RE: AS24 Apr 2021 08:18
Nothing continued :
On 8 February 2021, we established a commercial partnership with Mologic following several months’ collaborative work to provide Avacta with a faster route to market for the lateral flow rapid antigen test by CE marking it for professional use under Mologic’s existing ISO13485 quality system. The CE mark will then be transferred to Avacta after it receives ISO13485 accreditation, which is expected in April 2021.
The collaboration with Mologic also provides initial manufacturing capacity with the benefit of a short set-up time for the lateral flow test with Global Access Diagnostics (‘GAD’), in addition to the agreements with BBI Group, Abingdon Health and others, that will provide manufacturing capabilities that can be scaled to several millions of tests per month.
On 9th March 2021, we announced a royalty bearing license agreement with Biokit, a Werfen Company, to develop and commercialise an Affimer-based in-vitro diagnostic test.
Operating highlights – Therapeutics
Established a partnered programme (‘AffyXell Therapeutics’) in South Korea with Daewoong Pharmaceutical Co. Ltd., to develop the next generation of cell and gene therapies, incorporating Affimer® proteins to enhance the immune-modulatory effects. Programme subsequently expanded to provide access to the Affimer® platform for neutralising Affimer® therapies for the treatment of seriously ill patients with COVID-19 and to also prepare to rapidly develop similar therapies for future global pandemics.
Demonstrated initial proof-of-concept for its proprietary new class of drug conjugate, ‘TMAC®’, in a pre-clinical animal model of cancer.
Expanded the existing multi-target collaboration and development agreement with LG Chem Life Sciences (‘LG Chem’) to include new programmes incorporating Avacta’s Affimer XT™ serum half-life extension system, deal worth up to $98.5 million plus royalties.
Appointment of Neil Bell as Chief Development Officer responsible for the late stage pre-clinical and early clinical development of Avacta’s pipeline of pre|CISION™ pro-drugs and Affimer®
Submitted the Clinical Trial Authorisation (CTA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for a phase I dose-escalation and expansion study of AVA6000 pro-doxorubicin, Avacta’s first pre|CISION™ FAP-activated prodrug.
On schedule to select the next pre|CISION™ prodrug chemotherapy clinical development candidate from the pipeline by the end of 2021.
Significant progress with in-house Affimer® bispecific programmes towards selection of a clinical development candidate by the end of 2021. Two new programmes initiated, building on the AVA004 PD-L1 antagonist programme: AVA027, a PD-L1/TGfß receptor trap combination, and AVA028, a PD-L1/IL2 bispecific.
Post-period highlights – Therapeutics
On 7 January 2021, we announced the licensing agreement with Point Biopharma Inc to provide access to Avacta’s pre|CISION™ technology for the development of tumour-activated