those that are difficult/intractable to access by
current antibody therapies. These include clinically important targets such as G-protein coupled
receptors (GPCRs) and ion channels.
The Company also plans to continue further drug discovery and development directed towards
other drug targets and diseases with its i-body technology platform.
Further information can be found at: www.adalta.com.au
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About XL-protein GmbH
XL-protein is a German biotech company commercializing the ground-breaking PASylation®
technology, which enables the design of biopharmaceuticals with extended plasma half-life and
enhanced action. With its strong proprietary technology position XL-protein focuses at the
preclinical as well as clinical development of PASylated proteins and peptides in various disease
areas. The company is enganged in several biological drug programs with renowned pharma
partners.
Further information can be found at: www.xl-protein.com
About PASylation®
Rapid kidney clearance is a drawback of most therapeutic proteins and peptides.
Conformationally disordered polypeptide chains with large hydrodynamic volume made of the Lamino
acids Pro, Ala, and/or Ser (PAS) provide an alternative to chemical conjugation with PEG
in order to extend the plasma half-life of biologics. PAS sequences are hydrophilic, uncharged
biological polymers with PEG-like biophysical properties. In contrast, beside chemical coupling
PAS polypeptides offer simple fusion to a biological drug at the genetic level as well as
biodegradability, thus preventing tissue accumulation. PASylation has been successfully applied
to a series of biopharmaceuticals, including interferon, leptin, exendin, coagulation factors,
lipocalins and Fab fragments, yielding several drug candidates currently on the route towards
clinical study.

Kontakt:

XL-protein GmbH
Claus Schalper, CEO
Tel: +49 8161 53730 90
Email: bd@xl-protein.com

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