Date: 2017-11-13
Type of information: Licensing agreement
Compound: PASylation® technology applied to AD-114
Company: AdAlta (Australia) XL-protein (Germany)
Therapeutic area: Fibrotic diseases
Type agreement: licensing
Action mechanism:
- i-body.
- PASylation® technology is a biological alternative to PEGylation 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, thereby enabling manufacture of a fully active protein in various host organisms, including Escherichia coli.
- PAS (Proline, Alanine and/or Serine) 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.
- 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. I-bodies are 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.
Disease: fibrosis
Details:
- • On November 7, 2016, AdAlta and XL-protein announced 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.
- AdAlta has been granted a research and evaluation license to apply the PASylation technology to AD-114.
- 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.
- 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 idiopathic pulmonary fibrosis.
Financial terms:
- Financial terms have not been disclosed.
Latest news:
- • On November 13, 2017, AdAlta announced the signing of a commercial agreement with XL-protein, granting exclusive rights to deploy PASylation® technology for extended activity of AdAlta’s fibrosis therapy, AD-114, in the human body. The initial agreement concluded in November 2016 has granted Adalta a research and evaluation license to apply the PASylation technology to AD-114. The new agreement is for a commercial license, enabling AdAlta to use XL-protein’s PASylation technology in a commercial setting.
In the period between announcements, AdAlta and XL-protein have successfully developed and evaluated AD-114 in combination with PASylation technology. PASylated AD-114 has demonstrated an extended circulating half-life in the non-human primate studies completed to date and, as a result, increased the therapeutic effect of AD-114. PASylated AD-114 will enable less frequent administration of AD-114 in the clinic, thus making it ideal for treating chronic indications such as idiopathic pulmonary fibrosis.
Adalta is on track to commence the first in-human Phase 1 trial for AD-114 in the second half of 2018.
Is general: Yes
