Avacta Group plc (LON:AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, has provided a business update for the 12 months ended 31 December 2020 and post-period. Preliminary results for the financial year ended 31 December 2020 are expected to be released mid-April.
Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:
“The significant progress achieved in both the Diagnostics and Therapeutics Divisions during 2020 has already enabled us to deliver major value inflection points during the first weeks of 2021.
“We are very excited by the commercial potential of our scalable, rapid coronavirus test. The recently announced clinical data strongly reflects the excellent analytical performance demonstrated in the lab and suggests that it may be, to date, the most sensitive S1 spike protein lateral flow test. We are now confidently proceeding into full clinical validation to support a CE Mark, with a potential commercial launch for professional use around the end of the first quarter of this year.
“Despite unprecedented pressures on the Diagnostics Division, we now have in place the infrastructure to support the commercial launch of this test. Importantly, we are close to completing the establishment of a complex supply chain for the scalable manufacture of the test kits and we are making timely progress in instituting a quality management system to support the required ISO13485 accreditation for medical devices.
“In line with commitments we made during the fund raise last summer, in the Therapeutics Division we expanded our in-house pre-clinical pipeline and also kept our partnered programmes moving forwards, despite the restrictions of COVID-19 safe-working.
“In December, we submitted a Clinical Trial Authorisation (CTA) to the UK’s MHRA for our lead pre|CISION™ platform drug candidate, AVA6000 Pro-doxorubicin, and I am delighted that we recently received approval from the Agency to proceed with the phase 1 study, which we expect will dose first patient around the middle of the year.
“I am very proud of the Avacta team and how they have overcome the substantial challenges presented by the pandemic and continued to progress programmes and generate significant shareholder value. I look forward to updating the market on the very exciting milestones ahead of us in due course.”
Operational Highlights
Diagnostics Division
· AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test shows excellent analytical sensitivity of 50 pg/ml of S1 spike protein with a read time of 20 minutes. As far the Group is aware, this is currently the most sensitive S1 spike lateral flow test available. On 16 February 2021, we announced the initial clinical evaluation of this test using anterior nasal swab samples (30 positive and 26 negative samples) which demonstrated a sensitivity of 96.7% for samples with an infectious viral load (PCR Ct value < 26) and a specificity of 100%.
· BAMS™ SARS-CoV-2 Antigen Test clinical evaluation underway at a UK NHS hospital site. Initial performance data are encouraging and work is continuing to refine the assay protocol for use in the clinical workflow on hospital-based MALDI-TOF instruments. On 28 January 2021 we entered a collaboration agreement with Bruker Corporation to evaluate the clinical utility and commercial potential of this test.
· On 21 December 2020 we announced a licensing agreement with Astrea Bioseparations Limited (“Astrea”) for the use of the Affimer platform in affinity purification applications; £0.5m upfront payment and an ongoing services revenue stream plus a royalty on future product sales by Astrea.
· The Group is in the process of establishing ISO13485 accreditation, a critical quality assurance system for a developer and legal manufacturer of diagnostic products and medical devices. The Group passed the first audit by the Group’s Notified Body (BSI Group) and the final audit will occur in March 2021.
· On 8 February 2021 we established a commercial partnership with Mologic 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 by the end of March 2021.
· The collaboration with Mologic also provides initial manufacturing capacity 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 million tests per month.
· Strengthened and expanded diagnostics management team with the appointment of a Product Manager, Head of Product Development and Operations Director.
Therapeutics Division
· The Group has continued to make good progress with both in-house and partnered programmes despite limitations on laboratory staffing due to COVID-safe working practices.
o On 18 February 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) approved the CTA for AVA6000 Pro-doxorubicin, the Group’s lead pre|CISION™ prodrug, for a phase 1, first-in-human, open label, dose-escalation and expansion study in patients with locally advanced or metastatic selected solid tumours.
§ The Group anticipates dosing first patients in mid-2021 subject to COVID-19 restrictions on hospital resources with first pharmacokinetics read-out possible before the year end.
o On schedule to select the next pre|CISION prodrug chemotherapy clinical development candidate from the pipeline by the end of 2021. Lead programmes include AVA3996 a FAPα activated proteasome inhibitor, AVA7500 a FAPα activated platin, and AVA7000 a FAPα activated taxane.
o 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/TGfβ receptor trap combination and AVA028, a PD-L1/IL2 bispecific.
o In-vivo studies of the lead TMAC programmes ongoing to support selection of a clinical development candidate from the pipeline: AVA04-VbP and a second undisclosed Affimer-VbP programme.
· On 18 August 2020 we announced the expansion of 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. The agreement included an undisclosed additional upfront payment, plus near-term pre-clinical milestones and longer-term clinical development milestones totalling $98.5m with additional royalties on all future Affimer XT product sales by LG Chem.
· On 7 January 2021 we announced the license agreement with Point Biopharma Inc to provide access to Avacta’s pre|CISION™ technology for the development of tumour-activated radiopharmaceuticals. The terms of the agreement include a significant, undisclosed upfront payment.
· Rapidly established a highly experienced Clinical Development Team. Appointed Neil Bell as Chief Development Officer on 11 August 2020. Additional key appointments of Head of Chemistry, Manufacturing and Controls (CMC), Head of Clinical Operations and Head of Translational Sciences will together manage an extensive outsourced network of drug development service providers.
· On 1 February 2021, AffyXell Therapeutics (“AffyXell”), the joint venture with Daewoong Pharmaceuticals (“Daewoong”), closed a series A venture capital investment of $7.3m to further develop its pipeline of next generation cell and gene therapies.
Corporate
The Group’s cash position at the 31 December 2020 was £48m slightly higher than market forecasts.
