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.”