Avacta Group, the biopharma business based in Wetherby and Cambridge, has partnered with Swiss life sciences company Selexis to develop a clinical candidate to human trials.
Together, the two companies will develop the Chinese hamster ovary cell line that will be used to manufacture Avacta’s first Affirmer clinical candidate for first-time-in-human clinical trials.
Avacta says this “major milestone” means its on track to submit applications for an Affirmer PD-L1 inhibitor for investigational new drug application and clinical trial approval 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.
“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,” said Alastair Smith, Avacta Group CEO.
“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.”